Zaltrap ea lithethefatsi: litaelo tsa tšebeliso

Khoebo lebitso la lithethefatsi: Zaltrap

Lebitso le sa Tšoaneleheng Kantle ho Naha: Aflibercept

Foromo ea boholo: tharollo ea infusion tsepamisa mohopolo

Lintho tse sebetsang: entlibercept

Sehlopha sa Pharmacotherapeutic: moemeli oa antitumor

Sebopeho sa pharmacological:

Lithethefatsi tsa antitumor. Aflibercept ke protheine e kopantsoeng ea fusion e nang le VEGF (endothelial vascular grow factor) e tlamang likarolo tsa libaka tsa extracellular tsa VEGF 1 receptor le VEGF 2 receptor tse amanang le sebaka sa Fc (sekhechana sa sekhahla se llang) sa motho immunoglobulin G1 (IgG1). Aflibercept e hlahisoa ho sebelisoa theknoloji ea DNA e kopantsoeng e sebelisa mokhoa oa Chinese hamster ovary cell expression system (CHO) K-1. Aflibercept ke glycoprotein ea Chimeric e nang le boima ba molek'hule ea 97 kDa, glycosylation ea protheine e eketsa 15% ho boima bohle ba molek'hule, e lebisang ho boima ba limolek'hule tsa aflibercept ea 115 kDa. Endothelial vascular grow factor A (VEGF-A), endothelial vascular grow factor B (VEGF-B) and placental grow factor (P1GF) ke tsa VEGF-lelapa la lintlha tsa angiogenic tse ka sebetsang e le mabaka a matla a methogenic, chemotactic le vascular permeability-susumetsang bakeng sa lisele tsa endothelial. VEGF-A e sebetsa ka li-receptor tyrosine kinases tse peli - VEGFR-1 le VEGFR-2, e holim 'a lisele tsa endothelial. P1GF le VEGF-B li tlama feela VEGFR-1 receptor tyrosine kinase, eo, ntle le boteng ba lisele tsa endothelial, le eona e teng holim'a leukocytes. Ts'ebetso e feteletseng ea li-receptor tsena tsa VEGF-A e ka lebisa ho ts'ebetsong ea methapo ea methapo le ho eketseha ha methapo ea methapo. P1GF e amana hape le nts'etsopele ea methapo ea methapo ea methapo ea methapo le ho kenella ka hare ho tumellano le lisele tse nang le tšoaetso. Aflibercept e sebetsa e le "receptor-trap" e kopaneng e kopanyang VEGF-A e nang le kamano e fetang ea VEGF-A receptors, ho ekelletsa moo e tlama le ligands tse amanang le VEGF-B le P1GF. Aflibercept e tlama ho VEGF-A ea motho, VEGF-B le P1GF ka sebopeho sa mechini e tsitsitseng ea inert e se nang mesebetsi ea tlhaho. Ho sebetsa e le "sefi" bakeng sa ligands, aflibercept e thibela ho tlangoa hoa ligands tsa semmuso ho li-receptor tsa bona, ka tsela eo li thibele ho fetisoa ha lipontšo ka li-receptor tsena. Aflibercept e thibela ts'ebetso ea li-receptor tsa VEGF le keketseho ea lisele tse endothelial, ka tsela eo li thibela ho etsoa ha likepe tse ncha tse fanang ka tumello ka oksijene le limatlafatsi. Aflibercept e tlama ho VEGF-A ea motho (the equilibrium dissociation kamehla (Cd) ke 0.5 pmol bakeng sa VEGF-A165 le 0.36 pmol bakeng sa VEGF-A121), ho P1GF ea motho (Cd 39 pmol ho P1GF-2), ho VEGF-B (Cd ea motho) 1.92 pmol) ka sebopeho sa setsi sa inert se tsitsitseng se se nang ts'ebetso ea tlhaho ea likokoana-hloko.

Matšoao a sebeliso:

Metastatic colorectal cancer (MKRP) (ho bakuli ba baholo) e hanyetsanang le chemalipapy e nang le oxaliplatin kapa e tsoetseng pele kamora ts'ebeliso ea eona (Zaltrap ha e kopantsoe le regimen ho kenyelletsa irinotecan, fluorouracil, calcium folinate (FOLFIRI).

Contraindication:

Hypersensitivity to aflibercept or any of vacipi of the drug Zaltrap, ho tsoa mali haholo, khatello ea methapo, khatello ea lithethefatsi, ho nyekeloa ke pelo ho sa feleng ha sehlopha sa III-IV (sehlopha sa NYHA), ho se sebetse hantle ha sebete (ho haella ha data bakeng sa ts'ebeliso) kenyelletso ea 'mele oa vitreous (ka lebaka la thepa ea hyperosmotic ea lithethefatsi Zaltrap), boimana, nako ea ho anyesa, bana le bacha ast lilemo tse 18 (ka lebaka la ho haelloa ke phihlelo ena e lekaneng ka kopo ya).Litlhoko-hloko: ho se sebetse hantle ha renal, khatello ea mali ea methapo, mafu a bohlokoa a tsamaiso ea methapo ea pelo (CHD, sehlopha sa I-II sa lefu la pelo le sa foleng ho latela boemo ba NYHA), botsofe, maemo a akaretsang a lintlha ≥2 ka tekanyo ho hlahloba boemo bo akaretsang ba mokuli ECOG ( Sehlopha sa Bo-ralitaba ba Joint Oncologists).

Tekanyetso le tsamaiso:

Zaltrap e tsamaisoa iv ka mokhoa oa infusion bakeng sa hora e le 1, e lateloa ke ts'ebeliso ea chemotherapeutic regimen FOLFIRI. Motsoako o khothalelitsoeng oa Zaltrap ha o kopana le chemotherapeutic regimen FOLFIRI ke boima ba 'mele ba 4 mg / kg. FOLFIRI chemotherapeutic regimen: ka letsatsi la pele la potoloho - ts'oaetso ea iv ka nako e le 'ngoe ka ho kenngoa ha irinotecan catheter ka lethal dose ea li-180 mg / m2 bakeng sa 90 min le calcium folinate (li-racemates tsa letsoho le letona) ka tekanyo ea 400 mg / m2 bakeng sa lihora tse 2 , e lateloang ke iv (bolus) tsamaiso ea fluorouracil ka tekanyetso ea 400 mg / m2, e lateloe ke ho kenella kahare ho inforous ea fluorouracil ka tekanyetso ea 2400 mg / m2 bakeng sa lihora tse 46. Lipotoloho tsa Chemotherapy li phetoa libeke tse ling le tse ling tse peli. Phekolo le Zaltrap e lokela ho tsoelapele ho fihlela lefu le tsoela pele kapa chefo e sa amoheleheng e hlaha.

Litla-morao:

Lintho tse etsahalang khafetsa tse bonts'ang khafetsa (HP) tsa maemo ohle a boima (tse nang le maqhubu a ≥20%) bonyane 2% li atileng haholo ka mofuta oa Zaltrap / FOLFIRI chemotherapeutic regimen ho feta ka mofuta oa FOLFIRI chemotherapeutic regimen (ka tsela e fokotsehang ea ketsahalo): leukopenia, lets'ollo, "neutropenia", proteinuria, ho eketsa ts'ebetso ea ACT, stomatitis, mokhathala, ts'ebetso ea ALT, ho eketsa khatello ea mali, ho fokotseha boima ba 'mele, ho fokotse takatso ea lijo, nko ea mpeng, bohloko ba ka mpeng, dysphonia, khatello e eketsehileng ea khatello serum creatinine le hlooho. Hangata, li-HP tse latelang tsa boima ba 3-4 (tse nang le maqhubu a ≥5%) li ile tsa bonoa, hangata ke 2% khafetsa ka mofuta oa Zaltrap / FOLFIRI chemotherapeutic regimen ho feta ka mofuta oa FOLFIRI chemotherapeutic regimen (ka tatellano ea liketsahalo tse fokotsang): neutropenia, lets'ollo, khatello ea mali e eketsehang, leukopenia, stomatitis, mokhathala, proteinuria le asthenia. Ka kakaretso, ho khaoloa hoa kalafo ka lebaka la ho ba teng ha liketsahalo tse bohloko (tsa maemo ohle a boima) ho ile ha bonoa ho 26.8% ea bakuli ba fumanang regimen ea Zaltrap / FOLFIRI chemotherapy ha e bapisoa le 12.1% ea bakuli ba amohelang regulen ea chemotherapy ea FOLFIRI. Li-HP tse tloaelehileng ka ho fetisisa tse bakileng ho hana ha phekolo ho ≥1% ea bakuli ba fumanang mofuta oa chemotherapy ea Zaltrap / FOLFIRI e ne e le asthenia / mokhathala, tšoaetso, letšollo, ho felloa ke metsi, khatello e eketsehileng ea mali, stomatitis, mathata a venous thromboembolic, neutropenia le proteinuria. Phetoho ea lithethefatsi Zaltrap (phokotso ea litekanyetso le / kapa se sieo) e entsoe ka 16,7%. Kamora ho phekoloa ha potoloho ea kalafo e fetang matsatsi a 7 ho ile ha bonoa ho 59.7% ea bakuli ba fumanang mofuta oa kalafo ea chemotherapy ea Zaltrap / FOLFIRI ha bapisoa le bakuli ba 42,6% ba amohelang kalafo ea chemotherapy ea FOLFIRI. Lefu le bakoang ke mabaka a mang, ntle le lefu ka lebaka la ho eketseha ha mafu, le bonoeng nakong ea matsatsi a 30 kamora potoloho ea ho qetela ea "chemotherapeutic regimen" e tlalehiloe ho 2,6% ea bakuli ba fumanang regimen ea Zaltrap / FOLFIRI chemotherapy le ho 1.0% ea bakuli ba fumanang regimen ea kalafo ea chemotherapy ea FOLFIRI. Sesosa sa lefu ho bakuli ba fumanang kalafo ea chemotherapy ea Zaltrap / FOLFIRI e ne e le ts'oaetso (ho kenyeletsa le neutropenic sepsis) ho bakuli ba 4, ho felloa ke metsi ho bakuli ba 2, hypovolemia ho mokuli a le mong, lefu la methapo ea methapo ea mafu ho lefu la mokuli a le 1, lefu la phepelo ea methapo. pneumonia, le pulmonary thromboembolism) ho bakuli ba 3, maqeba a ka mpeng (ho tsoa mali ho tsoa mpeng ea duodenal, ho ruruha ha mpa ea mpa, ho kenella ka botlalo) ho bakuli ba 3, lefu la bakuli ba sa tsejoeng. Fana ka bakuli ba 2.Litla-morao tsa HP le litlolo tsa laboratori tse bonoang ho bakuli ba tšoaroang ke Zaltrap / FOLFIRI chemotherapy regimen (ho ea ka MedDRA) li hlahisoa ka tlase. Lintlha tsa HP li ne li hlalosoa e le karabelo e sa rateheng ea kliniki kapa tlhekefetso maemong a laboratori, hangata e ne e le ≥2% e phahameng (bakeng sa HP ea methapo eohle ea boima) sehlopheng sa aflibercept ha se bapisoa le sehlopha sa placebo thutong e entsoeng ho bakuli ba nang le ICP. Bohlokoa ba HP bo ne bo thathamisitsoe ho ea ka NCI CTC (National Cancer Institute General Toxicity Rating Scale) mofuta oa 3.0. Ho lekola khafetsa ea HP (ho latela sehlopha sa WHO): khafetsa (≥10%), khafetsa (≥1% - li-degrees tsa 3), hangata maemo a pherekano (li-degree tsa 33), ka mokhoa o sa lekanyetsoang - pholiso ea leqeba le sa senyeheng (ho pharalla ha methapo ea maqeba , ho hloleha ha anastomoses) (likhato tsohle tsa ho teba le maemo a 33 a boima).

Lintlha tsa laboratori le tsa ts'ebetso: khafetsa - ho eketsa ts'ebetso ea ACT, ALT (litekanyetso tsohle tsa boima ba 'mele), ho theoha ha boima ba' mele (likhahla tsohle tsa boima ba), hangata - ts'ebetso e atileng ea ACT, ALT ≥3 degrees, boima ba mmele bo theohile.

Ho sebelisana le lithethefatsi tse ling:

Lithuto tse hlophisitsoeng tsa tšebelisano ea lithethefatsi le Zaltrap ha li so etsoa. Lithutong tse bapisoang, litlatsetso tsa litlamorao tsa mahala le tse tlameletsoeng hammoho le lithethefatsi tse ling li ne li tšoana le tsa monotherapy, e leng se bonts'ang hore metsoako ena (oxaliplatin, sisplatin, fluorouracil, irinotecan, docetaxel, pemetrexed, gemcitabine le erlotinib) ha e ame pharmacokine aflibercepta. Aflibercept, le eona ha ea ka ea ama pharmacokinetics ea irinotecan, fluorouracil, oxaliplatin, cisplatin, docetaxel, pemetrexed, gemcitabine, le erlotinib.

