What is this medication?

DUVELISIB (doo ve lis ib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It treats chronic lymphocytic leukemia and small lymphocytic lymphoma.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Copiktra

What should I tell my care team before I take this medication?

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

• infection
• lung or breathing disease, like asthma
• stomach or intestine problems
• an unusual or allergic reaction to duvelisib, other medicines, foods, dyes, or preservative
• pregnant, or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take this medicine with or without food. However, you should always take it the same way. 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.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

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.

What may interact with this medication?

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

• flibanserin
• lomitapide
• lonafarnib

This medicine may also interact with the following medications:

• certain antibiotics like erythromycin or clarithromycin
• certain antivirals for HIV or hepatitis
• certain medicines for fungal infections like ketoconazole, itraconazole, or posaconazole
• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
• midazolam
• rifampin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your health care provider for regular check ups on your progress. It may be some time before you see the benefit from 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.

This medicine may increase your risk of getting an infection. Call your health care provider for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Do not become pregnant while taking this medicine or for 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 1 month after stopping it. There is a potential for serious side effects to an unborn child. Talk to your health care provider for more information. Do not breast-feed an infant while taking this medicine and for 1 month after stopping it.

This medicine may make it more difficult to father a child. Talk to your health care provider if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

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
• cough
• diarrhea
• mouth sores
• rash, fever, and swollen lymph nodes
• redness, blistering, peeling, or loosening of the skin, including inside the mouth
• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine

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

• bone pain
• muscle pain
• nausea
• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store between 20 and 25 degrees C (68 and 77 degrees F). Keep this medicine in the original container. Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, empty the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.