Indications & Uses
Ibrutab is indicated for:
Pharmacology
Ibrutinib is a small-molecule inhibitor of BTK. It works by forming a covalent bond with a cysteine residue in the active site of BTK, and this blocks the enzyme's activity. BTK is a signaling molecule in the B-cell antigen receptor (BCR) and cytokine receptor pathways. Through its role in signaling from the B-cell surface receptors, BTK activates the pathways that B-cell trafficking, chemotaxis and adhesion need.
Nonclinical studies show that ibrutinib inhibits the proliferation and survival of malignant B-cells in vivo. They also show that it inhibits cell migration and substrate adhesion in vitro.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Mantle Cell Lymphoma and Marginal Zone Lymphoma
The recommended dose of Ibrutinib for MCL and MZL is 560 mg, taken as four 140 mg capsules by mouth once daily. Treatment continues until the disease progresses or the side effects become unacceptable.
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Waldenstrom Macroglobulinemia (WM)
For CLL/SLL and WM, the recommended dose of Ibrutinib is 420 mg, taken as three 140 mg capsules by mouth once daily, again until the disease progresses or the side effects become unacceptable. The dose is the same when Ibrutinib is used for CLL/SLL together with bendamustine and rituximab (given every 28 days for up to 6 cycles): 420 mg, which is three 140 mg capsules, by mouth once daily until disease progression or unacceptable toxicity.
Side Effects
Several adverse reactions to ibrutinib are covered in more detail in other sections of the labeling. These are hemorrhage, infections, cytopenias, atrial fibrillation, hypertension, second primary malignancies and tumor lysis syndrome. Two more important adverse reactions to know about are diarrhea and visual disturbance.
Cautions & Contraindications
Contraindications
Don't give Ibrutinib to anyone who is hypersensitive to the active substance or to any of the excipients.
Pregnancy & Breastfeeding
Pregnancy
Ibrutinib is a kinase inhibitor, and animal studies show it can harm the fetus. When pregnant rats and rabbits were given ibrutinib during organogenesis, at exposures up to 2 to 20 times the clinical doses of 420 to 560 mg daily, it caused embryofetal toxicity, including malformations. If ibrutinib is used during pregnancy, or if a patient becomes pregnant while taking it, she should be told about the possible hazard to the fetus. The background risk of major birth defects and miscarriage in the people this medicine is indicated for is not known.
Lactation
There is no information on whether ibrutinib or its metabolites are present in human milk. The effects on a breastfed infant, and on milk production, are also not known.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Pediatric Use
The safety and effectiveness of Ibrutinib in children have not been established.
Geriatric Use
Clinical studies of Ibrutinib included 905 patients. Of these, 62% were ≥ 65 years of age and 21% were ≥75 years of age. Doctors saw no overall difference in how well the medicine worked between younger and older patients. Anemia (all grades) and Grade 3 or higher pneumonia happened more often in older patients treated with Ibrutinib.
Hepatic Impairment
Ibrutinib is metabolized in the liver. In a hepatic impairment study, the data showed an increase in Ibrutinib exposure. Its safety has not been evaluated in cancer patients with mild to severe hepatic impairment by Child-Pugh criteria. Patients should be monitored for signs of Ibrutinib toxicity, and the dose modification guidance should be followed as needed. Ibrutinib is not recommended for patients with moderate or severe hepatic impairment.
Overdose
There's no specific experience in managing an overdose of Ibrutinib in patients. One healthy subject had reversible Grade 4 rises in the liver enzymes AST and ALT after taking a dose of 1680 mg. If a patient takes more than the recommended dose, monitor them closely and give appropriate supportive treatment.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Ibrutinib in a dry place, below 30°C, and away from light. Keep it out of the reach of children.
Common questions about Ibrutab 140 mg
What is Ibrutab 140 mg Tablet?
Ibrutab 140 mg Tablet is a medicine that contains Ibrutinib. It is made by Eskayef Pharmaceuticals Ltd., Narayanganj. It belongs to the Targeted Cancer Therapy group of medicines.
What is Ibrutab used for?
Ibrutab is used for: Cancer.
What are the side effects of Ibrutab?
Several adverse reactions to ibrutinib are covered in more detail in other sections of the labeling. These are hemorrhage, infections, cytopenias, atrial fibrillation, hypertension, second primary malignancies and tumor lysis syndrome.
Can I take Ibrutab during pregnancy or while breastfeeding?
Pregnancy Ibrutinib is a kinase inhibitor, and animal studies show it can harm the fetus. When pregnant rats and rabbits were given ibrutinib during organogenesis, at exposures up to 2 to 20 times the clinical doses of 420 to 560 mg daily, it caused embryofetal toxicity, including malformations. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Ibrutab?
There's no specific experience in managing an overdose of Ibrutinib in patients. One healthy subject had reversible Grade 4 rises in the liver enzymes AST and ALT after taking a dose of 1680 mg. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Ibrutab?
Keep Ibrutinib in a dry place, below 30°C, and away from light. Keep it out of the reach of children.
Do I need a prescription for Ibrutab?
Ibrutab is a prescription (Rx) medicine. Take it as your doctor advises.