Letsatsi la ho felloa ke nako: Lilemo tse 3

Lipehelo tsa Khefu ea Litlama: ka ngollano

Contraindication

- Hypersensitivity ho aflibercept kapa mang kapa mang ea fumanang lithethefatsi,

- khatello ea mali ea methapo, ha e khonehe khalemelo ea bongaka,

- Ho hloleha ha pelo ho sa feleng ka sehlopha sa IV-IV (sehlopha sa NYHA),

- ho hloleha ho matla ha sebete (ho haella ha ts'ebeliso ea data),

- ts'ebeliso ea ophthalmic kapa tsamaiso ho 'mele oa vitreous (ka lebaka la thepa ea sehlahisoa sa hyperosmotic),

- nako ea ho anyesa,

- bana le bacha ba ka tlase ho lilemo tse 18 (ka lebaka la ho hloka tsebo e lekaneng ea kopo).

ho hloleha ho matla ha renal,

- maloetse a bohlokoa a ramatiki a methapo ea pelo (lefu la pelo le pelo, lefu la pelo le sa foleng la I-II ho latela sehlopha sa NYHA),

- Boemo bo akaretsang> lintlha tse 2 ka sekhahla ho lekola boemo bo akaretsang ba mokuli ECOG (Sehlopha sa Oncologists sa Europe Bochabela).

Mokhoa oa ho sebelisa: litekanyetso le kalafo

Kahare e le infusion bakeng sa hora e le 'ngoe, e lateloang ke ts'ebeliso ea "regother" ea chemotherapeutic FOLFIRI.

Tekanyetso e khothalelitsoeng hammoho le mofuta oa FOLFIRI chemotherapeutic regimen ke boima ba 'mele ba 4 mg / kg.

Chemotherapy scheme FOLFIRI:

ka letsatsi la pele la potoloho - ho kenella ka nako e le 'ngoe ho kenella kahare ho Yinotecan lethalong la li-180 mg / m2 bakeng sa metsotso e 90 le "folule" ea khalase ea letsoho le letsohong le letona) ka tekanyo ea 400 mg / m2 bakeng sa lihora tse 2, e lateloe ke intravenous (bolus ) kenyelletso ea fluorouracil ka tekanyetso ea 400 mg / m2, e lateloe ke ho kenella kahare ho fluorouracil ka tekanyetso ea 2400 mg / m2 bakeng sa lihora tse 46.

Lipotoloho tsa chemotherapy li phetoa libeke tse ling le tse ling tse peli.

Phekolo e lokela ho tsoelapele ho fihlela kholo ea mafu kapa chefo e sa amoheleheng e hlaha.

Litlhahiso tsa ho lokisa kalafo ea dosing / ho lieha kalafo

Phekolo e lokela ho khaotsa:

- Ka nts'etsopele ea ho tsoa mali haholo,

- ka nts'etsopele ea ho hloekisa mabota a pampitšana ea mala,

- ka sebopeho sa fistula,

- ka nts'etsopele ea khatello ea maikutlo kapa khatello e matla ea methapo ea mali,

- ka nts'etsopele ea mathata a bophelo bo botle,

- ka nts'etsopele ea nephrotic syndrome kapa thrombotic microangiopathy,

- ka nts'etsopele ea methapo e matla ea hypersensitivity (ho kenyelletsa bronchospasm, ho hema ka thata, angioedema, anaphylaxis),

- e khahlanong le pholiso ea leqeba e hlokang ho kenella kalafong,

- ka nts'etsopele ea reversible posterior encephalopathy syndrome (POPs), hape e tsejoang e le reversible posterior leukoencephalopathy (POPs).

Bonyane libeke tse 4 pele ho ts'ebetso e reriloeng, kalafo e nang le Zaltrap e lokela ho emisoa ka nakoana.

E liehile chemotherapy Zaltrap / FOLFIRI

Neutropenia kapa thrombocytopenia: Ts'ebeliso ea kalafo ea chemotherapeutic ea Zaltrap / FOLFIRI e lokela ho lieha ho fihlela palo ea li-neutrophils maling a potoloho e nyolohela ho> 1500 / μl le / kapa palo ea liplatelete maling a pheriferale e nyolohela ho> 75000 / μl.

Boitšoaro bo bobebe kapa bo leka-lekaneng (ho kenyelletsa ho pepesa letlalo, lekhopho, uritisaria, le pruritus): Phekolo e lokela ho emisoa ka nakoana ho fihlela karabelo e emisa. Haeba ho hlokahala, ho emisa karabelo ea hypersensitivity, ho ka etsahala ho sebelisa GCS le / kapa antihistamines.

Likoloeling tse latelang, o ka nahana ka tlhahlobo ea lihlahisoa tsa bongaka ba GCS le / kapa li-antihistamines.

Liphetoho tse matla tsa hypersensitivity (ho kenyelletsa bronchospasm, dyspnea, angioedema, le anaphylaxis): Chemotherapy regimen Zaltrap / FOLFIRI e lokela ho tlohelloa mme kalafo e reretsoeng ho emisa ts'ebetso ea hypersensitivity e lokela ho khaotsa.

Pholoso ea kalafo ka Zaltrap le tokiso ea litekanyetso

Keketseho ea khatello ea mali: U lokela ho emisa tšebeliso ea lithethefatsi ka nakoana ho fihlela u laola taolo ea khatello ea mali.

Ka nts'etsopele e pheta-phetoang ea keketseho e bonts'itsoeng ea khatello ea mali, ts'ebeliso ea lithethefatsi e lokela ho emisoa ho fihlela taolo holim'a keketseho ea khatello ea mali e fihlelle mme ka lipotoloho tse latelang li fokotsa tekanyetso ea tsona ho 2 mg / kg boima ba 'mele.

Proteinuria: Hoa hlokahala ho emisa ts'ebeliso ea lithethefatsi bakeng sa proteinuria> 2 g / ka letsatsi, ho qala kalafo ho ka etsahala kamora ho fokotsa proteinuria ho 2 g / ka letsatsi; tšebeliso ea Zaltrap e lokela ho emisoa ho fihlela protheine e fokotseha ka 20%, bonyane 2% khafetsa ha o sebelisa chemotherapy regimen Zaltrap / FOLFIRI ho fapana le mofuta oa FOLFIRI chemotherapeutic regimen (ka tatellano ea liketsahalo): leukopenia, lets'ollo, neutropenia, protheine, ts'ebetso ea ACT e eketsehileng, stomatitis, mokhathala, thrombocytopenia Alt, e ile ea eketseha khatello ea mali, ho lahleheloa ke boima ba 'mele, fokotseha takatso ea lijo, epistaxis, bohloko mpeng, dysphonia, e ile ea eketseha creatinine serum mahloriso le hlooho.

Li-HP tse latelang tsa boima ba 3-4 li ne li shejoa hangata (ka maqhubu a> 5%), bonyane 2% khafetsa ha u sebelisa mokhoa oa Zaltrap / FOLFIRI chemotherapeutic regimen ho feta ha u sebelisa mofuta oa FOLFIRI chemotherapeutic regimen (molemong oa ho fokotsa sekhahla sa liketsahalo): neutropenia, lets'ollo, khatello ea mali e eketsehang, leukopenia, stomatitis, mokhathala, proteinuria le asthenia.

Ka kakaretso, ho khaoloa hoa kalafo ka lebaka la ho ba teng ha liketsahalo tse bohloko (tsa maemo ohle a boima) ho ile ha bonoa ho 26.8% ea bakuli ba fumanang regimen ea Zaltrap / FOLFIRI chemotherapy ha e bapisoa le 12.1% ea bakuli ba amohelang regulen ea chemotherapy ea FOLFIRI.

Li-HP tse tloaelehileng ka ho fetisisa tse bakileng ho tlohela kalafo ho> 1% ea bakuli ba fumanang mofuta oa kalafo ea chemotherapy ea Zaltrap / FOLFIRI e ne e le asthenia / mokhathala, tšoaetso, lets'ollo, ho felloa ke metsi, khatello e eketsehileng ea mali, stomatitis, mathata a venous thromboembolic, neutropenia le proteinuria.

Phetoho ea litekanyetso (phokotso ea litekanyetso le / kapa se siiloeng) e entsoe ka 16.7%. Kamora ho phekoloa ha potoloho ea kalafo e fetang matsatsi a 7 ho ile ha bonoa ho 59.7% ea bakuli ba fumanang mofuta oa kalafo ea chemotherapy ea Zaltrap / FOLFIRI ha bapisoa le bakuli ba 42,6% ba amohelang kalafo ea chemotherapy ea FOLFIRI.

Lefu le bakoang ke mabaka a mang, ntle le lefu ka lebaka la ho eketseha ha mafu, le bonoeng nakong ea matsatsi a 30 kamora potoloho ea ho qetela ea "chemotherapeutic regimen" e tlalehiloe ho 2,6% ea bakuli ba fumanang regimen ea Zaltrap / FOLFIRI chemotherapy le ho 1.0% ea bakuli ba fumanang regimen ea kalafo ea chemotherapy ea FOLFIRI. Sesosa sa lefu ho bakuli ba fumanang mofuta oa chemotherapy ea Zaltrap / FOLFIRI e ne e le ts'oaetso (ho kenyeletsa le neutropenic sepsis) ho bakuli ba 4, ho felloa ke metsi ho bakuli ba 2, hypovolemia ho mokuli a le mong, lefu la methapo ea methapo ea methapo ho 1 mokuli, ho hloleha ha phepelo ea matšoafo, pneumonia ea phello e matla) le pulmonary embolism) ho bakuli ba 3, maqeba a ka mpeng (ho tsoa mali ho tsoa ka mpeng ea duodenal, ho ruruha ha mpa ea mpa, ho kenella ka botlalo ka mpa) ho bakuli ba 3, sephetho se bolaeang se tsoang ho sa tsejoeng mabaka a totobetseng ho bakuli ba 2.

Litla-morao tsa HP le litlolo tsa laboratori tse bonoang ho bakuli ba tšoaroang ke Zaltrap / FOLFIRI chemotherapy regimen (ho ea ka MedDRA) li hlahisoa ka tlase. Lintlha tsa HP li ne li hlalosoa e le karabelo e sa rateheng ea kliniki kapa tlhekefetso maemong a laboratori, maqhubu a eona e ne e le 2% e phahameng (bakeng sa HP ea methapo eohle ea boima) sehlopheng sa aflibercept ha se bapisoa le sehlopha sa placebo thupelong e entsoeng ho bakuli ba nang le ICP. Bohlokoa ba HP bo ne bo thathamisitsoe ho ea ka NCI CTC (National Cancer Institute General Toxicity Rating Scale) mofuta oa 3.0.

Boikemisetso ba khafetsa ea HP (ho latela sehlopha sa WHO): hangata haholo (> 10%), khafetsa (> 1% - 0,1% - 0,01% - li-degree tsa 3).

Ho tsoa maling le methapo ea methapo ea kutlo: khafetsa - leukopenia (methapo eohle ea ho teba le> 3 degrees ofverity), neutropenia (methapo eohle ea ho teba le ho fihlela ho 3 degrees), thrombocytopenia (degrees tsohle), hangata - febrile neutropenia ea methati eohle ea boima le> Li-degrees tsa 3 tsa ho teba, thrombocytopenia> likhato tse 3 tsa boima.

Ka lehlakoreng la tsamaiso ea 'mele ea ho itšireletsa mafung: hangata - li-hypersensitivity reaction (li-degree tsohle tsa ho teba), ka tsela e sa lekanyetsoang - li-hypersensitivity reaction> Mehato e 3 ea ho teba.

Ho tloha lehlakoreng la metabolism le phepo e nepahetseng: khafetsa - ho fokotseha ha takatso ea lijo (li-degree tsohle tsa ho teba), khafetsa - ho omella (methapo eohle ea boima le> li-degrees tsa 3), tahlehelo ea takatso ea lijo> likhato tse 3 tsa boima.

Ho tloha lehlakoreng la ts'ebetso ea methapo: hangata khafetsa - hlooho ea hlooho (ea methapo eohle e boima), hangata - hlooho ea hlooho> likhato tse 3 tsa ho teba, hangata - - reversible posterior encephalopathy syndrome (SARS).

Ho tsoa ho tsamaiso ea methapo ea pelo: hangata haholo - khatello ea mali e eketsehileng (ea li-degree tsohle tsa ho teba) (ho karolo ea 54 lekholong ea bakuli ba neng ba e-na le keketseho ea khatello ea mali> likhato tse 3 tsa khatello e matla, keketseho ea khatello ea mali e ntlafalitsoeng nakong ea potoloho ea pele ea kalafo), ho tsoa mali / hemorrhage (likhato tsohle) ho teba), mofuta o atileng haholo oa ho tsoa mali ho ba likeleli tse nyane (li-degrees tsa 1-2 tsa ho teba), hangata tse amanang le mathata a ramatiki (ATEO) (joalo ka mathata a tšohanyetso a amanang le lefu la sethoathoa, ho kenyelletsa le tlhaselo ea nakoana ea boko. angina pectoris, intracardiac thrombus, infracardiac infarction, arterial thromboembolism le ischemic colitis) (methapo eohle ea ho teba), venous thromboembolic complication (VTEO) (vein thrombosis e tebileng le pulmonary embolism) ea methati eohle ea ho teba, ho tsoa mali> lilemo tse 3 tsa ho teba ha sekhahla. ho kenyelletsa ho tsoa mali ka mpeng, hematuria, ho tsoa mali ka mor'a lits'ebetso tsa bongaka, maqhubu a sa tsejoeng - ho bakuli ba fumanang Zaltrap, nts'etsopele ea hemorrhage e matla ea intracranial le hemorrhage ea pulmonary e tlalehiloe ny / hemoptysis, ho kenyelletsa le sephetho se bolaeang.

