therapeutic index P-gp substrate; 100 mg/day PO if taking a strong CYP3A inhibitor.
Geriatric
400 mg/day PO; 200 mg/day PO if taking a moderate CYP3A inhibitor, P-gp inhibitor, or narrow therapeutic index P-gp substrate; 100 mg/day PO if taking a strong CYP3A inhibitor.
Adolescents
Safety and efficacy have not been established.
Children
Safety and efficacy have not been established.
Infants
Safety and efficacy have not been established.
Neonates
Safety and efficacy have not been established.
DOSING CONSIDERATIONS
Hepatic Impairment
No venetoclax dosage adjustment is necessary in patients with mild or moderate hepatic impairment. Venetoclax has not been eva luated in patients with severe hepatic impairment (total bilirubin greater than 3-times the upper limit of normal); therefore, the dosage in these patients is not known.
Renal Impairment
No venetoclax dosage adjustment is necessary in patients with mild or moderate renal impairment. Venetoclax has not been eva luated in patients with severe renal impairment (creatinine clearance less than 30 mL/min) or in patients receiving dialysis; therefore, the dosage in these patients is not known.
Dosage Guidance with Concomitant CYP3A4 Inhibitor/Inducer or P-glycoprotein (P-gp) Inhibitor/Substrate Use:
Strong CYP3A inhibitors: Use is contraindicated at initiation or during the dose titration phase. If concomitant use of a strong CYP3A4 inhibitor is required after the titration phase, reduce the venetoclax dosage by at least 75% to a maximum of 100 mg/day. When the strong CYP3A4 inhibitor is discontinued, wait 2 to 3 days and then resume the recommended venetoclax dosage (or prior dosage if less).
Moderate CYP3A inhibitors: Avoid concomitant use. Consider alternative agents. If concomitant use is required, reduce the venetoclax dosage by at least 50% to a maximum of 200 mg/day. When the moderate CYP3A4 inhibitor is discontinued, wait 2 to 3 days and then resume the recommended venetoclax dosage (or prior dosage if less).
Strong or moderate CYP3A inducers: Avoid concomitant use. Consider alternative agents.
P-gp inhibitors: Avoid concomitant use. Consider alternative agents. If concomitant use is required, reduce the venetoclax dosage by 50% to a maximum of 200 mg/day. If concomitant use is required, reduce the venetoclax dosage by at least 50% to a maximum of 200 mg/day. When the P-gp inhibitor is discontinued, wait 2 to 3 days and then resume the recommended venetoclax dosage (or prior dosage if less).
P-gp substrates with a narrow therapeutic index: Avoid concomitant use. If concomitant use is required, administer the P-gp substrate at least 6 hours before venetoclax.
ADMINISTRATION
Oral Administration
Oral Solid Formulations
Take venetoclax with a meal and water at the same time each day.
Swallow tablets whole; do not chew, crush, or break tablets.
Patients should drink 6 to 8 glasses (about 56 ounces total) of water each day at 2 days before the first dose, on the day of the first dose, and each time the dose is increased.
Keep venetoclax in the original packaging during the first 4 weeks of treatment; do not transfer the tablets to a different container.
If a dose is missed, take within 8 hours of missing the dose. If more than 8 hours have passed, skip the dose that day and take the dose the next day at the scheduled time.
If vomiting occurs after a dose, do not take another dose that day; resume dosing the next day at the usual time.
STORAGE
Venclexta:
- Store below 86 degrees
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