Imbruvica
Ibrutinib
Imbruvica capsules
What is Imbruvica?
Imbruvica 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 in adults who have received at least one prior treatment.
Imbruvica is used to treat chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in adults, including those who carry a deletion in chromosome 17 (17p deletion).
Imbruvica is used to treat Waldenström’s macroglobulinemia (WM) in adults.
Imbruvica is also used to treat chronic graft-versus-host disease (cGVHD) in adults and children 1 year of age and older after failure of 1 or more lines of systemic therapy.
It is not known if this medicine is safe and effective in children under 1 year of age.
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 Imbruvica 1 time a day at about the same time each day.
Imbruvica comes as capsules, tablets, and oral suspension.
Swallow the tablet or capsule whole and do not crush, chew, break, or open it.
Take this medicine with a full glass of water, at the same time each day. Drink plenty of liquids while you are taking Imbruvica.
The oral suspension is for use in children and must be administered using the oral dosing syringe provided. Follow the Instructions for Use leaflet that comes with the medicine for detailed information on how to measure and give each dose to your child. Ask your pharmacist if you have any questions.
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.
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 to 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 in adults with B-cell malignancies (MCL, CLL/SLL, WM and MZL) include:
• diarrhea;

• tiredness;

• muscle and bone pain;

• rash; or

• bruising.

Common Imbruvica side effects in adults or children 1 year of age and older with cGVHD include:
• diarrhea;

• tiredness;

• low red blood cell count (anemia);

• bruising;

• low platelet count;

• muscle and joint pain;

• fever;

• muscle spasms;

• mouth sores (stomatitis);

• bleeding;

• nausea;

• stomach pain;

• pneumonia; or

• headache.

Diarrhea is a common side effect in people who take Imbruvica. Drink plenty of fluids during treatment 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.
