Leniolisib

Leniolisib is a prescription medication used for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS). 

• Leniolisib is available under the following different brand names: Joenja.

Common side effects of Leniolisib include:

• Headache, 
• Sinusitis, 
• Atopic dermatitis.
• Diarrhea.
• Hair loss.
• Back pain.
• Neck pain.

Serious side effects of Leniolisib include:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• A fast heartbeat.
• Fever.

Rare side effects of Leniolisib include:

• None

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Tablet

• 70 mg

Activated Phosphoinositide 3-kinase Delta Syndrome

Adult dosage

• Below 45 kg: No recommended dose
• Above 45 kg: 70 mg orally every 12 hours

Pediatric dosage

• Below 12 years: Safety and efficacy not established.
• 12 years and above and weighing 45 kg or more: 70 mg orally every 12 hours
• Below 45 kg: No recommended dose

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Leniolisib has severe interactions with no other drugs.
• Leniolisib has serious interactions with at least 149 other drugs.
• Leniolisib has moderate interactions with the following drugs.
  • adenovirus types 4 and 7 live, oral
  • BCG vaccine live.
  • cholera vaccine
  • dengue vaccine
  • Ebola Zaire vaccine
  • influenza virus vaccine quadrivalent, intranasal
  • measles (rubeola) vaccine
  • measles mumps and rubella vaccine, live.
  • measles, mumps, rubella, and varicella vaccine, live.
  • poliovirus vaccine live oral trivalent
  • rotavirus oral vaccine, live.
  • rubella vaccine
  • Smallpox (vaccinia) and monkeypox vaccine, live, nonreplicating.
  • smallpox (vaccinia) vaccine, attenuated.
  • smallpox (vaccinia) vaccine, live.
  • typhoid polysaccharide vaccine
  • typhoid vaccine live.
  • varicella virus vaccine live.
  • yellow fever vaccine
• Leniolisib has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Leniolisib?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Leniolisib?”

Cautions

• Based on findings in animals, may cause fetal harm when administered to pregnant females
• Drug interaction overview
• Substrate of CYP3A4
  • Inhibitor of CYP1A2, BCRP, OATP1B1, OATP1B3
• Vaccines
  • Caution, monitor
  • Live, attenuated vaccinations may be less effective if administered during leniolisib treatment.
• Strong CYP3A4 inhibitors
  • Avoid coadministration.
  • Leniolisib exposure was increased 2-fold when coadministered with itraconazole, a strong CYP3A4 inhibitor.
• Strong and moderate CYP3A4 inducers
  • Avoid coadministration.
  • Strong and moderate CYP3A4 inducers may reduce leniolisib systemic exposure and thus reduce leniolisib efficacy.
• Sensitive CYP1A2 substrates
  • Avoid coadministration.
  • Coadministration may increase CYP1A2 systemic exposure.
  • Avoid CYP1A2 substrates that have a narrow therapeutic index.
• BCRP, OATP1B1, and OAP1B3 substrates
  • Avoid coadministration.
  • Effect of leniolisib on BCRP, OATP1B1, and OATP1B3 substrates has not been studied clinically
  • Owing to a possible increase in systemic exposure to these substrates, avoid concomitant use.

Pregnancy and Lactation

• Leniolisib 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 (see Data). 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.
• Pregnancy Testing
  • Verify the pregnancy status in females of reproductive potential before initiating this drug.
• Contraception
  • 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.
• Lactation
  • 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. 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