Ibrutinib (Oral route)
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. This medicine is also used to treat patients with CLL who carry a deletion in chromosome 17 (17p deletion), which is associated with poor responses to standard treatment for CLL. 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:
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.
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.
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, atrial fibrillation, hypertension, infections, diarrhea), which may require caution in patients receiving this medicine.
|All Trimesters||D||Studies 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.|
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.
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.
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
- St John's Wort
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:
- Atrial fibrillation (heart rhythm problem), history of or
- Bleeding 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.
Do not eat grapefruit or Seville oranges, or drink grapefruit juice while you are using this medicine.
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.
- For chronic lymphocytic leukemia:
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.
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. 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 atrial flutter or atrial fibrillation. Check with your doctor right away if you have fast or irregular heartbeats, trouble breathing, lightheadedness, dizziness, or fainting after using this medicine.
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 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:
- 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
- cough or hoarseness
- decreased frequency or amount of urine
- difficult, burning, or painful urination
- dizziness or lightheadedness
- dry mouth
- fast or irregular heartbeat
- frequent urge to urinate
- increased thirst
- irregular heartbeat
- 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
- 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
- More common
- decreased appetite
- difficulty having a bowel movement (stool)
- heartburn or indigestion
- joint or muscle pain
- lack or loss of strength
- muscle stiffness or spasms
- small red or purple spots on the skin
- stomach discomfort, upset, or pain
- swelling or inflammation of the mouth
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:
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:
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: 11/4/2014