Applies to tremelimumab: intravenous solution.

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:

More common

• Bleeding gums
• body aches or pain
• bone pain
• chest pain or tightness
• chills
• constipation
• coughing up blood
• depressed mood
• difficulty swallowing
• dry skin and hair
• diarrhea
• dizziness
• ear congestion
• feeling cold
• hoarseness or husky voice
• headache
• increased menstrual flow or vaginal bleeding
• loss of voice
• muscle cramps, spasms, pain, stiffness, tenderness, or weakness
• nervousness
• nosebleeds
• paralysis
• prolonged bleeding from cuts
• red or dark brown urine
• red or black, tarry stools
• sensitivity to heat
• sleeplessness
• slow heartbeat
• sneezing
• sore throat
• stomach cramps, tenderness, or pain
• stuffy or runny nose
• swollen glands in the neck
• trouble breathing
• trouble sleeping
• unusual tiredness or weakness
• weight gain or loss

Less common

• Agitation
• bloating
• blood in the urine or stools
• bloody or cloudy urine
• coma
• confusion
• darkened urine
• darkening of the skin
• decreased urine output
• drowsiness
• hostility
• irritability
• lethargy
• lightheadedness
• muscle twitching
• fainting
• fast heartbeat
• fever
• general feeling of discomfort or illness
• indigestion
• loss of appetite
• mental depression
• nausea
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• pinpoint red spots on the skin
• rapid, shallow breathing
• rapid weight gain
• seizures
• skin rash
• stupor
• sweating
• swelling of the face, ankles, or hands
• swelling of the face, feet, or lower legs
• thickening of bronchial secretions
• unusual bleeding or bruising
• vomiting
• yellow eyes or skin

Rare

• Light-colored stools
• sudden severe weakness
• upper right abdominal or stomach pain

Incidence not known

• Anxiety
• back, leg, or stomach pain
• blistering, peeling, or loosening of the skin
• blue or pale skin
• blurred vision or other change in vision
• burning, tingling, numbness, or pain the hands, arms, feet, or legs
• burning feeling the chest or stomach
• chest discomfort
• difficulty in chewing or talking
• difficulty in moving
• double vision
• drooping eyelids
• eye pain, tearing
• facial swelling
• inability to move the arms and legs
• joint pain
• numbness or tingling in the fingers, face, or feet
• pain, swelling, or redness in the joints
• painful or difficult urination
• red irritated eyes
• red skin lesions, often with a purple center
• redness, soreness, or itching skin
• redness of the eye
• seeing flashes or sparks of light
• seeing floating spots before the eyes
• sensation of pins and needles
• sensitivity of the eye to light
• severe headache
• sores, ulcers, or white spots on the lips or in the mouth
• stabbing pain
• stiff neck or back
• stomach upset or discomfort
• sudden numbness and weakness in the arms and legs
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• swollen or painful glands
• veil or curtain appearing across part of vision

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:

More common

• Lack or loss of strength
• loss or thinning of the hair

For Healthcare Professionals

Applies to tremelimumab: intravenous solution.

Cardiovascular

-Ischemic stroke occurred in one patient.^[Ref]

Common (1% to 10%): Hemorrhage

Uncommon (0.1% to 1%): Cardiac arrest

Frequency not reported: Myocarditis, ischemic stroke^[Ref]

Dermatologic

-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]

Very common (10% or more): Rash (27% to 32%), pruritus (11% to 23%), alopecia (10%)^[Ref]

Endocrine

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

Very common (10% or more): Hypothyroidism (13% to14%)

Common (1% to 10%): Hyperthyroidism^[Ref]

General

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

-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.^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (22% 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 (21% to 77%), lymphocytopenia (20% 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

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

Very common (10% or more): Increased aspartate aminotransferase (63%), increased alanine aminotransferase (56%), increased bilirubin (12% to 41%), increased Gamma Glutamyl Transferase (38%)

Common (1% to 10%): Hepatitis

Uncommon (0.1% to 1%): Hepatic failure, immune-mediated hepatitis^[Ref]

Metabolic

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

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

Very common (10% or more): Decreased appetite (17% to 28%), edema (10%), hyponatremia (14% to 55%), hypernatremia (15%), hypokalemia (21%), hyperglycemia (42%), hyperkalemia (49%), hypocalcemia (58%), hypomagnesemia (12%)^[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (22% 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 (26% to 36%), pyrexia (13% to 19%), decreased sodium (46%), increased alkaline phosphatase (33% to 41%), increased glucose (39%), decreased calcium (34%), decreased albumin (27% to 31%), increased potassium (28%), increased lipase (12% to 35%)

Common (1% to 10%): Sepsis, death, increased amylase (41%)

Frequency not reported: Death^[Ref]

-Decreased sodium, increased alkaline phosphatase, 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

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

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

Renal

Very common (10% or more): Increased creatinine (21% to 89%)

Common (1% to 10%): Acute kidney injury

Frequency not reported: Nephritis^[Ref]

Respiratory

-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]

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]