Gavreto 100 mg Capsule
PDF Leaflet Revision Date: 17 October 2023
Clinical Summary
Quick overview from the medicine insert
Indication
Treatment of adult patients with RET fusion-positive NSCLC, RET-mutant MTC, and RET-fusion positive thyroid cancer.
Dosage (summary)
400 mg orally once daily; adjust for adverse reactions.
Special Populations
- Elderly: No adjustment needed
- Renal impairment: No adjustment for mild/moderate
- Hepatic impairment: No adjustment for mild
Pregnancy & Breastfeeding
Potential for fetal harm; effective contraception required during treatment and for 2 weeks after.
Key Drug Interactions
- Avoid strong CYP3A4 inhibitors
- Avoid strong CYP3A4 inducers
Contraindications
- Hypersensitivity to pralsetinib or excipients
Common side effects
- Fatigue
- Hypertension
- Pneumonitis
- Nausea
- Vomiting
Counselling Points
- Take on an empty stomach
- Monitor for respiratory symptoms
- Report any signs of bleeding
- Use effective contraception
Serious warnings
- Severe pneumonitis/ILD
- Severe hypertension
- Severe hepatic transaminase elevations
- Severe hemorrhagic events
Important Disclaimer
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