Brand Name Imbruvica Common Name ibrutinib
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How does this medication work? What will it do for me?
Ibrutinib belongs to the class of medications called tyrosine kinase inhibitors. Specifically, it is called a Bruton’s tyrosine kinase (BTK) inhibitor. It is used to treat people with chronic lymphocytic leukemia (CLL) who have tried at least one other type of therapy.
Ibrutinib works by preventing the cancerous cells from reproducing and increasing in number.
How should I use this medication?
The recommended adult dose of ibrutinib is 420 mg taken by mouth, once daily.
In order to keep a constant amount of ibrutinib in your body, so it can be most effective, try to take this medication at the same time every day. The capsules should be swallowed whole. Do not crush or chew the capsules.
Ibrutinib may be taken with food or on an empty stomach. Avoid grapefruit juice and Seville oranges while you are taking ibrutinib.
It is important to drink plenty of fluids while you are taking ibrutinib. This will help keep your kidneys working properly and help to keep you hydrated.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as prescribed by your doctor.
If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.
What form(s) does this medication come in?
Each hard white gelatin capsule marked with “ibr 140 mg” in black ink contains 140 mg of ibrutinib. Nonmedicinal ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate; capsule and black ink: gelatin, titanium dioxide (E171), iron oxide black (E172), and shellac.
Who should NOT take this medication?
Do not take this medication if you are allergic to ibrutinib or any ingredients of the medication.
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
- muscle or joint aches
- sore mouth
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- blurred vision
- fever with low white blood cells
- irregular heart beat or palpitations
- persistent or severe diarrhea
- signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
- signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don’t stop bleeding)
- signs of dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)
- signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
- signs of bleeding in the stomach (e.g., bloody, black, or tarry stools, spitting up of blood, vomiting blood or material that looks like coffee grounds)
- signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Anemia: Ibrutinib may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.
Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.
Birth control: Effective birth control must be used during treatment and for at least 3 months after stopping therapy. If you are using birth control pills or another form of hormonal birth control, you should also use a barrier method such as condoms or diaphragms. Tell your doctor immediately if you become pregnant while using this medication.
Men who are taking ibrutinib must also use effective birth control during treatment and for at least 3 months after stopping therapy.
Bleeding: This medication may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.
Diarrhea and dehydration: Ibrutinib causes diarrhea in many patients. Diarrhea causes fluid loss from the body and can complicate cancer treatment. If you experience diarrhea while taking ibrutinib, contact your doctor as soon as possible.
Drowsiness/reduced alertness: Ibrutinib may affect the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other hazardous tasks until you have determined how this medication affects you.
Increased white blood cells: When you first start to take ibrutinib, your blood tests may show a dramatic increase in the number of white blood cells in the body. This is a temporary occurrence and does not necessarily mean that the illness is getting worse. The number of white blood cells should slowly return to normal. Your doctor will monitor the progress of this with blood tests.
Infection: Ibrutinib reduces the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.
Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.
Contact your doctor immediately if you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin.
Other cancers: People taking this medication have reported a higher number of other cancers such as melanoma. Talk to your doctor about cancer screening and your risk of developing another type of cancer.
Tumour lysis syndrome: Ibrutinib, like many other cancer medications, causes many cancer cells to be suddenly killed when treatment is first started. This can overwhelm the body with waste products from the cells. As a result, the body may not be able to keep up with getting rid of all the waste. When this happens, you may experience nausea, shortness of breath, cloudy urine, or joint pain. This is called tumour lysis syndrome. Your doctor may prescribe some medications to help your body get rid of the waste products. Make sure you understand how to use these medications and report any of these signs or symptoms to your doctor immediately.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if ibrutinib passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Because of the risk of serious effects to the baby if it does pass into breast milk, breast-feeding should be discontinued while taking this medication.
Children: The safety and effectiveness of using this medication have not been established for children.
Seniors: Seniors may experience a greater number of side effects with this medication.
What other drugs could interact with this medication?
There may be an interaction between ibrutinib and any of the following:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
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