Rozlytrek 100 & 200 Mg 100 mg, 200 mg Capsule

Rozlytrek 100 & 200 Mg 100 mg, 200 mg Capsule

S4
PDF Leaflet Revision Date: 23 May 2023

API: Entrectinib | Company: Roche Products

Clinical Summary

Quick overview from the medicine insert

Indication

Treatment of NTRK fusion-positive solid tumours and ROS1-positive NSCLC.

Dosage (summary)

Adults: 600 mg once daily; Paediatrics: 300 mg/mu00b2 once daily.

Special Populations

  • Elderly
  • Renal impairment
  • Hepatic impairment

Pregnancy & Breastfeeding

May cause fetal harm; avoid breastfeeding.

Key Drug Interactions

  • Strong CYP3A inhibitors
  • Moderate CYP3A inhibitors
  • CYP3A inducers

Contraindications

  • Hypersensitivity to entrectinib

Common side effects

  • Fatigue
  • Nausea
  • Diarrhoea
  • Cognitive disorders
  • Fractures

Counselling Points

  • Monitor for cognitive changes
  • Avoid pregnancy
  • Do not drive if affected

Serious warnings

  • Congestive heart failure
  • QT interval prolongation
Important Disclaimer

The Rozlytrek 100 & 200 Mg 100 mg, 200 mg Capsule professional information leaflet below is the property of Roche Products 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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