Generic name: ibrutinib
Brand name: Imbruvica
Dosage form: oral tablet, oral capsule
Drug class: BTK inhibitors
What is ibrutinib?
Ibrutinib is a type of cancer medication called a kinase inhibitor.
Ibrutinib helps to slow down how quickly certain blood cancers progresses 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 multiple.
Ibrutinib comes as both tablets and capsules. It was approved by the US Food and Drug Administration (FDA) in 2013 and was the first effective and selective BTK inhibitor to be approved.
What is ibrutinib used for?
Ibrutinib is a prescription medicine used to treat adults with:
- Mantle cell lymphoma (MCL) who have received at least one prior treatment
- Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL)
- Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion
- Waldenström’s macroglobulinemia (WM)
- Marginal zone lymphoma (MZL) who require a medicine by mouth or injection (systemic therapy) and have received a certain type of prior treatment
- Chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy
It is not known if ibrutinib is safe and effective in children.
What should I tell my doctor before taking ibrutinib?
Before taking ibrutinib, 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 ibrutinib 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
How should I take ibrutinib?
- Take ibrutinib exactly as your healthcare provider tells you to take it.
- Take ibrutinib 1 time a day.
- Swallow ibrutinib capsules or tablets whole with a glass of water.
- Do not open, break, or chew ibrutinib capsules.
- Do not cut, crush, or chew ibrutinib tablets.
- Take ibrutinib at about the same time each day.
What happens if I miss a dose?
If you miss a dose of ibrutinib take it as soon as you remember on the same day. Take your next dose of ibrutinib at your regular time on the next day. Do not take extra doses of ibrutinib to make up for a missed dose.
What happens if I overdose?
If you take too much ibrutinib call your healthcare provider or go to the nearest hospital emergency room right away.
What should I avoid while taking ibrutinib?
You should not drink grapefruit juice, eat grapefruit, or eat Seville oranges (often used in marmalades) during treatment with ibrutinib. These products may increase the amount of ibrutinib in your blood.
- Mantel cell lymphoma and marginal zone lymphoma: 560 mg taken orally once daily.
- Chronic lymphocytic leukemia/small lymphocytic lymphoma,Waldenström’s macroglobulinemia and chronic graft verses host disease: 420 mg taken orally once daily.
Detailed Ibrutinib dosage information
What are the side effects of ibrutinib?
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
- 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.
- 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.
- 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.
- 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:
- muscle and bone pain
The most common side effects of ibrutinib in adults with cGVHD include:
- mouth sores (stomatitis)
- muscle spasms
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 ibrutinib.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Ibrutinib side effects (more detail)
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.
Ibrutinib drug interactions (more detail)
Pregnancy and breastfeeding
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.
- Store ibrutinib capsules and tablets at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep ibrutinib capsules in the original container with the lid tightly closed.
- Keep ibrutinib tablets in the original carton.
Keep ibrutinib and all medicines out of the reach of children.
What are the ingredients in ibrutinib?
Active ingredient: ibrutinib
Capsules: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The 70 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, and black ink. The 140 mg capsule shell contains gelatin, titanium dioxide, and black ink.
Tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The film coating for each tablet contains ferrosoferric oxide (140 mg, 280 mg, and 420 mg tablets), polyvinyl alcohol, polyethylene glycol, red iron oxide (280 mg and 560 mg tablets), talc, titanium dioxide, and yellow iron oxide (140 mg, 420 mg, and 560 mg tablets).
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