Ibrutinib, sold under the brand name Imbruvica among others, is a small molecule drug that inhibits malignant B-cell proliferation and survival by irreversibly binding the protein Bruton’s tyrosine kinase.
Imbruvica is not a chemotherapy drug but one of what are termed “targeted therapies.” Targeted therapy is the result of years of research dedicated to understanding the differences between cancer cells and normal cells. Since its launch in 2013, Imbruvica has received 11 FDA approvals across six disease areas:
Imbruvica is used:
- to treat people with mantle cell lymphoma (MCL; a fast-growing cancer that begins in the cells of the immune system) who have already been treated with at least one other chemotherapy medication,
- to treat people with chronic lymphocytic leukemia (CLL; a type of cancer that begins in the white blood cells) and small lymphocytic lymphoma (SLL; a type of cancer that begins mostly in the lymph nodes),
- to treat people with Waldenstrom’s macroglobulinemia (WM; a slow-growing cancer that begins in certain white blood cells in your bone marrow),
- to treat people with marginal zone lymphoma (MZL; a slow growing cancer that begins in a type of white blood cells that normally fights infection) who have already been treated with a certain type of chemotherapy medication,
- and to treat people with chronic graft vs host disease (cGVHD; a complication of hematopoietic stem-cell transplant [HSCT; a procedure that replaces diseased bone marrow with healthy bone marrow] that may start a while after the transplant and last for a long time) after being treated unsuccessfully with 1 or more medications.
What are the most common side effects of imbruvica?
The most common side effects in the clinical trials were:
- Low white blood cell count.
- Low blood platelet count.
- Low red blood cell count.
- Muscle and bone pain.
The general list of Imbruvica side effects include:
- stomach pain
- heartburn or indigestion
- decreased appetite
- excessive tiredness or weakness
- muscle, bone, and joint pain
- muscle spasms
- swelling of the hands, feet, ankles, or lower legs
- sores in the mouth and throat
- difficulty falling asleep or staying asleep
- cough, runny or stuffed nose
- blurred vision
- dry or watery eyes
- pink eye
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:
- swelling of the face, throat, tongue, lips, and eyes
- difficulty swallowing or breathing
- unusual bruising or bleeding
- pink, red, or dark brown urine
- bloody or black, tarry stools
- nose bleeding
- bloody vomit; or vomiting blood or brown material that resembles coffee grounds
- fast or irregular heartbeat
- shortness of breath
- chest discomfort
- dizziness, lightheadedness or feeling faint
- vision changes
- headache (that lasts a long time)
- fever, chills, cough, red, warm skin, or other signs of infection
- changes in your speech
- decreased urination
- painful, frequent, or urgent urination
Imbruvica may increase your risk of developing certain types of cancer including cancer of the skin or other organs. Talk to your doctor about the risks of taking ibrutinib.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
Imbruvica Safety Information
Before taking Imbruvica,
- tell your doctor and pharmacist if you are allergic to ibrutinib, any other medications, or any of the ingredients in ibrutinib capsules or tablets. Ask your pharmacist for a list of the ingredients.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants (‘blood thinners’) such as warfarin (Coumadin, Jantoven); antifungals such as fluconazole (Diflucan), itraconazole (Onmel, Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend); antiplatelet medications such as clopidogrel (Plavix), prasugrel (Effient), ticagrelor (Brilinta), and ticlopidine; aprepitant (Emend); carbamazepine (Carbatrol, Epitol, Tegretol, Teril); clarithromycin (Biaxin, Prevpac), digoxin (Lanoxin); diltiazem (Cardizem, Cartia, Tiazac, others); erythromycin (E.E.S., Erythrocin, others), certain medications to treat human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) such as efavirenz (Sustiva, in Atripla), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); methotrexate (Otrexup, Rasuvo, Trexall, Xatmep); nefazodone; phenytoin (Dilantin, Phenytek); rifampin (Rifadin, Rifamate, Rimactane, others); verapamil (Calan, Covera, in Tarka, others); and telithromycin (no longer available in the U.S.; Ketek). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor what herbal products you are taking, especially St. John’s Wort.
- tell your doctor if you have an infection or recently had surgery. Also tell your doctor if you smoke or if you have or have ever had diabetes, an irregular heartbeat, hypertension (high blood pressure), high cholesterol, bleeding problems, or heart, kidney, or liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, are breast-feeding, or if you plan on fathering a child. You should not become pregnant while you are taking Imbruvica. If you are female, you will need to take a pregnancy test before you start treatment and should use birth control to prevent pregnancy during your treatment with Imbruvica and for 1 month after you stop taking the medication. If you are male, you and your female partner should use birth control during your treatment with Imbruvica and continue for 1 month after your final dose. If you or your partner become pregnant while taking, Imbruvica call your doctor immediately. Imbruvica can cause fetal harm.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking Imbruvica. Your doctor may tell you to stop taking Imbruvica 3 to 7 days before the surgery or procedure.