Leniolisib is used to treat adults and children 12 years of age and older who have activated phosphoinositide 3-kinase delta syndrome (APDS; an genetic condition that decreases the activity of the immune system and can result in recurrent infections, swollen lymph nodes and spleen, and a certain type of lymphoma [a type of blood cancer]). Leniolisib is in a class of medications called kinase inhibitors. It works by blocking the signals that cause abnormalities in the immune system, which improves the functions of the immune system.

Leniolisib comes as a tablet to take by mouth. It is usually taken with or without food twice a day, about 12 hours apart. Take leniolisib at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take leniolisib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you vomit with 1 hour after you take leniolisib, take another dose as soon as possible. If you vomit more than 1 hour after you take leniolisib, do not take another dose. Continue your regular dosing schedule.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Before taking leniolisib,

• tell your doctor and pharmacist if you are allergic to leniolisib, any other medications, or any of the ingredients in leniolisib tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• The following nonprescription or herbal products may interact with leniolisib: St. John's Wort. Be sure to let your healthcare provider know that you are taking this medication before you start taking leniolisib. Do not start this medication while taking leniolisib without talking to your healthcare provider.
• tell your doctor if you have or have ever had liver problems.
• tell your doctor if you are pregnant or plan to become pregnant. You will need to take a pregnancy test before you take leniolisib. You should not become pregnant while you are taking leniolisib. You should use effective birth control to prevent pregnancy during your treatment with leniolisib and for 1 week after your final dose. Talk to your doctor about birth control methods that will work for you. If you become pregnant while taking leniolisib, call your doctor immediately. Leniolisib may harm the fetus.
• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while receiving leniolisib and for 1 week after your final dose.
• do not have any vaccinations without talking to your doctor.

Take the missed dose as soon as you remember it. However, if it is less than 6 hours before your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Leniolisib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• nasal congestion, runny nose
• dry and itchy skin
• red or scaly rash
• diarrhea
• tiredness
• neck or back pain
• hair loss
• fever
• fast heartbeat

Leniolisib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Keep all appointments with your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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