Stivarga 40 Mg 40 mg FC tablets

Stivarga 40 Mg 40 mg FC tablets

S4
PDF Leaflet Revision Date: 01 June 2020

API: Regorafenib | Company: Bayer

Clinical Summary

Quick overview from the medicine insert

Indication

Treatment of metastatic colorectal cancer, gastrointestinal stromal tumors, and hepatocellular carcinoma.

Dosage (summary)

160 mg orally once daily for 3 weeks, followed by 1 week off.

Special Populations

  • Hepatic impairment
  • Renal impairment

Pregnancy & Breastfeeding

Contraindicated in pregnancy and breastfeeding; may cause fetal harm.

Key Drug Interactions

  • CYP3A4 inhibitors
  • CYP3A4 inducers
  • BCRP substrates

Contraindications

  • Hypersensitivity to regorafenib
  • Pregnancy
  • Breastfeeding
  • Gastrointestinal perforation

Common side effects

  • Hand-foot skin reaction
  • Fatigue
  • Diarrhea
  • Hypertension
  • Infection

Counselling Points

  • Take with a light meal
  • Monitor for liver function abnormalities
  • Use effective contraception during treatment

Serious warnings

  • Severe liver injury
  • Gastrointestinal perforation
  • Myocardial ischemia
  • Increased risk of hemorrhage
Important Disclaimer

The Stivarga 40 Mg 40 mg FC tablets professional information leaflet below is the property of Bayer and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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