Indications & Uses
Nivolunix 100 Injection is indicated for:
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Dosage Recommended Dosage for Unresectable or Metastatic Melanoma: Single Agent: The recommended dose of Nivolumab as a single agent is either: 240 mg every 2 weeks or 480 mg every 4 weeks. Administered as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity. With Ipilimumab : The recommended dose of Nivolumab is 1 mg/kg administered as an intravenous infusion over 30 minutes, followed by ipilimumab 3 mg/kg administered as an intravenous infusion over 90 minutes on the same day, every 3 weeks for a maximum of 4 doses or until unacceptable toxicity, whichever occurs earlier. After completing 4 doses of the combination, administer Nivolumab as a single agent, either: 240 mg every 2 weeks or 480 mg every 4 weeks administered as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity.Recommended Dosage for Adjuvant Treatment of Melanoma: The recommended dose of Nivolumab is either: 240 mg every 2 weeks or 480 mg every 4 weeks administered as an intravenous infusion over 30 minutes until disease recurrence or unacceptable toxicity for up to 1 year.Recommended Dosage for NSCLC: The recommended dose of Nivolumab is either: 240 mg every 2 weeks or 480 mg every 4 weeks administered as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity.Recommended Dosage for RCC: The recommended dose of Nivolumab as a single agent is either: 240 mg every 2 weeks or 480 mg every 4 weeks administered as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity.Recommended Dosage for cHL: The recommended dose of Nivolumab is either: 240 mg every 2 weeks or 480 mg every 4 weeks administered as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity.Recommended Dosage for SCCHN: The recommended dose of Nivolumab is either: 240 mg every 2 weeks or 480 mg every 4 weeks administered as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity.Recommended Dosage for Urothelial Carcinoma: The recommended dose of Nivolumab is either: 240 mg every 2 weeks or 480 mg every 4 weeks administered as an intravenous infusion over 30 minutes until disease progressionor unacceptable toxicity.Recommended Dosage for CRC: The recommended dose of Nivolumab is 240 mg every 2 weeks administered as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity.Recommended Dosage for HCC: The recommended dose of Nivolumab is either: 240 mg every 2 weeks or 480 mg every 4 weeks administered as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity.
Side Effects
Most common adverse reactions (≥20%) in patients were: Nivamoas a single agent: fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper respiratory tract infection, pyrexia, headache, and abdominal pain. Nivamo with ipilimumab for melanoma: fatigue, rash, diarrhea, nausea, pyrexia, vomiting, and dyspnea. Nivamo with ipilimumab for renal cell carcinoma: fatigue, rash, diarrhea, musculoskeletal pain, pruritus, nausea, cough, pyrexia, arthralgia, and decreased appetite.
Cautions & Contraindications
Warnings & Precautions
Immune-mediated pneumonitis: Withhold for moderate and permanently discontinue for severe or life-threatening pneumonitis.Immune-mediated colitis: Withhold Nivamo when given as a single agent for moderate or severe and permanently discontinue for life-threatening colitis. Withhold Nivamo when given with ipilimumab for moderate and permanently discontinue for severe or life-threatening colitis.Immune-mediated hepatitis: Monitor for changes in liver function. Withhold for moderate and permanently discontinue for severe or life-threatening transaminase or total bilirubin elevation.Immune-mediated endocrinopathies: Withhold for moderate or severe and permanently discontinue for life-threatening hypophysitis. Withhold for moderate and permanently discontinue for severe or life-threatening adrenal insufficiency. Monitor for changes in thyroid function. Initiate thyroid hormone replacement as needed. Monitor for hyperglycemia. Withhold for severe and permanently discontinue for life-threatening hyperglycemia.Immune-mediated nephritis and renal dysfunction: Monitor for changes in renal function. Withhold for moderate or severe and permanently discontinue for life-threatening serum creatinine elevation.Immune-mediated skin adverse reactions: Withhold for severe and permanently discontinue for life-threatening rash.Immune-mediated encephalitis: Monitor for changes in neurologic function. Withhold forb new-onset moderate to severe neurological signs or symptoms and permanently discontinue for immune-mediated encephalitis.Infusion reactions: Discontinue Nivamo for severe and life-threatening infusion reactions. Interrupt or slow the rate of infusion in patients with mild or moderate infusion reactions.Complications of allogeneic HSCT after Nivamo: Monitor for hyperacute graft-versus-host-disease (GVHD), grade 3-4 acute GVHD, steroid requiring febrile syndrome, hepatic veno-occlusive disease, and other immune-mediated adverse reactions. Transplant-related mortality has occurred.Embryo-fetal toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception.