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What is APDS?

APDS is a rare, inherited disease*

  • In people without APDS, the PI3K delta pathway regulates the development, growth, and division of white blood cells (made up of B and T cells). These white blood cells can help the body fight off infections. When the PI3K delta pathway is working properly, there is a healthy balance of immature and functional cells
  • In people with APDS, a genetic variant causes the PI3K delta pathway to be hyperactive. This means the development of B and T cells can be altered and create an imbalance of immature and functional cells. This makes it difficult for the body to fight infections and is thought to cause APDS symptoms

APDS, activated PI3K delta syndrome.

*APDS is a primary immunodeficiency, also known as an inborn error of immunity (or IEI).

This is a graphical representation of a complex biological process.
APDS, activated PI3K delta syndrome.

*APDS is a primary immunodeficiency, also known as an inborn error of immunity (or IEI).

How APDS could
affect you

People with APDS can suffer from a wide range of signs and symptoms.

APDS is a progressive disease, which means it may continue to develop and worsen over time. Part of that progression could lead to permanent, life-threatening organ damage or lymphoma (a type of blood cancer that affects the lymph nodes).

A genetic test can provide a definitive diagnosis of APDS, so it’s important to test as soon as possible. Because APDS can be genetic, family members may also be affected.

Click on each dot to read about APDS signs and symptoms
Tap on each dot to read about APDS signs and symptoms
Difficulty breathing, coughing up phlegm (mucus), wheezing, and chest pain which may lead to permanent lung damage over time
Frequent and severe respiratory tract infections, viral infections, sinus infections, or ear infections
Autoimmune and autoinflammatory diseases
Enlarged liver and spleen
Low blood cell count (red blood cells, white blood cells, platelets) which can make you fatigued or result in infections
Lymphoma
Diarrhea, abdominal pain, cramping, blood in stool, or inability to absorb nutrients

Living with APDS

Until now, available therapies have only treated the symptoms of APDS, not the source of the disease.

Joenja works to treat APDS at the source of the imbalance in your immune system caused by PI3K delta hyperactivity.

Not actual patients.

How APDS could
affect you

People with APDS can suffer from a wide range of signs and symptoms.

APDS is a progressive disease, which means it may continue to develop and worsen over time. Part of that progression could lead to permanent, life-threatening organ damage or lymphoma (a type of blood cancer that affects the lymph nodes).

A genetic test can provide a definitive diagnosis of APDS, so it’s important to test as soon as possible. Because APDS can be genetic, family members may also be affected.

Click on each dot to read about APDS signs and symptoms
Tap on each dot to read about APDS signs and symptoms
Difficulty breathing, coughing up phlegm (mucus), wheezing, and chest pain which may lead to permanent lung damage over time
Frequent and severe respiratory tract infections, viral infections, sinus infections, or ear infections
Autoimmune and autoinflammatory diseases
Enlarged liver and spleen
Low blood cell count (red blood cells, white blood cells, platelets) which can make you fatigued or result in infections
Lymphoma
Diarrhea, abdominal pain, cramping, blood in stool, or inability to absorb nutrients

Living with APDS

Until now, available therapies have only treated the symptoms of APDS, not the source of the disease.

Joenja works to treat APDS at the source of the imbalance in your immune system caused by PI3K delta hyperactivity.

Not actual patients.

Approved Use

JOENJA® (leniolisib) is a prescription medicine that is used to treat activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adults and children 12 years of age and older.

Important Safety Information

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 receiving JOENJA.

Approved Use

JOENJA® (leniolisib) is a prescription medicine that is used to treat activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adults and children 12 years of age and older.

Important Safety Information

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 receiving JOENJA.

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

It is not known if JOENJA passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take JOENJA.

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.

The most common side effects of JOENJA include headache, inflammation of sinuses, and dry, itchy, and inflamed skin (eczema). These are not all the possible side effects of JOENJA. Tell your healthcare provider about any side effect that bothers you or does not go away.

You can also report negative side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch, or Pharming Medical Affairs at (800) 930-5221.

For more information, please see the full Prescribing Information.

USO APROBADO

JOENJA® (leniolisib) is a prescription medicine that is used to treat activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adults and children 12 years of age and older.

INFORMACION DE SEGURIDAD IMPORTANTE

Informe a su proveedor de atención médica si está embarazada o planea quedar embarazada. JOENJA puede hacerle daño a el feto. Su proveedor de atención médica le hará una prueba de embarazo antes de que empiece a recibir JOENJA.

USO APROBADO

JOENJA® (leniolisib) es un medicamento de venta con receta médica que se utiliza para tratar el síndrome de fosfoinositida 3-cinasa delta activada (PI3Kδ) en adultos y niños mayores de 12 años.

INFORMACION DE SEGURIDAD IMPORTANTE

Informe a su proveedor de atención médica si está embarazada o planea quedar embarazada. JOENJA puede hacerle daño a el feto. Su proveedor de atención médica le hará una prueba de embarazo antes de que empiece a recibir JOENJA.

Utilice un método anticonceptivo eficaz para prevenir el embarazo mientras esté tomando JOENJA y durante una semana después de dejar de tomar JOENJA. Si planea quedar embarazada, continue tomando su método anticonceptivo durante una semana después de dejar de tomar JOENJA. Hable con su médico sobre qué tipo de método anticonceptivo es adecuado para usted mientras toma JOENJA.

Se desconoce si JOENJA pasa a la leche materna. Hable con su médico sobre la mejor manera de alimentar a su bebé si toma JOENJA.

Dígale a su médico todos los medicamentos que esté tomando, incluso los adquiridos con o sin receta, vitaminas y suplementos a base de hierbas. JOENJA y ciertos medicamentos pueden afectarse entre sí.

Informe a su médico si tiene programada una inmunización (vacuna). JOENJA puede afectar la eficacia de una vacuna.

Conozca los medicamentos que toma. Lleve una lista de sus medicamentos y enséñesela a su proveedor de atención médica y a su farmacéutico cuando adquiera un medicamento nuevo.

Los efectos secundarios más frecuentes de JOENJA incluyen dolor de cabeza, inflamación de los senos paranasales y sequedad, y picor e inflamación de la piel (eczema). Estos no son todos los posibles efectos secundarios de JOENJA. Informe a su médico de cualquier efecto secundario que le moleste o que no desaparezca.

También puede informar sobre los efectos secundarios negativos a la FDA en el 1-800-FDA-1088 o www.fda.gov/medwatch, o a Pharming Medical Affairs en el (800) 930-5221.

Para más información, consulte la Información de prescripción completa.