Umbralisib (Oral)

Umbralisib is used to treat marginal zone lymphoma (MZL) that has come back (relapsed) or did not respond to treatment (refractory) in patients who have received at least one previous treatment (e.g., anti-CD20-based treatment). It is also used to treat follicular lymphoma (FL) that has come back or did not respond to treatment in patients who have received at least 3 previous treatments.

This medicine is available only with your doctor's prescription.

This medicine was withdrawn from the U.S. market on June 1, 2022, due to safety concerns.

It is very important that your doctor checks your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment and for at least 1 month after the last dose. Men with female partners who can become pregnant should use an effective form of birth control during treatment and for at least 1 month after the last dose. If you think you have become pregnant, tell your doctor right away.

Some men who use this medicine have become infertile (unable to have children). Talk to your doctor before using this medicine if you plan to have children.

This medicine may cause serious infections. Check with your doctor right away if you have chest pain, fever or chills, confusion, cough or hoarseness, dizziness, fainting, fast heartbeat, lightheadedness, lower back or side pain, painful or difficult urination, sneezing, sore throat, tightness in the chest, or trouble breathing.

Umbralisib can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may cause severe diarrhea or non-infectious colitis. Check with your doctor right away if you have fever, pain, stomach cramps, tenderness, or watery or bloody diarrhea.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause serious skin reactions (e.g., exfoliative dermatitis). Check with your doctor right away if you have cracks in the skin, flushing, redness of the skin, loss of heat from the body, rash, red, swollen skin, scaly skin, or unusually warm skin.

In deciding to use a medicine, you and your doctor will weigh the risks against the benefits of the medicine. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on the effects of umbralisib in children. Safety and effectiveness have not been established.

Geriatric

Studies conducted so far have not shown any geriatric-specific issues that would limit the use of umbralisib in older adults. However, older patients may be more likely to experience unwanted effects (for example, serious infections), which may require caution in patients taking umbralisib.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may adjust the dose, or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or specific types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional how to take your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Allergy to aspirin—Use with caution. This medicine contains a yellow dye called tartrazine, which may cause allergic reactions (including asthma) in patients with this allergy.

• Infection—May reduce your body's ability to fight infections.

• Liver disease or
• Stomach or bowel problems—Use with caution. These conditions may worsen.

Along with its necessary effects, Umbralisib (Oral) may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor right away if any of the following side effects happen:

More common

• Black, tarry stools
• bladder pain
• bleeding gums
• bloody or cloudy urine
• body aches or pain
• chest pain or tightness
• chills
• clay colored stools
• confusion
• cracks in the skin
• cough
• dark urine
• decreased appetite
• difficult, burning, or painful urination
• dizziness or lightheadedness
• ear congestion
• fainting
• fast heartbeat
• fever
• frequent urge to urinate
• headache
• itching, skin rash
• loss of heat from the body
• loss of voice
• lower back or side pain
• muscle or bone pain
• nausea and vomiting
• pain or tenderness around the eyes and cheekbones
• pale skin
• pinpoint red spots on the skin
• rapid, shallow breathing
• red, swollen skin
• scaly skin
• sneezing
• stomach cramps, tenderness, or pain
• stuffy or runny nose
• sore throat
• swelling of the hands, ankles, feet, or lower legs
• trouble breathing
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• watery or bloody diarrhea
• yellow eyes or skin

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to Umbralisib (Oral). Your health care professional may also be able to tell you how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Ukoniq

Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Swallow the tablet whole. Do not crush, break, cut, or chew it.

It is best to take this medicine with food. Take the medicine at the same time each day.

You may also receive medicines to help prevent infections during treatment with this medicine.

Drink plenty of water each day to help prevent dehydration caused by diarrhea.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For marginal zone lymphoma or follicular lymphoma: Adults—800 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose and it is more than 12 hours until your next scheduled dose, take it as soon as possible, and then go back to your regular schedule. If you miss a dose and it is less than 12 hours until your next scheduled dose, skip the missed dose and take your next dose at the regular time.

If you vomit after taking a dose, do not take an extra dose. Take the next dose at the regular time.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.