• Monitor for signs and symptoms of diarrhea and dehydration. At 1st signs of diarrhea, advise patient to ↑ oral fluids and start antidiarrheal therapy. If Grade 2 or 3 diarrhea occurs, hold therapy until recovery to Grade ≤1. If recovery occurs in ≤28 days, resume at same or one lower dose as clinically indicated. If recovery occurs in >28 days or recurrence occurs, resume at one lower dose for Grade 2 or permanently discontinue for Grade 3. If Grade 4 diarrhea occurs, permanently discontinue capivasertib.
• Monitor skin for erythema, rash, and urticaria. If Grade 2 skin reactions occur, hold therapy until recovery to Grade ≤1; then resume at same dose. If symptoms persist or recur, resume at one lower dose. If Grade 3 skin reactions occur, hold therapy until recovery to Grade ≤1. If recovery occurs in ≤28 days, resume at same dose. If recovery occurs in >28 days, resume at one lower dose. For recurrent Grade 3 or Grade 4 skin reactions, permanently discontinue capivasertib.

Lab Test Considerations:

• Verify negative pregnancy test before starting therapy.
• Monitor CBC with differential, triglycerides, and serum creatinine periodically during therapy.
• Evaluate fasting plasma glucose (FPG) and A1c and optimize FPG prior to initiating therapy. Monitor FPG on Day 3 or 4 of the dosing week during Weeks 1, 2, 4, 6, and 8; then monthly; and as clinically indicated. Monitor A1c every 3 mo and as clinically indicated. If hyperglycemia occurs, monitor FPG at least twice weekly until ↓ to baseline. Consider consultation with health care provider experienced in treating hyperglycemia for therapy with antihyperglycemics and monitor FPG at least once weekly for 2 mo, followed by once every 2 wk or as clinically indicated. If FPG >upper limit of normal (ULN)–160 mg/dL or A1c >7%, consider initiation or intensification of oral diabetic therapy. If FPG 161–250 mg/dL, hold therapy until ≤160 mg/dL. If recovery occurs in ≤28 days, resume at same dose. If recovery occurs in >28 days, resume at one lower dose. If FPG 251–500 mg/dL, hold therapy until ≤160 mg/dL. If recovery occurs in ≤28 days, resume at one lower dose. If recovery occurs in >28 days, permanently discontinue capivasertib. If FPG >500 mg/dL, hold therapy. If FPG ↓ to ≤500 mg/dL within 24 hr, follow guidance for the relevant grade. If FPG remains >500 mg/dL for >24 hr, or if ketoacidosis or life-threatening sequelae occur at any FPG level, permanently discontinue capivasertib.