Ibrutinib IPI 140 mg

1. Dosage:

- 140 mg

2. What Ibrutinib IPI is and what is it used for:

Ibrutinib IPI is a prescription medicine used to treat adults with mantle cell lymphoma (MCL) who have received at least one prior treatment, chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL), chronic lymphocytic leukaemia(CLL)/small lymphocytic lymphoma (SLL) with 17p deletion, Waldenstrom macroglobulinemia (WM), marginal zone lymphoma (MZL) who require a medicine by mouth or injection and have received a certain type of prior treatment, and chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy. It is not known if Ibrutinib IPI is safe and effective in children.

3. What you need to know before you take Ibrutinib IPI:

Before taking Ibrutinib IPI, tell your doctor about all of your medical conditions, including if you:

- Have had recent surgery or plan to have surgery.

- Have bleeding problems.

- Have or had heart rhythm problems, smoke, or a medical condition that increases your risk of heart disease, such as high blood pressure, high cholesterol, or diabetes.

- Have an infection.

- Have liver problems.

- Are pregnant or plan to become pregnant. Ibrutinib IPI can harm your unborn baby. If you can become pregnant, your doctor will do a pregnancy test before starting treatment with Ibrutinib IPI. Tell your doctor if you are pregnant or think you may be pregnant during treatment with Ibrutinib IPI.

- Females who can become pregnant should use effective birth control during treatment with Ibrutinib IPI and for 1 month after the last dose.

- Males with female partners who can become pregnant should use effective birth control, such as condoms, during treatment with Ibrutinib IPI and for 1 month after the last dose.

- Are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with Ibrutinib IPI and for 1 week after the last dose.

Tell your doctor about all the medicines you take.

4. How and When to Take Ibrutinib IPI:

- Take Ibrutinib IPI exactly as your doctor tells you to take it.

- Take Ibrutinib IPI 1 time a day.

- Swallow Ibrutinib IPI capsules whole with a glass of water.

- Do not open, break, or chew Ibrutinib IPI capsules.

- Take Ibrutinib IPI at about the same time each day.

- If you miss a dose of Ibrutinib IPI take it as soon as you remember on the same day. Take your next dose of Ibrutinib IPI at your regular time on the next day. Do not take extra doses of Ibrutinib IPI to make up for a missed dose.

- If you take too much Ibrutinib IPI call your doctor or go to the nearest hospital emergency room right away.

- You should not drink grapefruit juice, eat grapefruit, or eat Seville oranges during treatment with Ibrutinib IPI. These may increase the amount of Ibrutinib IPI in your blood.

5. Possible Side Effects:

Ibrutinib IPI may cause serious side effects, including:

- Bleeding problems (haemorrhage) are common during treatment with Ibrutinib IPI and can also be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your doctor if you have any signs of bleeding including blood in your stools or black stools, pink or brown urine, unexpected bleeding or severe bleeding you cannot control, vomiting blood or vomiting that looks like coffee grounds, coughing up blood or blood clots, increased bruising, dizziness, weakness, confusion, change in your speech, or headache that lasts a long time or severe headache.

- Infections can happen during treatment with Ibrutinib IPI. These infections can be serious and may lead to death. Tell your doctor right away if you have a fever, chills, weakness, confusion, or other signs or symptoms of an infection during treatment with Ibrutinib IPI.

- Decrease in blood cell counts. Decreased blood counts are common with Ibrutinib IPI, but can also be severe.

- Heart problems. Serious heart rhythm problems, heart failure and death have happened in people treated with Ibrutinib IPI, especially in people who have an increased risk of heart disease, have an infection, or have had heart rhythm problems in the past. Tell your doctor if you get any symptoms of heart problems, such as feeling as if your heart is beating fast and irregularly, lightheadedness, dizziness, shortness of breath, swelling of the feet ankles or legs, chest discomfort, or fainting. If you develop any of these symptoms.

- High blood pressure. New or worsening high blood pressure has happened in people treated with Ibrutinib IPI.

- Second primary cancer. New cancers have happened during treatment with Ibrutinib IPI, including cancers of the skin or other organs.

- Tumour lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death.

The most common side effects of Ibrutinib IPI in adults with B-cell malignancies (MCL, CLL/SLL, WM, and MZL) include:

- Diarrhoea.

- Tiredness.

- Muscle and bone pain

- Rash

- Bruising

The most common side effects of Ibrutinib IPI in adults with cGVHD include:

- Tiredness.

- Bruising.

- Diarrhoea.

- Mouth sores.

- Muscle spasms.

- Nausea.

- Pneumonia.

Diarrhoea is a common side effect in people who take Ibrutinib IPI. Drink plenty of fluids during treatment with Ibrutinib IPI to help you reduce your risk of losing too much fluids (dehydration) due to diarrhoea. Tell your doctor if you have diarrhoea that does not go away. These are not the only possible side effects of Ibrutinib IPI. Call your doctor for medical advice about side effects.