Ho tloha ts'ebetsong ea ho phefumoloha: khafetsa haholo - ho haella ha moea (oa methapo eohle e boima), nosebleeds (ea methapo eohle e boima), dysphonia (ea methapo eohle e boima), khafetsa - bohloko ho oropharynx (li-degree tsohle tsa ho teba), rhinorrhea (ke feela rhinorrhea e ileng ea bonoa ho teba), khafetsa - ho haella ha moea> likhato tse 3 tsa boima, nko ea sephiri> likhato tse 3 tsa boima, dysphonia> likhato tse 3 tsa ho teba, bohloko ho oropharynx> likhato tse 3 tsa ho teba.

Ho tsoa ho ts'ebetso ea tšilo ea lijo: hangata khafetsa - lets'ollo (methapo eohle ea ho tebela le maemo a 3 a boima ba 'mele), stomatitis (methapo eohle ea ho teba le> 3 degrees ea ho teba), bohloko ba ka mpeng (methapo eohle ea ho teba), bohloko bo ka mpeng e kaholimo. , khafetsa - bohloko ba ka mpeng> li-degrees tse 3 tsa ho ruruha, mahlaba ka mpeng e kaholimo> likhato tse 3 tsa ho teba, li-hemorrhoid (li-degrees tsohle tsa ho teba), mali a tsoang mokokotlong (methapo eohle e boima), bohloko bo kahare ho rectum (methati eohle ea ho teba), ho opeloa ke leino (meno digrii tsohle tsa ho teba), aphthous stomatitis (likhato tsohle tsa ho teba ja), sebopeho sa fistulas (anal, intestinal-urinary, kantle ka mpeng e nyane-letlalo, lesapo la mokokotlo, mpa-kahare) (li-degree tsohle tsa ho teba), ka tsela e sa lekanyetsoang - sebopeho sa methapo ea gastrointestinal fistulas> likhato tse 3 tsa ho teba, ho tlatselletsa ha marako a mpa ea mpa Methapo e 3 ea ho teba, ho kenyelletsa le litlolo tse bolaeang tsa mabota a seterata sa ka mpeng, ho tsoa madi ho tsoa mokokotlong> likhato tse 3 tsa ho ruruha, aphthous stomatitis> likhato tse 3 tsa boima, bohloko bo kahare ho rectum> 3 degrees.

Ho tloha letlalong le ho kenella linthong tse ling: hangata khafetsa - palema ea limela erythrodysesthesia (boholo bohle ba boima), hangata - hyperpigmentation ea letlalo (methati eohle ea ho teba), palery erythrodysesthesia syndrome> li-degrees tsa 3.

Ho tsoa ts'ebetsong ea urine: khafetsa - proteinuria (ho ea ka tlhaiso-leseling e kopaneng ea laboratori) (methati eohle ea boima), keketseho ea mahloriso a serum creatinine (li-degree tsohle tse boima, hangata - proteinuria> li-degree tsa 3), hangata - nephrotic syndrome. Mokuli a le mong ea nang le proteinuria le khatello ea mali e eketsehileng ho bakuli ba 611 ba fumaneng kalafo ka kalafo ea kalafo ea Zaltrap / FOLFIRI chemotherapy o ile a fumanoa a e-na le thrombotic microangiopathy.

Liphetoho tse akaretsang: khafetsa - maemo a asthenic (li-degree tsohle tsa ho teba), maikutlo a ho tepella (methati eohle ea ho tsitsipana le> li-degrees tsa 3), hangata - maemo a ho tiisa (> li-degrees tsa 3), ka mokhoa o sa lekanyetsoang - pholiso ea leqeba le sa foleng (ho fapana ha methapo ea leqeba, ho hloleha ha anastomoses ) (li-degrees tsohle tsa ho teba le> li-degrees tsa 3).

Lintlha tsa laboratori le tsa lisebelisoa: khafetsa - ho eketsa ts'ebetso ea ACT, ALT (litekanyetso tsohle tsa boima ba 'mele), ho theola boima ba' mele (li-degree tsohle tsa boima), khafetsa - ts'ebetso e eketsehang ea ACT, ALT> likhato tse 3 tsa boima, ho fokotsa boima ba 'mele.

Khafetsa karabelo e mpe lihlopheng tse ikhethang tsa bakuli

Ho bakuli ba tsofetseng (> lilemo tse 65), ts'oaetso ea lets'ollo, ho tsekela, "asthenia", ho fokotsa boima ba 'mele le ho felloa ke metsi' meleng ho ne ho phahame ho feta 5% ho bakuli ba banyane lilemong. Bakuli ba tsofetseng ba lokela ho betoa leihlo ka botlalo bakeng sa nts'etsopele ea letšollo le / kapa ho felloa ke metsi 'meleng.

Ho bakuli ba nang le bothata ba ho ruruha ba renal ka nako eo ho neng ho qala ho sebelisoa moriana, ts'oaetso ea HP e ne e bapisoa le ea bakuli ba sa sebetseng hantle ka nako eo e neng e qala ho sebetsa ka eona. Ho bakuli ba nang le mathata a ho leka-lekanya a renal, ho hlaha ha HP e se nang phepo ho ne ho ka bapisoa le ho bakuli ntle le ho hloleha ha moko, ntle le keketseho ea khafetsa ea ho fokola hoa mmele (ka likhato tsohle tsa ho teba ha maikutlo) ke> 10%.

Joalo ka lithethefatsi tse ling tsohle tsa protheine, aflibercept e na le monyetla oa ho ba le bokhoni ba ho ba le immunogenicity. Ka kakaretso, ho latela liphetho tsa liteko tsohle tsa kalafo ea oncological, ha ho le ea mong oa bakuli ea bonts'itseng karolo e phahameng ea lithibela-mafu e le hore e ka qojoa.

Ha ho na data mabapi le polokeho ea ho nka Zaltrap ho tekanyetso e fetang 7 mg / kg hang ka mor'a libeke tse peli kapa 9 mg / kg hang libekeng tse tharo. HP e atileng haholo e bonoang ka mefuta ena ea dosing e ne e tšoana le ea HP e hlokometsoeng ka tšebeliso ea lithethefatsi ho litekanyetso tsa kalafo.

Ha ho na le litlhare tse tobileng bakeng sa moriana ona.Haeba ho na le lithibela-mafu tse ngata, bakuli ba hloka kalafo e tšehetsang, haholo-holo ho lekola le kalafo ea khatello ea methapo ea kutlo le proteinuria. Mokuli o lokela ho hlahlojoa ka hloko ho tseba le ho hlokomela HP efe kapa efe.

Litaelo tse khethehileng

Pele o qala kalafo le pele ho potoloho e 'ngoe le e ngoe e ncha ea kalafo ka aflibercept, ho kgothaletswa ho etsa tlhahlobo ea mali ka kakaretso ka tlhaloso ea foromo ea leukocyte.

Ka nts'etsopele ea pele ea neutropenia> likhato tse 3 tsa ho teba, ts'ebeliso ea bongaka ea G-CSF e lokela ho nkoa, ho ekelletsa moo, ho bakuli ba nang le kotsi e eketsehileng ea ho ba le mathata a neutropenic, ho hlahisoa ha G-CSF bakeng sa thibelo ea neutropenia ho khothalletsoa.

Bakuli ba lokela ho lula ba beiloe leihlo bakeng sa matšoao le matšoao a ho lutla le mali. Aflibercept ha ea lokela ho fuoa bakuli ba nang le ho tsoa mali haholo.

Bakuli ba lokela ho shebelloa bakeng sa matšoao le matšoao a ho hloekisa mabota a pampitšana ea ka mpeng. Tabeng ea ho hloekisa mabota a seterata sa ka mpeng, kalafo e nang le aflibercept e lokela ho emisoa.

Ka nts'etsopele ea fistulas, kalafo e nang le aflibercept e lokela ho khaotsa.

Nakong ea kalafo ka aflibercept, ho kgothaletswa ho beha leihlo khatello ea mali ka mor'a libeke tse ling le tse ling tse peli, ho kenyelletsa le ho hlahloba khatello ea mali pele ho ts'ebeliso ea kalafo, kapa hangata ho latela lipontšo tsa bongaka nakong ea kalafo ka aflibercept. Tabeng ea khatello e eketsehang ea mali nakong ea kalafo ka aflibercept, kalafo e nepahetseng ea antihypertensive e lokela ho sebelisoa le khatello ea mali e hlahlojoe khafetsa. Ka keketseho e fetelletseng ea khatello ea mali, kalafo e nang le aflibercept e lokela ho emisoa ho fihlela khatello ea mali e fokotseha ho boleng ba sepheo, 'me ka lipotoloho tse latelang, litekanyetso tsa aflibercept li lokela ho fokotsoa ho 2 mg / kg. Tabeng ea nts'etsopele ea khatello ea maikutlo kapa khatello ea methapo e matla ea methapo, tsamaiso ea lithethefatsi tse amanang le lithethefatsi e lokela ho emisoa.

Ho hlokahala hore motho a be hlokolosi ha a fana ka Zaltrap ho bakuli ba nang le lefu la pelo le pelo, joalo ka lefu la pelo le ho nyekeloa ke pelo. Ha ho na liteko tsa tliliniki tsa taolo ea lithethefatsi ho bakuli ba nang le pelo e sa sebetseng hantle ea sehlopha sa IV le IV ho latela sehlopha sa NYHA.

Haeba mokuli a theha ATEO, kalafo ka aflibercept e lokela ho khaotsa.

Pele ho ts'ebetso e 'ngoe le e' ngoe ea aflibercept, proteinuria e lokela ho ikemisetsa ho sebelisa mohala oa tlhahlobo kapa ho bona hore na protheine / creatinine e moroto ho bona nts'etsopele kapa kholo ea protheine. Bakuli ba nang le moriana oa protheine / moriana oa moroto> 1 ba lokela ho tseba palo ea protheine ka har'a moroto oa letsatsi le letsatsi.

Ka nts'etsopele ea nephrotic syndrome kapa thrombotic microangiopathy, kalafo e nang le aflibercept e lokela ho khaotsa.

Haeba ho e-ba le karabelo e matla ea hypersensitivity (ho kenyelletsa bronchospasm, ho hema ka thata, angioedema le anaphylaxis), kalafo e lokela ho khaotsa mme kalafo e nepahetseng e reretsoeng ho emisa maikutlo ana e lokela ho qala.

Haeba karabelo e bobebe ea hypersensitivity ho tsoalo e hlaha (ho kenyeletsa le hyperemia ea letlalo, lekhopho, urticaria, pruritus), kalafo e lokela ho emisoa ka nakoana ho fihlela karabelo e raroloha. Haeba ho hlokahala ka tliliki, li-corticosteroids le / kapa li-antihistamine li ka sebelisoa ho emisa sena. Likoloeling tse latelang, o ka nahana ka tlhahlobo ea lihlahisoa tsa bongaka ba GCS le / kapa li-antihistamines. Ha u qala kalafo ea bakuli ba kileng ba ba le maikutlo a hypersensitivity reaction, tlhokomeliso e lokela ho sebelisoa ho bakuli ba bang, nts'etsopele ea methapo ea hypersensitivity e ile ea bonoa, leha ba le prophylaxis, ho kenyelletsa ts'ebeliso ea corticosteroids.

Ts'ebeliso ea aflibercept e lokela ho emisoa bonyane libeke tse 4 kamora ts'ebetso e kholo ea ts'ebetso ea ho buoa le ho fihlela leqeba la ho hlatsoa le folile ka botlalo. Bakeng sa ts'ebetso e nyane ea ts'ebetso, joalo ka ts'ebetso ea venous catheter, biopsy, leseli la meno, kalafo e nang le aflibercept e ka qala / ea qala kamora hore leqeba la ho buoa le fole ka botlalo.Bakeng sa bakuli ba nang le pholiso ea leqeba le holofetseng ba hlokang ts'ebetso ea bongaka, ts'ebeliso ea aflibercept e lokela ho emisoa.

Li-POP li ka bonahatsoa ke phetoho maemong a kelello, ho ts'oaroa ha sethoathoa, ho nyekeloa, ho hlatsa, hlooho le mathata a pherekano. Ho hlahlojoa ha LUTS ho netefatsoa ke tlhahlobo ea MRI ea boko. Ho bakuli ba nang le POPs, ts'ebeliso ea aflibercept e lokela ho emisoa.

Bakuli ba seng ba tsofetse (> ea lilemo tse 65) ba na le kotsi e eketsehang ea ho ba le lets'ollo, ho tsekela, ho ruruha, ho fokotsa boima ba 'mele le ho felloa ke metsi' meleng. Bakeng sa ho fokotsa kotsi, bakuli ba joalo ba hloka ho hlahlojoa ka hloko bakeng sa tlhahlobo ea bongaka le kalafo ea matšoao le lets'ollo le ho felloa ke metsi 'meleng.

