Tremelimumab Side Effects

Medically reviewed by Drugs.com. Last updated on May 15, 2024.

Applies to tremelimumab: intravenous solution.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests before receiving this medicine to make sure you are not pregnant. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

Tell your doctor right away if you have a cough, chest tightness, or any type of breathing problem with this medicine. These could be symptoms of a serious lung problem (eg, pneumonitis).

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, a loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Colitis (inflammation of the bowels) may occur with this medicine. Tell your doctor right away if you have stomach pain or tenderness, watery or bloody diarrhea, or fever after receiving the medicine.

Adrenal, pituitary, or thyroid gland problems may occur while you are receiving this medicine. Tell your doctor if you have changes in mood or behavior, constipation, dry skin or hair, feeling cold, sensitivity to heat, sweating, trouble sleeping, or weight changes.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Check with your doctor if you have a headache, confusion, seizures, stiff neck, or vomiting while receiving this medicine. These may be symptoms of encephalitis.

Check with your doctor right away if you have a severe headache, drowsiness, confusion, general feeling of illness, or stiff neck or back while receiving this medicine. These may be symptoms of meningitis.

This medicine may cause inflammation of the heart muscle (myocardium) called myocarditis. Check with your doctor right away if you have chest pain or discomfort, fever, chills, a fast heartbeat, or trouble breathing.

Call your doctor right away if you have difficulty with breathing, swallowing, or talking, muscle weakness, severe tiredness, or sudden numbness and weakness in the arms or legs. These could be symptoms of a nervous system problem.

Pancreatitis (swelling of the pancreas) may occur while you are receiving this medicine. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

This medicine may cause a rare but serious type of allergic reaction called an infusion reaction, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you start to have a skin rash, dizziness, trouble breathing, chest tightness, swelling in your face or hands, fever, or chills while you are receiving this medicine.

Serious skin reactions (eg, exfoliative dermatitis, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic syndrome (DRESS), or toxic epidermal necrolysis) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red, irritated eyes, red skin lesions, often with a purple center, severe acne or a skin rash, sore throat, sores or ulcers on the skin, mouth, or lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness after receiving this medicine.

Call your doctor right away if you have fever, joint pain, muscle tenderness, weakness, pain, or cramps, skin rash, unusual tiredness or weakness, or weight loss. These could be symptoms of a muscle problem.

Serious side effects of tremelimumab

Along with its needed effects, tremelimumab may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking tremelimumab:

Other side effects of tremelimumab

Some side effects of tremelimumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to tremelimumab: intravenous solution.

General adverse events

The most common adverse reactions with a frequency of 20% or more were nausea (37%), decreased appetite (25%), and fatigue (22%). The most common Grade 3 or 4 laboratory abnormalities with a frequency of more than 10% were neutropenia (39%), leukopenia (21%), lymphocytopenia (20%), anemia (20%), hyponatremia (14% to 55%), increased lipase (12%), and thrombocytopenia (11%).

Hepatocellular Carcinoma:

The most common adverse reactions with a frequency of 20% or more were rash, diarrhea, fatigue, pruritus, musculoskeletal pain, and abdominal pain. The most common laboratory abnormalities with a frequency of 40% or more were increased AST, increased ALT, decreased hemoglobin, decreased sodium, increased bilirubin, increased alkaline phosphatase, and decreased lymphocytes.

The most common adverse reactions leading to treatment discontinuation with a frequency of 1% or more were hemorrhage, diarrhea, increased AST, and hepatitis.

Non-Small Cell Lung Cancer (NSCLC):

The most common adverse reactions with a frequency of 20% or more in patients with metastatic NSCLC were nausea, fatigue, musculoskeletal pain, decreased appetite, rash, and diarrhea.

The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (11%), anemia (5%), diarrhea (2.4%), thrombocytopenia (2.4%), pyrexia (2.4%), and febrile neutropenia (2.1%).^[Ref]

Cardiovascular

• Common (1% to 10%): Hemorrhage
• Uncommon (0.1% to 1%): Cardiac arrest
• Frequency not reported: Myocarditis, ischemic stroke^[Ref]

Ischemic stroke occurred in one patient.^[Ref]

Dermatologic

• Very common (10% or more): Rash (up to 32%), pruritus (up to 23%), alopecia (10%)^[Ref]

Rash includes eczema, erythema, dermatitis, drug eruption, erythema multiforme, pemphigoid, rash, rash maculo-papular, rash papular, rash pruritic and rash pustular.

