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Joenja® (leniolisib)

The first and only precision therapy that targets the
underlying immune defect in patients with APDS1-3

Find out how Joenja gets to the source of APDS

How Joenja works

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Explore the results with Joenja in treating APDS

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Explore what’s available for patient access & support

Access & support

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Sponsored genetic testing is available for patients with APDS and their families

Recognizing the symptoms of APDS and conducting genetic testing are crucial for diagnosing and managing the condition4,5

Explore sponsored genetic testing option

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APDS, activated PI3Kδ syndrome.

References: 1. Joenja (leniolisib). Prescribing information. Pharming Healthcare, Inc. 2. Pharming Group. Pharming announces US FDA approval of Joenja® (leniolisib) as the first and only treatment indicated for APDS. Press release. March 24, 2023. Accessed January 9, 2026. https://www.pharming.com/news/pharming-announces-us-fda-approval-joenja-leniolisib-first-and-only-treatment-indicated-apds 3. Rao VK, Webster S, Šedivá A, et al. A randomized, placebo-controlled phase 3 trial of the PI3Kδ inhibitor leniolisib for activated PI3Kδ syndrome. Blood. 2023;141(9):971-983. doi:10.1182/blood.2022018546 4. Coulter TI, Chandra A, Bacon CM, Babar J, et al. Clinical spectrum and features of activated phosphoinositide 3-kinase δ syndrome: A large patient cohort study. J Allergy Clin Immunol. 2017;139(2):597-606.e4. doi:10.1016/j.jaci.2016.06.021 5. Data on file. Pharming Healthcare, Inc.

Indications and Usage

JOENJA® (leniolisib) is a kinase inhibitor indicated for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older.

Indications and Usage

JOENJA® (leniolisib) is a kinase inhibitor indicated for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older.

Important Safety Information

Verify pregnancy status in females of reproductive potential prior to initiating treatment with JOENJA.

JOENJA may cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus and to use highly effective methods of contraception during treatment with JOENJA and for 1 week after the last dose. Additionally, advise women not to breastfeed during treatment with JOENJA and for 1 week after the last dose.

Live, attenuated vaccinations may be less effective if administered during JOENJA treatment.

JOENJA may cause hypersensitivity reaction(s), including anaphylaxis. Advise patients to discontinue JOENJA and to seek immediate medical attention if they develop any signs and symptoms of serious allergic reactions.

Use of JOENJA in patients with moderate to severe hepatic impairment is not recommended. There is no recommended dosage for patients weighing less than 45 kg.

Avoid co-administration of JOENJA with other medications known to be strong CYP3A4 inhibitors, strong or moderate CYP3A4 inducers, or BCRP, OATP1B1, and OATP1B3 substrates.

The most common adverse reactions (incidence >10%) were headache, sinusitis, atopic dermatitis, and weight gain.

Seven (33%) patients receiving JOENJA developed an absolute neutrophil count (ANC) between 500 and 1500 cells/microL. No patients developed an ANC <500 cells/ microL and there were no reports of infection associated with neutropenia.

Before prescribing JOENJA, please read the full Prescribing Information.

What Is APDS?

How Joenja Works

Joenja Results & Safety

Dosing & Administration

Access & Resources

APDS Assist Resources

Request a Rep

Full Prescribing Information Contact Us Privacy Policy Terms of Use Cookie Policy

Joenja and logo are registered trademarks of Pharming Intellectual Property, B.V.

© 2026 Pharming Healthcare, Inc. All rights reserved.
JOE-US-2023-0026v10 05/26

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