Opdivo Qvantig Side Effects

Generic name: hyaluronidase / nivolumab

Note: This document provides detailed information about Opdivo Qvantig Side Effects associated with hyaluronidase / nivolumab. Some dosage forms listed on this page may not apply specifically to the brand name Opdivo Qvantig.

Applies to hyaluronidase / nivolumab: subcutaneous solution.

Important warnings This medicine can cause some serious health issues

Hyaluronidase and nivolumab causes your immune system to attack tumor cells, but it could also attack healthy organs and tissues in your body, causing serious or life-threatening side effects.

Some side effects may need to be treated with other medicines, and your cancer treatments may be delayed.

Call your doctor at once if you have: a cough, shortness of breath, chest pain, vision changes, muscle pain or weakness, stomach pain, diarrhea, blood in your stools, urinating less, dark urine, yellowing of your skin or eyes, frequent headaches, dizziness, confusion, increased thirst or urination, skin problems, numbness or tingling, feeling cold, or weight gain or loss.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Call your doctor at once if you have:

• severe or ongoing diarrhea, severe stomach pain, bloody or tarry stools;

• confusion, drowsiness, memory problems, neck stiffness, muscle pain, weakness, muscle cramps, balance problems, irregular heartbeat;

• eye pain, numbness or tingling in your arms or legs;

• (if you have had a stem cell transplant) feeling sick or uneasy, with pain or swelling;

• low red blood cells (anemia)--pale skin, tiredness, feeling light-headed, cold hands and feet;

• skin problems--rash, peeling, blistering, swollen glands, fever or flu-like symptoms, painful sores in your mouth, nose, throat, or genital area;

• liver problems--loss of appetite, nausea, vomiting, itching, easy bruising or bleeding, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• lung or kidney problems--new or worsening cough, chest pain, swelling, urinating less, feeling tired or short of breath, blood in your urine; or

• signs of a hormonal disorder--frequent or unusual headaches, vision problems, fast heartbeats, dizziness, fainting, mood or behavior changes, hunger, increased thirst or urination, constipation, hair loss, hoarse or deepened voice, sweating, feeling cold, weight gain or loss.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• muscle, joint, back, or bone pain;

• feeling weak, tired, or short of breath;

• numbness, tingling, or burning pain in your hands or feet;

• diarrhea, stomach pain, nausea, vomiting, constipation, loss of appetite, altered sense of taste;

• skin rash, itchy skin, mouth sores;

• redness, rash, or blisters on the palms of your hands or the soles of your feet;

• cold symptoms such as stuffy nose, sneezing, sore throat;

• increased blood pressure;

• fever, cough, headache;

• low levels of thyroid hormone;

• pain and burning when you urinate; or

• liver problems.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For healthcare professionals

Applies to hyaluronidase / nivolumab: subcutaneous solution.

General adverse events

The most common adverse reactions reported with use of subcutaneous nivolumab-hyaluronidase as monotherapy included musculoskeletal pain, fatigue, pruritus, rash, hypothyroidism, diarrhea, cough, and abdominal pain.

The safety of this drug was based on the safety profile of IV nivolumab across multiple indications, clinical studies, patient populations, and in combination with chemotherapy or other treatments. The most common adverse reactions during use of IV nivolumab as monotherapy or in combination with other therapies included fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper respiratory tract infection, pyrexia, headache, abdominal pain, vomiting, urinary tract infection, hepatotoxicity, palmar-plantar erythrodysesthesia syndrome, stomatitis, hypertension, hypothyroidism, dysgeusia, and peripheral neuropathy.

Please refer to the manufacturer product information for this drug and any agents used in combination for a detailed description of all reported adverse effects and laboratory abnormalities related to treatment.^[Ref]

Cardiovascular

• Frequency not reported: Myocarditis, pericarditis, vasculitis

Dermatologic

• Very common (10% or more): Pruritus (16%), rash (15%)
• Frequency not reported: Psoriasis, erythema

Endocrine

• Very common (10% or more): Hypothyroidism (12%)
• Frequency not reported: Adrenal insufficiency, hyperthyroidism, thyroiditis, hypoparathyroidism

Gastrointestinal

• Very common (10% or more): Diarrhea (11%), abdominal pain (10%)
• Common (1% to 10%): Nausea, constipation, vomiting
• Frequency not reported: Colitis, pancreatitis, including increases in serum amylase and lipase levels, gastritis, duodenitis

Hematologic

• Very common (10% or more): Decreased hemoglobin (46%), decreased lymphocytes (36%), decreased albumin (25%)
• Frequency not reported: Eosinophilia
• Postmarketing reports: Aplastic anemia, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), immune thrombocytopenic purpura, hemophagocytic lymphohistiocytosis, autoimmune hemolytic anemia; fatal cases have been reported

Hepatic

• Very common (10% or more): Increased ALT (21%)
• Frequency not reported: Hepatitis, hepatotoxicity (especially in combination with cabozantinib)

Hypersensitivity

• Frequency not reported: Hypersensitivity reaction

Immunologic

• Common (1% to 10%): Immune-mediated reactions
• Frequency not reported: Sarcoidosis, solid organ (and other types of) transplant rejection
• Postmarketing reports: Allogenic hematopoietic stem cell transplant complications including treatment refractory, severe acute, and severe chronic graft-versus-host disease associated with use of IV nivolumab

Immune-mediated adverse reactions included immune-mediated nephritis, endocrinopathies, hepatitis/hepatotoxicity, colitis, pneumonitis, and dermatologic adverse reactions. Immune-mediated adverse reactions may be severe or fatal, and can occur in any organ system or tissue.

Local

• Common (1% to 10%): Injection site reaction

Metabolic

• Very common (10% or more): Decreased sodium (34%), increased potassium (34%), increased alkaline phosphatase (32%), increased calcium (29%)
• Common (1% to 10%): Hyperglycemia, decreased appetite

Musculoskeletal

• Very common (10% or more): Musculoskeletal pain (31%)
• Frequency not reported: Arthritis, myositis/polymyositis, rhabdomyolysis, and associated sequelae including renal failure, arthritis, polymyalgia rheumatica

Nervous system

• Frequency not reported: Peripheral neuropathy, meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barre syndrome, nerve paresis, autoimmune neuropathy

Ocular

• Frequency not reported: Uveitis, corneal graft transplant rejection
• Postmarketing reports: Vogt-Koyanagi-Harada syndrome, iritis, other ocular inflammatory toxicities

Other

• Very common (10% or more): Fatigue (20%)
• Common (1% to 10%): Edema

Renal

• Very common (10% or more): Creatinine increased (38%)
• Common (1% to 10%): Nephritis and renal dysfunction

Respiratory

• Very common (10% or more): Cough (11%)
• Frequency not reported: Pneumonitis, dyspnea

Frequently asked questions

• Opdivo vs Opdivo Qvantig: What is the Difference?

Further information

Opdivo Qvantig side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer