Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Imbruvica

Descriptions


Ibrutinib is used to treat mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) in patients with 17p deletion, Waldenström macroglobulinemia (WM), and marginal zone lymphoma (MZL). It is also used to treat chronic graft-versus-host disease (cGHVD) after one or more lines of treatment did not work. It interferes with the growth of cancer cells, which are eventually destroyed by the body. Ibrutinib is an antineoplastic agent (cancer medicine).

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

This product is available in the following dosage forms:

  • Capsule
  • 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 ibrutinib 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 ibrutinib in the elderly. However, elderly patients are more likely to have unwanted effects (eg, anemia, pneumonia, bleeding problems, high blood pressure, heart rhythm problems), which may require caution in patients receiving ibrutinib.

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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abciximab
  • Acenocoumarol
  • Anagrelide
  • Apixaban
  • Aprepitant
  • Ardeparin
  • Argatroban
  • Aspirin
  • Atazanavir
  • Bemiparin
  • Bivalirudin
  • Boceprevir
  • Carbamazepine
  • Certoparin
  • Cilostazol
  • Ciprofloxacin
  • Clarithromycin
  • Clopidogrel
  • Cobicistat
  • Conivaptan
  • Crizotinib
  • Cyclosporine
  • Dabigatran Etexilate
  • Dalteparin
  • Danaparoid
  • Desirudin
  • Diltiazem
  • Dipyridamole
  • Dronedarone
  • Drotrecogin Alfa
  • Duvelisib
  • Edoxaban
  • Enoxaparin
  • Enzalutamide
  • Eptifibatide
  • Erythromycin
  • Fluconazole
  • Fluvoxamine
  • Fondaparinux
  • Fosnetupitant
  • Fosphenytoin
  • Heparin
  • Idelalisib
  • Imatinib
  • Indinavir
  • Itraconazole
  • Ivosidenib
  • Ketoconazole
  • Larotrectinib
  • Lefamulin
  • Lepirudin
  • Letermovir
  • Lopinavir
  • Lorlatinib
  • Lumacaftor
  • Mitotane
  • Nadroparin
  • Nefazodone
  • Nelfinavir
  • Netupitant
  • Nilotinib
  • Parnaparin
  • Phenprocoumon
  • Phenytoin
  • Posaconazole
  • Prasugrel
  • Protein C
  • Reviparin
  • Rifampin
  • Ritonavir
  • Rivaroxaban
  • Saquinavir
  • St John's Wort
  • Sulfinpyrazone
  • Telaprevir
  • Telithromycin
  • Ticagrelor
  • Ticlopidine
  • Tinzaparin
  • Tirofiban
  • Treprostinil
  • Verapamil
  • Vorapaxar
  • Voriconazole
  • Warfarin

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Bitter Orange
  • Grapefruit Juice

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:

  • Atrial fibrillation (heart rhythm problem), history of or
  • Bleeding problems or
  • Diabetes or
  • Hypertension (high blood pressure) or
  • Stroke, history of—Use with caution. May make these conditions worse.
  • Infection—May decrease your body's ability to fight an infection.
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use

Take this medicine exactly 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 patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take this medicine at the same time each day.

Swallow the medicine whole with a glass of water. Do not open, crush, break, or chew it.

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

Do not drink grapefruit juice or eat grapefruit or Seville oranges with this medicine.

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 (capsules, tablets):
    • For chronic graft versus host disease, chronic lymphocytic leukemia or small lymphocytic lymphoma alone or together with bendamustine and rituximab or obinutuzumab, or Waldenström macroglobulinemia alone or together with rituximab:
      • Adults—420 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.
    • For mantle cell lymphoma and marginal zone lymphoma:
      • Adults—560 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.

Take the missed dose only if it is the same day as the scheduled dose.

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 while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Women should use an effective form of birth control during treatment and for 1 month after the last dose. Men should use an effective form of birth control during treatment and for 1 month after the last dose to prevent pregnancy in a sexual partner. If you think a pregnancy has occurred with this medicine, tell your doctor right away.

This medicine may cause bleeding problems. Check with your doctor right away if you have bloody or black, tarry stools, red or dark brown urine, severe stomach pain, unusual bleeding, bruising, or weakness, or vomiting of blood or material that looks like coffee grounds.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before and after having surgery.

This medicine may increase your risk of developing infections, including a serious brain infection called progressive multifocal leukoencephalopathy. Call your doctor right away if you have a cough that would not go away, back pain, dizziness or drowsiness, weight loss, night sweats, fever, chills, or flu-like symptoms, such as a runny or stuffy nose, headache, blurred vision, or feeling generally ill.

Ibrutinib 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 the 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 a heart condition called atrial flutter or atrial fibrillation. Check with your doctor right away if you have a fast or irregular heartbeat, trouble breathing, lightheadedness, dizziness, or fainting.

Using this medicine may increase your risk of getting new cancers, including skin cancer. Talk to your doctor if you have concerns about this risk.

This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a change in how much or how often you urinate, joint pain, rapid weight gain, muscle or joint pain, swelling of the feet or lower legs, or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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. Back pain
  2. bladder pain
  3. bloating or swelling of the face, arms, hands, lower legs, or feet
  4. bloody or black, tarry stools
  5. bloody or cloudy urine
  6. blurred vision
  7. body aches or pain
  8. chest pain
  9. chills
  10. confusion
  11. cough
  12. decreased frequency or amount of urine
  13. difficult, burning, or painful urination
  14. dizziness or lightheadedness
  15. drowsiness
  16. dry mouth
  17. fainting
  18. fast or irregular heartbeat
  19. fever
  20. frequent urge to urinate
  21. headache
  22. hoarseness
  23. increased thirst
  24. irregular heartbeat
  25. itching
  26. loss of appetite
  27. lower back or side pain
  28. nausea
  29. rapid weight gain
  30. seizures
  31. severe headache
  32. severe stomach pain
  33. sore throat
  34. tightness of the chest
  35. tingling of the hands or feet
  36. troubled breathing
  37. ulcers, sores, or white spots in the mouth
  38. unusual bleeding or bruising
  39. unusual tiredness or weakness
  40. unusual weight gain or loss
  41. vomiting
  42. vomiting of blood or material that looks like coffee grounds
  43. wrinkled skin

Less common

  1. Persistent non-healing sore
  2. pink skin growth
  3. reddish skin patch or irritated area
  4. shiny skin bump
  5. white, yellow or waxy scar-like area on the skin

Incidence not known

  1. Blistering, peeling, or loosening of the skin
  2. dark urine
  3. diarrhea
  4. difficulty swallowing
  5. general feeling of tiredness or weakness
  6. hives, skin rash
  7. joint pain, stiffness, or swelling
  8. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  9. light-colored stools
  10. muscle pain
  11. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  12. red skin lesions, often with a purple center
  13. red, irritated eyes
  14. 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. Belching
  2. decreased appetite
  3. difficulty having a bowel movement
  4. heartburn or indigestion
  5. indigestion
  6. lack or loss of strength
  7. muscle stiffness or spasms
  8. small red or purple spots on the skin
  9. stomach discomfort, upset, or pain
  10. swelling or inflammation of the mouth

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.