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Ibrutinib (Oral route)

Pronunciation:

eye-BROO-ti-nib

Brand Names:

  • Imbruvica

Dosage Forms:

  • Capsule

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Tyrosine Kinase Inhibitor

Uses of This Medicine:

Ibrutinib is used to treat mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) in patients who have received at least one previous treatment with another medicine. Ibrutinib interferes with the growth of cancer cells, which are eventually destroyed by the body. It is an antineoplastic agent (cancer medicine).

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

Before Using This Medicine:

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.

Children—

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.

Older adults—

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, which may require caution in patients receiving this medicine.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast-feeding—

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.

Other medicines—

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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Atazanavir
  • Boceprevir
  • Cobicistat
  • Lopinavir
  • Nelfinavir
  • Ritonavir
  • Saquinavir
  • Telaprevir
  • Tipranavir

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.

  • Abiraterone Acetate
  • Aprepitant
  • Carbamazepine
  • Ciprofloxacin
  • Clarithromycin
  • Conivaptan
  • Crizotinib
  • Darunavir
  • Delavirdine
  • Diltiazem
  • Enzalutamide
  • Erythromycin
  • Fluconazole
  • Fosamprenavir
  • Fosphenytoin
  • Imatinib
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Nefazodone
  • Phenobarbital
  • Phenytoin
  • Posaconazole
  • Primidone
  • Rifabutin
  • Rifampin
  • Rifapentine
  • St John's Wort
  • Telithromycin
  • Verapamil
  • Voriconazole

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.

  • 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:

  • Bleeding problems or
  • Kidney problems—Use with caution. May make these conditions worse.
  • Infection—May decrease your body's ability to fight infection.
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

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

Drink extra fluids so you will pass more urine while you are using this medicine. This may help prevent kidney problems.

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):
    • For chronic lymphocytic leukemia:
      • Adults—420 milligrams (mg) (three 140 mg capsules) once a day.
      • Children—Use and dose must be determined by your doctor.
    • For mantle cell lymphoma:
      • Adults—560 milligrams (mg) (four 140 mg capsules) once a day.
      • 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.

Storage—

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.

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

Precautions While Using This Medicine:

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 receive 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. Use an effective form of birth control while you are using this medicine to keep from getting pregnant. If you think you have become pregnant, 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.

Call your doctor right away if you have a cough that won't go away, weight loss, night sweats, fever, chills, or flu-like symptoms, such as a runny or stuffy nose, headache, blurred vision, or feeling generally ill. These may be symptoms of an infection.

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 kidney problems. Tell your doctor right away if you have a decreased frequency or amount of urine, bloody urine, increased thirst, lower back or side pain, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, or weight gain.

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.

Do not eat grapefruit or Seville oranges, or drink grapefruit juice while you are using this medicine.

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 (eg, St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

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
Bladder pain
bloating or swelling of the face, arms, hands, lower legs, or feet
bloody or black, tarry stools
bloody or cloudy urine
blurred vision
body aches or pain
chest pain
chills
confusion
cough or hoarseness
decreased frequency or amount of urine
difficult, burning, or painful urination
dizziness or lightheadedness
dry mouth
fainting
fever
frequent urge to urinate
increased thirst
irregular heartbeat
itching
loss of appetite
lower back or side pain
nausea and vomiting
rapid weight gain
severe headache
severe stomach pain
shortness of breath or troubled breathing
sore throat
tightness of the chest or wheezing
tingling of the hands or feet
ulcers, sores, or white spots in the mouth
unusual bleeding or bruising
unusual tiredness or weakness
unusual weight gain or loss
vomiting of blood or material that looks like coffee grounds
warmth on the skin
weight gain
wrinkled skin
Less common
Persistent non-healing sore
pink skin growth
reddish skin patch or irritated area
shiny skin bump
white, yellow or waxy scar-like area on the 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
Belching
decreased appetite
difficulty having a bowel movement (stool)
heartburn or indigestion
indigestion
joint or muscle pain
lack or loss of strength
muscle stiffness or spasms
rash
small red or purple spots on the skin
stomach discomfort, upset, or pain
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.


Last Updated: 4/4/2014

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