Ibrutinib, ILUDX, Ibrutinib 140mg 90'S Approval No. 07 L 0991/23 Validity Date 30-7-2026 Export to China 3% customs VAT

Introduction: Ibrutinib is a small molecule BTK inhibitor that can covalently bind to the cysteine ​​residue in the active center of BTK, thereby inhibiting its activity. It was approved for marketing by the U.S. Food and Drug Administration (FDA) on November 13, 2013, and is used to treat mantle cell lymphoma (MCL).

【Drug name】

Name: Ibrutinib Capsules

Product Name: ILUDX

 

【Specification】

1 4 0 mg

 

【Indications】

ILUDX is a prescription medicine used to treat patients with:

• Mantle cell lymphoma (MCL) who has received at least one prior therapy

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

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

• Waldenstrom's Macroglobulinemia (WM)

• Marginal zone lymphoma (MZL) who need oral or injected medicines (systemic therapy) and have been treated before

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 ILUDX 1 time daily.

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

• Take ILUDX at approximately the same time each day.

• If you miss a dose of ILUDX, take it as soon as you remember that day. Take your next dose of ILUDX at your normal time 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 effect】

ILUDX may cause serious side effects, including:

• Bleeding problems (hemorrhages) are common during treatment with ILUDX and can be serious and may result in death. Your risk of bleeding may be increased if you also take blood thinners.

Tell your healthcare provider if you have any signs of bleeding, including:

• Blood in your stool or black stool (looks like tar) • Increased bruising • Pink or brown urine • Dizziness

• Unexpected bleeding, or bleeding that is severe or uncontrollable • Weakness • Coughing up blood or blood clots • Fatigue

• Vomiting blood or vomit that looks like coffee grounds • Headache that lasts a long time

• Infections can occur during treatment with ILUDX. These infections can be serious and may result in death.

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

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

• Heart rhythm problems (atrial fibrillation and atrial flutter). Heart rhythm problems have occurred in people treated with ILUDX, especially those who are at increased risk for heart disease, have infections, or have had heart rhythm problems in the past. Tell your healthcare provider if you have any symptoms of heart rhythm problems, such as feeling a fast and irregular heartbeat, dizziness, lightheadedness, shortness of breath, chest discomfort, or fainting.

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

• Second primary cancers. New cancers that develop during ILUDX treatment, including skin cancer or cancer of other organs.

• Tumor lysis syndrome (TLS). TLS is caused by the rapid breakdown of cancer cells. TLS can lead to kidney failure, the need for dialysis, abnormal heart rhythms, seizures, and sometimes death. Your healthcare provider may do blood tests to check for TLS.

The most common side effects of ILUDX include:

• Diarrhea • Fever

• Rash • Nausea

• Bruising • Fatigue

• Muscle and bone pain

Diarrhea is a common side effect of people taking ILUDX. Drinking plenty of fluids during treatment with ILUDX can help lower your risk of losing too much fluid from diarrhea (dehydration). Tell your healthcare provider if you have diarrhea that doesn’t go away.

These are not all the possible side effects of ILUDX.

Call your doctor for medical advice about side effects.

 

【Storage】

• Store at temperatures not exceeding 86°F (30°C).

• Store ILUDX in its original container with the lid tightly closed.

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