Names and pronunciation
(dos-TAR-li-mab-gxly) Jemperli
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Drug reference
(dos-TAR-li-mab-gxly) Jemperli
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Func. class.: Antineoplastic, misc
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Chem. class.: PD-1 blocking antibody
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ACTION: Binds PD-1 ligands to the PD-1 receptor found on T cells, inhib- its T-cell proliferation and cytokine production
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USES: Endometrial cancer, solid tumors
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CONTRAINDICATIONS: Hyper- sensitivity, pregnancy, breastfeeding Precautions: Immune-mediated adverse reactions, pneumonitis, respiratory disorders
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SIDE EFFECTS CNS: Fatigue, asthenia, neurologic tox- icities GI: Diarrhea, nausea, vomiting, constipa- tion, hepatitis, colitis INTEG: Infusion-related reactions CV: Myocarditis GU: Nephritis RESP: Pneumonitis
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INTERACTIONS None known Lab/Drug Test Increase: alkaline phosphatase Decrease: lymphocytes, sodium, albumin
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DOSAGE AND ROUTES • Adult: : IV INF dose 1 through dose 4: 500 mg q3wk; then dose 5 onwards 1000 mg q6wk, give over 30 min
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Available forms: Injection 500-mg/ 10-mL (50 mg/mL) single-dose vial D
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Administer: • Visually inspect the solution for par- ticulate matter and discoloration; the so- lution is clear to slightly opalescent, col- orless to yellow • Discard the vial if visible particles are observed • Do not shake • Discard the vial if visible particles are observed • For the 500-mg dose, withdraw 10 mL of product and dilute in an IV infusion bag with 0.9% Sodium Chloride Injection USP or 5% Dextrose Injection USP (2-10 mg/mL; max 250 mL). Compatible infu- sion bags are polyolefin, ethylene vinyl acetate, or polyvinyl chloride with di(2- ethylhexyl) phthalate (DEHP) • For the 1000-mg dose, withdraw 10 mL from each of 2 vials (withdraw 20 mL total) and dilute in an IV bag containing 0.9% Sodium Chloride Injection USP or 5% Dextrose Injection USP (4-10 mg/mL; max 250 mL) • Mix by gentle inversion; do not shake • Discard unused portion • Storage: protect from light; store pre- pared solution at room temperature for up to 6 hr from the time of preparation until the end of infusion or refrigerated at 2°C-8°C (36ºF-46ºF) for up to 24 hr from time of preparation until end of in- fusion, allow the diluted solution to come to room temperature before use; do not freeze • Give over 30 min through an IV line using tubing made of polyvinyl chloride or platinum-cured silicon; fittings made of polyvinyl chloride or polycarbonate; and a sterile, nonpyrogenic, low-protein- binding, 0.2-micron, in-line or add-on filter • Do not admix or run drugs through the same infusion line
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Assess: • Severe and fatal immune-medi- ated adverse reactions: During and after last dose. Monitor for symptoms/ signs that may be immune-mediated ad- verse reactions. Monitor LFTs, creatinine, and thyroid function tests baseline and periodically during treatment. In cases of suspected immune-mediated adverse re- actions •Transplant-related complications: Closely monitor for febrile syndrome, GVHD, may be fatal • Pregnancy/breastfeeding: Do not use in pregnancy or breastfeeding, verify pregnancy status in those of reproductive potential before starting therapy, use ef- fective contraception during and for 4 mo after last dose • Infusion-related reactions: Assess for burning, redness, inflammation at the site; interrupt or slow infusion or discon- tinue if severe
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Evaluate: • Therapeutic response • Decreasing spread of endometrial cancer, solid tumors. Teach patient/fam- ily: • Pregnancy/breastfeeding: Not to use in pregnancy and breastfeeding, a pregnancy test will be obtained before starting treatment in those of pregnancy potential, use effective contraception during and for 4 mo after last dose
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CLINICAL CONSIDERATIONS
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PHARMACOKINETICS Half-life 23.5 days
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• Adult: : IV INF dose 1 through dose 4: 500 mg q3wk; then dose 5 onwards 1000 mg q6wk, give over 30 min
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