Serious Side Effects Requiring Immediate Medical Attention

Serious Side Effects Requiring Immediate Medical Attention

Adagrasib may cause the following serious side effects, some of which may be life-threatening:

1. Gastrointestinal problems: including severe nausea, vomiting, diarrhea, gastrointestinal bleeding, intestinal obstruction, colitis, or gastrointestinal stricture. If you vomit more than 6 times within 24 hours, have blood in vomit or vomit that looks like coffee grounds, have diarrhea more than 7 times per day beyond your usual frequency with inability to control bowel movements, abdominal pain, dizziness, weakness, or rapid heartbeat, contact your doctor immediately.

2. QTc interval prolongation: Abnormal electrical activity of the heart may lead to life-threatening arrhythmias (such as torsade de pointes) or sudden death. If you experience dizziness, fainting, or abnormal heartbeat (too fast, too slow, or irregular), seek medical attention immediately. Your doctor will regularly monitor your ECG and electrolyte levels during treatment.

3. Liver injury: Manifested as yellowing of the skin or eyes (jaundice), dark urine, light-colored stools, unusual tiredness, loss of appetite, right-sided abdominal pain, or unusual bleeding/bruising. Your doctor will draw blood to monitor liver function before and during treatment.

4. Lung inflammation (pneumonitis): Can be fatal. If you develop new or worsening difficulty breathing, cough, or fever, seek emergency care immediately.

What are the most common side effects?

Based on clinical trial data:

1. When used as monotherapy for non-small cell lung cancer: The most common side effects include nausea, diarrhea, vomiting, fatigue, musculoskeletal pain, abnormal kidney function, edema anywhere in the body, decreased appetite, and difficulty breathing.

2. When used in combination with cetuximab for colorectal cancer: Common side effects include rash, nausea, diarrhea, vomiting, fatigue, muscle and joint pain, headache, dry skin, abdominal pain, decreased appetite, edema, anemia, cough, dizziness, constipation, and nerve damage in the extremities.

3. Most side effects can be managed with medications (such as antiemetics, antidiarrheals) or dose adjustments. Please inform your doctor about how you are feeling at any time.

How to monitor and manage side effects?

Your healthcare team will perform the following tests regularly before and during treatment:

1. Electrocardiogram (ECG) to assess heart electrical activity.

2. Blood tests to monitor liver function, kidney function, electrolytes (especially potassium and magnesium), and blood cell counts.

3. Based on test results, your doctor may temporarily pause treatment, reduce the dose, or permanently discontinue adagrasib. If severe gastrointestinal reactions occur, your doctor will prescribe appropriate symptomatic medications. Do not adjust your dose or stop taking the medication on your own. If you experience any discomfort, even if not listed in this document, please proactively inform your medical team.