Imbruvica (Ibrutinib)
IMBRUVICA
Ibrutinib
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What is Imbruvica (ibrutinib)

What is Imbruvica (ibrutinib)?

Imbruvica is a medication prescribed for adult patients to treat various types of cancer. Imbruvica belongs to the drug class, kinase inhibitors. These medications work by slowing and/or stopping cancer cells from growing.

What are the Indications for Imbruvica?

Imbruvica is approved to treat:

  • Mantle cell lymphoma (MCL)
  • Chronic lymphocytic leukemia (CLL)
  • Small lymphocytic lymphoma (SLL
  • Waldenström’s macroglobulinemia (WM)
  • Marginal zone lymphoma (MZL)
  • Chronic graft versus host disease (cGVHD)

Imbruvica is not recommended:

  • If you are allergic to Imbruvica or any ingredients in Imbruvica
  • If you are pregnant or breastfeeding

How is Imbruvica used?

Storage

Imbruvica should be stored at room temperature between 68°F and 77°F (20°C – 25°C).

Keep out of reach of children.

Instruction

Take Imbruvica by mouth once daily, as directed by your doctor, with a full glass of water at the same time every day. Swallow the capsule or tablet whole. Do not chew, crush, or split the tablet or capsule.

If you miss a dose, take it as soon as you remember. If it is past the day you should have taken Imbruvica, skip the missed dose, and take your next dose at your next scheduled time.

Dosage

Imbruvica is available in

  • Capsule form: 70 mg and 140 mg
  • Tablet form: 140 mg, 280 mg, 420 mg, and 560 mg

Depending on your reaction to Imbruvica, your doctor may adjust your dose or discontinue treatment. Do not change your dosage and take more than what is prescribed without consulting with your doctor.

If you took more than prescribed, contact your doctor or seek emergency medical care right away.

Chronic lymphocytic leukemia (CLL) and Small lymphocytic lymphoma (SLL)

The recommended dosage is to take 420 mg once daily. Imbruvica can be taken in combination with rituximab or obinutuzumab, or with bendamustine and rituximab (BR). Imbruvica is recommended to be taken before rituximab or obinutuzumab.

Waldenström’s macroglobulinemia (WM)

The recommended dosage is to take 420 mg once daily. Imbruvica can be taken in combination with rituximab. Imbruvica is recommended to be taken before rituximab.

Marginal zone lymphoma (MZL) and Mantle cell lymphoma (MCL)

The recommended dosage is to take 560 mg once daily.

Chronic graft versus host disease (cGVHD)

The recommended dosage is to take 420 mg once daily.

Side Effects

It’s important to understand that although Imbruvica is FDA approved, it comes with side effects that may or may not affect you.

Before starting Imbruvica, you should discuss possible side effects with your doctor or pharmacist.

Common Side Effects

Not all side effects require medical attention. As your body adjusts to Imbruvica, side effects may go away.

Tell your doctor if you experience the following symptoms, and they become severe or do not go away on their own.

Diagnosis of MCL, CLL, SLL, WM, and MZL:

  • Rash
  • Easy bruising
  • Diarrhea
  • Tiredness
  • Muscle pain
  • Bone pain

Diagnosis of cGVHD:

  • Mouth sores
  • Easy bruising
  • Diarrhea
  • Tiredness
  • Nausea
  • Muscle spasms
  • Pneumonia

Serious Side Effects

Severe adverse reactions while taking Imbruvica can occur. Seek emergency medical care or call 911 if you experience any of the following symptoms:

  • Severe allergic reaction: severe rash or itching, swelling in the face, lips, tongue, or throat, rapid heartbeat, fainting or dizziness, or problems breathing or swallowing.
  • High blood pressure: blurred vision, pounding in ears or neck, severe headache.
  • Bleeding (hemorrhage)
  • Decreased blood cell counts
  • New cancer
  • Tumor lysis syndrome (TLS)
  • Heart problems
  • Infections

The information above does not list all possible side effects. Contact your doctor or pharmacist if you experience any side effects not listed. You or your doctor may report side effects to the FDA by calling 1-800-FDA-1088.

Warnings & Precautions

Before taking Imbruvica, tell your doctor or pharmacist:

  • If you are allergic to any medications such as Imbruvica
  • If you have or have had heart problems such as heart rhythm problems
  • If you have an infection
  • If you have had a recent surgery or plan to have surgery
  • If you have or have had bleeding problems
  • If you have or have had liver problems
  • If you are pregnant or plan to become pregnant
  • If you are breastfeeding or plan to breastfeed

Bleeding (hemorrhage)

Taking Imbruvica may lead to an increase in bleeding especially if you are also taking a blood thinner. Bleeding can be serious and lead to death.

