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What are the side effects of the drug opdivo?

See the DrugPatentWatch profile for opdivo

Common Side Effects of Opdivo

Opdivo (nivolumab), a PD-1 inhibitor used for cancers like melanoma and lung cancer, often causes fatigue, musculoskeletal pain, rash, itching, cough, decreased appetite, constipation, diarrhea, nausea, and dyspnea. These occur in more than 20% of patients in clinical trials.[1]

Serious Immune-Related Side Effects

Opdivo can trigger immune-mediated reactions by overactivating the immune system, affecting organs like the lungs, intestines, liver, endocrine glands, skin, kidneys, and nerves. Key risks include:
- Pneumonitis: Lung inflammation (3-5% incidence, potentially fatal).
- Colitis: Severe diarrhea or bowel perforation (1-5%).
- Hepatitis: Liver enzyme elevation or failure (1-5%).
- Endocrinopathies: Thyroid issues, adrenal insufficiency, or type 1 diabetes (5-10%).
- Skin reactions: Severe rash or Stevens-Johnson syndrome (rare but serious).
- Neuropathies or encephalitis: Nerve or brain inflammation (less than 1%, can be life-threatening).[1][2]

These require immediate medical intervention, often with steroids or immunosuppressants.

Side Effects by Combination Therapy

When combined with ipilimumab (Yervoy), risks intensify:
- Severe immune reactions rise to 40-60%, including higher rates of colitis (up to 20%) and pneumonitis (up to 10%).
- Chemotherapy combos increase nausea, anemia, and neutropenia.[1]

Side Effects in Specific Cancers or Populations

  • Melanoma: Higher skin and endocrine issues.
  • Lung cancer: More respiratory events.
  • Pediatric or elderly patients face amplified fatigue and infection risks; data is limited for under-12s.[1][2]

What Happens If Side Effects Occur?

Mild effects may resolve with dose adjustments; severe ones lead to permanent discontinuation in 20-30% of cases. Monitor with regular labs and imaging. Fatal outcomes occur in under 1%, often from immune reactions.[1]

Long-Term Risks and Patient Concerns

Late-onset effects like hypothyroidism or hypophysitis persist post-treatment. Fertility impacts are unclear; avoid pregnancy due to fetal harm risk. Patients report ongoing fatigue affecting quality of life.[2]

[1]: https://www.opdivo.com/safety
[2]: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125554s400lbl.pdf



Other Questions About Opdivo :

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