Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling.
• Severe and Fatal Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1) ] • Complications of Allogeneic HSCT [see Warnings and Precautions (5.2) ] • Most common adverse reactions (≥10%) with OPDIVO QVANTIG as monotherapy in patients with Renal Cell Carcinoma were: musculoskeletal pain, fatigue, pruritus, rash, hypothyroidism, diarrhea, cough, and abdominal pain.
(6.1) • Safety of OPDIVO QVANTIG for the following indications is based on safety of intravenous nivolumab in these populations.
The most common adverse reactions with intravenous nivolumab for these indications are presented below.
• As monotherapy for the treatment of advanced renal cell carcinoma;
adjuvant treatment of completely resected Stage IIB, IIC, III, or IV melanoma;
unresectable or metastatic melanoma;
adjuvant treatment of NSCLC, metastatic NSCLC;
squamous cell carcinoma of the head and neck;
urothelial carcinoma;
5 WARNINGS AND PRECAUTIONS • Immune-Mediated Adverse Reactions : (5.1) o Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis and hepatotoxicity, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, and immune-mediated nephritis and renal dysfunction.
o Monitor for early identification and management.
Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment.
o Withhold or permanently discontinue based on severity and type of reaction.
(2.4) • Complications of allogeneic HSCT : Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody.
Like all medications, Opdivo Qvantig can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: