Usual Adult Dose for Activated PI3K-Delta Syndrome

Recommended dosage: 70 mg orally twice daily

Comments:

• Should be taken approximately 12 hours apart, with or without food.
• Recommended only for patients weighing 45 kg and above.

Usual Pediatric Dose for Activated PI3K-Delta Syndrome

Recommended dosage:

• 12 years or older weighing 45 kg or greater: 70 mg orally twice daily

• Should be taken approximately 12 hours apart, with or without food.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Moderate to severe liver dysfunction: Not recommended.

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 12 years or less than 45 kg.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Oral use only. Administer with or without food.
• If a dose is missed by more than 6 hours, the patient should take the next scheduled dose.
• If vomiting occurs within 1 hour after administration, advise the patient to take a dose as soon as possible.

• Store at 20C to 25C (68F to 77F); excursions permitted between 15C to 30C (59F to 86F).
• Do not refrigerate.
• Store and dispense in the original container.

• This drug has not been studied in patients 65 years and older.
• Verify the pregnancy status of females of reproductive potential before initiating treatment and discuss potential risks to a fetus with pregnant patients.

• Pregnancy: Prior to initiation and during therapy

• Female patients should notify their healthcare provider if they are pregnant or planning to become pregnant while on this drug.
• Effective contraception is strongly advised during treatment with this drug and for one week after.
• Breastfeeding is not recommended while on this drug and for one week after the last dose.