Possible side effects of Nivolumab
Like all medicines, it can cause side effects, although not everybody gets them.
Keep in mind the important symptoms of inflammation. Nivolumab acts on the immune system and can cause inflammation in some parts of the body. Inflammation can cause serious damage to the body and some inflammatory conditions can be life-threatening and require treatment or discontinuation of nivolumab.
The following side effects have been reported in clinical trials with nivolumab:
Very common side effects (may affect more than 1 in 10 people)
- Decreased appetite;
- Diarrhea (watery, soft stools), nausea;
- Skin erythema, pruritus;
- Feeling tired or weakness.
Common side effects (may affect up to 1 in 10 people)
- Upper respiratory tract infections;
- Allergic reactions, related to the infusion of the medicine;
- Features of a hypofunctional thyroid such as fatigue or weight gain, or hyperfunction of the thyroid causing acceleration of the heart rate, sweating and weight loss;
- Hyperglycemia, high blood sugar levels;
- Inflammation of the nerves which causes numbness, weakness, tingling sensation or burning pain in the arms and legs; headache, dizziness;
- Blurred vision, dry eye;
- Hypertension, high blood pressure;
- Inflammation of the lungs (pneumonia), characterized by coughing and difficulty breathing, shortness of breath (dyspnea), cough;
- Inflammation of the intestine (colitis), mouth ulcers and cold sores (stomatitis), vomiting, stomach pain, constipation, dry mouth;
- Alteration of skin color with spots (vitiligo), dry skin, redness of the skin, unusual loss or thinning of hair;
- Pain in the muscles, bones and joints;
- Fever, edema (swelling).
Uncommon side effects (may affect up to 1 in 100 people)
- Severe infection of the lungs (pneumonia), bronchitis;
- Increase in some white blood cells;
- Decreased secretion of hormones by the adrenal glands (glands above the kidney), reduced functionality (hypopituitarism) or inflammation (hypophysitis) of the pituitary gland located at the base of the brain, swelling of the thyroid gland, or acids in the blood due to diabetes (diabetic ketoacidosis);
- Dehydration, increased acid levels in the blood;
- Inflammation of the liver (hepatitis);
- Yellowing of the skin and/or eyes (jaundice);
- Damage to nerves that causes numbness and weakness (polyneuropathy);
- Inflammation of the eye that causes pain and redness, vision problems or blurred vision;
- Increased heart rate;
- Inflammatory disease of blood vessels;
- Liquid around the lungs;
- Inflammation of the pancreas;
- Severe skin condition that causes red spots, often itchy, similar to those of measles, which starts in the limbs and sometimes on the face and the rest of the body (erythema multiforme), a skin disease with thickened patches of reddened skin, often with silvery scales (psoriasis), condition of the skin of the face in which the nose and cheeks are unusually red (rosacea), urticaria (pruritic, stinging rash);
- Inflammation of the muscles that causes pain or stiffness, pain in the joints;
- Inflammation of the kidney, renal failure;
- Pain, chest pain.
Rare side effects (may affect up to 1 in 1000 people)
- A disease that causes inflammation or enlargement of a lymph node (Kikuchi’s lymphadenitis);
- Blockage of the bile ducts;
- Temporary inflammation of the nerves causing pain, weakness and paralysis of the extremities (Guillain-Barré syndrome); loss of the protective covering of the nerves (demyelination), a condition in which the muscles become weak and easily fatigued (myasthenic syndrome), inflammation of the nerves, caused by the body attacking itself, which causes numbness, weakness, tingling or burning pain;
- Changes in heart rate and heart rhythm, fast heart rate, abnormal heart rhythm;
- Liquid in the lungs;
- Gastritis (inflammation of the stomach), ulcers of the small intestine;
- Severe and potentially fatal peeling of the skin (toxic epidermal necrolysis);
- Myopathy (muscle pain, tenderness or muscle weakness, not caused by exercise).
Tell your doctor immediately if you experience any of these side effects. Do not try to treat these symptoms with other medicines.
Changes in exam results
Nivolumab may cause alterations in the results of tests performed by the doctor, such as:
- Abnormal liver function tests (increase in liver enzymes aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase in the blood, increased levels of the bilirubin waste product in the blood);
- Abnormalities of renal function tests (increased creatinine in the blood);
- Reduction in the number of red blood cells (which carry oxygen), white blood cells (important for fighting infections) or platelets (cells that facilitate blood clotting);
- Increased levels of the fat-breaking and the starch-breaking enzymes;
- Increase or decrease in the amount of calcium or potassium;
- Increased or decreased levels of magnesium or sodium in the blood;
- Decrease in body weight.
21 February 2017 – The approval of Nivolumab by the Italian National Health Service was published today in the Gazzetta Ufficiale for patients with lung cancer with non-squamous histology.