Umbralisib

MEDWATCH ALERT

FDA Drug Safety Communication Posted June 1, 2022

The U.S. Food and Drug Administration (FDA) has removed approval of umbralisib. Studies have continued to show treatment with umbralisib to be associated with a light increased risk of death. The FDA has decided that risk of treatment with umbralisib is greater than any potential benefit.

Health care professionals should stop prescribing umbralisib and put patients on alternative treatments.

Patients should talk to your health care professionals about alternative treatments and stop taking umbralisib. Any unused umbralisib can be disposed of using a drug take-back location (https://www.fda.gov/drugs/disposal-unused-medicines-what-you-should-know/drug-disposal-drug-take-back-locations) or by taking the following steps:

• 1. Mix the medicine with an unappealing substance like dirt, cat litter, or coffee grounds; do not crush them
• 2. Place mixture in a container like a sealed plastic bag
• 3. Throw away the container in your home trash
• 4. Remove all personal information from the prescription labels of empty medicine bottles or packaging and then dispose of the bottles

Umbralisib is used to treat marginal zone lymphoma (MZL; a slow growing cancer that begins in a type of white blood cells that normally fight infection) in adults whose cancer has returned or did not respond to a certain type of medication. It is also used to treat follicular lymphoma (FL; a type of cancer that begins in the white blood cells) in adults whose cancer has returned or did not respond to at least three other medications. Umbralisib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.

Umbralisib comes as a tablet to take by mouth. It is usually taken once daily with food. Take umbralisib at around the same time 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 umbralisib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

If you vomit after taking the medication, do not take another dose. Continue your regular dosing schedule.

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

Before taking umbralisib,

• tell your doctor and pharmacist if you are allergic to umbralisib, aspirin, any other medications, tartrazine (a yellow dye in some processed foods and medications), or any of the ingredients in umbralisib tablets. Ask your pharmacist or check the Medication Guide 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.
• tell your doctor if you have an infection. Also, tell your doctor if have ever had have stomach or intestinal problems or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or if you plan on fathering a child. If you are female, you will need to take a pregnancy test before you start treatment and use birth control to prevent pregnancy during your treatment and for at least 1 month after your final dose. If you are a male, you and your partner should use birth control during your treatment with umbralisib and for 1 month after your final dose. Talk to your doctor about birth control methods that you can use during your treatment. If you or your partner become pregnant while taking umbralisib, call your doctor immediately. Umbralisib may harm the fetus.
• tell your doctor if you are breastfeeding. You should not breastfeed while you are taking umbralisib and for 1 month after your final dose.
• you should know that umbralisib may cause fertility problems in men. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.

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

If you miss a dose by less than 12 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 12 hours, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

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

• diarrhea
• vomiting
• nausea
• loss of appetite
• stomach pain
• tiredness
• swelling of the face, hands, or feet
• muscle, back, neck, or bone pain
• difficulty falling asleep or staying asleep

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• fever, sore throat, cough, difficulty breathing, wheezing, chills, or other signs of infection
• severe diarrhea; blood in your stools or black, tarry stools; pink or brown urine; vomiting blood or coffee ground vomit; or coughing up blood
• yellow eyes or skin; abdominal pain; bruising or bleeding; loss of appetite; yellow or brown-colored urine; pale stools; or pain in upper right part of stomach
• rash
• rash with fever or itching
• blisters or peeling skin
• painful sores or ulcers on your skin, lips, or mouth

Umbralisib 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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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. https://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 (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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

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.

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