Rash was life-threatening in 2.8% of patients.^[Ref]

Endocrine

• Very common (10% or more): Hypothyroidism (up to14%)
• Common (1% to 10%): Hyperthyroidism^[Ref]

Hypothyroidism includes increased blood thyroid stimulating hormone and hypothyroidism.^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (up to 27%), abdominal pain (20%), nausea (12% to 42%), vomiting (18%), constipation (19%), stomatitis (10%)
• Frequency not reported: Pancreatitis^[Ref]

Abdominal pain and diarrhea were life-threatening in 6% and 1.8% of patients, respectively.

Stomatitis includes mucosal inflammation and stomatitis.^[Ref]

Hematologic

• Very common (10% or more): Decreased hemoglobin (52%), decreased lymphocytes (41%), decreased platelets (29%), decreased leukocytes (20%), anemia (84%), thrombocytopenia (53%), leukopenia (up to 77%), lymphocytopenia (up to 67), neutropenia (71%)
• Common (1% to 10%): Febrile neutropenia^[Ref]

Decreased hemoglobin, decreased lymphocytes, decreased platelets, and decreased leukocytes were life-threatening in 4.8%, 11%, 1.6% and 0.8% of patients, respectively.^[Ref]

Hepatic

• Very common (10% or more): Increased AST (63%), increased ALT (64%), increased bilirubin (up to 41%), increased Gamma Glutamyl Transferase (38%)
• Common (1% to 10%): Hepatitis
• Uncommon (0.1% to 1%): Hepatic failure, immune-mediated hepatitis^[Ref]

Increased AST, increased ALT and increased bilirubin were life-threatening in 27%, 18% and 8% of patients, respectively.^[Ref]

Metabolic

• Very common (10% or more): Decreased appetite (up to 28%), edema (10%), hyponatremia (up to 55%), hypernatremia (15%), hypokalemia (21%), hyperglycemia (42%), hyperkalemia (49%), hypocalcemia (58%), hypomagnesemia (12%)^[Ref]

Decreased appetite was life-threatening in 1.3% of patients.

Edema includes face edema, localized edema, and edema peripheral.^[Ref]

Musculoskeletal

• Very common (10% or more): Musculoskeletal pain (up to 29%)^[Ref]

Musculoskeletal pain was life-threatening in 2.6% of patients.

Musculoskeletal pain includes arthralgia, arthritis, back pain, bone pain, musculoskeletal chest pain, musculoskeletal pain, myalgia, neck pain, non-cardiac chest pain, and spinal pain.^[Ref]

Nervous system

• Very common (10% or more): Headache (11%)
• Uncommon (0.1% to 1%): Intracranial hemorrhage^[Ref]

Headache includes headache and migraine.^[Ref]

Other

• Very common (10% or more): Fatigue/Asthenia (up to 36%), pyrexia (up to 19%), decreased sodium (46%), increased Alk Phos (up to 41%), increased glucose (39%), decreased calcium (34%), decreased albumin (up to 31%), increased potassium (28%), increased lipase (up to 35%), increased amylase (41%)
• Common (1% to 10%): Sepsis, death
• Frequency not reported: Death^[Ref]

Decreased sodium, increased Alk Phos, increased glucose, decreased albumin, and increased potassium were life-threatening in 15%, 8%, 14%, 0.5%, 3.8%, and 1.3% of patients, respectively.

Fatigue and pyrexia were life-threatening in 3.9% and 0.3% of patients.

Two patients died, among which one patient had sudden death with the use of this drug in combination with durvalumab and platinum-based chemotherapy.

Pyrexia includes increased body temperature, hyperpyrexia, hyperthermia, and pyrexia.^[Ref]

Psychiatric

• Very common (10% or more): Insomnia (10%)^[Ref]

Insomnia was life-threatening in 0.3% of patients.^[Ref]

Renal

• Very common (10% or more): Increased creatinine (up to 89%)
• Common (1% to 10%): Acute kidney injury
• Frequency not reported: Nephritis^[Ref]

Respiratory

• Very common (10% or more): Pneumonia (17%), cough/productive cough (12%), Upper respiratory tract infections (15%)
• Uncommon (0.1% to 1%): Pneumonitis
• Frequency not reported: Chronic obstructive pulmonary disease, dyspnea^[Ref]

Chronic obstructive pulmonary disease occurred in one patient.

Pneumonia includes lower respiratory tract infection, pneumocystis Jirovecii pneumonia, pneumonia, pneumonia aspiration, and pneumonia bacterial.

Upper respiratory tract infections include laryngitis, nasopharyngitis, pharyngitis, rhinitis, sinusitis, tonsillitis, tracheobronchitis and upper respiratory tract infection.^[Ref]

See also:

Further information

Tremelimumab 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.

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