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 atopic dermatitis..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
JOENJA 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.
The recommended dosage of JOENJA in adult and pediatric patients of 12 years age and older weighing 45 kg or greater is 70 mg which is administered orally twice daily approximately 12 hours apart, with or without food. There is no recommended dosage for patients weighing less than 45 kg.
The patient is advised to take the next dose as per the usual schedule if the missed dose has been more than 6 hours. They are also advised to take next dose as soon as possible if vomiting occurs within 1 hour after taking JOENJA, However, wait and take the next scheduled dos if it's been more than 1 hour.
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
none
Warnings
- Embryo fetal toxicity
It is essential to verify the pregnancy status prior to starting JOENJA treatment as it carries potential risk to developing fetus.
It was observed during the clinical studies that when JOENJA was administered to rats and rabbits during the period of organogenesis. JOENJA caused embryo-fetal toxicity including malformations at exposures that were 2-6 times higher than the maximum recommended human dose (MRHD) in APDS patients. Therefor, reproductive women are advised 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 JOENJA treatment.
Adverse Reactions
Clinical Trials Experience
In a 12-week, placebo-controlled portion of Study 2201 in which either JOENJA 70 mg (N=21) or placebo (N=10) was administered twice daily to patients with APDS, a greater incidence of adverse effects were observed in patients receiving JOENJA compared to placebo. The most common adverse effects were headache (24%), sinusitis (19%), and atopic dermatitis (14%). Others were Tachycardia (10%), Diarrhea (10%), Fatigue (10%), Pyrexia (10%), Back pain (10%), Neck pain (10%), and Alopecia (10%).
Postmarketing Experience
There is limited information regarding Leniolisib Postmarketing Experience in the drug label.
Drug Interactions
- JOENJA is a substrate of CYP3A4. Leniolisib exposure was increased 2-fold when co-administered with a strong CYP3A4 inhibitor like itraconazole. Concomitant use of JOENJA with strong CYP3A4 inhibitors should be avoided.
- Concomitant use of JOENJA with strong and moderate CYP3A4 inducers should be avoided because concomitant use of strong and moderate CYP3A4 inducers may result in reduced leniolisib exposure and thus reduced leniolisib efficacy.
- Avoid concomitant use of JOENJA with drugs that are primarily metabolized by isoenzyme CYP1A2 and have a narrow therapeutic index, as Leniolisib inhibits CYP1A2 in a time-dependent manner in vitro.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA): C There is no sufficient data regarding usage of JOENJA in pregnant women.
JOENJA can cause fetal harm based on findings from animal studies. It was observed during the clinical studies that when JOENJA was administered to rats and rabbits during the period of organogenesis. JOENJA caused embryo-fetal toxicity including malformations at exposures that were 2-6 times higher than the maximum recommended human dose (MRHD) in APDS patients.
Therefor, reproductive women are advised to use highly effective methods of contraception during treatment and for 1 week after the last dose.
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
The safety and effectiveness of JOENJA for the treatment of activated phosphoinositide 3-kinase delta syndrome have been established in pediatric patients 12 years of age and older but not below 12years.
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
Leniolisib is extensively (60%) metabolized by the liver. Hence, the use of JOENJA is not recommended in moderate to severe haptic impairment.
Females of Reproductive Potential and Males
JOENJA may cause fetal harm when administered to a pregnant woman based on animal studies. Therefor it is essential to run pregnancy screening for reproductive potential females prior to initiating JOENJA and pregnant mothers should be advised about the potential harm to developing fetus while on JOENJA.
Females are advised to follow contraception during the treatment course of JOENJA.
Immunocompromised Patients
There is no FDA guidance one the use of Leniolisib in patients who are immunocompromised.
Administration and Monitoring
Administration
JOENJA is available as 70mg tablets administered orally.
The recommended dosage in adult and pediatric patients 12 years of age and older weighing 45 kg or greater is 70 mg administered orally twice daily approximately 12 hours apart, with or without food. There is no recommended dosage for patients weighing less than 45 kg.
Monitoring
Advise patients that if vomiting occurs within 1 hour after taking JOENJA, take JOENJA as soon as possible. If vomiting occurs more than 1 hour after dosing, wait and take the next dose at the usual time.
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
Leniolisib is a kinase inhibitors which inhibits PI3K-delta by blocking the active binding site of PI3K-delta.
Leniolisib inhibits the signalling pathways that lead to increased production of PIP3, hyperactivity of the downstream mTOR/Akt pathway, and to the dysregulation of B and T cells.
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
- leniolisib median time to maximum plasma concentration (Tmax) occurred at about 1 hour postdose.
- The apparent terminal elimination t1/2 is approximately 10 hours. The volume of distribution of leniolisib is estimated to be 28.5 L in patients with APDS and was highly bound (94.5%) to plasma proteins.
- The mean recovery of total 14C-radioactivity following a single oral dose of 70 mg 14C-leniolisib was 92.5% (67.0% and 25.5% recovered via feces and urine, respectively) 168 hours postdose.
- 60% of leniolisib is metabolized by the liver, with CYP3A4 being the most predominant enzyme involved (95.4%) in the primary oxidative metabolism of leniolisib with minor contribution from other enzymes (3.5% CYP3A5, 0.7% CYP1A2 and 0.4% CYP2D6).
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
JOENJA is available in 70 mg tablet which is a yellow, oval-shaped, biconvex, bevelled edge film-coated tablet debossed with "70" on one side and "LNB" on the other side. It is supplied in bottles with a child-resistant cap of 60 tablets.
Storage
Its stored at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) and should not be refrigerated.
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.