Cotellic 20 Mg 20 mg FC tablets

Cotellic 20 Mg 20 mg FC tablets

S4
PDF Leaflet Revision Date: 15 March 2023

API: Cobimetinib | Company: Roche Products

Clinical Summary

Quick overview from the medicine insert

Indication

Treatment of unresectable or metastatic melanoma with BRAF V600 mutation.

Dosage (summary)

60 mg (3 tablets) once daily for 21 days, followed by a 7-day break.

Special Populations

  • Geriatric use
  • Renal impairment
  • Hepatic impairment

Pregnancy & Breastfeeding

Not recommended during pregnancy; contraindicated in breastfeeding.

Key Drug Interactions

  • CYP3A inhibitors
  • CYP3A inducers

Contraindications

  • Hypersensitivity to cobimetinib or excipients

Common side effects

  • Diarrhea
  • Nausea
  • Vomiting
  • Rash
  • Photosensitivity

Counselling Points

  • Avoid sun exposure
  • Use effective contraception
  • Monitor for visual disturbances

Serious warnings

  • New primary malignancies
  • Severe dermatologic reactions
  • Haemorrhage
  • Left ventricular dysfunction

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Cotellic 20 Mg 20 mg FC tablets
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