OPDIVO 100mg/10ml

OPDIVO (nivolumab) 100 mg/10 mL concentrate for solution for infusion. Single-use vial. For intravenous infusion only after dilution. Bristol-Myers Squibb. Indications: OPDIVO contains the active substance nivolumab, a monoclonal antibody that binds to PD-1 receptor, helping your immune system fight cancer. Used in adults to treat: advanced melanoma; melanoma after complete resection (adjuvant treatment); advanced non-small cell lung cancer; advanced renal cell carcinoma; classical Hodgkin lymphoma that has relapsed or not responded to previous treatments; advanced head and neck cancer; advanced urothelial carcinoma (bladder and urinary tract cancer). Contraindications: Do not use OPDIVO if you are allergic to nivolumab or any other ingredients. Warnings: OPDIVO can cause inflammation in different parts of your body including heart problems, lung problems (pneumonitis), diarrhea or intestinal inflammation (colitis), liver inflammation (hepatitis), kidney problems, hormone gland problems (thyroid, pituitary, adrenal glands), diabetes, severe skin reactions, muscle inflammation. Important to keep the patient alert card with you during treatment. Pregnancy and breastfeeding: Do not use OPDIVO if pregnant unless specifically recommended. Use effective contraception during treatment and for at least 5 months after last dose. Do not breastfeed during treatment. Not known if OPDIVO passes into breast milk. Driving and using machines: OPDIVO may have minor influence on ability to drive or use machines. Be cautious until you are sure OPDIVO does not affect you negatively. Administration: Given in hospital or clinic under supervision of experienced doctor. Recommended dose is 240 mg every 2 weeks or 480 mg every 4 weeks. Given as IV infusion over 30 or 60 minutes. Can be given in combination with ipilimumab. Composition: Active substance: nivolumab. Each mL contains 10 mg nivolumab. Each 10 mL vial contains 100 mg nivolumab. Other ingredients: sodium citrate dihydrate, sodium chloride, mannitol, pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid, water for injections. Package: 1 vial (10 mL) Sodium content: Contains 25 mg sodium per 10 mL vial. Warning: Read the package leaflet carefully before use. Keep the patient alert card with you. This summary is not complete. Always consult full prescribing information and your healthcare provider. Regulatory Disclaimer: This listing is for informational purposes only. Supply restricted to authorized channels where legally permitted. Consult your oncologist for individualized treatment decisions.