Duvelisib

IMPORTANT WARNING:

Duvelisib may cause serious or life-threatening infections. Tell your doctor if you have an infection, or if you have or have ever had cytomegalovirus (CMV; a viral infection that may cause symptoms in patients with weak immune systems). If you experience any of the following symptoms, call your doctor immediately: fever, sore throat, chills, shortness of breath, or other signs of infection.

Duvelisib may cause diarrhea or colitis (swelling of the large intestine). Tell your doctor if you have diarrhea or if you have ever had colitis or other conditions that affect your stomach or intestine. If you experience any of the following symptoms, call your doctor immediately: an increase in the number of bowel movements in a day, blood in your stool, or any stomach cramps or pain.

Duvelisib may cause serious or life-threatening skin reactions. If you experience any of the following symptoms, call your doctor immediately: new or worsening rash, rash with a fever, rash with itching, blisters or peeling skin, or painful sores or ulcers on your skin, lips, or in your mouth.

Duvelisib may cause serious or life-threatening pneumonitis (swelling of the lungs). Tell your doctor if you have lung disease or breathing problems. If you experience any of the following symptoms, call your doctor immediately: new or worsening cough, difficulty breathing, wheezing, or shortness of breath.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to duvelisib.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with duvelisib and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

IMPORTANT NOTICE:

MEDWATCH ALERT

[Posted 6/30/2022]

AUDIENCE: Patient, Health Professional, Pharmacy, Oncology

ISSUE: The FDA is warning that results from a clinical trial show a possible increased risk of death with Copiktra (duvelisib) compared to another medicine to treat a chronic blood cancer called leukemia and a lymphoma, a cancer found in the lymph nodes. The trial also found Copiktra was associated with a higher risk of serious side effects, including infections, diarrhea, inflammation of the intestines and lungs, skin reactions, and high liver enzyme levels in the blood. The FDA is notifying the public of these risks and is continuing to evaluate the safety of Copiktra. The FDA plans to hold a future public meeting to discuss the findings from the clinical trial and whether Copiktra should continue to be prescribed for patients. The FDA will update the public when more information is available.

BACKGROUND: Copiktra was approved to treat adults with chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two prior therapies that did not work or stopped working.

RECOMMENDATIONS:

• Patients should talk to your health care professional about the risks and benefits of receiving Copiktra for you. Discuss any questions or concerns you may have, including about possible alternative treatments.

• Health care professionals should consider the risks and benefits of continuing Copiktra in the context of other available treatments. Advise patients receiving Copiktra of the possible increased risk of death and higher risk of serious adverse events.

WHY is this medicine prescribed?

Duvelisib is used to treat chronic lymphocytic leukemia (CLL; a type of cancer that begins in the white blood cells) or small lymphocytic lymphoma (SLL; a type of cancer that begins mostly in the lymph nodes) that has returned or is unresponsive to at least two other treatments. Duvelisib is in a class of medications called kinase inhibitors. It works by blocking the signals that cause cancer cells to multiply. This helps to stop the spread of cancer cells.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Duvelisib comes as a capsule to take by mouth. It is usually taken twice daily with or without food. Take duvelisib 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 duvelisib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsule whole; do not open, chew, or break them.

Your doctor may decrease your dose of duvelisib or tell you to stop taking the medication for a time or permanently if you experience serious side effects during your treatment. This depends on how well the medication works for you and the side effects you experience. Talk to your doctor about how you are feeling during your treatment. Continue to take duvelisib even if you feel well. Do not stop taking duvelisib without talking to your doctor.

What SPECIAL PRECAUTIONS should I follow?

Before taking duvelisib,

• tell your doctor and pharmacist if you are allergic to duvelisib, any other medications, or any of the ingredients in duvelisib capsules. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking duvelisib. 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 duvelisib: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking duvelisib. Do not start any of these medications while taking duvelisib without discussing it with your healthcare provider.

• tell your doctor if you have or have ever had liver disease.

• tell your doctor if you are pregnant or plan to become pregnant. You must have a pregnancy test before you start taking duvelisib. You should not become pregnant during your treatment with duvelisib. If you are female, you should use birth control to prevent pregnancy during your treatment with duvelisib and at least 1 month after your final dose. If you are a male and your partner can become pregnant, you should use effective birth control during your treatment and for 1 month after your final dose. If you or your partner become pregnant while taking duvelisib, call your doctor immediately. Duvelisib may harm the fetus.

• tell your doctor if you are breastfeeding. You should not breastfeed while you are taking duvelisib and for at least 1 month after your final dose.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

If you miss a dose of duvelisib by less than 6 hours, take the missed dose as soon as you remember it and then take the next dose at the scheduled time. However, if you miss a dose by more than 6 hours, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

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

• nausea
• vomiting
• constipation
• tiredness
• headache
• muscle or join pain

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• yellow eyes or skin; abdominal pain; unexplained bruising or bleeding; loss of appetite; yellow or brown-colored urine; pale stools; or pain in the upper right part of the stomach

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

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

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.

What should I do in case of OVERDOSE?

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.

What OTHER INFORMATION should I know?

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

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.