Bakuli ba nang le index ea boemo bo akaretsang> lintlha tse 2 (lenaneong la tlhahlobo ea lintlha tse hlano ho isa ho tse 4 tsa ECOG ea Eastern Joint Oncology Group) kapa ba nang le mafu a tebileng a tšoaetsanoang ba ka ba le kotsi e kholo ea sephetho se sebe sa kalafo mme ba hloka tlhokomelo ea bongaka e hlokolosi bakeng sa ho lemoha kapele ho senyeha ha tleliniki.

Zaltrap ke tharollo ea hyperosmotic, sebopeho sa eona se sa lumellaneng le kenyelletso sebakeng sa intraocular. Setlhare se ke ke sa kenella 'meleng oa vitreous.

Ha ho lithuto tse entsoeng tse mabapi le phello ea Zaltrap mabapi le bokhoni ba ho khanna makoloi kapa liketso tse ling tse ka bang kotsi. Haeba bakuli ba ba le matšoao a amang pono ea bona le bokhoni ba ho tsepamisa mohopolo, le ho liehisa karabelo ea psychomotor, bakuli ba lokela ho eletsoa hore ba hane ho khanna makoloi le mesebetsi e meng e ka bang kotsi.

Bokhachane le pelehi

Ha ho na datha mabapi le ts'ebeliso ea aflibercept ho basali baimana. Ka lithuto tsa liteko, litlamorao tsa embryotoxic le teratogenic tsa aflibercept liphoofolong li ile tsa senoloa. Hobane angiogeneis ke ea bohlokoa haholo ho nts'etsopele ea "mouoane; thibelo ea angiogeneis le tsamaiso ea Zaltrap e ka baka litlamorao tse sa lokelang bakeng sa nts'etsopele ea kemaro. Ts'ebeliso ea moriana nakong ea kemolo e kopantsoe.

Basali ba lilemo tsa ho ba le bana ba lokela ho eletsoa ho qoba ho ima nakong ea kalafo le Zaltrap. Ba lokela ho tsebisoa ka monyetla oa litla-morao tsa lithethefatsi ho lesea.

Basali ba lilemo tsa ho ba le bana le banna ba nang le masea ba lokela ho sebelisa mekhoa e sebetsang ea thibelo ea bokhachane nakong ea kalafo le bonyane likhoeli tse 6 ka mor'a tekanyetso ea ho qetela ea moriana.

Ho na le menyetla ea tsoalo e sa sebetseng ho banna le basali nakong ea kalafo ka aflibercept (e ipapisitseng le lintlha tse fumanoeng lithutong tse entsoeng ka litšoene, ho banna le basali bao litlamorao li ileng tsa baka mathata a kemolo, ho feto-fetoha le maemo ka mora libeke tse 8-18.

Ha ho so ba le lithuto tsa tliliniki ho hlahloba litlamorao tsa Zaltrap mabapi le tlhahiso ea lebese la matsoele, ho ikarola ka thobalano le lebese la matsoele, le phello ea lithethefatsi ho masea.

Ha ho tsejoe hore na basali ba kenoe le basali ka lebese la matsoele. Leha ho le joalo, ka lebaka la taba ea hore ho ke ke ha khoneha ho khetholla monyetla oa ho kenella ka hare ho lebese la matsoele, hammoho le monyetla oa ho ba le maikutlo a mabe a tebileng a ka bakoang ke litlamorao ho masea, ho hlokahala hore e hane ho anyesa kapa ho se sebelise Zaltrap ( ho ipapisitse le bohlokoa ba tšebeliso ea lithethefatsi ho 'm'a).

Tšebelisano

Lithuto tse hlophisitsoeng tsa tšebelisano ea lithethefatsi le Zaltrap ha li so etsoa.

Boithuto bo bapisoang, litekanyetso tsa li-aflibercept tse sa lefelloeng le tse tlameletsoeng hammoho le lithethefatsi tse ling li ne li ts'oana le ho tsepamisa maikutlo ho aflibercept le monotherapy, ho bonts'a hore metsoako ena (oxaliplatin, cisplatin, fluorouracil, irinotecan, docetaxel, pemetrexed, gemcitabine, le erlotinib) ha e ame letho. pharmacokinetics of aflibercept.

Tlhophiso ea Nosological (ICD-10)

Mofumahali

Aflibercept ke protheine e 'ngoe e kopantsoeng e kopantseng VEGF (vascular endothelial grow factorendothelial vascular grow factor) likarolo tsa libaka tse tsoang kantle ho li-receptor VEGF-1 le VEGF-2 e hokahane le domain name ea Fc (sekhechana se nang le bokhoni ba ho lla) IgG₁ motho.

Aflibercept e hlahisoa ho sebelisoa theknoloji ea DNA e kopantsoeng e sebelisa mokhoa oa Chinese hamster ovary cell expression system (CHO) K-1.

Aflibercept ke glycoprotein ea Chimeric e nang le boima ba molek'hule ea 97 kDa, glycosylation ea protheine e eketsa 15% ho boima bohle ba molek'hule, e lebisang ho boima ba limolek'hule tsa aflibercept ea 115 kDa.

Endothelial vascular grow factor A (VEGF-A), endothelial vascular grow factor B (VEGF-B) le kholo ea kholo ea placental (PLGF) amanang le VEGF- lelapa la lintlha tsa angiogenic tse ka sebetsang e le li-mitogenic tse matla, chemotactic le vascular permeability ea lisele tsa endothelial. Ketso VEGF-A e phethoa ka li-receptor tyrosine kinases - VEGFR-1 le VEGFR- e haufi le lisele tsa endothelial. Plgf le VEGF-B tlama feela ho receptor tyrosine kinase VEGFR-1, eo, ntle le ho ba holim'a lisele tsa endothelial, e boetse e teng holim'a leukocytes. Ts'ebetso e kholo ea li-receptor tsena VEGF-A ho ka lebisa ho ho teba ha pelo le ho eketseha ha methapo ea methapo. Plgf hape e amanang le nts'etsopele ea methapo ea methapo ea methapo ea kutlo le ho kenella ka hare ho tumellano ea mmele ka lisele tse ruruhileng.

Aflibercept e sebetsa e le sesebelisoa se ts'oaroang se qhibilihang se tlamehang ho VEGF-A ka kamano e kholo ho feta li-receptor tsa matsoalloa VEGF-Antle le sena, o boetse a tlama ho ligands tse amanang VEGF-B le Plgf. Aflibercept e amana le motho VEGF-A, VEGF-B le Plgf ka ho theha mechini e tsitsitseng ea inert e se nang mesebetsi ea likokoana-hloko. E sebetsa e le sefi sa ligands, aflibercept e thibela ho tlangoa ha ligoss tsa semelo ho li-receptor tsa bona tse tsamaellanang mme ka tsela eo li thibele ho fetisoa ha lipontšo ka li-receptors tsena.

Aflibercept block receptor activation VEGF le keketseho ea lisele tse endothelial, ka tsela ena li thibela ho etsoa ha likepe tse ncha tse fanang ka tumello ka oksijene le limatlafatsi.

Aflibercept e amana le VEGF-A motho (equilibrium dissociation kamehla (Cd) - 0.5 pmole bakeng sa VEGF-A165 le 0.36 pmol bakeng sa VEGF-A121), s Plgf motho (cd 39 pmol bakeng la Plgf-2), s VEGF-B motho (Cd 1.92 pmol) ka sebopeho sa setsi sa inert se tsitsitseng se se nang ts'ebetso ea tlhaho e ka ikemiselitsoeng.

Ts'ebeliso ea aflibercept ho litoeba ka xenograft kapa allograft tumors e thibelitse kholo ea mefuta e fapaneng ea adenocarcinomas.

Ho bakuli ba nang le mofetše oa metastatic colorectal cancer (MKRP) ba kileng ba phekoloa ka kalafo e nang le oxaliplatin (e nang le kapa ka ntle ho tsamaiso ea bevacizumab), regimen regimen Zaltrap ® /FOLFIRI (fluorouracil, irinotecan, calcium folate) e bontšitse keketseho e kholo ea lipalo molemong oa bophelo bo bapisoang le mofuta oa chemotherapeutic FOLFIRI.

Mofumahali

Ho kenella Phuputsong e entsoeng pele ho mofuta oa tumor, litekanyetso tse sebetsang tsa biologic li ile tsa hokahanngoa le litekanyetso tse hlokahalang ho theha mohopolo oa potoloho ea mali le tsamaiso ea mali, e fetang tekanyo ea ho potoloha hoa mali le tsamaiso ea mali e amanang le methapo ea mali. VEGF. Likeletso li potoloha tsamaisong ea kemiso e amanang le VEGF aflibercepta ka keketseho ea tekanyetso ea eona e eketseha ho fihlela boholo VEGF ha e hokahane.Keketseho e 'ngoe ea lethal dose ea aflibercept e lebisa ho keketseho ea tekanyetso khoebong ea maqhubu a mahala a potoloha tsamaisong ea kemiso le ho eketseha hanyane hanyane ho khatello ea khokahano e amanang le VEGF aflibercepta.

Ho bakuli, Zaltrap ® e tsamaisoa ka tekanyetso ea 4 mg / kg iv ka beke tse ling le tse ling tse peli, ka nako eo ho nang le ts'oaetso e eketsehileng ea ho potoloha ha aflibercept ntle le ts'oaetso ea aflibercept e amanang le VEGF.

Ka tekanyo e khothalletsoang ea 4 mg / kg hang ka mor'a libeke tse ling le tse ling tse peli, khatello ea maikutlo a mahala e haufi le litekanyetso tsa C._s li fumanoe nakong ea potoloho ea bobeli ea kalafo ho se na mokhoa oa ho bokella (ho bokellana ka bongata ka ho lekana ha 1,2, ha ho bapisoa le ho kenella ka ente ea mahala ka ente ea pele).

Tsamaiso. V_s aflibercepta ea mahala ke lilithara tse 8.

Metabolism. Kaha aflibercept ke proteni, lithuto tsa metabolism ea eona ha li e-so etsoe. Aflibercept e lebelletsoe hore e kenelle ka har'a li-peptide tse nyane le amino acid e le 'ngoe.

Ho felisoa. The free aflibercept e potoloha tsamaisong ea kemiso e amana haholo le VEGF-family le sebopeho sa li-complexes tse sa sebetseng tse sa sebetseng. Ho lebelletsoe hore, joalo ka liprotheine tse ling tse kholo tse amanang le VEGF mme aflibercept ea mahala e tla tlosoa butle-butle tsamaisong ea kemiso ka mekhoa e meng ea bioloji, joalo ka protabolism ea protocol.

Ka tekanyetso e fetang 2 mg / kg, ho hlakisoa ha aflibercept ea mahala e ne e le 1 l / letsatsi le T ea ho qetela._1/2 Matsatsi a 6

Liprotheine tse phahameng tsa boima ba limolek'hule ha li hlahisoe ke liphio, ka hona ho lebelletsoe hore tlhahiso ea relibre ea aflibercept e ke ke ea fokola.

Linearity / nonlinearity ea ho tlosa. Mabapi le sepheo sa tlamo ea aflibercept ho sepheo sa eona (endo native VEGF) mahala aflibercept ho tekanyetso e ka tlase ho 2 mg / kg e bontšitse ho fokotseha ho potlakileng (ho seng moedi) ho tsepameng ea eona tsamaisong ea kemiso, kamoo ho hlakileng e amanang le kamano ea eona e phahameng e tlamang ho emisa tlhaho. VEGF. Boemong ba lethal dose ho tloha ho 2 ho isa ho 9 mg / kg, ho hlakisoa ha aflibercept ea mahala ho fetoha mola, ho bonahala ka lebaka la metjeko ea tlhaho ea boiketsiso e sa sebetseng, joalo ka protabolone catabolism.

Lihlopheng tse khethehileng tsa bakuli

Bana. Ka ho qala / ha ho hlahisoa lithethefatsi Zaltrap ® ka tekanyetso ea 2, 2,5, 3 mg / kg ka mor'a libeke tse ling le tse ling tse peli. Bakuli ba 8 ba bana ba nang le li-tumor tse tiileng (ba lilemo li 5 ho isa ho 17), karolelano ea T_1/2 Free aflibercept, e fumanoe kamora lethal la pele, e ne e ka ba matsatsi a 4 (matsatsi a 3 ho isa ho a 6).

Bakuli ba baholo. Nako ea lilemo ha e ame li-pharmacokinetics tsa aflibercept.

Bong Leha ho na le phapang ea tumello ea mahala ea li-aflibercept le V_d ho banna le basali, liphapang tse amanang le botona le botšehali ho ts'ebetsong ea eona ea ts'ebetso ha lia ka tsa bonoa ha li sebelisoa ka tekanyo ea 4 mg / kg.

Lenane la boima ba 'mele. Boima ba 'mele bo amme ho hlakisoa ha litlamorao tsa mahala le V_d Kahoo, ho bakuli ba nang le boima ba 'mele bo fetang lik'hilograma tse 100, keketseho ea ho pepesoa ha kemiso ea aflibercept e bonoe ke 29%.

