Joenja is a prescription medicine used to treat a rare, genetic disease that affects the immune system called activated phosphoinositide 3-kinase delta syndrome (APDS).

APDS is a type of primary immunodeficiency disorder that causes increased susceptibility to infections.

Joenja contains leniolisib which belongs to a new class of drugs called phosphoinositide 3-kinase delta (PI3Kẟ) inhibitors. Leniolisib works by inhibiting a certain cellular messenger that interferes with the normal development and function of immune cells in the body. 

What is Joenja used to treat?

Joenja is used to treat activated phosphoinositide 3-kinase delta syndrome (APDS) in adult and pediatric patients 12 years of age and older.

APDS is a primary immunodeficiency disease caused by genetic mutations in either the PIK3CD or PIK3R1 genes, which leads to hyperactivity of the PI3Kδ (phosphoinositide 3-kinase delta) pathway. Balanced signaling in the PI3Kδ pathway is essential for normal development and function of immune cells in the body.

Symptoms of APDS include frequent and severe infections of the ears, sinuses, and upper and lower respiratory tracts, as well as autoimmunity and inflammatory symptoms. People with APDS may also be at higher risk for cancers such as lymphoma.

Joenja can cause harm to an unborn baby. Tell your healthcare provider if you are pregnant or plan to become pregnant.

You will need to use effective birth control during treatment, and for one week after the last dose.

Usual Adult Dose for Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS):

70 mg orally twice daily

Comments:
- verify pregnancy status in females of reproductive potential prior to initiating treatment.

Use:
- treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older and weighing ≥45kg

Before you start treatment, tell your healthcare provider about all of your medical conditions.

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant. Joenja may harm your unborn baby. Your healthcare provider will do a pregnancy test before you start treatment.

Use effective birth control to prevent pregnancy during treatment, and for one week after you stop treatment. If you plan to become pregnant, continue taking your birth control for one week after you stop treatment. Talk to your doctor about what type of birth control method is right for you.

Breastfeeding

It is not known if this medicine passes into your breast milk. Breastfeeding is not advised during treatment, and for one week after the last dose.

Talk to your doctor about the best way to feed your baby during treatment.

Common side effects include:

• headache

• inflammation of sinuses

• eczema (dry, itchy, and inflamed skin).

These are not all the possible side effects. Tell your healthcare provider about any side effect that bothers you or does not go away.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Joenja and certain other medicines may affect each other.

Tell your healthcare provider if you are scheduled to receive an immunization (vaccine). Joenja may affect how well a vaccine works.

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.