Idelalisib tablets

What is this medicine?

IDELALISIB (eye del AL isib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat chronic lymphocytic leukemia, follicular B-cell non-Hodgkin lymphoma, and small lymphocytic lymphoma. It is not used as first-line therapy.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems like shortness of breath

• diarrhea

• low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• signs and symptoms of bleeding such as bloody or black, tarry stools; red or dark-brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eye, gums, or nose

• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine

• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

• stomach pain

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• cough

• nausea

• tiredness

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• alfuzosin

• conivaptan

• eletriptan

• eplerenone

• flibanserin

• isavuconazonium

• ivabradine

• lurasidone

• naloxegol

• simvastatin

• tolvaptan

• triazolam

• ubrogepant

This medicine may also interact with the following medications:

• certain medicines for anxiety like midazolam

• certain medicines for fungal infections like ketoconazole

• certain medicines for heart disease or irregular heart beat

• certain medicines for blood pressure like amlodipine, felodipine, nifedipine

• certain medicines for cholesterol like atorvastatin, lovastatin

• certain medicines for depression or psychotic disturbances

• certain medicines for erectile dysfunction

• certain medicines that treat or prevent blood clots like warfarin, enoxaparin, dalteparin, apixaban, dabigatran, and rivaroxaban

• ergot alkaloids like dihydroergotamine, ergotamine

• rifampin

• narcotic medicines for pain

What if I miss a dose?

If you miss a dose, take it as soon as you can. If your next dose is to be taken in less than 6 hours, then do not take the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children.

Store between 20 and 30 degrees C (68 and 86 degrees F). Keep this medicine in the original container. Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• infection

• liver disease

• lung or breathing disease, like asthma

• skin conditions or sensitivity

• an unusual or allergic reaction to idelalisib, other medicines, foods, dyes, or preservative

• pregnant, or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

You may need blood work done while you are taking this medicine.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your health care provider right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

Call your doctor or health care provider for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

Do not become pregnant while taking this medicine or for at least 1 month after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for 3 months after stopping it. There is a potential for serious side effects to an unborn child. Talk to your health care provider or pharmacist for more information. Do not breast-feed an infant while taking this medicine and for at least 1 month after stopping it.