Side Effects of Sotorasib: Serious Adverse Reactions, Common Side Effects, Side Effect Management

Sotorasib is a KRASG12C inhibitor developed by Amgen. It received accelerated approval from the U.S. Food and Drug Administration (FDA) in May 2021 and was subsequently launched.

I. Serious Side Effects of Sotorasib

While taking Sotorasib, consult your doctor immediately if you experience any of the following side effects:

Chest pain or tightness, cough, dark urine, fever or chills, light-colored stools, loss of appetite, nausea or vomiting, sneezing, sore throat, stomach pain, difficulty breathing, unusual tiredness or weakness, yellowing of the eyes or skin, etc.

II. Other Side Effects of Sotorasib

While taking Sotorasib, some side effects may be mild and may resolve on their own during treatment.

Common Side Effects

Consult your doctor if any of the following side effects persist:

Blistering, crusting, irritation, itching, or redness of the skin; constipation; cracked, dry, or scaly skin; diarrhea; difficulty moving; joint or bone pain; fatigue or loss of strength; muscle aches, cramps, pain, or stiffness; flat or slightly raised rash on the skin; swelling of the hands, ankles, feet, or lower legs; swelling of the testicles, etc.

III. Side Effects for Healthcare Professionals Reference

General Adverse Events

Common Adverse Reactions

Common adverse reactions to Sotorasib include diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough. The most common laboratory abnormalities include lymphocytopenia, decreased hemoglobin, increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), decreased calcium, increased alkaline phosphatase, increased urine protein, and decreased sodium.

Serious Adverse Reactions

Serious adverse reactions to Sotorasib include pneumonia, hepatotoxicity, and diarrhea. The most common severe (Grade 3 or higher) adverse reactions are increased ALT, increased AST, and diarrhea. Fatal adverse reactions include respiratory failure, pneumonia, cardiac arrest, heart failure, gastric ulcer, and pneumonitis.

Hematologic

Very common (10% or more): Lymphocytopenia (up to 48%), decreased hemoglobin (up to 43%), prolonged activated partial thromboplastin time (up to 23%), anemia.

Gastrointestinal

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

Frequency not reported: Gastric ulcer.

Hepatic

Very common (10% or more): Increased AST (up to 39%), increased ALT (up to 38%), hepatotoxicity (including increased ALT, increased AST, increased blood bilirubin, drug-induced liver injury, hepatitis, hepatotoxicity, abnormal liver function tests, increased transaminases; up to 25%).

Other

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

Common (1% to 10%): Peripheral edema.

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (including back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, myalgia, neck pain, non-cardiac chest pain, pain in extremity; up to 35%), arthralgia (up to 12%).

Genitourinary

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

Common (1% to 10%): Urinary tract infection.

Respiratory

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

Frequency not reported: Respiratory failure, pneumonitis, interstitial lung disease (ILD).

Cardiovascular

Common (1% to 10%): Hypertension.

Frequency not reported: Cardiac arrest, heart failure.

Metabolic

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

Common (1% to 10%): Hypokalemia, hyponatremia, hypocalcemia.

Dermatologic

Very common (10% or more): Rash (including dermatitis, acneiform dermatitis, rash, maculopapular rash, pustular rash; up to 12%).

Neurologic

Very common (10% or more): Headache.