Kopano ea morabe. Morabe le morabe ha lia ka tsa ama li-pharmacokinetics tsa aflibercept.

Ho hloleha ha sebete. Lithuto tse hlophisitsoeng mabapi le ts'ebeliso ea Zaltrap ® ho bakuli ba nang le bothata ba sebete ha li so etsoa.

Ho bakuli ba nang le "bilirubin" e ngata ea mali maling a eng kapa eng ea "Aciribin" e leng teng ka bongata maling . Ha ho na datha ho li-pharmacokinetics tsa aflibercept ho bakuli ba nang le ts'enyo e matla ea hepatic (ho kenella ka bongata ba bilirubin maling> 3 VGN ho litekanyetso life kapa life tsa ACT).

Ho hloleha hape Boithuto bo hlophisitsoeng mabapi le ts'ebeliso ea Zaltrap ® ho bakuli ba nang le bothata ba ho phekoloa ka methapo ha boa etsoa.

Ha ho phapang e fumanoeng ho systemation exposition (AUC) ea mahala ea kalafo ho bakuli ba nang le ho se sebetse hantle ha methapo e fapaneng ea matla ha ba sebelisa Zaltrap ® ka tekanyo ea 4 mg / kg.

Bokhachane le pelehi

Ha ho na datha mabapi le ts'ebeliso ea aflibercept ho basali baimana. Boithuto ho liphoofolo bo senotse litlamorao tsa embryotoxic le teratogenic ho aflibercept. Kaha angiogeneis ke ea bohlokoa haholo molemong oa kholo ea "makhopho, thibelo ea angiogeneis ka tsamaiso ea Zaltrap ® e ka lebisa litlamorao tse mpe bakeng sa nts'etsopele ea kemaro. Ts'ebeliso ea Zaltrap ® nakong ea bokhachane le ho basali ba kanna baimana ha e khothalletsoe.

Basali ba lilemo tsa ho ba le bana ba lokela ho eletsoa ho qoba ho ima nakong ea kalafo le Zaltrap ®, mme ba lokela ho tsebisoa ka monyetla oa litlamorao tse mpe tsa Zaltrap ® ho lesea.

Basali ba lilemo tsa ho ba le bana le banna ba nang le masea ba lokela ho sebelisa mekhoa e sebetsang ea thibelo ea bokhachane nakong ea kalafo le bonyane likhoeli tse 6 kamora lethal dose la ho qetela la kalafo.

Ho na le monyetla oa ho ba le letsoalo le sa tsoakoang ho banna le basali nakong ea kalafo ka aflibercept (ho ipapisitsoe le datha tse fumanoeng lithutong tse entsoeng ka litšoene, ho banna le basali bao litlamorao li ileng tsa baka tsoalo e sa sebetseng, e ka fetoloang ka mora libeke tse 8-18.

Lithuto tsa kliniki ho hlahloba litlamorao tsa Zaltrap ® ho tlhahiso ea lebese la matsoele, ho lokolloa ha aflibercept ka lebese la matsoele le phello ea lona ho masea ha e e-so tšoaroe.

Ha ho tsejoe hore na aflibercept e pepesitsoe lebeseng la matsoele. Leha ho le joalo, ka lebaka la taba ea hore ho ke ke ha khoneha ho khetholla monyetla oa ho kenella ka hare ho lebese la matsoele, hammoho le monyetla oa ho ba le litla-morao tse mpe tse bakoang ke ho phatloha hoa masea, ho hlokahala hore o hane ho anyesa kapa ho se sebelise Zaltrap ® (ho latela bohlokoa ba ho sebelisa lithethefatsi ho 'm'a).

Litlamorao

Liphetoho tse atileng haholo tse etsahalang (HP) (tsa maemo ohle a boima, tse nang le maqhubu a ≥20%), li bonoa bonyane 2% khafetsa ha li sebelisa regimen regimen Zaltrap ® /FOLFIRIho feta ka regimen ea chemotherapy FOLFIRIe ne e le HP e latelang (molemong oa ho fokotseha ha maemo): leukopenia, lets'ollo, "neutropenia", proteinuria, ts'ebetso e atolositsoeng ea Act, stomatitis, mokhathala, thrombocytopenia, ho eketsa ts'ebetso ea ALT, ho eketsa khatello ea mali, ho fokotseha boima ba 'mele, ho fokotse takatso ea lijo, nosebleeds, bohloko ba ka mpeng, dysphonia, ho eketseha ha serum creatinine le ho opeloa ke hlooho.

HP e atileng haholo ea boima ba li-degree tsa 3-4 (e nang le maqhubu a %5%), e bonoang bonyane 2% khafetsa ha o sebelisa regimen regimen Zaltrap ® /FOLFIRI bapisoa le regimen ea chemotherapy FOLFIRIe ne e le HP e latelang (ka tatellano ea liketsahalo): neutropenia, letšollo, khatello e phahameng ea mali, leukopenia, stomatitis, mokhathala, protheine le asthenia.

Ka kakaretso, ho khaoloa hoa kalafo ka lebaka la ketsahalo ea liketsahalo tse bohloko (tsa maemo ohle a boima) ho bonoe ho 26.8% ea bakuli ba fumanang regimen regimen Zaltrap ® /FOLFIRIbapisoa le 12.1% ea bakuli ba fumanang li-regimens tsa kalafo ea chemotherapy FOLFIRI. HP e tloaelehileng ka ho fetisisa, e sebelisitsoeng e le lebaka la ho hana kalafo ho ≥1% ea bakuli ba fumanang regimen regimen Zaltrap ® /FOLFIRIe ne e le: asthenia / mokhathala, tšoaetso, lets'ollo, ho felloa ke metsi, khatello e phahameng ea mali, stomatitis, mathata a venous thromboembolic, neutropenia le proteinuria.

Phetoho ea moriana oa lithethefatsi Zaltrap ® (phokotso ea litekanyetso le / kapa se sieo) e entsoe ka 16,7%. Kamora ho phekoloa ha potoloho ea kalafo e fetang matsatsi a 7 ho ile ha bonoa ho 59,7% ea bakuli ba fumanang regimen regimen Zaltrap ® /FOLFIRIbapisoa le bakuli ba fumanang lengolo la phekolo ea chemotherapy FOLFIRI.

Lefu le tsoang lisosa tse ling, ho tlatselletsa ho eketseha ha maloetse, le bonoang nakong ea matsatsi a 30 kamora potoloho ea hoqetela ea "chemotherapeutic regimen" e tlalehiloeng ho 2,6% ea bakuli ba fumanang regimen regimen Zaltrap ® /FOLFIRI, le ho 1% ea bakuli ba fumanang mofuta oa chemotherapy FOLFIRI. Sesosa sa lefu la bakuli ba fumanang mofuta oa chemotherapy Zaltra ® /FOLFIRIe ne e le: ts'oaetso (ho kenyeletsa neutropenic sepsis) ho bakuli ba 4, ho omella ho bakuli ba 2, hypovolemia ho mokuli a le 1, metaboliki ea methapo ea methapo ho mokuli a le mong, lefu la phepelo ea methapo (phumano ea phefumoloho e mpe, pneumonia le pulmonary embolism) ho 3. bakuli, mathata a mokokotlo oa mokokotlo (ho tsoa mali ho tsoa mpeng ea duodenal, ho ruruha ha mpa ea mpa, ho thibeleha ka botlalo) ho bakuli ba 3, lefu le bakoang ke mabaka a sa tsejoeng ho bakuli ba 2.

Ka tlase ke HP le tlhekefetso ea litekanyetso tsa laboratori tse bonoang ho bakuli ba fumanang mofuta oa chemotherapy Zaltrap ® /FOLFIRI ka karohano ea bona ka lihlopha tsa mekhatlo ea tsamaiso ho latela sehlopha sa Medical Dictionary bakeng sa liketso tsa taolo MedDRA.

Li-HP tse hlahisitsoeng ka tlase li hlalositsoe e le maikutlo afe kapa afe a sa rateheng a kliniki kapa lits'oants'o tse maemong a laboratori tse nang le ≥2% khafetsa (bakeng sa HP ea methapo eohle e boima) sehlopheng sa aflibercept ha se bapisoa le sehlopha sa placebo thupelong e entsoeng ho bakuli ba nang le ICP. Matla a HP a ne a khethiloe ho latela NCI CTC (Setsi sa Sechaba sa Kankere sa Tloaelo e TloaelehilengUS National Cancer Institute General Toxicity Rating Scale) mofuta oa 3.0.

Liketsahalo tsa HP li ile tsa khethoa ho latela tumellano ea WHO ka tsela e latelang: khafetsa - ≥10%, hangata - ≥1-1 incl. ≥3 botebo).

Karolong ea mali le tsamaiso ea methapo ea kutlo: khafetsa - leukopenia (ea maemo ohle a boima, ho kenyelletsa le ≥3rd degree ea boima), neutropenia (ea li-degree tsohle tsa boima, ho kenyeletsa le degree ea ver3rd ea boima), thrombocytopenia (degrees tsohle tsa ho teba), hangata - febrile neutropenia (ea maemo ohle a boima, ho kenyelletsa tekanyo ea boima ba ≥3), thrombocytopenia (≥3 degree ea boima).

Ho tsoa ho sesole sa 'mele: khafetsa - karabelo ea hypersensitivity (methapo eohle ea ho teba), hangata - hypersensitivity reaction (≥3rd ho teba).

Mathata a amanang le metabolism le phepo e nepahetseng: khafetsa - ho fokotseha ha takatso ea lijo (li-degree tsohle tsa ho teba), khafetsa - ho omella (litekanyo tsohle tsa boima le boemo ba boima ba ≥3), ho fokotseha ha takatso ea lijo (≥3 degree ea boima).

Ho tsoa tsamaisong ea methapo: khafetsa - hlooho e bohloko (ea li-degree tsohle tsa ho teba), khafetsa - hlooho e bohloko (≥3 tekanyo ea ho teba), hangata - POP.

Ho tsoa likepeng: khafetsa - keketseho ea khatello ea mali (ea methapo eohle e boima) (ho karolo ea 54% ea bakuli ba neng ba e-na le keketseho ea khatello ea mali (degree3 degree ea boima), keketseho ea khatello ea mali e ntlafalitsoeng nakong ea potoloho ea pele ea kalafo), ho tsoa mali / hemorrhage (ea methapo eohle e boima), mofuta o atileng haholo oa ho tsoa mali e ne e le nosebleeds e nyane (sekhahla se matla sa 1-2), hangata mathata a bophelo bo botle ba kelello (ATEO) (joalo ka likotsi tsa methapo ea methapo ea methapo, ho kenyelletsa le tlhaselo ea nakoana ea "cerebrovascular ischemic", angina pectoris, intracardiac t ombus, myocardial infarction, arterial thromboembolism le ischemic colitis) (methati eohle ea ho teba), venous thromboembolic complication (e tebileng vein thrombosis le pulmonary embolism) ea li-degree tsohle tsa ho teba, ho tsoa mali (≥3 degree ea boima, ka linako tse ling e bolaeang), ho kenyeletsa le gastrointestinal - ho tsoa mali ka mpeng, hematuria, ho tsoa mali ka mor'a lits'ebetso tsa bongaka, khafetsa ha ho tsejoe - ho bakuli ba fumanang Zaltrap ®, nts'etsopele ea methapo e matla ea methapo ea methapo le hemorrhage / hemoptysis e tlalehiloe, i.e. . ea bolaeang.

Ho tsoa ts'ebetsong ea ho hema, sefuba le litho tsa kahare: khafetsa - ho fokola ha moea (oa methapo eohle e boima), nosebleeds (ea methapo eohle e boima), dysphonia (ea methapo eohle e boima), hangata - bohloko ho oropharynx (methapo eohle ea ho teba), rhinorrhea (rhinorrhea ea bokhopo ba 1-2 feela e hlokometsoe) , khafetsa - bokhutšoanyane ba ho hema (≥3 tekanyo ea bokhopo), nosebleeds (≥3 tekanyo ea ho teba), dysphonia (≥3 degree ea boima), bohloko ho oropharynx (≥3 degree ea boima).

Ho tsoa pampiring ea ka mpeng: khafetsa - lets'ollo (la methapo eohle ea ho kenella ka botebo ho kenyeletsa boima ba ≥3rd), stomatitis (ea methapo eohle ea ho teba, ho kenyelletsa le ho angoa ha rd3), bohloko ba ka mpeng (ka methapo eohle e boima), bohloko ho bokaholimo ba (boholo ba bokhopo), hangata - bohloko ba ka mpeng ≥3 tekanyo ea ho teba, bohloko bo kahara mpa (≥3 degree ea boima), li-hemorrhoids (li-degrees tsohle tsa ho teba), mali a tsoang ho rectum (methati eohle ea boima) , bohloko bo kahare ho rectum (methapo eohle ea ho teba ha pelo), leino le opang (li-degree tsohle tsa ho teba), aphthous stomatitis (kaofela mekhahlelo e boima), litšoantšo fistulas (anal, intestinal-urinary, ka ntle ka mpeng ea (mala a manyane) maemo a boima, ho kenyelletsa tekanyo ea degree3 ea ho teba ha botebo), ho kenyelletsa le ho bola hoa mabota a karolo ea mpa, ho tsoa mali ho tsoa mokokotlong (degree3 tekanyo ea ho teba), aphthous stomatitis (degree3 degree ea boima), bohloko ho rectum ( ≥3 botebo).

