Ibrutinib capsules

What is ibrutinib?

ibrutinib is a cancer medicine that interferes with the growth and spread of cancer cells in the body.
Ibrutinib is used to treat mantle cell lymphoma in adults who have received at least one prior treatment.
Ibrutinib 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).
Ibrutinib is used to treat Waldenström’s macroglobulinemia (WM) in adults.
Ibrutinib 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

Ibrutinib 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.
Ibrutinib 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 Ibrutinib if you are allergic to ibrutinib.
To make sure Ibrutinib 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 Ibrutinib may increase your risk of developing other types of cancer. Ask your doctor about your specific risk.
Both men and women using Ibrutinib 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 Ibrutinib .
Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

How should I take Ibrutinib?

Take Ibrutinib exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Ibrutinib is usually taken until your body no longer responds to the medication.
Take Ibrutinib 1 time a day at about the same time each day.
Ibrutinib 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 Ibrutinib.
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 Ibrutinib.
Ibrutinib affects your immune system. You may get infections more easily, even serious or fatal infections. You will need frequent medical tests.
Ibrutinib 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 Ibrutinib?

Grapefruit and Seville oranges may interact with ibrutinib and lead to unwanted side effects. Avoid the use of grapefruit products and orange marmalades.

Ibrutinib side effects

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