Fulvestrant Mylan 250 mg Solution for injection.
PDF Leaflet Revision Date: 03 July 2024
Clinical Summary
Quick overview from the medicine insert
Indication
Treatment of oestrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women.
Dosage (summary)
500 mg intramuscularly as two 5 ml injections, one in each buttock, at 1-month intervals with an additional 500 mg dose 2 weeks after the initial dose.
Special Populations
- Renal impairment
- Hepatic impairment
Pregnancy & Breastfeeding
Contraindicated in pregnancy and breastfeeding; use effective contraception during treatment and for 2 years after.
Key Drug Interactions
- No significant drug interactions requiring dose adjustments
Contraindications
- Hypersensitivity to fulvestrant or excipients
- Severe hepatic impairment
- Pregnancy
- Breastfeeding
Common side effects
- Injection site reactions
- Asthenia
- Nausea
- Increased hepatic enzymes
Counselling Points
- Administer slowly (1-2 mins/injection)
- Monitor for hypersensitivity reactions
- Avoid use in children and adolescents
Serious warnings
- Caution in hepatic impairment
- Risk of thromboembolic events
- Potential risk of osteoporosis
Important Disclaimer
The Fulvestrant Mylan 250 mg Solution for injection. professional information leaflet below is the property of Mylan 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>>
Healthcare Professionals Only
This content is for registered healthcare professionals
Sign in or create a free account to read the full package insert.
Free for HPCSA-registered professionals. Powered by Medinsert.