Signs and symptoms include black stools or blood in your stools, pink or brown urine, uncontrolled or unexpected bleeding, blood clots, coughing up blood, dizziness, confusion, weakness, easy bruising, speech change, or a severe headache. Contact your doctor immediately if you exhibit any of these symptoms.

Heart problems

Taking Imbruvica can lead to serious heart problems such as heart failure which can lead to death. Your doctor will monitor your heart before and during the use of Imbruvica.

Signs and symptoms include feeling lightheadedness, dizziness, irregular or fast heartbeat, shortness of breath, fainting, chest discomfort, and swelling in your legs or feet. Contact your doctor immediately if you exhibit any of these symptoms.

Decreased blood cell count

Taking Imbruvica can result in low blood cell count including white blood cells, red blood cells, and platelet). Your doctor may require monthly blood tests to monitor your blood cells during your treatment with Imbruvica.

High Blood Pressure (hypertension)

Taking Imbruvica can increase your blood pressure which may require medication to control. Your doctor will monitor your blood pressure.

Infections

Taking Imbruvica can increase your risk of infections which can become serious and lead to death.

Signs and symptoms include chills, fever, confusion, or weakness. Contact your doctor immediately if you exhibit any of these symptoms.

New cancers

Taking Imbruvica can increase your risk of developing secondary cancer including skin cancer.

Tumor lysis syndrome (TLS)

Taking Imbruvica can lead to TLS resulting in kidney failure which can lead to death. Dialysis treatment may be needed. Your doctor may require regular blood tests to monitor your kidney.

Pregnant or planning to become pregnant

Taking Imbruvica while pregnant can impact the unborn baby. If you are a female patient, your doctor will conduct a pregnancy test before starting treatment of Imbruvica. If you are not pregnant but could become pregnant, you should use effective contraception during treatment of Imbruvica and up to 1 month after discontinuing Imbruvica.

If you are a male patient with female partners, you should use effective contraception during treatment of Imbruvica and 1 week after discontinuing Imbruvica.

Breastfeeding or planning to breastfeed

Studies have not been conducted to determine if Imbruvica will pass through to human milk. However, due to severe possible side effects, breastfeeding should be discontinued while on treatment with Imbruvica including up to 1 week after discontinuing Imbruvica.

Interactions & Contraindications

Before taking Imbruvica, tell your doctor or pharmacist if you take any medications, herbal supplements, or vitamins.

Grapefruit and Seville oranges

Consuming grapefruit or Seville oranges while on treatment with Imbruvica may increase the potency of Imbruvica. This can lead to an increased risk of severe side effects including bleeding, nausea, vomiting, low blood cells, and kidney problems. Grapefruit and Seville oranges should be avoided while on treatment with Imbruvica unless otherwise directed.

Frequently Asked Questions

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The active ingredient in Imbruvica is ibrutinib.

Imbruvica capsules may contain the following inactive ingredients:  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.

Imbruvica tablets may contain the following inactive ingredients: 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).

Imbruvica is available in capsule and tablet form.

Imbruvica is approved to treat:

  • Mantle cell lymphoma (MCL)
  • Chronic lymphocytic leukemia (CLL)
  • Small lymphocytic lymphoma (SLL
  • Waldenström’s macroglobulinemia (WM)
  • Marginal zone lymphoma (MZL)
  • Chronic graft versus host disease (cGVHD)

Imbruvica is not recommended if you are allergic to Imbruvica or any ingredients in Imbruvica or if you are pregnant or breastfeeding.

Serious allergic reactions include severe rash or itching, swelling in the face, lips, tongue, or throat, rapid heartbeat, fainting or dizziness, or problems breathing or swallowing.

Common side effects include diarrhea, tiredness, nausea, easy bruising, constipation, vomiting, abdominal pain, decreased appetite, muscle pain, anemia, and low blood cells.

Take Imbruvica by mouth, as directed, with a full glass of water. Do not chew, split, and crush the capsule or tablet.

If you miss a dose, take it as soon as you remember. If it is past the day you should have taken Imbruvica, skip the missed dose, and take your next dose at your next scheduled time.

If you took more than prescribed, contact your doctor or seek emergency medical care right away.

Do not consume grapefruit or Seville oranges and marmalades while taking Imbruvica.

Imbruvica should be taken as directed until discontinued by your doctor. Your doctor may discontinue Imbruvica if your condition progresses, you no longer require therapy, you have severe adverse reactions, or are unable to tolerate Imbruvica.

Yes, with a prescription, you can purchase Imbruvica online. Buying medications online is convenient and often less expensive than purchasing at your local pharmacy.