Description and Brand Names

Drug information provided by: IBM Micromedex

Descriptions


Umbralisib is used to treat marginal zone lymphoma (MZL) that has come back (relapsed) or did not respond to the treatment (refractory) in patients who have received at least one previous treatment (eg, 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 product is available in the following dosage forms:

  • Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of umbralisib in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of umbralisib in the elderly. However, elderly patients are more likely to have unwanted effects (eg, serious infections), which may require caution in patients receiving umbralisib.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, 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 condition.
  • Infection—May decrease your body's ability to fight an infection.
  • Liver disease or
  • Stomach or bowel problems—Use with caution. May make these conditions worse.

Proper Use

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.

Precautions

It is very important that your doctor check 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 sexual 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. Males with female partners who are able to 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 yo 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 medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical 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 (eg, 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.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  1. Black, tarry stools
  2. bladder pain
  3. bleeding gums
  4. bloody or cloudy urine
  5. body aches or pain
  6. chest pain or tightness
  7. chills
  8. clay colored stools
  9. confusion
  10. cracks in the skin
  11. cough
  12. dark urine
  13. decreased appetite
  14. difficult, burning, or painful urination
  15. dizziness or lightheadedness
  16. ear congestion
  17. fainting
  18. fast heartbeat
  19. fever
  20. frequent urge to urinate
  21. headache
  22. itching, skin rash
  23. loss of heat from the body
  24. loss of voice
  25. lower back or side pain
  26. muscle or bone pain
  27. nausea and vomiting
  28. pain or tenderness around the eyes and cheekbones
  29. pale skin
  30. pinpoint red spots on the skin
  31. rapid, shallow breathing
  32. red, swollen skin
  33. scaly skin
  34. sneezing
  35. stomach cramps, tenderness, or pain
  36. stuffy or runny nose
  37. sore throat
  38. swelling of the hands, ankles, feet, or lower legs
  39. trouble breathing
  40. ulcers, sores, or white spots in the mouth
  41. unusual bleeding or bruising
  42. unusual tiredness or weakness
  43. watery or bloody diarrhea
  44. yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways 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

  1. 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 may report side effects to the FDA at 1-800-FDA-1088.