Indications & Uses
Nivorest 40 is indicated for:
Pharmacology
Nivolumab works on the PD-1 pathway. When the ligands PD-L1 and PD-L2 bind to the PD-1 receptor on T cells, T-cell proliferation and cytokine production are inhibited. Some tumors upregulate these PD-1 ligands, and signaling through this pathway can contribute to blocking the active immune surveillance of tumors by T cells.
Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody. It binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2. This releases the inhibition of the immune response that the PD-1 pathway causes, and that includes the anti-tumor immune response. In syngeneic mouse tumor models, blocking PD-1 activity decreased tumor growth.
When nivolumab (anti-PD-1) is combined with ipilimumab (anti-CTLA-4), the inhibition of both targets improves T-cell function more than either antibody does alone. This gives better anti-tumor responses in metastatic melanoma and advanced RCC. In murine syngeneic tumor models, dual blockade of PD-1 and CTLA-4 also increased anti-tumor activity.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
The recommended dosage of Nivolumab for unresectable or metastatic melanoma, when used as a single agent, is either 240 mg every 2 weeks or 480 mg every 4 weeks. It is given as an intravenous infusion over 30 minutes, and treatment continues until the disease progresses or toxicity becomes unacceptable. When Nivolumab is combined with ipilimumab, the dose is 1 mg/kg as an intravenous infusion over 30 minutes. Ipilimumab 3 mg/kg follows on the same day as an intravenous infusion over 90 minutes. This is repeated every 3 weeks for a maximum of 4 doses or until unacceptable toxicity, whichever occurs earlier. After the 4 doses of the combination, Nivolumab is given alone, either 240 mg every 2 weeks or 480 mg every 4 weeks, as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity. In adjuvant treatment of melanoma, the dosage is either 240 mg every 2 weeks or 480 mg every 4 weeks as an intravenous infusion over 30 minutes, continued until disease recurrence or unacceptable toxicity, for up to 1 year. In NSCLC, the recommended dosage is either 240 mg every 2 weeks or 480 mg every 4 weeks as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity. As a single agent in RCC, the recommended dose is either 240 mg every 2 weeks or 480 mg every 4 weeks, given as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity. The cHL dosage is either 240 mg every 2 weeks or 480 mg every 4 weeks as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity. SCCHN uses the same two options, 240 mg every 2 weeks or 480 mg every 4 weeks, as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity. Urothelial carcinoma is also treated with either 240 mg every 2 weeks or 480 mg every 4 weeks as an intravenous infusion over 30 minutes, until disease progression or unacceptable toxicity. In CRC, the recommended dose is 240 mg every 2 weeks as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity. HCC patients receive either 240 mg every 2 weeks or 480 mg every 4 weeks as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity.
Side Effects
The most common side effects of nivolumab, reported in 20% or more of patients, differ a little by how it was used. As a single agent, they were 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. Nivolumab given with ipilimumab for melanoma caused fatigue, rash, diarrhea, nausea, pyrexia, vomiting, and dyspnea. The same combination for renal cell carcinoma caused fatigue, rash, diarrhea, musculoskeletal pain, pruritus, nausea, cough, pyrexia, arthralgia, and decreased appetite.
Cautions & Contraindications
Warnings & Precautions
Immune-mediated pneumonitis: withhold Nivolumab for moderate pneumonitis, and stop it permanently if the pneumonitis is severe or life-threatening. Immune-mediated colitis: when Nivolumab is given as a single agent, withhold it for moderate or severe colitis and stop it permanently for life-threatening colitis. When it is given with ipilimumab, withhold it for moderate colitis and stop it permanently for severe or life-threatening colitis. Immune-mediated hepatitis: monitor for changes in liver function. Withhold for moderate rises in transaminase or total bilirubin, and stop permanently if the rise is severe or life-threatening. Immune-mediated endocrinopathies: for hypophysitis, withhold for moderate or severe cases and stop permanently if it is life-threatening. For adrenal insufficiency, withhold for moderate cases and stop permanently if it is severe or life-threatening. Monitor for changes in thyroid function and start thyroid hormone replacement as needed. Monitor for hyperglycemia too. Withhold for severe hyperglycemia and stop permanently if it is life-threatening. Immune-mediated nephritis and renal dysfunction: monitor for changes in renal function. Withhold for moderate or severe serum creatinine elevation, and stop permanently if the elevation is life-threatening. Immune-mediated skin adverse reactions: withhold for severe rash and stop permanently for life-threatening rash. Immune-mediated encephalitis: monitor for changes in neurologic function. Withhold for new-onset moderate to severe neurological signs or symptoms, and stop permanently for immune-mediated encephalitis. Infusion reactions: stop Nivolumab for severe and life-threatening infusion reactions. In patients with mild or moderate infusion reactions, interrupt the infusion or slow its rate. Complications of allogeneic HSCT after Nivolumab: monitor for hyperacute graft-versus-host-disease (GVHD), grade 3 to 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: Nivolumab can cause fetal harm. Advise patients of the potential risk to a fetus and of the need to use effective contraception.
Pregnancy & Breastfeeding
Pregnancy: Nivolumab can harm the unborn baby when a pregnant woman is given it. This is based on how the medicine works and on animal studies. The effects are likely to be greater in the second and third trimesters. There are no human data on the risk, so pregnant women should be told about the possible risk to the baby.
Lactation: No one knows whether Nivolumab passes into human milk. Many drugs, including antibodies, do pass into breast milk, and Nivolumab could cause serious adverse reactions in a nursing infant. For this reason, women should stop breastfeeding during treatment with Nivolumab.
Contraception: Because of how Nivolumab works, it can harm the baby if given to a pregnant woman. Women who could become pregnant should use effective contraception during treatment and for at least 5 months after the last dose of Nivolumab.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Storage
Keep Nivolumab vials in a refrigerator at 2°C-8°C, and leave them in the original carton so the light can't get to them. Don't freeze the vials or shake them. Keep the medicine out of the reach of children.
Common questions about Nivorest 40 40 mg
What is Nivorest 40 40 mg Injection?
Nivorest 40 40 mg Injection is a medicine that contains Nivolumab. It is made by Everest Pharmaceuticals Ltd. It belongs to the Immunological Chemotherapy group of medicines.
What is Nivorest 40 used for?
Nivorest 40 is used for: Cancer.
What are the side effects of Nivorest 40?
The most common side effects of nivolumab, reported in 20% or more of patients, differ a little by how it was used. As a single agent, they were 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.
Can I take Nivorest 40 during pregnancy or while breastfeeding?
Pregnancy: Nivolumab can harm the unborn baby when a pregnant woman is given it. This is based on how the medicine works and on animal studies. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Nivorest 40?
Keep Nivolumab vials in a refrigerator at 2°C-8°C, and leave them in the original carton so the light can't get to them. Don't freeze the vials or shake them.
Do I need a prescription for Nivorest 40?
Nivorest 40 is a prescription (Rx) medicine. Take it as your doctor advises.