"The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion), which is associated with poor responses"...
What is IMBRUVICA?
IMBRUVICA is a prescription medicine used to treat people with:
- Mantle cell lymphoma (MCL) who have received at least one prior treatment
- Chronic lymphocytic leukemia (CLL) who have received at least one prior treatment
- Chronic lymphocytic leukemia (CLL) with 17p deletion
- Waldenstrom's macroglobulinemia (WM) It is not known if IMBRUVICA is safe and effective in children.
What should I tell my healthcare provider before taking IMBRUVICA?
Before you take IMBRUVICA, tell your healthcare provider about all of your medical conditions, including if you:
- have had recent surgery or plan to have surgery. Your healthcare provider may stop IMBRUVICA for any planned medical, surgical, or dental procedure.
- have bleeding problems
- have or had heart rhythm problems, smoke, or have a medical condition that increases your risk of heart disease, such as high blood pressure, high cholesterol, or diabetes
- have an infection
- have liver problems
- are pregnant or plan to become pregnant. IMBRUVICA can harm your unborn baby. You should not become pregnant while taking IMBRUVICA.
- are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take IMBRUVICA or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and overthe-counter medicines, vitamins, and herbal supplements. Taking IMBRUVICA with certain other medicines may affect how IMBRUVICA works and can cause side effects.
How should I take IMBRUVICA?
- Take IMBRUVICA exactly as your healthcare provider tells you to take it.
- Take IMBRUVICA 1 time a day.
- Swallow IMBRUVICA capsules whole with a glass of water. Do not open, break, or chew IMBRUVICA capsules.
- Take IMBRUVICA at about the same time each day.
- If you miss a dose of IMBRUVICA take it as soon as you remember on the same day. Take your next dose of IMBRUVICA at your regular time on the next day. Do not take 2 doses of IMBRUVICA on the same day to make up for a missed dose.
What should I avoid while taking IMBRUVICA?
- You should not drink grapefruit juice, eat grapefruit, or eat Seville oranges (often used in marmalades) while you are taking IMBRUVICA. These products may increase the amount of IMBRUVICA in your blood.
What are the possible side effects of IMBRUVICA?
IMBRUVICA may cause serious side effects, including:
- Bleeding problems can happen during treatment with IMBRUVICA that can be serious and may lead to death. Tell your healthcare provider if you have any signs of bleeding, including: blood in your stools or black stools (looks like tar), pink or brown urine, unexpected bleeding or bleeding that is severe or that you cannot control, vomit blood or vomit looks like coffee grounds, cough up blood or blood clots, increased bruising, feel dizzy or weak, confusion, change in your speech, or a headache that lasts a long time. Your risk of bleeding may increase if you are also taking a blood thinner medicine.
- Infections can happen during treatment with IMBRUVICA. These infections can be serious and may lead to death. Tell your healthcare provider right away if you have fever, chills, weakness, confusion, or other signs or symptoms of an infection while taking IMBRUVICA.
- Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with IMBRUVICA, but can also be severe. Your healthcare provider should do monthly blood tests to check your blood counts.
- Heart rhythm problems (atrial fibrillation and atrial flutter). Heart rhythm problems have happened in people treated with IMBRUVICA, especially in people who have an increased risk for heart disease, have an infection, or who have had heart rhythm problems in the past. Tell your healthcare provider if you get any symptoms of heart rhythm problems, such as feeling as if your heart is beating fast and irregular, lightheadedness, dizziness, shortness of breath, chest discomfort, or you faint.
- Second primary cancers. New cancers have happened in people who have been treated with IMBRUVICA, including cancers of the skin or other organs.
- Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS.
- Kidney problems. Kidney failure and death have happened in people with MCL receiving IMBRUVICA treatment.
The most common side effects of IMBRUVICA include: diarrhea, tiredness, muscle and bone pain, bruising, nausea, upper respiratory tract infection, and rash.
Diarrhea is a common side effect in people who take IMBRUVICA. Drink plenty of fluids during treatment with IMBRUVICA to help reduce your risk of losing too much fluid (dehydration) due to diarrhea. Tell your healthcare provider if you have diarrhea that does not go away.
These are not all the possible side effects of IMBRUVICA.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800FDA-1088.
How should I store IMBRUVICA?
- Store IMBRUVICA at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep IMBRUVICA in the original container with the lid tightly closed.
Keep IMBRUVICA and all medicines out of the reach of children.
General information about the safe and effective use of IMBRUVICA
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use IMBRUVICA for a condition for which it was not prescribed. Do not give IMBRUVICA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about IMBRUVICA that is written for health professionals.
What are the ingredients in IMBRUVICA?
Active ingredient: ibrutinib
Inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate. The capsule shell contains gelatin, titanium dioxide and black ink.
Last reviewed on RxList: 2/5/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Imbruvica Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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