Idelalisib Oral Tablet (IDELALISIB - ORAL)

Instructions

Swallow the medicine without crushing or chewing it.

Keep the medicine in its original container.

This medicine may be taken with or without food.

This medicine will work best if you take it at about the same time every day.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget to take a dose on time, take it if you remember within 6 hours of the scheduled dose. If you don’t remember until after more than 6 hours, skip the missed dose and return to your regular schedule with the next dose. Do not take 2 doses of this medicine at one time.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

This medicine is associated with a rare but very serious medical condition. Please speak with your doctor about symptoms you should look out for while on this medicine. Notify your doctor immediately if you develop those symptoms.

Some patients on this medicine have developed severe, life-threatening infections. Please speak with your doctor about the risks and benefits of using this medicine.

This medicine has been associated with a rare but serious skin rash. If you notice any red, peeling or blistered skin, contact your doctor immediately.

This medicine is associated with a rare, but serious problem of the liver. Speak to your doctor about the early signs of liver problems and the benefits and risks of using this medicine.

Do not use the medication any more than instructed.

This medicine may reduce your body's ability to fight infections. Avoid contact with people with colds, flu or other infections. Contact your doctor if you develop fever, cough, sore throat, or chills.

Speak with your health care provider before receiving any vaccinations.

Do not breastfeed while on this medicine. You may safely start breastfeeding 1 month after stopping treatment.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

Women must use reliable forms of birth control while taking this medicine and for 1 month after stopping to prevent pregnancy.

Men with a female partner who is of childbearing age must use reliable birth control during sexual activity while taking this medicine and for 3 months after stopping to prevent pregnancy.

Do not take St. John's wort while on this medicine.

Women who are pregnant or in their childbearing years should not touch or handle this medicine. This medicine can be absorbed through the woman's skin and harm the unborn baby.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Always refill this medicine before it runs out.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• agitated feeling or trouble sleeping
• diarrhea
• lack of energy and tiredness
• headaches
• mouth sores or irritation
• stomach upset or abdominal pain

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• loss of balance
• bleeding or bruising
• wheezing or difficulty breathing
• difficulty concentrating
• confusion
• cough that does not go away
• severe, watery or bloody diarrhea
• dizziness
• swelling of the legs, feet, and hands
• fainting
• fever or chills
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• seizures
• shortness of breath
• red, peeling or blistering skin
• sore throat
• difficulty speaking
• severe stomach or bowel pain
• blood in stool
• swelling in the neck or throat
• blurring or changes of vision
• weakness

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.