Nivolumab OPDYTA 100 Mg Injection

Q1: What cancers does Nivolumab (OPDYTA) treat?

Nivolumab treats unresectable or metastatic melanoma, metastatic NSCLC post-platinum chemotherapy, advanced renal cell carcinoma, relapsed classical Hodgkin lymphoma, recurrent/metastatic head and neck squamous cell carcinoma, and hepatocellular carcinoma after sorafenib.

Q2: How does Nivolumab work?

Nivolumab is a PD-1 immune checkpoint inhibitor. It blocks the PD-1 receptor on T-cells, preventing tumor cells from using the PD-L1/PD-L2 pathway to escape immune detection. This restores the immune system's ability to recognize and destroy cancer cells.

Q3: How is Nivolumab administered?

It is given as an intravenous infusion over 30 minutes (as monotherapy) to 60 minutes (with ipilimumab), every 2 weeks at 240mg or every 4 weeks at 480mg. It is always given in a clinical setting under medical supervision.

Q4: What are immune-related adverse events (irAEs)?

Because Nivolumab activates the immune system, it can cause inflammation in healthy organs — called immune-related adverse events. These can affect the lungs (pneumonitis), bowel (colitis), liver (hepatitis), skin, kidneys, endocrine glands, and nervous system.

Q5: What are the most common side effects?

Common side effects include fatigue, rash, pruritus (itching), diarrhea, nausea, and decreased appetite. Most are immune-mediated and respond to corticosteroid treatment.

Q6: What serious immune-related side effects require emergency care?

Seek immediate care for: new or worsening shortness of breath (pneumonitis), severe or bloody diarrhea (colitis), yellowing of skin/eyes (hepatitis), severe skin blistering, hormonal symptoms (thyroid dysfunction, adrenal insufficiency), or severe muscle weakness.

Q7: How are immune-related side effects managed?

Most irAEs are managed by withholding Nivolumab and starting systemic corticosteroids (prednisolone/methylprednisolone). Severe irAEs require high-dose IV steroids and often permanent discontinuation of treatment.

Q8: Can Nivolumab be combined with other cancer treatments?

Yes. Nivolumab is FDA-approved in combination with ipilimumab (another checkpoint inhibitor) for melanoma and RCC. It is also combined with chemotherapy in NSCLC and gastric cancer. Combinations carry higher irAE risk.

Q9: Is Nivolumab safe during pregnancy?

No. Nivolumab can cause fetal harm and premature birth. It is contraindicated during pregnancy. Effective contraception is required during treatment and for at least 5 months after the final dose.

Q10: What monitoring is required during Nivolumab treatment?

Regular blood tests for liver function, thyroid function, cortisol, and kidney function are needed. Imaging to assess treatment response (typically every 8–12 weeks) and clinical monitoring for irAEs are also required throughout treatment.

Q11: How should Nivolumab vials be stored?

Store at 2°C–8°C in the refrigerator. Do not freeze or shake. Protect from light. Keep in the original carton. Once diluted for infusion, use within 24 hours.

Q12: Is Nivolumab available without a prescription?

No. Nivolumab is a specialist prescription-only immunotherapy drug administered exclusively in hospital oncology settings by trained healthcare professionals.