Leniolisib
Brand names: Joenja
Drug class:
Antineoplastic Agents
Usage of Leniolisib
Leniolisib phosphate has the following uses:
Leniolisib phosphate is indicated for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older.
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How to use Leniolisib
General
Leniolisib phosphate is available in the following dosage form(s) and strength(s):
Tablets: 70 mg (of leniolisib)
Dosage
It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:
Verify pregnancy status in females of reproductive potential prior to initiating treatment.
Pediatric Patients
Dosage and AdministrationAdults
Dosage and AdministrationWarnings
Contraindications
Warnings/Precautions
Embryo-fetal Toxicity
Based on findings in animals, leniolisib may cause fetal harm when administered to a pregnant woman. Administration of leniolisib to rats and rabbits during the period of organogenesis caused embryo-fetal toxicity including malformations at exposures that were 2-6 times higher than the maximum recommended human dose (MRHD) in patients with phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) based on AUC comparisons.
Verify the pregnancy status of patients of reproductive potential prior to starting treatment. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use highly effective methods of contraception during treatment and for 1 week after the last dose.
Vaccinations
Live, atTenuated vaccinations may be less effective if administered during leniolisib treatment.
Specific Populations
PregnancyLeniolisib can cause fetal harm based on findings from animal studies. There are no available data on leniolisib use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
In animal reproduction studies, oral administration of leniolisib to pregnant rats and rabbits during the period of organogenesis at exposures approximately 2-6 times the MRHD on an AUC basis, produced embryofetal toxicity including malformations. Advise pregnant women of the potential risk to a fetus.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage of clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
LactationThere are no data on the presence of leniolisib or its metabolites in human milk or the effects on the breastfed infant or milk production. Because of the potential for serious adverse reactions from leniolisib in the breastfed child, advise women not to breastfeed during treatment with the drug and for 1 week after the last dose.
Females and Males of Reproductive PotentialBased on findings from animal studies, leniolisib may cause fetal harm when administered to a pregnant woman.
Verify the pregnancy status in females of reproductive potential prior to initiating leniolisib phosphate.
Advise female patients of reproductive potential to use highly effective contraception during treatment with leniolisib and to continue contraception for 1 week after the last dose.
Pediatric UseThe safety and effectiveness of leniolisib for the treatment of activated phosphoinositide 3-kinase delta syndrome have been established in pediatric patients 12 years of age and older. Use of leniolisib for this indication is supported by evidence from an adequate and well-controlled study in adult and pediatric patients 12 years of age and older. There is no recommended dosage for pediatric patients 12 years of age and older who weigh less than 45 kg.
The safety and effectiveness of leniolisib phosphate have not been established in pediatric patients below the age of 12 years.
Geriatric UseBecause clinical studies of leniolisib did not include any patients 65 years of age and older, it cannot be determined whether they respond differently from younger adult patients.
Hepatic ImpairmentLeniolisib is extensively (60%) metabolized by the liver. The effect of hepatic impairment on the pharmacokinetics of leniolisib has not been studied. The use of leniolisib in patients with moderate to severe hepatic impairment is not recommended.
Common Adverse Effects
Most common adverse reactions (incidence >10%) were headache, sinusitis, and atopic dermatitis.
What other drugs will affect Leniolisib
Specific Drugs
It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:
Disclaimer
Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
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