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Overview: Joenja is used to treat a rare genetic condition called activated phosphoinositide 3-kinase delta syndrome (APDS). It works by blocking the activity of an overactive protein. Common side effects may include headache, inflammation of the sinuses, stomach pain, and cough. Get medical help right away if you have any signs of a serious allergic reaction, such as trouble breathing, wheezing, or swelling of the face, lips, mouth, tongue, or throat. Tell your health care provider about all medicines, herbal products, and supplements that you are using during treatment with Joenja.

Uses

What is Joenja used for?

Joenja (leniolisib) is commonly used to treat activated phosphoinositide 3-kinase delta syndrome (APDS), which is a rare inherited condition that affects the immune system.

How Joenja Treats APDS

Joenja may also be used for other conditions as determined by your health care provider.

How does Joenja work (mechanism of action)?

People with APDS have a faulty gene that makes a certain protein too active. This affects how certain types of white blood cells grow and work. 

Joenja is a type of medicine known as a kinase inhibitor. It blocks the overactive protein, which can help white blood cells grow and work normally. 

How is Joenja supplied (dosage forms)?

Brands and other names

  • Joenja

Dosage forms and strengths

  • 40 mg, 50 mg, and 70 mg oral tablets

How should I store Joenja?

Joenja should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. Do not refrigerate.

Side Effects

What are the most common side effects of Joenja?

The most common side effects of Joenja are listed below. These side effects may vary based on your age. Tell your health care provider if you have any of these side effects that bother you.

  • Headache
  • Inflammation of the sinuses (sinusitis)
  • Atopic dermatitis, which can lead to itchy, dry, and irritated skin
  • Stomach pain
  • Cough
  • Infection in the nose, throat, or lungs
  • Weight gain

There may be other side effects of Joenja that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Joenja?

While less common, the most serious side effects of Joenja are described below, along with what to do if they happen.

Severe Allergic Reactions. Joenja may cause allergic reactions, which can be serious. Stop taking Joenja and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Warnings & Precautions

Who should not use Joenja?

Allergies to Ingredients. People who are allergic to any of the following should not take Joenja.

  • Joenja 
  • Leniolisib
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Joenja.

What should I know about Joenja before using it?

Do not take Joenja unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Joenja with other people, even if they have the same condition as you. It may harm them.

Keep Joenja out of the reach of children.

What should I tell my health care provider before using Joenja?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Joenja is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any health conditions, including liver problems. 

Vaccines. Talk with your health care provider about any vaccines that you may need. Certain vaccines may not work as well while you are taking Joenja. Tell your health care provider about any vaccines you have recently received or have scheduled.

Other Medicines and Supplements. Joenja may interact with other medicines and supplements. Before taking Joenja, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Joenja may cause harm to a fetus. You should not be pregnant before starting Joenja. If you can get pregnant, you should use effective birth control while taking Joenja and for 1 week after your last dose. Tell your health care provider if you are pregnant or plan to become pregnant.

Breastfeeding. Do not breastfeed while you are taking Joenja and for 1 week after your last dose. It is not known if Joenja passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Joenja?

For more information about Joenja, you can visit the drugmaker’s website at www.joenja.com or call them at 877-796-2737.

Interactions

Does Joenja interact with foods or drinks?

There are no known interactions between Joenja and foods or drinks. Joenja may be taken with or without food.

It is unknown if drinking alcohol will affect Joenja.

Does Joenja interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Joenja.

  • Itraconazole (Sporanox, Tolsura), ketoconazole, posaconazole (Noxafil), or voriconazole (Vfend), which is a medicine used for fungal infections
  • Clarithromycin, which is a medicine used for bacterial infections
  • Ritonavir (Norvir), lopinavir/ritonavir (Kaletra), or nelfinavir (Viracept), which is a medicine commonly used to treat HIV
  • Efavirenz, which is a medicine commonly used to treat HIV
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • Rosuvastatin (Crestor), which is a medicine to lower cholesterol
  • Phenobarbital, phenytoin (Dilantin, Phenytek, and others), or primidone, which is a medicine that may be used to treat seizures
  • St. John’s wort, which is a supplement that may be used for depression

Many other medicines may alter the blood levels of Joenja, and vice versa. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Joenja. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Joenja?

If you or someone else has used too much Joenja, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Joenja?

If you miss a dose by 6 hours or less, take it as soon as you remember. If you miss a dose by more than 6 hours, skip the missed dose and only take your next dose at the usual time. Do not take double or extra doses.

If you throw up within 1 hour of taking Joenja, take another dose as soon as possible. If you throw up more than 1 hour after taking Joenja, do not take an extra dose. Take your next dose at your usual time.