Ka lehlakoreng la letlalo le lisele tse nyane: khafetsa - palema ea limela ea palema erythrodysesthesia (boholo ba boima ba eona), hangata - hyperpigmentation ea letlalo (methati eohle ea boima), palery erythrodysesthesia syndrome (botebo ba 33).

Ho tsoa liphio le pampitšana ea ho ntša metsi: khafetsa - proteinuria (ho ea ka tlhaiso-leseling e kopaneng ea kliniki le ea laboratori) (methati eohle ea boima), keketseho ea mahloriso a serum (li-degrees tsohle tsa ho teba), hangata - proteinuria (≥3 degree ea boima), hangata - nephrotic syndrome. Mokuli a le mong ea nang le proteinuria le khatello ea mali e eketsehileng ho bakuli ba 611 ba phekotsoeng ka kalafo ea chemotherapy Zaltrap ® /FOLFIRI, o ile a fumanoa a e-na le thrombotic microangiopathy.

Mathata a akaretsang le lintho tse etsahalang setsing sa ente: khafetsa - maemo a asthenic (methati eohle ea ho teba), maikutlo a ho tepella (litekanyo tsohle tsa ho teba, ho kenyeletsa le boemo ba boima ba ≥3), hangata - maemo a ho tiisa (boemo ba 33), ka mokhoa o sa lekanyetsoang - pholiso ea leqeba la ho senya ( ho se lekane ha methapo ea leqeba, ho hloleha ha anastomoses) (methati eohle ea boima, ho kenyelletsa tekanyo ea ≥3 ea tekanyo).

Lintlha le tsebiso ea laboratori: khafetsa - ts'ebetso e eketsehang ea ACT, ALT (methati eohle ea boima bo fokotsehileng), ho theola boima ba 'mele (methati eohle ea boima), hangata - ts'ebetso e eketsehang ea ACT, ALT (degree ea 33 ea boima), e fokotse boima ba' mele (≥3rd degree ea boima) .

Khafetsa ea HP lihlopheng tse ikhethang tsa bakuli

Boloetse. Ho bakuli ba tsofetseng (≥ lilemo tse 65), ts'oaetso ea letšollo, ho tsekela, asthenia, ho fokotsa boima ba 'mele le ho felloa ke metsi' meleng e ne e phahame ho feta 5% ho bakuli ba lilemo tse nyane. Bakuli ba tsofetseng ba lokela ho betoa leihlo ka botlalo bakeng sa nts'etsopele ea letšollo le / kapa ho felloa ke metsi 'meleng.

Ho hloleha hape Bakeng sa bakuli ba nang le bothata ba ho fokola ha renal nakong ea ho qala ts'ebeliso ea Zaltrap ®, ts'oaetso ea HP e ne e bapisoa le ho bakuli ntle le ts'ebetso ea renal e sa sebetseng ka nako ea ho qala ts'ebeliso ea Zaltrap ®. Ho bakuli ba nang le mathata a ho leka-lekanya a renal, ho hlaha ha HP e sa pheleng hangata ho ne ho ka bapisoa le ho bakuli ntle le ho hloleha ha methapo, ntle le litekanyetso tsa ho fokolloa ke matla tsa "10%" kaofela.

Immunogenicity Joalo ka lithethefatsi tse ling tsohle tsa protheine, aflibercept e na le monyetla oa ho ba le bokhoni ba ho ba le immunogenicity.Ka kakaretso, ho latela liphetho tsa liteko tsohle tsa kalafo ea oncological, ha ho le ea mong oa bakuli ea bonts'itseng karolo e phahameng ea lithibela-mafu e le hore e ka qojoa.

Tšebeliso ea lithethefatsi kamora ho bapatsa

Ho tsoa pelong: maqhubu a sa tsejoeng - ho nyekeloa ke pelo, ho fokotsehile ha karolo ea ejection ea ventricle e tloheleng.

Ho tloha lehlakoreng la lisele tsa musculoskeletal le li-connective: maqhubu a sa tsejoeng - osteonecrosis ea mohlahare. Ho bakuli ba nkang kalafo ea morao-rao, ho tlalehiloe linyeoe tsa mohlahare oa osteonecrosis, haholo ho bakuli ba nang le mabaka a itseng a tšoaetso ea mohlahare, joalo ka ts'ebeliso ea litsphosphonates le / kapa lits'ebetso tse hlaselang tsa meno.

Tekanyetso le tsamaiso

Iv, ka sebopeho sa infusion ea hora e le 'ngoe e lateloang ke ho hlahisoa ha mofuta oa chemotherapeutic FOLFIRI. Tekanyetso e khothalletsoang ea Zaltrap ®, e sebelisoang hammoho le regimen ea chemotherapeutic FOLFIRIke 4 mg / kg.

Chemotherapy regimen FOLFIRI

Ka letsatsi la pele la potoloho - mananeo a iv ka nako e le 'ngoe a sebelisa catheter ea Yinotecan e tsoang lethong la 180 mg / m 2 bakeng sa 90 min le calcium folate (leqhetsoana le letsohong le letona) ka tekanyo ea 400 mg / m 2 bakeng sa 2 h, s. kamora ho latela iv (bolus) tsamaiso ea fluorouracil ka tekanyo ea 400 mg / m 2, e lateloe ke ho kenella kahare ho fluorouracil ka tekanyetso ea 2400 mg / m 2 bakeng sa lihora tse 46

Lipotoloho tsa chemotherapy li phetoa libeke tse ling le tse ling tse peli.

Phekolo ka Zaltrap ® e lokela ho tsoelapele ho fihlela kholo ea mafu kapa nts'etsopele ea chefo e sa amoheleheng.

Litlhahiso tsa ho lokisa kalafo ea dosing / ho lieha kalafo

Phekolo ka Zaltrap ® e lokela ho khaotsa maemong a latelang:

- Nts'etsopele ea ho tsoa mali haholo,

- Nts'etsopele ea ho hloekisa mabota a pampitšana ea mala,

- nts'etsopele ea khatello ea maikutlo kapa khatello e matla ea methapo ea mali,

- nts'etsopele ea mathata a bophelo bo botle,

- nts'etsopele ea nephrotic syndrome kapa "thrombotic microangiopathy"

- nts'etsopele ea liphetoho tse matla tsa hypersensitivity (ho kenyelletsa bronchospasm, ho hema ka thata, angioedema, anaphylaxis),

- tlolo ea pholiso ea maqeba, e hlokang hore motho a kenelle kalafong,

- nts'etsopele ea reversible posterior encephalopathy syndrome (POPs), hape e tsejoang e le reversible posterior leukoencephalopathy (POPs).

Bonyane libeke tse 4 pele ho ts'ebetso e reriloeng, kalafo e nang le Zaltrap ® e lokela ho emisoa ka nakoana.

Bakeng sa tlhaiso-leseling e batsi ka chefo ea irinotecan, fluorouracil le calcium folate, bona litaelo bakeng sa ts'ebeliso ea bona.

Lihlopheng tse khethehileng tsa bakuli

Bana. Ts'ireletseho le katleho ho bakuli ba bana ha e so thehiloe.

Phuputsong e mabapi le polokeho le mamello ka keketseho ea lethal dose, bakuli ba 21 ba lilemo li 2 ho isa ho tse 21 (ba bolela lilemo tse 12,9) ba nang le tumor tse tiileng ba amohela Zaltrap ® ka tekanyetso ea 2 ho isa ho 3 mg / kg iv ka nako ea libeke tse peli. Litekanyetso tsa pharmacokinetic tsa litlamorao tse sa lefelloeng li ile tsa hlahlojoa ho tse robeli tsa bakuli bana (ba lilemo li 5 ho isa ho 17) bona Pharmacokinetics, karolwana "Lihlopheng tse khethehileng tsa bakuli". Tekanyetso e kholo e mamelletsoeng thutong e ne e le tekanyetso ea 2,5 mg / kg, e neng e le tlase ho tekanyetso e sireletsehileng le e sebetsang ho batho ba baholo ba nang le mofetše oa metastatic colorectal.

Bakuli ba baholo. Bakuli ba seng ba tsofetse ha ba hloke phetoho ea tekanyetso ea Zaltrap ®.

Ho hloleha ha sebete. Lithuto tse hlophisitsoeng mabapi le ts'ebeliso ea Zaltrap ® ho bakuli ba nang le bothata ba sebete ha li so etsoa. Ho ipapisitsoe le tlhahlobo ea bongaka, ho pepeseha hoa tlhaho ea li-aflibercept ho bakuli ba fokolang le ho leka-lekanya ho hloleha ha sebete ho ne ho tšoana le ho bakuli ba nang le ts'ebetso e tloaelehileng ea sebete.

Bopaki ba kliniki bo fana ka maikutlo a hore ho fetoloa ha lethalamo la aflibercept ho bakuli ba bonolo le ho leka-lekanya ho hloleha ha sebete ha ho hlokehe.

Ha ho na data ea ts'ebeliso ea aflibercept ho bakuli ba nang le bothata bo boholo ba hepatic.

Ho hloleha hape Lithuto tse hlophisitsoeng mabapi le ts'ebeliso ea Zaltrap ® ho bakuli ba nang le ts'ebetso ea renal e holofetseng ha lia etsoa. Ho ipapisitsoe le tlhahlobo ea tliliniki, ho pepesetsoa hoa aflibercept ho bakuli ba fokolang le ho leka-lekanya ho hlaphoheloa ke pheko ho ne ho tšoana le ho bakuli ba nang le ts'ebetso e tloaelehileng ea renal.

Bopaki ba kliniki bo fana ka maikutlo a hore ha ho hlokahale hore ho lokisoe tekanyetso ea pele ea kalafo ho bakuli ba nang le phofshoana ea ho hlaphoheloa kelellong ha ho hlokahale. Ho na le datha e nyane haholo mabapi le ts'ebeliso ea lithethefatsi ho bakuli ba nang le bothata bo matla ba ho phekoloa ke lefu la masapo, ka hona tlhokomeliso e lokela ho ba teng ha u sebelisa lithethefatsi ho bakuli ba joalo.

Malebela mabapi le ho hlophisoa ha tharollo le kenyelletso ea bona

Setlhare se lokela ho sebelisoa tlasa tataiso ea ngaka e nang le boiphihlelo ts'ebelisong ea lithethefatsi tsa antitumor.

Se ke oa kenella ka ho teba. Se ke oa kenya ente ka jete (leha e le ho potlaka ebile e sa liehe).

Zaltrap ® ha e reretsoe tsamaiso ea methapo.

Joalo ka litokisetso tsohle tsa botsoali, pele ho tsamaiso, tharollo e hlapollotsoeng ea Zaltrap ® e lokela ho hlahlojoa ka mokhoa o hlakileng bakeng sa boteng ba likaroloana kapa discoloration.

Litharollo tsa Zaltrap ® tse kopilitsoeng li lokela ho tsamaisoa ho sebelisoa li-infusion tsa IV tse entsoeng ka PVC tse nang le diethylhexyl phthalate (DEHP), PVC e se nang DEHP, empa e na le trioctyltrimellate (TOTM), polypropylene, PE, e koahetsoeng ka hare ho PVC, polyurethane.

Li-infusion tsa IV li lokela ho ba le lipilara tsa polyethersulfone tse bophara ba 0,2 micons. Se ke oa sebelisa lifilimi tsa polyvinylidene fluoride (PVDF) kapa li-nylon.

Ka lebaka la khaello ea lithuto tsa ho ikamahanya le maemo, Zaltrap ® ha ea lokela ho kopanngoa le lithethefatsi tse ling kapa li-sol sol, ntle le tharollo ea 0.9% sodium chloride le 5% dextrose tharollo.

Ho hlophisoa ha tharollo ea infusion le ho sebetsana le eona

Tharollo ea infusion ea lithethefatsi Zaltrap ® e lokela ho lokisoa ke setsebi sa bongaka maemong a aseptic tumellanong le ts'ebetso e bolokehileng ea ts'ebetso.

Se ke oa sebelisa botlolo ka sethethefatsi haeba tharollo ea mohopolo e na le likaroloana tse sa sebetseng kapa ho na le phetoho ea 'mala oa eona.

Lisebelisoa tsa infusion tse entsoeng ka PVC tse nang le DEHP kapa polyolefin (ntle le PVC le DEHF) li lokela ho sebelisoa.

Feela bakeng sa infusion e kenang kahare ka lebaka la hyperosmolarity (1000 mosmol / kg) ea Zaltrap ® concentrate.

Setlhare ha se reretsoe ho entoa 'meleng oa vitreous.

Ho tsepamisa mohopolo ea lithethefatsi Zaltrap ® e tlameha ho ts'oaroa. Tlosa sekhahla se hlokahalang sa Zaltrap ® ho tsepamisa mohopolo ebe o hlapollela palo e hlokahalang ka tharollo ea 0.9% ea sodium chloride bakeng sa ente kapa 5% dextrose tharollo ea ente.

