Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

JOENJA (NDA-217759)

(LENIOLISIB PHOSPHATE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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09/11/2026 (SUPPL-6)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

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Adverse Reactions in Patients 12 Years of Age and Older with APDS

The safety of JOENJA reflects exposure based on 38 adult and pediatric patients 12 years of age and older with activated phosphoinositide 3-kinase delta (PI3K?) syndrome (APDS) from the placebo-controlled portion of Study 2201 [see Clinical Studies (14)] and additional open-label clinical safety data. Thirty-seven of 38 patients received JOENJA 70 mg orally twice daily for at least 25 weeks and 66% were exposed for 96 weeks or longer. Median duration of JOENJA treatment was approximately 2 years, and 4 patients had more than 5 years of JOENJA exposure.

The data below are based on the 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. Demographics of the patients who participated in this study are summarized in Clinical Studies [see Clinical Studies (14)]. Table 2 presents the number of patients and incidence, rounded to the nearest percent, of adverse reactions that occurred in 2 or more patients treated with JOENJA and for which the incidence in patients treated with JOENJA was greater than the incidence in patients treated with placebo.

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

Table 2 Adverse Reactions Reported by 2 or More JOENJA-Treated Adult and Pediatric Patients 12 Years of Age and Older and More Frequently than Placebo (Study 2201)

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Adverse Reactions in Pediatric Patients 4 Years to Less Than 12 Years of Age with APDS

The safety of JOENJA in pediatric patients 4 years to less than 12 years of age who weigh 27 kg or greater with APDS was based on 8 patients in a single-arm, open-label safety and pharmacokinetic study (Study LE3301) [see Clinical Pharmacology (12.3)]. Pediatric patients 4 years to less than 12 years of age received the recommended dosage of JOENJA based on body weight at baseline for at least 12 weeks and up to 24 weeks.

Adverse reactions reported in pediatric patients 4 years to less than 12 years of age were consistent with adverse reactions reported in adults and pediatric patients 12 years of age and older. Additional common adverse reactions reported in pediatric patients 4 years to less than 12 years of age who weigh 27 kg or greater (reported by 3 or more patients) were abdominal pain, cough, and respiratory tract infection.

Specific Adverse Reactions

Laboratory Abnormalities

Seven (33%) patients 12 years of age and older (n=21) and five (63%) patients 4 years to less than 12 years of age and weighing 27 kg or greater (n=8) developed an absolute neutrophil count (ANC) between 500 and 1500 cells/microL after receiving JOENJA. No patients developed an ANC < 500 cells/microL and there were no reports of infection associated with neutropenia.

Weight Increase

In the open-label clinical trial study portion of Study 2201, five (14%) patients 12 years of age and older (n=37) experienced weight gain. Some patients became overweight or obese.

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

The safety and effectiveness of JOENJA for the treatment of activated phosphoinositide 3-kinase delta syndrome have been established in pediatric patients 4 years of age and older who weigh 27 kg or greater. Use of JOENJA 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 (Study 2201) [see Clinical Studies (14)], and safety and pharmacokinetic data from a single-arm, open-label study (Study LE 3301) in pediatric patients 4 years to less than 12 years of age. A total of 8 pediatric patients aged 4 to less than 12 years in Study LE3301 received the recommended dosage of JOENJA based on body weight. The pharmacokinetic data demonstrated no clinically significant difference between pediatric patients younger than 12 years of age and adult and pediatric patients 12 years of age and older [see Clinical Pharmacology (12.3)]. Safety of JOENJA in pediatric patients aged 4 years to less than 12 years were consistent with adult and pediatric patients aged 12 years and older. Additional adverse reactions reported in pediatric patients aged 4 years to less than 12 years who weigh 27 kg or greater were abdominal pain, cough, and respiratory tract infection [see Adverse Reactions (6.1)].

The safety and effectiveness of JOENJA have not been established in pediatric patients younger than 4 years of age or who weigh less than 27 kg.

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05/28/2025 (SUPPL-5)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.3 Risk of Hypersensitivity Reactions, Including Anaphylaxis

Newly added subsection:

Hypersensitivity reaction(s), including anaphylaxis, have been reported in postmarketing setting. If a clinically significant hypersensitivity reaction occurs, discontinue JOENJA and institute appropriate therapy [see Adverse Reactions (6.2)].

6 Adverse Reactions

Additions and/or revisions underlined:

The following clinically significant adverse reactions are described elsewhere in the labeling:

Risk of Hypersensitivity Reactions, Including Anaphylaxis [see Warnings and Precautions (5.3)]
6.1 Clinical Trials Experience
Additions and/or revisions underlined:
…
Specific Adverse Reactions
…
Weight Increase
In the open-label clinical trial (n=37), five patients (14%) experienced weight gain. Some patients became overweight or obese.
6.2 Postmarketing Experience
Newly added subsection:
The following adverse reactions have been identified during postapproval use of JOENJA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune System Disorders: hypersensitivity (anaphylaxis)

7 Drug Interactions

7.2 Effects of JOENJA on Other Drugs

Additions and/or revisions underlined:

BCRP, OATP1B1, and OATP1B3 Substrates

Concomitant use of JOENJA with BCRP, OATP1B1, and OATP1B3 substrates should be avoided.

JOENJA is an inhibitor of BCRP, OATP1B1, and OATP1B3 transporters. Administration of JOENJA increases exposure of BCRP, OATP1B1, and OATP1B3 substrates [see Clinical Pharmacology (12.3)], which may increase the risk of adverse reactions related to these substrates.

8 Use in Specific Populations

8.1 Pregnancy

Additions and/or revisions underlined:

…

In a pre- and postnatal developmental toxicity study, leniolisib was administered orally to pregnant rats at oral doses of 10, 30, and 90 mg/kg/day from gestation day 7 through postnatal day 21. Leniolisib at a dose of 90 mg/kg/day (approximately 5 times the exposure at the MRHD on an AUC basis) was associated with a slight decrease in the percentage of pups born that survived 21 days postpartum (lactation index) and decreased pup body weights were observed prior to weaning.

8.2 Lactation

Additions and/or revisions underlined:

Risk Summary

There are no data on the presence of leniolisib or its metabolites in human milk or the effects on the breastfed infant or milk production. Leniolisib is present in rat milk (see Data). When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because of the potential for serious adverse reactions from leniolisib in the breastfed child, advise women not to breastfeed during treatment with JOENJA and for 1 week after the last dose.

Data

Animal Data

Leniolisib was present in the milk of lactating rats administered oral doses of 10, 30, and 90 mg/kg/day from gestation day 7 through postnatal day 21. Leniolisib concentrations were approximately 2- to 3-fold higher in milk than in maternal plasma. The concentration of leniolisib in animal milk does not necessarily predict the concentration of drug in human milk.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

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Vaccinations

Instruct patients to inform the healthcare providers that they are taking JOENJA prior to a potential vaccination [see Warnings and Precautions (5.2)].

Risk of Hypersensitivity Reactions, Including Anaphylaxis

Advise patients to discontinue JOENJA and to seek immediate medical attention if they develop any signs and symptoms of serious allergic reactions [see Warnings and Precautions (5.3)].

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