Generic name: ibrutinib (eye BROO ti nib)
Brand name: Imbruvica
Drug class: BTK inhibitors
Imbruvica (ibrutinib) is a cancer medicine that interferes with the growth and spread of cancer cells in the body.
Imbruvica is used to treat mantle cell lymphoma, marginal zone lymphoma, Waldenstrom's macroglobulinemia, chronic lymphocytic leukemia, and small lymphocytic lymphoma.
Imbruvica is also used to treat chronic graft-versus-host disease.
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
You should not use Imbruvica if you are allergic to ibrutinib.
To make sure Imbruvica is safe for you, tell your doctor if you have:
- an infection;
- liver disease;
- bleeding problems;
- a heart rhythm disorder; or
- risk factors for heart disease (such as diabetes, smoking, being overweight, having high blood pressure or high cholesterol).
Using Imbruvica may increase your risk of developing other types of cancer. Ask your doctor about your specific risk.
Both men and women using Imbruvica should use birth control to prevent pregnancy. Ibrutinib can harm an unborn baby if the mother or father is using this medicine.
Keep using birth control for at least 1 month after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Imbruvica .
Do not breastfeed while using this medicine, 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. Imbruvica is usually taken until your body no longer responds to the medication.
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 tablet or capsule whole and do not crush, chew, break, or open it.
If you need surgery or dental work, tell your surgeon or dentist you currently use this medicine. You may need to stop for a short time.
Call your doctor if you have severe or ongoing diarrhea. You can easily become dehydrated while taking Imbruvica.
Ibrutinib affects your immune system. You may get infections more easily, even serious or fatal infections. You will need frequent medical tests.
Imbruvica can make it easier for you to bleed, even from a minor injury. Seek medical attention if you have bleeding that will not stop. Bleeding may also happen inside your body, such as in your stomach or intestines, or in your brain.
Store in the original package at room temperature, away from moisture and heat.
Dosing information
Usual Adult Dose for Lymphoma:
560 mg orally once a day 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 for Chronic Lymphocytic Leukemia:
As a single agent or in combination with bendamustine and rituximab or with obinutuzumab:
420 mg orally once daily until disease progression or unacceptable toxicity
Comments:
-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 for non-Hodgkin's Lymphoma:
420 mg orally once a day
Duration of Therapy:
-WM: Until disease progression or unacceptable toxicity
-cGVHD: Until disease progression, recurrence of an underlying malignancy, or unacceptable toxicity
Comments:
-WM: Management of hyperviscosity may include plasmapheresis before and during therapy, which will not require dosing modifications.
-cGVHD: When a patient no longer requires therapy, discontinue this drug considering the medical assessment of the individual patient.
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 for Graft Versus Host Disease:
420 mg orally once a day
Duration of Therapy:
-WM: Until disease progression or unacceptable toxicity
-cGVHD: Until disease progression, recurrence of an underlying malignancy, or unacceptable toxicity
Comments:
-WM: Management of hyperviscosity may include plasmapheresis before and during therapy, which will not require dosing modifications.
-cGVHD: When a patient no longer requires therapy, discontinue this drug considering the medical assessment of the individual patient.
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 lead to unwanted side effects. Avoid the use of grapefruit products and orange marmalades.
Imbruvica side effects
Get emergency medical help if you have signs of an allergic reaction t0 Imbruvica: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using Imbruvica and call your doctor at once if you have:
- severe or ongoing diarrhea;
- chest pain, pounding heartbeats or fluttering in your chest, feeling like you might pass out;
- severe headache, blurred vision, pounding in your neck or ears;
- pale skin, cold hands and feet;
- easy bruising or bleeding (nosebleeds, bleeding gums);
- signs of bleeding inside your body - dizziness, confusion, problems with speech, prolonged headache, black or bloody stools, pink or brown urine, or coughing up blood or vomit that looks like coffee grounds;
- signs of infection - fever, chills, weakness, mouth sores, cough with mucus, trouble breathing;
- kidney problems - little or no urinating, swelling in your feet or ankles; or
- signs of tumor cell breakdown - tiredness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth;
Common Imbruvica side effects may include:
- diarrhea, nausea;
- fever, cough, trouble breathing;
- blisters or ulcers in your mouth;
- feeling tired;
- bruising, rash; or
- muscle pain, 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.
What other drugs will affect Imbruvica?
Other drugs may interact with ibrutinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.