Imbruvica  (ibrutinib) 90 capsules

What is Imbruvica?

Imbruvica is used alone or in combination with other medications to treat adults with certain types of blood cancers.

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,
• 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),
• Waldenstrom’s macroglobulinemia (WM; a slow-growing cancer that begins in certain white blood cells in your bone marrow),
• 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
• 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.

Your doctor will make sure you have the correct tumor type to be treated with Imbruvica.

Imbruvica belongs to a class of medications called kinase inhibitors. Ibrutinib works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.

Imbruvica side effects

Get emergency medical help if you have signs of an allergic reaction to Imbruvica: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Imbruvica may cause a brain infection that can lead to disability or death. Tell your doctor if you have problems with speech, thought, vision, or muscle movement. These symptoms can get worse quickly.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

• fever, chills, sore throat;
• mouth sores, red or swollen gums;
• pale skin, easy bruising, unusual bleeding; or
• chest discomfort, wheezing, dry cough or hack, rapid weight loss.

Imbruvica can cause you to bleed more easily. Call your doctor or seek emergency medical attention if you have:

• easy bruising, unusual bleeding, or any bleeding that will not stop;
• bleeding inside your body – weakness, dizziness; pink or brown urine; abnormal vaginal bleeding; bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
• bleeding in your brain – sudden weakness (especially on one side of the body), severe headache, problems with speech or vision.

Imbruvica may cause serious side effects. Call your doctor at once if you have:

• severe or ongoing diarrhea;
• heart problems – swelling, rapid weight gain, feeling short of breath;
• heart rhythm disorders – dizziness, chest pain, shortness of breath, fast or irregular heart rate, feeling light-headed;
• high blood pressure – severe headache, blurred vision, pounding in your neck or ears;
• low blood cell counts – fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
• kidney problems – swelling, urinating less, feeling tired or short of breath; or
• signs of tumor cell breakdown – tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Imbruvica side effects may include:

• diarrhea, nausea, stomach pain;
• fever, cough, trouble breathing;
• mouth sores;
• feeling tired;
• low blood cell counts;
• muscle spasms;
• bruising, rash; or
• muscle, joint, or bone pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Warnings

Imbruvica can make it easier for you to bleed. Contact your doctor or seek emergency medical attention if you have easy bruising, unusual bleeding, or any bleeding that will not stop..

Call your doctor at once if you have signs of bleeding inside your body, such as: dizziness, confusion, headache, speech problems, black or bloody stools, pink or brown urine, or coughing up blood or vomit that looks like coffee grounds..

Imbruvica also affects your immune system. You may get infections more easily, even serious or fatal infections. Tell your doctor if you have a fever, chills, cough, mouth sores, or other signs of infection..

Before taking this medicine

To make sure Imbruvica is safe for you, tell your doctor if you have ever had:

• an infection;
• bleeding problems;
• take a blood thinner such as warfarin;
• a heart rhythm disorder;
• risk factors for heart disease (such as diabetes, smoking, being overweight, having high blood pressure or high cholesterol);
• low blood cell counts;
• recent surgery or plan to have surgery, medical or dental procedure; or
• liver disease.

Taking Imbruvica may increase your risk of developing other cancers. Ask your doctor about this risk.

You may need to have a negative pregnancy test before starting this treatment.

Ibrutinib can harm an unborn baby if the mother or the father is using Imbruvica.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using Imbruvica and for at least 1 month after your last dose.
• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 1 month after your last dose.
• Tell your doctor right away if a pregnancy occurs.

Do not breastfeed while using Imbruvica, and for at least 1 week after your last dose.

How should I take Imbruvica?

Take Imbruvica exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Doses are based on body surface area (height and weight). Your dose may change if you gain or lose weight or if you are still growing.

Take this medicine with a full glass of water, at the same time each day. Drink plenty of liquids while you are taking Imbruvica.

Swallow the Imbruvica tablet or capsule whole and do not crush, chew, break, or open it.

Shake the oral suspension (liquid). Measure a dose with the supplied measuring device (not a kitchen spoon).

Tell your healthcare providers if you have a planned surgery.

You may get dehydrated during prolonged illness. Call your doctor if you are sick with vomiting or diarrhea.

You may get infections or bleed more easily. You will need frequent blood and medical tests.

Store Imbruvica in the original container at room temperature, away from moisture and heat.

Store the Imbruvica oral suspension (liquid) at room temperature away from moisture and heat. Do not freeze. Throw away after 60 days of first opening.

Dosing Information

Usual Adult Dose for Lymphoma:

560 mg orally once a day

Comments:
-Therapy should be continued until disease progression or unacceptable toxicity.

Uses:
-For the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy
-For the treatment of adult patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy

Usual Adult Dose of Imbruvica for Chronic Lymphocytic Leukemia:

420 mg orally once a day

Comments:
-Therapy should be continued until disease progression or unacceptable toxicity.
-This drug can be administered as a single agent, in combination with rituximab or obinutuzumab, or in combination with bendamustine and rituximab.
-When administering in combination with rituximab or obinutuzumab, consider administering this drug prior to rituximab or obinutuzumab when given on the same day.

Uses:
-For the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)
-For the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with 17p deletion

Usual Adult Dose of Imbruvica for non-Hodgkin’s Lymphoma:

420 mg orally once a day

Comments:
-Therapy for Waldenstrom’s Macroglobulinemia (WM) should be continued until disease progression or unacceptable toxicity.
-When used for WM, this drug can be administered as a single agent or in combination with rituximab.
-Therapy for cGVHD should be continued until disease progression, recurrence of an underlying malignancy, or unacceptable toxicity

Uses:
-For the treatment of adult patients with Waldenstrom’s macroglobulinemia (WM)
-For the treatment of adult patients with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy

Usual Adult Dose of Imbruvica for Graft Versus Host Disease:

420 mg orally once a day

Comments:
-Therapy for Waldenstrom’s Macroglobulinemia (WM) should be continued until disease progression or unacceptable toxicity.
-When used for WM, this drug can be administered as a single agent or in combination with rituximab.
-Therapy for cGVHD should be continued until disease progression, recurrence of an underlying malignancy, or unacceptable toxicity

Uses:
-For the treatment of adult patients with Waldenstrom’s macroglobulinemia (WM)
-For the treatment of adult patients with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy

What happens if I miss a dose?

Take the missed dose on the same day you remember it. Take your next dose at the regular time and stay on your once-daily schedule. Do not take 2 doses on the same day.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Imbruvica?

Grapefruit and Seville oranges may interact with ibrutinib and cause side effects. Avoid consuming grapefruit products and orange marmalades.

What other drugs will affect Imbruvica?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Other drugs may interact with ibrutinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.