【Drug Name】

Name:Ibrutinib Capsules

Product Name: ILUDX

【Specification】

140mg

【Indications】

ILUDX is a prescription medicine used to treat people with:

• Mantle cell lymphoma (MCL) who have received at least one prior treatment

• Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL)

• Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion

• Waldenström’s macroglobulinemia (WM)

• Marginal zone lymphoma (MZL) who require a medicine by mouth or injection (systemic therapy) and have received a

certain type of prior treatment

It is not known if ILUDX is safe and effective in children.

【Recommended Dosage】

• Take ILUDX exactly as your healthcare provider tells you to take it.

• Take ILUDX 1 time a day.

• Swallow ILUDX capsules whole with a glass of water. Do not open, break, or chew ILUDX capsules.

• Take ILUDX at about the same time each day.

• If you miss a dose of ILUDX take it as soon as you remember on the same day. Take your next dose of ILUDX at your regular time on the next day. Do not take 2 doses of ILUDX on the same day to make up for a missed dose.

• If you take too much ILUDX call your healthcare provider or go to the nearest hospital emergency room right away.

【Side Effects】

ILUDX may cause serious side effects, including:

• Bleeding problems (hemorrhage) are common during treatment with ILUDX, 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 healthcare provider if you have any signs of bleeding, including:

• blood in your stools or black stools (looks like tar)

• increased bruising

• pink or brown urine

• dizziness

• unexpected bleeding, or bleeding that is severe or that you cannot control

• weakness

• confusion

• vomit blood or vomit looks like coffee grounds

• cough up blood or blood clots

• change in your speech

• headache that lasts a long time

• Infections can happen during treatment with ILUDX. These infections can be serious and may lead to death.

Tell your healthcare provider right away if you have fever, chills, weakness, confusion, or other signs or symptoms of an infection during treatment with ILUDX.

• Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with ILUDX, but can also be severe. Your healthcare provider should do monthly blood tests to check your blood counts.

• Heart rhythm problems (atrial fibrillation and atrial flutter). Heart rhythm problems have happened in people treated with ILUDX, especially in people who have an increased risk for heart disease, have an infection, or who have had heart rhythm problems in the past. Tell your healthcare provider if you get any symptoms of heart rhythm problems, such as feeling as if your heart is beating fast and irregular, lightheadedness, dizziness, shortness of breath, chest discomfort, or you faint.

• High blood pressure (hypertension). New or worsening high blood pressure has happened in people treated with ILUDX. Your healthcare provider may start you on blood pressure medicine or change current medicines to treat your blood pressure.

• Second primary cancers. New cancers have happened during treatment with ILUDX, including cancers of the skin or other organs.

• Tumor 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. Your healthcare provider may do blood tests to check you for TLS.

The most common side effects of ILUDX include:

• diarrhea

• muscle and bone pain

• rash

• nausea

• bruising

• tiredness

• fever

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

These are not all the possible side effects of ILUDX.

Call your doctor for medical advice about side effects.

【Storage】

• Store at or below 86°F (30°C).

• Keep ILUDX in the original container with the lid tightly closed.

Keep ILUDX and all medicines out of the reach of children.