Nibalap 250 mg (Tablet)

Unit Price: ৳ 350.00 (1 x 12: ৳ 4,200.00)
Strip Price: ৳ 4,200.00

Medicine Details

Category Details
Generic Lapatinib
Company Aristopharma ltd

Indications

  • Indicated for advanced or metastatic breast cancer
  • Indicated for postmenopausal women with hormone receptor-positive metastatic breast cancer

Pharmacology

  • 4-anilinoquinazoline kinase inhibitor
  • Inhibits EGFR and HER2 receptors
  • Additive effect with 5-FU
  • Non-cross-resistance with Trastuzumab
  • Highly bound to albumin and alpha-1 acid glycoprotein
  • Undergoes extensive metabolism by CYP3A4 and CYP3A5
  • Terminal phase half-life of 14.2 hours
  • Predominantly metabolized by CYP3A4/5
  • Negligible renal excretion

Dosage & Administration

  • Recommended dose of 1,250 mg once daily
  • Administered orally in combination with Capecitabine or Letrozole
  • Dose adjustment if hepatic impairment is present
  • Caution when coadministered with strong CYP3A4 inhibitors or inducers

Interaction

  • Inhibits CYP3A4, CYP2C8, and P-glycoprotein
  • Interacts with Midazolam, Paclitaxel, and Digoxin
  • Increased systemic exposure with Ketoconazole, decreased exposure with Carbamazepine
  • Substrate of P-glycoprotein
  • Potential interaction with acid-reducing agents

Contraindications

  • Contraindicated in patients with known severe hypersensitivity

Side Effects

  • Common adverse reactions include diarrhea, palmar-plantar erythrodysesthesia, nausea, rash, vomiting, and fatigue

Pregnancy & Lactation

  • Potential fetal harm if administered during pregnancy
  • Advised not to breastfeed during treatment

Precautions & Warnings

  • May decrease left ventricular ejection fraction
  • Hepatotoxicity observed in clinical trials
  • Management and monitoring of diarrhea
  • Associated with interstitial lung disease and pneumonitis
  • Linked to QT prolongation and severe cutaneous reactions

Use in Special Populations

  • Dose modification guidelines for cardiac events, hepatic impairment, diarrhea, and concomitant strong CYP3A4 inhibitors/inducers

Overdose Effects

  • No known antidote for overdoses
  • Maximum oral doses administered in clinical trials
  • Supportive measures for treatment of overdose

Therapeutic Class

  • Cytotoxic Chemotherapy

Storage Conditions

  • Store below 30°C in a dry place

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