Butinib 140 mg (Capsule)

Unit Price: ৳ 500.00 (3 x 10: ৳ 15,000.00)
Strip Price: ৳ 5,000.00

Medicine Details

Category Details
Generic Ibrutinib
Company Drug international ltd

Indications

  • Treatment of Mantle Cell Lymphoma
  • Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
  • Treatment of Waldenstrom Macroglobulinemia (WM)
  • Treatment of Marginal Zone Lymphoma
  • Patients with 17p deletion Chronic Lymphocytic Leukemia
  • Patients requiring systemic therapy
  • Patients who have received anti-CD 20-based therapy

Pharmacology

  • Small-molecule inhibitor of BTK
  • Forms a covalent bond with a cysteine residue
  • Inhibits BTK enzymatic activity
  • Signaling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways
  • Inhibits malignant B-cell proliferation and survival
  • Inhibits cell migration and substrate adhesion

Dosage

  • Recommended dose for Mantle Cell Lymphoma is 560 mg once daily
  • Recommended dose for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Waldenstrom Macroglobulinemia (WM) is 420 mg once daily
  • Dose when used in combination with bendamustine and rituximab

Administration

  • Administer orally once daily at the same time each day
  • Swallow the capsules whole with water
  • Avoid opening, breaking, or chewing the capsules

Interaction

  • Co-administration with CYP3A inhibitors should be avoided
  • Butinib dose should be reduced if a moderate CYP3A inhibitor must be used
  • Co-administration with strong CYP3A inducers should be avoided

Contraindications

  • Hypersensitivity to the active substance or excipients

Side Effects

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

Pregnancy & Lactation

  • Potential fetal harm
  • Need to apprise patients of 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 in pediatric patients not established
  • No overall differences in effectiveness observed between younger and older patients
  • Increased occurrence of anemia and pneumonia in older patients
  • Increase in Butinib exposure in hepatic impairment
  • Safety not evaluated in cancer patients with mild to severe hepatic impairment
  • Monitor patients for signs of Butinib toxicity

Overdose Effects

  • Limited specific experience in the management of Butinib overdose
  • Reversible Grade 4 hepatic enzyme increases observed in one case
  • Closely monitor patients who ingest more than the recommended dosage

Therapeutic Class

  • Targeted Cancer Therapy

Storage Conditions

  • Store below 30°C
  • Protect from light
  • Keep out of the reach of children

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