Indications for Ibrutinib (Imbruvica)

Ibrutinib (Imbruvica) is a type of medication called a kinase inhibitor, used to treat several types of blood cancers, as well as a serious complication of allogeneic stem cell transplants known as chronic graft-versus-host disease (cGVHD).

Indications for Ibrutinib (Imbruvica)

Ibrutinib (Imbruvica) is a prescription medicine used to treat:

Adults with mantle cell lymphoma (MCL) who have received at least one prior treatment.

Adults with chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL).

Adults with chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL) with a specific chromosomal abnormality (17p deletion).

Adults with Waldenström's macroglobulinemia (WM).

Adults with marginal zone lymphoma (MZL) who require systemic therapy and have received a specific type of prior treatment.

Patients with chronic graft-versus-host disease (cGVHD) after failure of one or more prior systemic therapies in adults and children aged 1 year and older.

Important Usage Information for Ibrutinib (Imbruvica)

1. Inform Your Doctor About Your Medical History

Before taking Ibrutinib (Imbruvica), tell your healthcare provider about all of your medical conditions, including if you:

Have had recent surgery or plan to have surgery. Your healthcare provider may stop Lucius Pharmaceuticals Ibrutinib (Imbruvica) for any planned medical, surgical, or dental procedure.

Have bleeding problems.

Have or have had heart rhythm problems, smoke, or have medical conditions that increase the risk of heart problems, such as high blood pressure, high cholesterol, or diabetes.

Have an infection.

Have liver problems.

2. Instructions for Taking Tablets or Capsules

Take Ibrutinib (Imbruvica) exactly as your healthcare provider tells you to.

Take Ibrutinib (Imbruvica) once daily at about the same time each day.

Swallow the Imbruvica capsules or tablets whole with a glass of water.

Do not open, break, or chew the capsules.

Do not cut, crush, or chew the tablets.

3. Instructions for Taking Oral Suspension

Step 1: Prepare and Check Supplies

Check your child's prescribed dose in milliliters (mL). Find the mL marking on the syringe that matches your child's prescribed dose.

Get the bottle and the syringe ready.

Step 2: Record or Check the Discard Date

Use within 60 days after first opening the bottle.

Step 3: Shake the Bottle Well Before Each Use

Step 4: Remove the Bottle Cap

Push down on the cap and turn it counter-clockwise to remove it from the bottle. Do not remove the bottle adapter.

Step 5: Connect the Syringe to the Bottle

Make sure the syringe is clean and dry before using. Gently push the syringe tip into the adapter. Turn the assembled bottle and syringe upside down.

Step 6: Fill the Syringe

Slowly pull the plunger down to a level a little past your prescribed dose in milliliters (mL). Check for air bubbles.

Step 7: Remove Air Bubbles and Adjust to the Prescribed Dose (mL)

Hold the syringe with the tip up and tap the side to move any air bubbles to the tip.

With the syringe still connected to the bottle, push the plunger up to remove the air bubbles from the top.

Air bubbles must be removed to make sure you get the correct dose. If you still see air bubbles, repeat steps 6 and 7.

Step 8: Remove the Syringe from the Bottle

Place the assembled bottle upright. Hold the middle of the syringe and carefully pull the syringe out of the bottle.

Step 9: Give the Ibrutinib Oral Suspension

Place the tip of the syringe against the inside of your child's cheek.

Slowly push the plunger all the way in to give the entire dose.

Step 10: Close the Bottle

Put the cap back on the bottle. Make sure the bottle cap is closed tightly after each use.

Step 11: Rinse the Syringe

Recommended Dosage for Ibrutinib (Imbruvica)

For Mantle Cell Lymphoma and Marginal Zone Lymphoma

The recommended dose is 560 mg (four 140 mg capsules) taken orally once daily.

For Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Waldenström's Macroglobulinemia

The recommended dose is 420 mg (three 140 mg capsules) taken orally once daily.

For Chronic Graft-Versus-Host Disease in Patients 12 Years and Older

Adult Patients: The recommended dose is 420 mg taken orally once daily.

Patients 1 to less than 12 years of age: The recommended dose is 240 mg/m² taken orally once daily (up to a maximum dose of 420 mg).

Side Effects of Ibrutinib (Imbruvica)

1. Serious Side Effects

Bleeding problems: Signs include blood in your stool or black stool (looks like tar), pink or brown urine, unexpected bleeding, or bleeding that is severe or you cannot control, vomit blood or vomit that looks like coffee grounds, coughing up blood or blood clots, increased bruising, dizziness, weakness, confusion, changes in speech, headache that lasts a long time or severe headache.

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

Heart problems: Serious heart rhythm problems (ventricular arrhythmia, atrial fibrillation, and atrial flutter), heart failure, and death have happened in people treated with Ibrutinib, especially in those with increased risk for heart disease, infection, or previous heart rhythm problems. Tell your healthcare provider if you get any symptoms of heart problems, such as feeling your heart beat fast and irregularly, dizziness, lightheadedness, shortness of breath, swelling of your feet, ankles, or legs, chest discomfort, or fainting.

High blood pressure (hypertension): New-onset high blood pressure or worsening of existing high blood pressure has occurred in people treated with Ibrutinib.

Decreased blood cell counts: Decreased blood cell counts (white blood cells, platelets, and red blood cells) are common with Ibrutinib.

Second primary cancers: New cancers have occurred during treatment with Ibrutinib, including cancers of the skin or other organs.

Tumor Lysis Syndrome (TLS): TLS is caused by the fast breakdown of cancer cells. TLS can lead to kidney failure and the need for dialysis, abnormal heart rhythm, seizure, and sometimes death.

2. Common Side Effects

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

Diarrhea.

Tiredness.

Muscle and bone pain..

Rash.

Bruising.

In Chronic Graft-Versus-Host Disease: The most common side effects of Ibrutinib in adults and children 1 year of age and older with cGVHD include:

Tiredness.

Muscle and joint pain.

Nausea.

Low red blood cell count (anemia).

Fever.

Stomach pain.

Bruising.

Muscle spasms.

Pneumonia.

Diarrhea.

Mouth sores (stomatitis).

Headache.

Low platelet count.

Bleeding.

Drug Interactions with Ibrutinib (Imbruvica)

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking Ibrutinib (Imbruvica) with certain other medicines may affect how Ibrutinib works and could cause side effects.

How to Store Ibrutinib (Imbruvica)

Ibrutinib Capsules and Tablets:

Store at room temperature between 20°C to 25°C (68°F to 77°F). Store the capsules in the original container with the lid tightly closed. Store the tablets in the original package.

Ibrutinib Oral Suspension:

Store between 2°C to 25°C (36°F to 77°F). Do not freeze the oral suspension. Use the oral suspension within 60 days after first opening the bottle. After 60 days, safely throw away any unused medicine.

Active Ingredient in Ibrutinib (Imbruvica)

Active Ingredient: Ibrutinib.