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Ibrutinib

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

Medically reviewed by Philip Thornton, DipPharm. Last updated on Apr 4, 2023.

What is 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.

What is ibrutinib used for?

Ibrutinib is a prescription medicine used to treat :

It is not known if it is safe and effective in children under 1 year of age.

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:

How should I take ibrutinib?

How should I take ibrutinib tablets and capsules

How should I take ibrutinib oral suspension

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 at your regular time on the next day. Do not take extra doses of this medication 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.

Dosing information

The recommended dose of ibrutinib for:

What are the side effects of ibrutinib?

Ibrutinib may cause serious side effects, including:

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

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

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.

Interactions

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.

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.

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.

Storage

Keep ibrutinib and all medicines out of sight and reach of children.

What are the ingredients in ibrutinib?

Active ingredient: ibrutinib

Inactive ingredients:

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).

Oral suspension: benzyl alcohol, citric acid monohydrate, disodium hydrogen phosphate, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, purified water and sucralose.

Ibrutinib is distributed and marketed by Pharmacyclics LLC South San Francisco, CA 94080 USA. It is also marketed by Janssen Biotech, Inc. Horsham, PA 19044 USA.

Popular FAQ

Imbruvica (ibrutinib) is usually continued indefinitely if it is being well tolerated, there is limited disease progression, and toxicity has not occurred. Continue reading

According to the Drugs.com price guide which bases its price on the Drugs.com discount card which is accepted at most U.S. pharmacies, the cost for Imbruvica 420mg tablet is around $597 per tablet or $16,734 for a supply of 28 tablets depending on the pharmacy you visit. Prices are for cash paying customers only and are not valid with insurance plans. Continue reading

Stopping ibrutinib can result in a disease flare-up in patients with chronic lymphocytic leukemia (CLL). A 2020 study in The Oncologist found that approximately 25% of ibrutinib patients with a median interruption period of 8 days experienced a flare or rapid CLL progression. Continue reading

A 2021 phase III study in the Journal of Clinical Oncology found that while both medications have similar efficacy, acalabrutinib was better tolerated with fewer side effects. Continue reading

In some people, very good partial clinical responses to Imbruvica may occur within three to six months. Imbruvica is usually given until disease progression or unacceptable toxicity occurs, or in the case of graft vs host disease, recurrence of an underlying malignancy. The average duration of Imbruvica therapy in clinical trials has been around 41 months (range, 2–51 months). Continue reading

Hair loss (alopecia) has not been noted as a side effect of ibrutinib (Imbuvica) in the product label. Textural hair changes (softening, straightening or curliness) and nail changes (brittle fingernails and toenails) were noted in a study evaluating ibrutinib use over the long term for treatment of chronic lymphocytic leukemia (CLL). Continue reading

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.