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Description
PRODUCT DESCRIPTION:
Fulvestran is a selective estrogen receptor degrader (SERD) used in the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women. It works by binding to and accelerating the degradation of estrogen receptors, thereby blocking the growth of hormone-sensitive tumors.
This injectable formulation is available in 250 MG/ML and 500 MG/ML strengths in ready-to-use pre-filled syringes, ensuring precision, convenience, and reduced contamination risk in clinical settings.
Fulvestran is often used as a first-line or subsequent-line treatment, especially in patients who have progressed on prior endocrine therapy.
Formulation & Presentation:
- Dosage Form: Injectable Pre Filled Syringe
- Presentation: Pre-Filled Syringe (customizable as per market demand)
- Available Strengths:
- 250 MG/ML Pre-filled Syringe
- 500 MG/ML Pre-filled Syringe
- Route of Administration: Intra-Muscular (IM), or as per clinical indication and severity (As per physician’s discretion or decision)
Therapeutic Indications:
- Hormone receptor-positive metastatic breast cancer in postmenopausal women
- First-line treatment in combination with targeted therapies (as per local guidelines)
- Second-line monotherapy after progression on prior anti-estrogen therapy
Side Effects:
- COMMON:
- Injection site pain
- Nausea
- Fatigue
- Hot flashes
- Joint pain
- SERIOUS (RARE):
- Thromboembolic events
- Liver enzyme elevations
- Hypersensitivity or allergic reactions
- Vaginal bleeding
- PRECAUTIONS:
- Administer via intramuscular injection only (preferably gluteal)
- Regular liver function monitoring recommended during prolonged use
- Caution in patients with bleeding disorders or hepatic impairment
- Not recommended during pregnancy or lactation
- Ensure cold chain storage (2–8°C) is maintained throughout distribution
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TECHNICAL INFORMATION
Product Specifications
- HSN Code: To be assigned per international classification standards & import jurisdiction
- Weight: Approx. 40g per Carton (With Packaging)
- Dimensions: (15 x 1 x 8 CMS)
- Shelf Life: 24 to 36 months under recommended storage conditions from date of manufacture or as per label specifications. Cold chain mandatory.
- Storage: 2–8°C (Do not freeze). Requires cold-chain logistics. Protect from moisture and direct sunlight. Use strictly as per label guidelines.
Regulatory Status & Supply Information
- Regulatory Status: WHO-GMP Compliant Manufacturing. Further certifications available on request
- Exports Ready Dossiers: Dossier Available (CTD/eCTD formats)
- Stability: Compliant
- MOQ: Negotiable, based on market & registration status
- Export Options: Available for private label, institutional supply, or branded export
Who Should Source This Product?
- Oncology Hospitals & Breast Cancer Centers requiring advanced endocrine therapy
- Institutional Buyers & Government Procurement Bodies offering breast cancer treatment programs
- NGOs & Health Missions addressing access to cancer care in underserved populations
- Pharmaceutical Importers & Oncology Distributors looking for high-compliance oncology injectables
- Regulated Market Partners seeking dossier-ready, GMP-compliant oncology products
Why Source from PHARMET?
- Single-window sourcing for diverse pharma needs
- Export-ready documentation & regulatory support
- Adaptable documentation support for effective registration
- Trusted consortium network simplifying India’s complex pharma supply chain
- