Leniolisib
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alen Antony Pathil, M.D.[2]
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Overview
Leniolisib is a kinase inhibitor that is FDA approved for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older.. Common adverse reactions include headache, sinusitis, and
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Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Leniolisib FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Leniolisib FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
There is limited information regarding Leniolisib Contraindications in the drug label.
Warnings
There is limited information regarding Leniolisib Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Leniolisib Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Leniolisib Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Leniolisib Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Leniolisib in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Leniolisib in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Leniolisib during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Leniolisib in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Leniolisib in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Leniolisib in geriatric settings.
Gender
There is no FDA guidance on the use of Leniolisib with respect to specific gender populations.
Race
There is no FDA guidance on the use of Leniolisib with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Leniolisib in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Leniolisib in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Leniolisib in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Leniolisib in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Leniolisib Administration in the drug label.
Monitoring
There is limited information regarding Leniolisib Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Leniolisib and IV administrations.
Overdosage
There is limited information regarding Leniolisib overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Leniolisib Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Leniolisib Mechanism of Action in the drug label.
Structure
There is limited information regarding Leniolisib Structure in the drug label.
Pharmacodynamics
There is limited information regarding Leniolisib Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Leniolisib Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Leniolisib Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Leniolisib Clinical Studies in the drug label.
How Supplied
There is limited information regarding Leniolisib How Supplied in the drug label.
Storage
There is limited information regarding Leniolisib Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Leniolisib Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Leniolisib interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
JOENJA
Look-Alike Drug Names
There is limited information regarding Leniolisib Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.