Ts'oarello ea aflibercept tharollong ea infusion kamora ho hlapolla mohatla oa Zaltrap ® e lokela ho ba maemong a 0,6-8 mg / ml.

Ho tloha ponong ea likokoana-hloko, tharollo e hlapolotsoeng ea Zaltrap ® e lokela ho sebelisoa hang-hang, botsitso ba eona ba 'mele le lik'hemik'hale bo bolokoa nako e telele ho fihlela lihora tse 24 ka mocheso oa 2-8 ° C le ho fihlela lihora tse 8 ho mocheso oa 25 ° C.

Li-vials tsa lithethefatsi Zaltrap ® li etselitsoe tšebeliso e le 'ngoe. Tekanyo efe kapa efe ea lithethefatsi tse sa sebelisoang tse setseng ka viking e tlameha ho lahloa ho latela litlhoko tse loketseng tsa Serussia. Se ke oa phunya sethala sa vial hape kamora hore nale e se e kentsoe.

Bongata

Ha ho na tlhahisoleseling mabapi le polokeho ea ho nka Zaltrap ® ka tekanyetso e fetang 7 mg / kg hang libekeng tse ling le tse ling tse 9 kapa 9 mg / kg hang libekeng tse tharo.

Matšoao HP e atileng haholo e bonoang ka litlhaloso tsena tsa dosing e ne e tšoana le ea HP e hlokometsoeng le moriana o noang ka tekanyetso ea kalafo.

Phekolo: pheko ea tlhokomelo e ea hlokahala, haholo-holo ho shebella le kalafo ea khatello e eketsehang ea mali le proteinuria. Ha ho na le litlhare tse tobileng tsa Zaltrap ®. Mokuli o lokela ho ba tlhatlhobong e haufi ea bongaka ho khetholla le ho hlokomela HP efe kapa efe e hlalositsoeng karolong ea "Side Athonse".

Fomu ea tokollo

Nahanela tharollo ea infusion, 25 mg / ml. 4 ml ea lithethefatsi ka botlolong ea khalase e se nang mebala (mofuta oa I), e koahetsoeng ka sethala sa rabara sa brkidutyl ka sekepe sa aluminium crimp ka reng e tiileng le disk e tiisang. 1 kapa 3 Fl. ka mokotleng oa karete. 8 ml ea lithethefatsi ka botlolong ea khalase e se nang mebala (mofuta oa I), e koahetsoeng ka sethala sa rabara sa brongosutyl ka sekepe sa aluminium crimp ka reng e tiileng le disk e tiisang. 1 Fl. ka mokotleng oa karete.

Litaelo tsa ts'ebeliso ea Zaltrap

Lintho tse sebetsang: aflibercept 25 mg
Baeti: sodium phosphate monohydrate (E339), sodium hydrogen phosphate heptahydrate (E339), citric acid monohydrate (E330), sodium citrate dihydrate (E331), granular sodium chloride, sucrose, Polysorbate 20 (E433), hydrochloric acid 36% (E507xrox), hydrochloric acid (E524), metsi a ente.
Tlhaloso Mokelikeli o pherese o se nang 'mala kapa o pherese e' mala o mosehla, o litšila litšila mochesong.

Tlhaloso ea lithethefatsi

Setlhare ke sa sehlopha sa antitumor agents. E hlahisoa ka mokhoa oa ho tsepamisa mohopolo, ho tloha moo ho rarolloang tharollo ea infusion. Lebitso le sa ameheng la machabeng le anngoe. Mabitso a khoebo ke Zaltrap le Eilea.

Matšoao a ho sebelisoa

Ka nako e ts'oanang, ho nkuoa tekanyetso e itseng ea folic acid, irinotecan le fluorouracil. Lisebelisoa tsena kaofela li sebelisetsoa chemotherapy ho bakuli ba nang le mofetše oa colorectal, ha e bontša ho hanyetsa ho hoholo ha li-antitumor agents. Hape, "Zaltrap" e sebelisetsoa ho khutla.

Ts'ebetso ea pharmacological ea aflibercept

Tlas'a tšusumetso ea aflibercept, li-receptors tse fanang ka sebopeho sa methapo e mecha ea mali bakeng sa phepo le ho ntlafatsa kholo ea tumor e khaotsa ho sebetsa. Ka lebaka la hore ha ho na mali a lekaneng a phalloang, neoplasm butle-butle e fokotseha ka boholo, lisele tsa atypical li khaotsa ho arohana le ho hola.

Tlhahisoleseling ea hore na metabolism ea protheine ea aflibercept e etsahala joang ha e fumanehe. Bo-rasaense ba fana ka maikutlo a hore e ikarola ka har'a amino acid le li-peptide. Karolo e sebetsang e ntšoa 'meleng ka matsatsi a ts'eletseng ka mantle. Liphio ha li kopanele ho ntšoa ha chelete.

Litaelo tsa ts'ebeliso "Zaltrap"

Moriana o kenngoa mothapong ka hora. Litekanyetso li baloa ho 4 mg ka kilogram ea boima ba 'mele. Ngoliso ea chemotherapeutic e tla ba ka tsela e latelang:

1. Letsatsing la pele la kalafo, ho sebelisoa catheter e nang le sebopeho sa Y, ka thuso ea moo infusions e kenang e kenngoeng hammoho le irinotecan ka boholo ba limilimitara tse 180 kaimithara. Ts'ebetso e nka metsotso e 90. Calcium calcium e fanoa ka lihora tse peli ho litekanyetso tsa 400 mg le tekanyo e lekanang ea fluorouracil,
2. Tšusumetso e latelang e tla tsoelapele ka lihora tse 46. Tabeng ena, fluorouracil e tsamaisoa ka tekanyetso ea 2400 mg.

Potoloho ena ea phekolo e phetoa libeke tse ling le tse ling tse peli. Bakeng sa batho ba nang le lefu la tsoekere, litekanyetso ha li hloke ho fetoloa.

Ts'oaetso e lokela ho etsoa ke ngaka e nang le boiphihlelo ts'ebetsong ea chemotherapeutic.

Ka sebopeho se sa sebetsoang le ka jet, lithethefatsi ha lia lokela ho fanoa maemong afe kapa afe.

Pele o sebelisoa, tharollo e hlahlojoa ka hloko. E lokela ho ba ea ponahalo e nepahetseng ntle le likaroloana tse sa sebetseng.

Se ke oa sebelisa likhoele tsa nylon kapa polyvinylidene fluoride nakong ea infusions.

Kaha ha ho na tlhahisoleseling mabapi le motsoako oa sethethefatsi le lithethefatsi tse ling, ho lumelloa ntho feela e nang le tharollo ea sodium chloride kapa dextrose.

Ke ngaka feela e lokelang ho lokisa tharollo bakeng sa tsamaiso ea methapo, ho boloka melao ea asepsis. Se ke oa sebelisa botlolo e nang le likaroloana tse sa sebetseng kapa 'mala oa moriana o fetohile. Kamora ho hlapoloha, mokokotlo oa aflibercept e lokela ho ba sebakeng sa 0,6-8 mg / ml. Hoa hlokahala ho sebelisa moriana o felisitsoeng hang-hang, kaha ho bolokoa ha botsitso ba 'mele le lik'hemik'hale ho ka bonoa feela motšehare.

Molemong oa ho reka "Zaltrap", theko ea eona le polokelo

O ka reka moriana khemising. Ho etsa sena, o hloka ho fana ka lengolo la ngaka. Kantle ho eona, thekiso ea lithethefatsi ha e qheleloe ka thoko. Litsenyehelo tsa botlolo ea sethethefatsi li tsoa ho li-ruble tse 8500.

Setlhare se lokela ho ba ka kamoreng eo mocheso o sa phahamang ho feta 8 mme o se tlase ho 2 degrees. Moriana ha oa lokela ho pepesetsoa khanya ea letsatsi.

O ka boloka moriana ona lilemo tse tharo ho tloha ka letsatsi la tlhahiso. Kamora ho fela ha nako ena, o ka se sebelise lithethefatsi, ka hona li tlameha ho lahloa.

Maikutlo mabapi le "Zaltrap"

"Saltrap" e ile ea tšoara ntate oa ka. Ena ke moriana o motle, o sebetsa hantle khahlanong le hlahala, empa litla-morao li lula li hlaha. Ho molemo hore ba e ente hang ka libeke tse ling le tse ling tse peli, hobane ntate o ne a le thata haholo ho mamella chemotherapy. Empa litlhahlobo li bonts'itse hore neoplasm e ea fokotseha.

Kamora ho hlahisoa ha Zaltrap, hlooho ea ka e ne e opa khafetsa, ho bile le letsoai le ho hlatsa, ke ne ke batla ho robala. Empa moriana o ama hlahala kapele. Ka hona, bakeng sa ho fumana sephetho se setle, o ka mamella.

Le mori lithethefatsi li theko e boima le boemo kamora hore li mpe, empa li hlile lia thusa. Ka thuso ea lithuto tse 'maloa, ke ile ka khona ho tlosa hlahala. Lingaka li re ho na le monyetla o fokolang oa ho khutla hape. Pele ho moriana ona, ke ile ka tšoaroa ke ba bang, empa phello ea bona e ile ea tsoela pele ka nakoana. Ka mor'a Zaltrap, ha ke e-so be le matšoao a kankere ka lilemo tse 'maloa.

Re tla leboha haholo haeba u e lekanya le ho e arolelana marang-rang a sechaba

Lokolla liforomo le sebopeho

Tsepamisa maikutlo eo tharollo ea infusion e lokiselitsoeng ho eona. Liphoofolo li na le bophahamo ba 4 ml le 8 ml. Palo ea ntho ea mantlha ea aflibercept ke 25 mg ho 1 ml. Khetho ea bobeli ke tharollo e entsoeng ka lithaelese tse entsoeng bakeng sa tsamaiso ea methapo. 'Mala oa tharollo o hlakile kapa o na le tint e' mala o mosehla.

Karolo e ka sehloohong ke protheine ea mehleng ea khale. Lintho tse tsoang ho bona: sodium phosphate, asiti ea acid, hydrochloric acid, sucrose, chloride ea sodium, sodium hydroxide, metsi.

Aflibercept e thibela mosebetsi oa li-receptor, tse ikarabellang bakeng sa ho theha methapo e mecha ea mali e fepang tumor le ho kenya letsoho kholong ea eona e kholo. Ho sala ntle le phepelo ea mali, neoplasm e qala ho fokotseha ka boholo. Ts'ebetso ea kholo le karohano ea lisele tsa eona tsa atypical ea emisa.

Aflibercept e thibela tšebetso ea li-receptor, tse ikarabellang bakeng sa ho theha methapo e mecha ea mali.

Ka tlhokomelo

Ho lekola khafetsa boemo ba bophelo bo botle ho bakuli ba nang le ho se sebetse hantle ha masapo, khatello ea methapo ea mali, lefu la pelo le mathata a methapo ea pelo ea ho hloleha hoa hlokahala. Ka tlhokomeliso, moriana o laetsoe bakuli ba tsofetseng le ba boemo bo bobe ba bophelo bo botle, haeba tekanyo ea litekanyetso e sa phahame ho feta lintlha tse peli.

U ka nka Zaltrap joang?

Intravenous tsamaiso - infusion bakeng sa hora e 1. Tekanyetso e tloaelehileng ke 4 mg ka kilogram ea boima ba 'mele. Phekolo e saennoa motheong oa mofuta oa chemotherapeutic:

• letsatsi la pele la phekolo: Ho kenella kahare ho catheter e nang le sebopeho sa Y e sebelisang Irinotecan 180 mg / m² bakeng sa metsotso e 90, Kalsiamo ea khalsiamo bakeng sa metsotso e 120 ka tekanyo ea 400 mg / m² le 400 mg / m² Fluorouracil,
• infusion e tsoelang pele e nka lihora tse 46 ka tekanyetso ea Fluorouracil 2400 mg / m².

Intravenous tsamaiso - infusion bakeng sa hora e 1.

Potoloho e phetoa ka mor'a matsatsi a 14.

Phekolo ea ka mpeng

Letšollo, bohloko ba ka mpeng ba methapo e mengata, nts'etsopele ea li-hemorrhoids, sebopeho sa "fistulas" ho "anus" senya "senya", "mala". Ho opeloa ke leino ho ka 'na ha etsahala, leqhubu la mokokotlo, ho opeloa ke mokokotlo. Fistulas tsamaisong ea tšilo ea lijo le litlolo tse ntle tsa mabota ha li etsahale hangata, e leng se ka lebisang lefung la mokuli.

Matšoao a mabe a tsoang tsamaisong ea phefumoloho: dyspnea hangata e ba teng.

Ho tsoa ho tsamaiso ea methapo ea pelo

E qhomela khatello ea mali, mali a tsoang ka hare. Ho bakuli ba bangata: thromboembolism, tlhaselo ea ischemic, angina pectoris, kotsi e kholo ea infarction ea myocardial. Ka seoelo: ho buloa ha hemaniocerebral hemorrhage, ho tšoeloa ke mali, ho etsa hore mali a fokotsehe ka mpeng ea mpa, e leng lisosa tsa lefu.

