Leniolisib Dosage

Medically reviewed by Drugs.com. Last updated on Oct 19, 2023.

Usual Adult Dose for Activated PI3K-Delta Syndrome

Weight 45 kg or greater: 70 mg orally twice a day

Comments:

• Doses should be given about 12 hours apart.
• There is no recommended dose for patients weighing less than 45 kg.
• Pregnancy testing in females of reproductive potential is recommended before starting treatment.

Use: For the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS)

Usual Pediatric Dose for Activated PI3K-Delta Syndrome

12 years and older:

• Weight 45 kg or greater: 70 mg orally twice a day

Comments:

• Doses should be given about 12 hours apart.
• There is no recommended dose for patients weighing less than 45 kg.
• Pregnancy testing in females of reproductive potential is recommended before starting treatment.

Use: For the treatment of APDS

Renal Dose Adjustments

Renal dysfunction: Data not available

Liver Dose Adjustments

Mild liver dysfunction: Data not available
Moderate to severe liver dysfunction: Not recommended

Comment:

• This drug is extensively metabolized by the liver; the effect of liver dysfunction on the pharmacokinetics of this drug has not been studied.

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:

• Before initiating therapy, verify the pregnancy status of females of reproductive potential.
• Administer orally with or without food; each dose should be given approximately 12 hours apart.
• If a dose is missed by more than 6 hours, wait and administer the next dose at the usual time.
• If vomiting occurs within 1 hour after dosing, administer this drug as soon as possible. If vomiting occurs more than 1 hour after dosing, wait and administer the next dose at the usual time.

Storage requirements:

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

Patient advice:

• Seek immediate medical attention if signs/symptoms of serious allergic reactions occur.
• Prior to any vaccinations, inform health care providers that you are taking this drug.
• Breastfeeding is not recommended during treatment and for 1 week after the last dose.
• Female patients of childbearing potential: This drug may cause harm to a fetus.
• Notify your health care provider of a known/suspected pregnancy.
• Use highly effective contraception during treatment and for 1 week after the last dose.

See also:

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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