Applies to sotorasib: oral tablet.

Serious side effects of Sotorasib

Along with its needed effects, sotorasib 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 immediately if any of the following side effects occur while taking sotorasib:

More common

• Chest pain or tightness
• cough
• dark urine
• fever or chills
• light-colored stools
• loss of appetite
• nausea or vomiting
• sneezing
• sore throat
• stomach pain
• trouble breathing
• unusual tiredness or weakness
• yellow eyes or skin

Other side effects of Sotorasib

Some side effects of sotorasib 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

• Blistering, crusting, irritation, itching, or reddening of the skin
• constipation
• cracked, dry, scaly skin
• diarrhea
• difficulty in moving
• joint or bone pain
• lack or loss of strength
• muscle aches, cramps, pain, or stiffness
• rash with flat lesions or small raised lesions on the skin
• swelling of the hands, ankles, feet, or lower legs
• swelling of the testes

For Healthcare Professionals

Applies to sotorasib: oral tablet.

General

The most common adverse reactions were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough; the most common laboratory abnormalities were decreased lymphocytes, decreased hemoglobin, increased AST, increased ALT, decreased calcium, increased alkaline phosphatase, increased urine protein, and decreased sodium. Serious adverse reactions occurred in 50% of patients treated with this drug and included pneumonia, hepatotoxicity, and diarrhea; the most common severe (Grade 3 or greater) adverse reactions were increased ALT, increased AST, and diarrhea. Fatal adverse reactions included respiratory failure, pneumonitis, cardiac arrest, cardiac failure, gastric ulcer, and pneumonia.

Permanent discontinuation of this drug due to an adverse reaction occurred in 9% of patients; adverse reactions leading to permanent discontinuation of therapy included hepatotoxicity, increased ALT, increased AST, and drug-induced liver injury.^[Ref]

Hematologic

Very common (10% or more): Decreased lymphocytes (up to 48%), decreased hemoglobin (up to 43%), increased activated partial thromboplastin time (up to 23%), anemia^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 42%), nausea (up to 26%), vomiting (up to 17%), constipation (up to 16%), abdominal pain (included abdominal pain, upper abdominal pain, lower abdominal pain; up to 15%)

Frequency not reported: Gastric ulcer^[Ref]

Hepatic

Very common (10% or more): Increased AST (up to 39%), increased ALT (up to 38%), hepatotoxicity (included increased ALT, increased AST, increased blood bilirubin, drug-induced liver injury, hepatitis, hepatotoxicity, increased liver function test, increased transaminases; up to 25%)^[Ref]

Among 357 patients who received this drug in a clinical trial, hepatotoxicity occurred in 1.7% (all grades) and 1.4% (Grade 3). Among 359 patients who received this drug in a clinical trial, 17% had increased ALT/increased AST (Grade 3: 6%; Grade 4: 0.6%); the median time to first onset of increased ALT/AST was 8 to 9 weeks (range: 0.3 to 42 weeks). Increased ALT/AST leading to dose interruption or reduction occurred in 7% of patients; this drug was discontinued due to increased ALT/AST in 1.7% of patients. In addition to dose interruption or reduction, 5% of patients received corticosteroids for the treatment of hepatotoxicity.^[Ref]

Other

Very common (10% or more): Decreased calcium (up to 35%), increased alkaline phosphatase (up to 33%), decreased sodium (up to 28%), fatigue (included fatigue, asthenia; up to 26%), decreased albumin (up to 22%), edema (included generalized edema, localized edema, edema, peripheral edema, periorbital edema, testicular edema; up to 15%), pyrexia

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

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (included back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, myalgia, neck pain, noncardiac chest pain, pain in extremity; up to 35%), arthralgia (up to 12%)^[Ref]

Genitourinary

Very common (10% or more): Increased urine protein (up to 29%)

Common (1% to 10%): Urinary tract infection^[Ref]

Respiratory

Among 359 patients who received this drug in a clinical trial, ILD/pneumonitis occurred in 0.8% of patients; all cases were Grade 3 or 4 at onset, and 1 case was fatal. The median time to first onset for ILD/pneumonitis was 2 weeks (range: 2 to 18 weeks). This drug was discontinued due to ILD/pneumonitis in 0.6% of patients.^[Ref]

Very common (10% or more): Cough (included cough, productive cough, upper airway cough syndrome; up to 20%), dyspnea (included dyspnea, exertional dyspnea; up to 16%), pneumonia (included pneumonia, aspiration pneumonia, bacterial pneumonia, staphylococcal pneumonia; up to 12%)

Frequency not reported: Respiratory failure, pneumonitis, interstitial lung disease (ILD)^[Ref]

Cardiovascular

Common (1% to 10%): Hypertension

Frequency not reported: Cardiac arrest, cardiac failure

Metabolic

Very common (10% or more): Decreased appetite (up to 13%)

Common (1% to 10%): Hypokalemia, hyponatremia, hypocalcemia^[Ref]

Dermatologic

Very common (10% or more): Rash (included dermatitis, acneiform dermatitis, rash, maculopapular rash, pustular rash; up to 12%)^[Ref]

Nervous system

Very common (10% or more): Headache