Ibrukast Capsule

Ibrukast 140 mg (Ibrutinib) is an anti-cancer drug recognized for patients with different types of blood cancer in adults. Ibrukast 140 mg (Ibrutinib) is a highly potent tyrosine kinase (Bruton’s) inhibitor that prevents the spread of irregular blood cells. Ibrutinib carries out its action by delaying the activities of irregular proteins which acts as a catalyst for duplication of affected cells.

Ibrukast 140 mg (Ibrutinib) is taken in the form of capsules taken orally at the same time every day. The dose can be taken with or without food until the disease persists or patients are seen with unacceptable toxicity. The recommended dosing schedule for different types of blood cancer has been shown in the table below.

Table: Recommended dosing schedule of Ibrukast 140 mg (Ibrutinib):

Type of blood cancer

Description

Dosing regimen

Number of tablets

Mantle Cell Lymphoma (MCL)

Overgrowth of abnormal blood cells (B cells)

560 mg once daily

4 tablets of 140 mg

Marginal Zone Lymphoma (MZL)

Excessive growth of abnormal blood cells (B cells) in the outer regions of lymph tissues

Chronic Lymphocytic Leukemia (CLL)

Cancer type starting in the bone marrow (lymphocytic overgrowth) which extends into the blood-stream

420 mg once daily

3 tablets of 140 mg

Small Lymphocytic Leukemia (SLL)

Cancer type causing excessive growth of abnormal blood cells (lymphocytes)

Waldenstrom’s Macroglobulinemia (WM)

A cancerous tumor that triggers an overgrowth of abnormal blood cells (lymphocytes with high levels of IgM)

Chronic Graft versus Host Disease (cGVHD)

Multiorgan syndrome leading to inflammation of tissues leading to permanent organ damage

Dose Modifications due to problems in the liver (hepatic impairment):

If the patients are suffering from a mild hepatic impairment, only 1 capsule (140 mg dose) of Ibrukast 140 mg (Ibrutinib) is recommended. However, in moderate and severe hepatic impairment, Ibrukast 140 mg (Ibrutinib) is not administered.

Side-effects and Warning signs of Ibrukast 140 mg (Ibrutinib):

Serious side-effects and warnings:

There are certain serious side-effects associated with the use of Ibrukast 140 mg (Ibrutinib) with different signs and symptoms. Patients should be immediately taken to the hospital if they are seen with these complications.

• Bleeding complications (Hemorrhage): Signs and symptoms include,
• Persistent headache
• Weakness
• Confusion
• Dizziness
• Vomiting blood or coffee-coloured substance
• Unexpected or severe bleeding
• Change in speech
• Pink or brown urine
• Blood in the stools
• Infections: Signs and symptoms include,
• Weakness
• Confusion
• Chills
• Fever
• Problems with the rhythm of the heart (Cardiac Arrhythmias): Found in patients who had a history of serious heart disease, an infection, or heart rhythm problems with symptoms like,
• Irregular heartbeats
• Dizziness
• Shortness of breath (dyspnea)
• Uneasiness in chest
• Fainting
• High blood pressure (Hypertension)
• Second primary cancers including skin or organ cancers
• Tumor lysis syndrome (TLS) caused due to rapid breakdown of cancerous cells. It can sometimes cause problems including,
• Kidney failure
• Seizure
• Abnormal rhythms of the heart
• Problems to the fetus: Avoid pregnancy while taking Ibrukast 140 mg (Ibrutinib) and 1 month after the final dose.

Dose Modifications due to serious side-effects:

If patients are seen with toxicity occurring due to above-mentioned side-effects, the following dosing schedule could be opted.

Occurrence of toxicity

MCL & MZL dosing modification

CLL, SLL, WM, and cGVHD dosing modification

1st

560 mg daily (4 × 400 mg)

420 mg daily (3 × 400 mg)

2nd

420 mg daily (3 × 400 mg)

280 mg daily (2 × 400 mg)

3rd

280 mg daily (2 × 400 mg)

140 mg daily (1 × 400 mg)

4th

Stop Ibrukast 140 mg (Ibrutinib)

Stop Ibrukast 140 mg (Ibrutinib)

Most common side-effects:

Based on the type of blood cancer, Ibrukast 140 mg (Ibrutinib) have different side-effects with diarrhea being the most common one.

MCL, MZL, CLL, SLL & WM

cGVHD

Bruising

Bruising

Tiredness

Tiredness

Rashes

Mouth sores (stomatitis)

Nausea

Nausea

Fever

Pneumonia

Pain in the muscles and bones

Muscle spasms

Note:

• Drink plenty of fluids while taking Ibrukast 140 mg (Ibrutinib) for preventing dehydration due to diarrhea.
• These are not all possible side-effects of Ibrukast 140 mg (Ibrutinib), please ask your doctor for additional info.