Alpelisib is typically used in combination with fulvestrant. The focus on special populations in this text covers only the Alpelisib component, including pregnancy, lactation, and contraception. It is recommended to review this in conjunction with the prescribing information for fulvestrant.
Use of Alpelisib in Special Populations
Pregnancy
Females of reproductive potential must have their pregnancy status verified prior to initiating Alpelisib; effective contraception should be used during treatment and for 1 week after the final dose. If you become pregnant or suspect you are pregnant, inform your doctor immediately.
Lactation
Do not breastfeed during treatment with Alpelisib and for 1 week following the final dose.
Females and Males of Reproductive Potential / Contraception
Females of reproductive potential should use effective contraception during treatment and for 1 week after the last dose. Male patients with female partners of reproductive potential should use condoms and effective contraception during treatment and for 1 week after the last dose.
Pediatric Use
The safety and effectiveness of Alpelisib in pediatric patients have not been established.
Geriatric Use
No overall differences in the efficacy of Alpelisib were observed between patients aged 65 years and older compared to younger patients. There were insufficient numbers of patients aged 75 years and older to assess whether safety and effectiveness differ in this group.
Renal Impairment
1. Mild to moderate renal impairment (creatinine clearance 30 to less than 90 mL/min): No dosage adjustment is required.
2. Severe renal impairment (creatinine clearance less than 30 mL/min): The effect on Alpelisib pharmacokinetics is currently unknown, requiring physician judgment based on the specific clinical situation.
Hepatic Impairment
No dose adjustment is required for patients with mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, or C), but hepatic function should be monitored regularly.
Patients with Abnormal Blood Glucose
The safety of Alpelisib in patients with pre-existing glucose abnormalities has not been established.
Precautions During Medication Use
1. What to Do in Case of Overdose
Accidental overdoses reported in clinical trials resulted in adverse reactions consistent with the known safety profile, including hyperglycemia, nausea, fatigue, and rash.
If an overdose is suspected, contact a doctor immediately or go to the nearest emergency department; do not wait and observe at home.
2. Keep a Blood Glucose Monitor at Home
The median time to the first onset of hyperglycemia is 15 days, occurring as early as day 5. Relying on "feeling thirsty" is far less reliable than monitoring actual glucose numbers.
3. Do Not Ignore Diarrhea
Diarrhea can lead to dehydration and acute kidney injury. If diarrhea occurs, initiate antidiarrheal treatment immediately, increase oral fluid intake, and inform your physician.