Tšusumetso ho bokhoni ba taolo ea methapo

Ha ho na datha thutong ea hore na litlamorao li ka bakoa ke eng litlamorao. Ho khothalletsoa ho hana ho khanna le ho sebetsa ka mekhoa e rarahaneng haeba mokuli a e-na le litlamorao ho tsoa ho tsamaiso ea methapo e kholo, mathata a kelello.

Pele ho potoloho e ncha ea phekolo (ka matsatsi a mang le a mang a 14), tlhahlobo ea mali e lokela ho etsoa.

Pele ho potoloho e ncha ea phekolo (ka matsatsi a mang le a mang a 14), tlhahlobo ea mali e lokela ho etsoa. Setlhare se fanoa feela sepetlele bakeng sa karabelo e tlang ka nako matšoao a ho felloa ke metsi, ho hloekisa mabota a pampitšana ea ka mpeng.

Bakuli ba nang le index ea bophelo bo botle ba lintlha tse 2 kapa ho feta ba na le kotsi ea liphetho tse bohloko. Ba hloka ho lula ba beiloe tlhokomelong ea bongaka bakeng sa ho fumana tšoaetso ea bophelo bo botle ka nako e loketseng.

Ho thehoa ha fistulas ho sa tsotelehe hore na ba hokae, ke sesupo sa ho felisoa ha kalafo. Ha hoa lumelloa ho sebelisa meriana ena kalafong ea bakuli ba entseng ts'ebetso e kholo ea ts'ebetso (ho fihlela maqeba a fola ka botlalo).

Banna le basali ba lilemo tsa ho ba le bana ba lokela ho sebelisa mekhoa e fapaneng ea thibelo ea bokhachane nakong ea likhoeli tse tšeletseng (eseng ka tlase ho moo) kamora tekanyetso ea ho qetela ea Zaltrap. mohopolo oa ngoana ha oa lokela ho qheleloa ka thoko.

Tharollo ea Zaltrap ke hyperosmotic. Sebopeho sa eona ha se kenyeletse ts'ebeliso ea lithethefatsi bakeng sa sebaka sa intraocular. Ho thibetsoe ho hlahisa tharollo 'meleng oa vitreous.

Sebelisa botsofaling

Ho na le kotsi e kholo ea ho ba le lets'ollo la nako e telele, ho tsekela, ho theola boima ba 'mele ka potlako le ho omella hoa metsi ho bakuli ba sehlopha sa lilemo tse 65 le ho feta. Phekolo ea Saltrap e lokela ho etsoa feela ka taolo ea basebetsi ba bongaka. Ponong ea pele ea letšollo kapa ho felloa ke metsi, ho hlokahala kalafo ea matšoao hanghang.

Phekolo ea Saltrap e lokela ho etsoa feela ka taolo ea basebetsi ba bongaka.

Sebelisa nakong ea bokhachane le pelehi

Lintlha ka ts'ebeliso ea Zaltrap ho basali baimana le ba anyang ha li fumanehe.

Ha ho fanoe ka likotsi tse ka bang le litlamorao tse mpe ho ngoana, sethethefatsi sa antitumor ha se ngoletsoe lihlopha tsena tsa bakuli.

Tlhahisoleseling ea hore na motsoako o sebetsang oa moriana o kenelletsoe lebeseng la letsoele ha o joalo. Haeba ho hlokahala, sebelisa moriana o sebelisang kalafo ea mofets'e ho motsoetse, ho nyekeloa ho lokela ho hlakoloa.

Moetsi

Sanofi-Aventis Deutschland GmbH, Jeremane.

Pheko ea lithethefatsi tsa tumor

Liphello tsa Antitumor tsa livithamini

Ksenia, ea lilemo li 55, Moscow: “Tsela ea Zaltrap e ne e fuoe ntate ho fumana kalafo ea mofets'e. Setlhare sena se lokile, sea sebetsa, empa se thata haholo. Kamehla ho na le matšoao a lehlakoreng. Ke hantle hore e fanoa hang ka mor'a libeke tse ling le tse ling tse peli, hobane kamora ho phekoloa ka chemotherapy boemo ba ntate bo lula bo mpefala ka nakoana, empa liteko li bontšitse mokhoa o motle oa phokotso ea neoplasm. ”

Eugene ea lilemo li 38, Astana: “Ke ile ka utloa litla-morao tse ngata ho tsoa Zaltrap. Boemo e ne e le bo bobe feela: ho nyekeloa, ho hlatsa, hlooho e sa feleng, bofokoli bo matla. Empa moriana o sebetsa tumelong kapele. Kameho ea tšebeliso ea eona kalafong ea mofets'e e bohlokoa ho pholoha tlhokofatso ena kaofela. "

Alina, ea lilemo li 49, Kemerovo o re: “Ena ke lithethefatsi tse theko e boima, 'me boemo ba kamora kalafo ea chemotherapy ka bona ke hore ha ke batle ho phela. Empa ea sebetsa. Ketsahalong e le 'ngoe, hlahala ea ka e ile ea batla e nyamela. Ngaka e itse ho na le monyetla oa ho khutla hape, empa liperesente tse nyane. Lithethefatsi tse ling li ile tsa sebelisoa pele ho Zaltrap, empa litlamorao e bile tsa nakoana, 'me ka mor'a moo ke phetse ntle le matšoao a mofets'e ka lilemo tse tharo. ”

Zaltrap e ka kenngoa

Pele u nka meriana ena, bolella ngaka ea hau ka meriana ea hau ea morao-rao, lipilisi tse fanang ka phepo e nepahetseng (mohlala, livithamini, tlatsetso ea tlhaho, jj), maikutlo a ho kula, maloetse a teng le maemo a bophelo a hona joale (jk. Moimana, ho buuoa ho tlang, joalo-joalo).

Litlamorao tsa lithethefatsi li ka phatlalatsoa haholoanyane maemong a itseng a mmele oa hau. Ela moriana joalo ka ha u laetsoe ke ngaka ea hau kapa u latele litaelo tsa tšebeliso e fanoeng ke moriana oo. Tekanyetso ea lithethefatsi e latela boemo ba hau. Bolella ngaka ea hau haeba ho se na liphetoho kapa boemo ba hao bo ntse bo mpefala.

Lintlha tsa bohlokoa tsa ho buisana le mofani oa hau oa tlhokomelo ea bophelo bo botle li thathamisitsoe ka tlase.

• Hlahloba bakuli ba tsofetseng haholo bakeng sa lets'ollo le ho omella

Fumana haholoanyane: Litlhokomelo le melao ea ts'ebeliso

Ho fumana tlhaiso-leseling ena, ka kopo etela ngaka ea hau, setsebi sa meriana kapa u bale tlhahisoleseling ho liphutheloana tsa sehlahisoa.

Zaltrap Injectable e fumaneha ka har'a lipakete tse latelang ka likhetho tse latelang tsa matla

Packaging e fumanehang ea Zaltrap: 4MG

Moriana o hlahisoa ke lik'hamphani tse latelang

E lumelletsoe ho sebelisa lisebelisoa tse boima tsa indasteri ha u ntse u sebelisa sethethefatsi see? Haeba u ikutloa u otsela, ho tsekela, ho opeloa ke hlooho, kapa ho opeloa ke hlooho ha u ntse u nka Zaltrap Injectable, joale u ka hloka ho tlohela ho khanna le lisebelisoa tse boima tsa indasteri.

U lokela ho khaotsa ho khanna haeba ho sebelisa lithethefatsi ho etsa hore o ts'oenyehe, u be monyebe kapa u be le khatello ea maikutlo. Lingaka li khothaletsa ho emisa tšebeliso ea joala ka lithethefatsi tse joalo, hobane joala haholo bo ntlafatsa litlamorao le ho otsela. Ka kopo sheba liphetho tsena 'meleng oa hau ha u sebelisa Zaltrap Injectable.

Etsa bonnete ba hore u buisana le ngaka ea hau bakeng sa likeletso tse mabapi le litšobotsi tsa 'mele oa hau le bophelo bo botle ka kakaretso. Na moriana o (sehlahisoa) o oa lemalla kapa o lemalla? Lithethefatsi tse ngata ha li lemalle kapa hona ho lemalla.

Maemong a mangata, mmuso o beha lithethefatsi tse ka lemalloang joalo ka lithethefatsi tse laoloang. Mohlala, graph H kapa X India le graph II-V ho la USA. Ka kopo bala tlhaiso-leseling e pakiloeng ea moriana ho etsa bonnete ba hore setlhare sena ha se nkuoe se laoloa.

Ntle le moo, u se ke oa inahanela ebile u se ke ua tloaela 'mele oa hau ka meriana ntle le ho buisana le ngaka ea hau. Na hoa khoneha ho khaotsa ho e nka hang-hang, kapa na ke hloka ho fokotsa tekanyetso? Meriana e meng e tlameha ho khaotsa butle-butle ka lebaka la phello ea ho hlaphoheloa.

Etsa bonnete ba hore u buisana le ngaka ea hau bakeng sa likeletso tse mabapi le litšobotsi tsa 'mele oa hau, bophelo bo botle ka kakaretso le meriana e meng eo u e noang.

Haeba u hopotse tekanyetso e latelang, e nke kapele kamoo ho ka khonehang. Haeba tumellano ea kopano e atametse, o ka tlola tumellano ea pejana mme o tsoele pele ho latela kemiso ea hau e tloaelehileng ea meriana. Se ke oa nka tekanyetso e eketsehileng ho etsa lethal dose e lahlehileng.

Haeba u kopana le boemo bona khafetsa, nahana ka ho theha likhopotso kapa botsa setho sa lelapa la hau ho boloka kemiso.

Etsa bonnete ba hore o teana le ngaka ea hau hore u fetole kemiso bakeng sa ho lefella meriana e lahlehileng (haeba u hlolohetsoe matsatsi a mangata).

Se ke oa feta tekanyetso e khothalletsoang. Ho sebelisa lithethefatsi haholo ha ho na ho fokotsa boemo ba hau, hape ho ka baka chefo le litlamorao tse mpe. Haeba u tseba ka overdose ea Zaltrap Injectable, ikopanye le lits'ebeletso tsa maemo a tšohanyetso, sepetlele kapa sepetlele se haufi.

Etsa bonnete ba hore o tlisa sephutheloana, sejana kapa lebitso la moriana ho tsamaisa tlhahlobo ea maikutlo. Se ke oa fetisetsa lithethefatsi tsa hau ho batho ba bang, le haeba ba le boemong bo tšoanang le ba hau, kapa ho bonahala eka ho uena maemo a hau a na le matšoao a mangata a tšoanang, hobane sena se ka lebisa ho overdid.

• Boloka litokisetso tsa mocheso oa kamoreng, sebakeng se phodileng le hole le khanya ea letsatsi. Se ke oa chesa litokisetso haeba tlhokahalo e joalo e sa fanoe ka mokhoa o hlakileng ho litaelo. Boloka meriana e hole le liphoofolo le bana.

  Se ke oa kena-kenana le litokisetso tsa ntloaneng kapa litsing tsa metsi, haeba sena se sa hlakeloe ka botlalo ka litaelo. Meriana e lahliloeng ka tsela ena e ka baka kotsi e kholo tikolohong.

  Bakeng sa tlhaiso-leseling e batsi mabapi le ho lahla Zaltrap Injectable, ikopanye le mofani oa litsebeletso tsa bophelo bo botle.

Le tekanyetso e le 'ngoe e felileng ea Zaltrap e ka kengoang e ka baka litlamorao tse mpe. Etsa bonnete ba hore u buisana le ngaka ea hau haeba u ikutloa u fokola kapa u opeloa. Ntle le moo, sethethefatsi se felileng se ka lahleheloa ke katleho ho loants'a lefu la hau.

Ho etsa bonnete ba polokeho ea hau, ho bohlokoa haholo ho hana ho nka meriana e felileng.

Haeba u tšoeroe ke lefu le hlokang meriana e sa khaotseng (lefu la pelo, ho tsitsipana, karabelo e behang bophelo bohle kotsing), o hloka ho theha mocha o tšepahalang oa puisano le mofani oa hau oa lithethefatsi hore o lule o na le mefuta e mengata ea meriana e ncha e nang le bophelo bo tloaelehileng ba shelefo.

Ka kopo ikopanye le setsebi sa tlhokomelo ea bophelo bo botle kapa setsebi sa meriana, 'me u shebe le tlhaiso-leseling e fumanehang ka har'a sehlahisoa.

1. LABEL e hlophisitsoeng letsatsi le letsatsi: tharollo ea ZALTRAP-ziv-aflibercept, tsepamisa mohopolo https://dailymed.nlm.nih.gov/dailymed/dr ...... - O fumane monyetla: October 12, 2016.
2. Likhetho tsa NHS. Ke lokela ho etsa eng ha ke fetoa ke tekanyetso ea lithibela-mafu? - E fumane phihlello: Phupu 14, 2016.
3. Na U Kile Ua Hloka Tekanyetso ea Motsoako oa Hao? - E fumane phihlello: Phupu 3, 2016.
4. Cancer.Net (2014).

Bohlokoa ba ho nka kalafo ea hau ka nepo - E fihlelletse: Phupu 3, 2016.