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    Active Ingredient
    Nivolumab 10 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    40 mg / 4 ml

    partial basket chart 82231 15445

    Vial

    100 mg / 10 ml

    partial basket chart 82248 15444

    Related information


    Dosage

    Melanoma: The recommended dose of Nivolumab is 3 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.
    The recommended dose of OPDIVO in combination with ipilimumab is 1 mg/kg administered as an intravenous infusion over 60 minutes, followed by ipilimumab on the same day, every 3 weeks for 4 doses. The recommended subsequent dose of OPDIVO, as a single agent, is 3 mg/kg as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. Review the Full Prescribing Information for ipilimumab
    prior to initiation.
    NSCLC, RCC, cHL, SCCHN, Urothelial Carcinoma, CRC, HCC: The recommended dose of OPDIVO is 3 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.
    Dose Modifications: Recommendations for OPDIVO modifications are provided in Table 1 at the attached doctor’s leaflet. When OPDIVO is administered in combination with ipilimumab, if OPDIVO is withheld, ipilimumab should also be
    withheld.
    There are no recommended dose modifications for hypothyroidism or hyperthyroidism.
    Interrupt or slow the rate of infusion in patients with mild or moderate infusion reactions.
    Discontinue OPDIVO in patients with severe or life-threatening infusion reactions.
    See prescribing information for full details.


    Indications

    Unresectable or Metastatic Melanoma:
    – OPDIVO (nivolumab) as a single agent is indicated for the treatment of patients with advanced (unresectable or metastatic) melanoma in adults.
    – OPDIVO (nivolumab), in combination with ipilimumab, is indicated for the treatment of patients with advanced (unresectable or metastatic) melanoma.
    Metastatic Non-Small Cell Lung Cancer: OPDIVO (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
    Renal Cell Carcinoma: OPDIVO (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
    Classical Hodgkin Lymphoma: OPDIVO (nivolumab) is indicated for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin. This indication is approved based on overall response rate.
    Squamous Cell Carcinoma of the Head and Neck: OPDIVO is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.
    Urothelial Carcinoma: OPDIVO (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:
    – have disease progression during or following platinum-containing chemotherapy
    – have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
    Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Metastatic Colorectal Cancer: OPDIVO is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
    Hepatocellular Carcinoma: OPDIVO is indicated for the treatment of patients with hepatocellular carcinoma Child-Pugh A after sorafenib therapy.


    Contra-Indications

    Hypersensitivity to Nivolumab or to any of the excipients.


    Special Precautions

    Immune-Mediated Colitis: Monitor patients for immune-mediated colitis. Administer corticosteroids at a dose of 1 to 2 mg/kg/day prednisone equivalents followed by corticosteroid taper for severe (Grade 3) or life-threatening (Grade 4) colitis. Administer corticosteroids at a dose of 0.5 to 1 mg/kg/day prednisone equivalents followed by corticosteroid taper for moderate (Grade 2) colitis of more than 5 days duration; if worsening or no improvement occurs despite initiation of corticosteroids, increase dose to 1 to 2 mg/kg/day prednisone equivalents.
    Immune-Mediated Hepatitis: Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids at a dose of 1 to 2 mg/kg/day prednisone equivalents for Grade 2 or greater transaminase elevations, with or without concomitant elevation in total bilirubin. See prescribing information for full details.
    Immune-Mediated Nephritis and Renal Dysfunction: Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids at a dose of 1 to 2 mg/kg/day prednisone equivalents followed by corticosteroid taper for life-threatening (Grade 4) serum creatinine elevation and permanently discontinue Nivolumab.
    See prescribing information for full details.


    Side Effects

    Rash, Pruritus, Cough, Upper respiratory tract infection, Peripheral edema.
    See prescribing information for full details.


    Drug interactions

    No formal pharmacokinetic drug-drug interaction studies have been conducted with this drug.


    Pregnancy and Lactation

    Pregnancy: Based on its mechanism of action and data from animal studies, this drug can cause fetal harm when administered to a pregnant womanThe effects of OPDIVO are likely to be greater during the second and third trimesters of pregnancy. There are no available human data informing the drug-associated risk. Advise pregnant women of the potential risk to a fetus.
    Lactation: It is not known whether this drug is present in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from OPDIVO, advise women to discontinue breastfeeding during treatment with OPDIVO.
    See prescribing information for full details.


    Overdose

    There is no information on overdose with this drug.


    Important notes

    Storage: Store OPDIVO under refrigeration at 2°C to 8°C (36°F to 46°F). Protect OPDIVO from light by storing in the original package until time of use. Do not freeze or shake.


    Manufacturer
    Bristol-Myers Squibb, USA
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