Ibrutinib

Generic name: Ibrutinib
Brand names: Imbruvica
Dosage form: oral tablet, oral capsule, oral suspension
Drug class: BTK inhibitors

Usage of Ibrutinib

Ibrutinib (Imbruvica) is a type of medication called a kinase inhibitor, which is used to treat various blood cancers and also a serious complication of allogeneic stem cell transplants called chronic graft versus host disease (cGVHD).

Ibrutinib helps to slow down how quickly certain blood cancers progress by working against cancerous B cells, a type of white blood cell. It does this by blocking Bruton's tyrosine kinase (BTK) signaling. BTK is a protein found on B cells that instructs B cells to remain alive and multiply. Ibrutinib also blocks the activity of a similar protein called interleukin-2-inducible T-cell kinase (ITK). It's thought that this action and it's ability to block BTK helps in cGVHD.

Ibrutinib was first approved by the US Food and Drug Administration (FDA) in 2013.

Ibrutinib side effects

Ibrutinib may cause serious side effects, including:

Bleeding problems (hemorrhage) are common during treatment with ibrutinib, and can also be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. 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

dizziness

weakness

confusion

change in your speech

headache that lasts a long time or severe headache

Infections can happen during treatment with ibrutinib. 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 during treatment with ibrutinib.

Heart problems. Serious heart rhythm problems (ventricular arrhythmias, atrial fibrillation and atrial flutter), heart failure and death have happened in people treated with ibrutinib, 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 problems, such as feeling as if your heart is beating fast and irregular, lightheadedness, dizziness, shortness of breath, swelling of the feet, ankles or legs, chest discomfort, or you faint. If you develop any of these symptoms, your healthcare provider may do a test to check your heart (ECG) and may change your ibrutinib dose.

High blood pressure (hypertension). New or worsening high blood pressure has happened in people treated with ibrutinib. Your healthcare provider may start you on blood pressure medicine or change current medicines to treat your blood pressure.

Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with ibrutinib, but can also be severe. Your healthcare provider should do monthly blood tests to check your blood counts.

Second primary cancers. New cancers have happened during treatment with ibrutinib, 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.

The most common side effects of ibrutinib in adults with B-cell malignancies (MCL, CLL/SLL, WM and MZL) include:

diarrhea

tiredness

muscle and bone pain

rash

bruising

The most common side effects of ibrutinib in adults or children 1 year of age and older with cGVHD include:

tiredness

muscle and joint pain

nausea

low red blood cell count (anemia)

fever

stomach pain

bruising

muscle spasms

pneumonia

diarrhea

mouth sores (stomatitis)

headache

low platelet count

bleeding

Diarrhea is a common side effect in people who take ibrutinib. Drink plenty of fluids during treatment with ibrutinib 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 this medication.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Ibrutinib

Tell your doctor if you are pregnant or plan to become pregnant. Ibrutinib can harm your unborn baby. If you are able to become pregnant, your healthcare provider will do a pregnancy test before starting treatment with ibrutinib. Tell your healthcare provider if you are pregnant or think you may be pregnant during treatment with ibrutinib.

Females who are able to become pregnant should use effective birth control (contraception) during treatment with ibrutinib and for 1 month after the last dose.

Males with female partners who are able to become pregnant should use effective birth control, such as condoms, during treatment with ibrutinib and for 1 month after the last dose.

Tell your doctor if you are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with ibrutinib and for 1 week after the last dose.

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How to use Ibrutinib

The recommended dose of ibrutinib for:

Mantel cell lymphoma and marginal zone lymphoma is 560 mg taken orally once daily.

Chronic lymphocytic leukemia/small lymphocytic lymphoma and Waldenström’s macroglobulinemia is 420 mg taken orally once daily.

Chronic graft versus host disease in patients 12 years and older in 420 mg taken orally once daily. In patients aged 1 to less than 12 years of age the recommended dose is 240 mg/m2 taken orally once daily (up to a dose of 420 mg).

What other drugs will affect Ibrutinib

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking ibrutinib with certain other medicines may affect how ibrutinib works and can cause side effects.

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