Caboz 20 mg (Capsule)

Unit Price: ৳ 400.00 (3 x 10: ৳ 12,000.00)
Strip Price: ৳ 4,000.00

Medicine Details

Category Details
Generic Cabozantinib
Company Beacon pharmaceuticals plc

Title

  • Cabozantinib Capsules

Categories

  • Medicine
  • Oncology
  • Pharmacology
  • Cancer Treatment

Description

  • Cabozantinib capsules are indicated for the treatment of advanced renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC) in patients who have been previously treated with Sorafenib.
  • It inhibits the tyrosine kinase activity of various receptors, involved in normal cellular function and pathologic processes.
  • Recommended dosage is 60 mg once daily without food, with specific instructions for administration, dosing modifications, and pediatric use.
  • Contraindicated in patients with known hypersensitivity to Cabozantinib or its components.
  • Side effects may include hemorrhage, perforations and fistulas, thrombotic events, hypertension, diarrhea, palmar-plantar erythrodysesthesia, proteinuria, osteonecrosis of the jaw, wound complications, and reversible posterior leukoencephalopathy syndrome.
  • It can cause fetal harm, and effective contraception is advised for females of reproductive potential.
  • Storage conditions include keeping the capsules below 30°C in a cool and dry place.

Indications

  • Renal Cell Carcinoma
  • Hepatocellular Carcinoma

Pharmacology

  • Mode of action:
    • Inhibition of various tyrosine kinase receptors including MET, VEGFR, AXL, RET, ROS1, and more
  • Absorption: Median time to peak concentration is 3 to 4 hours post-dose.
  • Distribution: Oral volume of distribution is approximately 319 L. Highly protein-bound in human plasma.
  • Elimination: Predicted terminal half-life is approximately 99 hours. Clearance at steady state is estimated to be 2.2 L/hr.
  • Metabolism: A substrate of CYP3A4 in vitro.
  • Excretion: Approximately 81% of the total administered radioactivity was recovered within a 48-day collection period.

Dosage administration

  • Renal cell carcinoma: 60 mg once daily without food, until clinical benefit ends or unacceptable toxicity is experienced.
  • Hepatocellular carcinoma: 60 mg once daily without food, until disease progression or unacceptable toxicity.
  • Pediatric use: Safety and effectiveness in pediatric patients have not been established.
  • Additional instructions:
    • Stop treatment at least 28 days prior to scheduled surgery
    • Do not substitute capsules with tablets
    • Administer at least 1 hour before or at least 2 hours after eating
    • Swallow capsules whole, do not crush
    • Do not take a missed dose within 12 hours of the next dose
    • Dose modification for certain patients with hepatic impairment and those taking CYP450 inhibitors or inducers

Interaction

  • With cyp3a4 inhibitors: Avoid coadministration to reduce risk of exposure-related adverse reactions
  • With cyp3a inducers: Avoid coadministration to maintain efficacy
  • Additional interaction:
    • Avoid grapefruit or grapefruit juice
    • Avoid St. John's Wort

Contraindications

  • Known hypersensitivity to the product or its components

Side effects

  • Hemorrhage
  • Perforations and Fistulas
  • Thrombotic Events
  • Hypertension and Hypertensive Crisis
  • Diarrhea
  • Palmar-plantar Erythrodysesthesia
  • Proteinuria
  • Osteonecrosis of the Jaw
  • Wound Complications
  • Reversible Posterior Leukoencephalopathy Syndrome

Pregnancy lactation

  • Pregnancy: Can cause fetal harm, advise against use during pregnancy
  • Lactation: No information on presence in human milk, advise against breastfeeding during treatment and for 4 months after the final dose
  • Contraception: Effective contraception is advised for females of reproductive potential
  • Infertility: May impair fertility in females and males, based on findings in animals

Precautions warnings

  • Hemorrhage: Discontinue for severe hemorrhage
  • Perforations fistulas: Monitor for signs and symptoms, discontinue if appropriate management is not possible
  • Thrombotic events: Discontinue in case of serious thrombotic events
  • Hypertension crisis: Do not initiate in uncontrolled hypertension, monitor blood pressure regularly
  • Diarrhea: Withhold and resume at reduced dose based on severity
  • Palmar plantar erythrodysesthesia: Withhold and resume at reduced dose based on severity
  • Proteinuria: Monitor urine protein regularly, discontinue if nephrotic syndrome develops
  • Osteonecrosis of the jaw: Perform oral examination, withhold prior to dental surgery, advise for good oral hygiene practices
  • Wound complications: Stop at least 28 days prior to scheduled surgery, resume based on wound healing
  • Reversible posterior leukoencephalopathy syndrome: Evaluate in case of specific symptoms, discontinue if diagnosed
  • Embryo fetal toxicity: Can cause fetal harm, advise pregnant women and females of reproductive potential to use effective contraception

Overdose effects

  • Reported case: One case of overdosage resulted in various symptoms including memory impairment, mental status changes, cognitive disturbance, weight loss, and increase in BUN.

Therapeutic class

  • Tyrosine Kinase Inhibitor

Storage conditions

Keep below 30°C in a cool and dry place, away from sunlight. Keep out of reach of children.

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