Ibrucent 140 mg (Capsule)

Indications

• Mantle Cell Lymphoma
• Chronic Lymphocytic Leukemia
• Waldenstrom Macroglobulinemia
• Marginal Zone Lymphoma

Pharmacology

• Inhibitor of BTK
• Covalent bond with cysteine residue
• Inhibition of BTK enzymatic activity
• Signaling molecule of B-cell antigen receptor
• Inhibits malignant B-cell proliferation
• Inhibits cell migration and substrate adhesion

Dosage

• Recommended dose for MCL and MZL: 560 mg once daily
• Recommended dose for CLL/SLL and WM: 420 mg once daily
• Recommended dose for CLL/SLL in combination with bendamustine and rituximab: 420 mg once daily

Administration

• Orally administered once daily
• Swallow capsules whole with water

Interaction

• Avoid co-administration with strong and moderate CYP3A inhibitors
• Avoid co-administration with strong CYP3A inducers

Contraindications

• Hypersensitivity to the active substance or any excipients

Side Effects

• Hemorrhage
• Infections
• Cytopenias
• Atrial Fibrillation
• Hypertension
• Second Primary Malignancies
• Tumor Lysis Syndrome
• Diarrhea
• Visual Disturbance

Pregnancy & Lactation

• Can cause fetal harm based on animal studies
• Potential hazard to the fetus
• Unknown risk of major birth defects and miscarriage
• No information on presence in human milk or effects on breastfed infant

Use in Special Populations

• Safety and effectiveness not established in pediatric patients
• 62% of patients in clinical studies were ≥ 65 years of age
• 21% of patients were ≥ 75 years of age
• No overall differences in effectiveness between younger and older patients
• Increase in Ibrucent exposure in hepatic impairment

Overdose Effects

• Reversible Grade 4 hepatic enzyme increases
• Closely monitor patients who ingest more than the recommended dosage
• Provide appropriate supportive treatment

Therapeutic Class

• Targeted Cancer Therapy

Storage Conditions

• Store in a dry place below 30°C
• Protect from light
• Keep out of the reach of children

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