Health Guide
Drug Guide

Ibrutinib (Oral route)

Pronunciation:

eye-BROO-ti-nib

Brand Names:

Dosage Forms:

Classifications:

Therapeutic

Antineoplastic Agent

Pharmacologic

Tyrosine Kinase Inhibitor

Uses of This Medicine:

Ibrutinib is used to treat mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and Waldenström macroglobulinemia (WM). 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.

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.

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 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.

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.

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:

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

Do not eat grapefruit products 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.

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 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 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. A negative pregnancy test is needed before women start using this medicine. Women must prevent pregnancy during treatment and for up to 1 month after the last dose. Men must prevent pregnancy in a sexual partner during treatment and for up to 1 month after the last dose. 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 won't 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:

This medicine may cause a heart condition called atrial flutter or atrial fibrillation. Check with your doctor right away if you have fast or irregular heartbeats, 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 decrease or change in urine amount, joint pain, stiffness, or swelling, lower back, side, or stomach pain, a rapid weight gain, 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 (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
Back pain
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
convulsions
cough or hoarseness
decreased frequency or amount of urine
difficult, burning, or painful urination
dizziness or lightheadedness
drowsiness
dry mouth
fainting
fast or irregular heartbeat
fever
frequent urge to urinate
headache
increased thirst
irregular heartbeat
itching
loss of appetite
lower back or side pain
nausea and vomiting
rapid weight gain
severe headache
severe stomach pain
sore throat
tightness of the chest
tingling of the hands or feet
troubled breathing
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
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: 9/15/2016

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