Leniolisib
Leniolisib is a once-targeted kinase inhibitor pill used to treat activated PI3K delta syndrome (APDS), a rare immune condition, in adults and children 12 and older.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Leniolisib: Patient Information Guide
A plain-language walkthrough of Leniolisib — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
What Leniolisib is used for
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Leniolisib is used for one condition.
- Joenja treats activated PI3Kδ syndrome (APDS) in adults and children 12 years and older.
How Leniolisib works
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Leniolisib is a kinase inhibitor. It blocks the active site of PI3K-delta, an enzyme that is overactive in APDS because of gene changes. Blocking it lowers signaling through the pAkt and mTOR/Akt pathway and reduces the abnormal activation and growth of B and T cells.
It is much more selective for PI3K-delta than for related enzymes such as PI3K-alpha, beta and gamma.
How Leniolisib is taken (dosage)
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Joenja is a tablet taken by mouth twice daily, about 12 hours apart. You can take it with or without food. It is for people 12 and older who weigh at least 45 kg.
- Missed a dose by more than 6 hours: skip it and take the next dose at the usual time.
- Vomited within 1 hour: take a dose as soon as possible.
- Vomited more than 1 hour after: wait for the next usual dose.
Always follow your prescriber's directions.
Leniolisib side effects in detail
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The most common side effects in studies were:
- Headache
- Sinusitis
- Atopic dermatitis (eczema)
- Tachycardia (fast heart rate)
- Diarrhea, fatigue, fever
- Back pain, neck pain, hair loss
Some people had lower neutrophil counts (a type of white blood cell) on blood tests, and some gained weight. Serious allergic reactions, including anaphylaxis, have been reported. Get emergency help if that happens.
Leniolisib warnings and precautions
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Pregnancy risk: Joenja may harm an unborn baby. Pregnancy status must be checked before starting. Use highly effective birth control during treatment and for 1 week after the last dose.
- Serious allergic reactions (anaphylaxis) can happen. Stop the medicine and get help.
- Live, attenuated vaccines may be less effective during treatment.
- Not recommended in moderate to severe liver impairment.
Leniolisib interactions: what it interacts with
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Some medicines change how much leniolisib is in your body, or the other way around.
- Strong CYP3A4 inhibitors (like itraconazole): raise leniolisib levels about 2-fold. Avoid.
- Strong and moderate CYP3A4 inducers (like rifampin, efavirenz): may lower levels and reduce effectiveness. Avoid.
- BCRP, OATP1B1 and OATP1B3 substrates (like rosuvastatin): leniolisib raises their levels, which may increase their side effects. Avoid.
- Live vaccines: may work less well.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
Before taking Leniolisib
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- No contraindications are listed.
- Females who could become pregnant need a pregnancy test first and need effective birth control.
- Do not breastfeed during treatment and for 1 week after the last dose.
- Not recommended with moderate to severe liver impairment.
- Not established for children under 12 or those under 45 kg.
- Adults 65 and older were not studied.
Leniolisib overdose: if you take too much
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If too much is taken, you should be watched for any signs of side effects. Treatment is supportive care, including checking vital signs and clinical status. Contact a doctor or poison control right away.
Pharmacodynamics: what Leniolisib does in the body
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Leniolisib lowers the number of B cells that show active pAkt signaling. Higher drug levels generally led to a bigger and longer-lasting reduction. At the usual dose at steady state, the average reduction was about 80%.
Pharmacokinetics: how your body processes Leniolisib
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Leniolisib reaches its peak level about 1 hour after a dose in healthy people. Food is unlikely to make a meaningful difference. It builds up modestly with twice-daily dosing and reaches steady levels in about 2 to 3 days, with an effective half-life of about 7 hours.
The liver breaks down about 60% of it, mostly through CYP3A4. It leaves the body mainly through feces and urine. Teens 12 to 17 had similar exposure to adults.
How to store Leniolisib
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Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) . Do not refrigerate.
📄 Written from Leniolisib’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Leniolisib
145 supplements and herbal products have documented interactions with Leniolisib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 100
- Minor · 42
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Leniolisib: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Leniolisib — the kind of thing our pharmacy team would talk through with you at the counter.
What is Joenja for?
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How do I take it?
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What if I miss a dose or throw up?
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What side effects should I expect?
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Is it safe in pregnancy?
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Do my other medicines matter?
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Is Leniolisib available over the counter?
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When was Leniolisib first available?
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💬 Answers drafted from Leniolisib’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 More about Leniolisib on HelloPharmacist
💊 Leniolisib forms and strengths (how it comes)
Leniolisib is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Joenja is used to treat APDS in adults and children 12 years and older.
- Joenja is taken by mouth twice a day, about 12 hours apart, with or without food.
- Joenja has no recommended dose for people under 45 kg.
- If you miss a Joenja dose by more than 6 hours, wait and take the next dose at the usual time.
- If you vomit within 1 hour of taking Joenja, take it again as soon as possible. If it is more than 1 hour, wait for the next usual dose.
📊 Leniolisib on the U.S. market: products, makers and brands
How Leniolisib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
📈 How widely Leniolisib is used (Medicaid data)
A general measure of how commonly Leniolisib is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Leniolisib is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Leniolisib prescribed? Of the 1,599 medications we measure, Leniolisib ranks #1,492 by Medicaid prescriptions — more than 7% of them.
Utilization by Leniolisib product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
leniolisib 70 MG Oral Tablet
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2633015
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Leniolisib, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 1 listed Leniolisib NDCs with Medicaid activity.
🔍 Compare Leniolisib products
A representative set of FDA-listed product records for Leniolisib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 70 mg | Oral | Pharming Healthcare Inc. × 3 listings | NDA | View NDC → |
Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Leniolisib NDCs →
📈 Leniolisib side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Leniolisib — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Leniolisib in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ Leniolisib FDA approval history
How Leniolisib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Leniolisib recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2633005 1 dose form · 1 strength
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Dose form (SCDF) Oral Tablet RxCUI 2633014In current FDA listingsClinical drug / strength (SCD) 70 MGRxCUI 2633015
Look up RxCUI 2633005 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Leniolisib supply and shortage status
Whether Leniolisib is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Leniolisib brand names
🏭 Who makes Leniolisib: manufacturers and labelers
Leniolisib drug class (RxNorm)
Leniolisib belongs to the Kinase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Sources for this Leniolisib page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Pharming Healthcare Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.