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Adverse reactions of Capivasertib

Capanertinib may cause serious side effects, including the following:

Hyperglycemia (Elevated Blood Glucose)

Hyperglycemia is relatively common in patients taking capanertinib and may progress to severe symptoms. Untreated severe hyperglycemia can lead to diabetic ketoacidosis in patients receiving capanertinib treatment. Diabetic ketoacidosis is a life-threatening condition that requires hospitalization and may result in death in severe cases.

Healthcare providers will monitor your blood glucose levels before you start capanertinib treatment and during the treatment course. The safety of capanertinib in patients with type 1 diabetes or those using insulin to control blood glucose has not been clearly established. If you have a history of diabetes, your healthcare provider will monitor your blood glucose more frequently.

If you experience any symptoms of hyperglycemia, inform your healthcare provider immediately. These symptoms include: extreme thirst, dry mouth, increased frequency or volume of urination, blurred vision, increased appetite with weight loss, abdominal pain, unusual fatigue, confusion, nausea and vomiting, breath with a fruity odor, dry or flushed skin, difficulty breathing, and drowsiness.

Diarrhea

Diarrhea is relatively common during capanertinib treatment and can be severe. Severe diarrhea may cause significant fluid loss from the body, leading to dehydration. If you develop diarrhea-related symptoms, such as loose or watery stools, contact your healthcare provider promptly. Your healthcare provider will advise you to increase fluid intake or prescribe medications to treat diarrhea.

Skin Reactions

Skin reactions are relatively common in patients taking capanertinib and may progress to severe symptoms.

If you develop new or worsening skin rashes, skin redness, fever, blistering of the lips/eyes/mouth, skin blistering, skin peeling, or dry skin, inform your healthcare provider or seek medical attention immediately.

If you experience any of the above specific severe side effects, your healthcare provider may adjust your dosage, suspend treatment, or discontinue capanertinib therapy entirely.

The most common side effects of capanertinib include: nausea, fatigue, vomiting, mouth ulcers, and abnormalities in some blood test results.

The above is not a complete list of all potential side effects of capanertinib. If you have any questions related to side effects, consult your healthcare provider for professional medical advice.

from FDA，2024.09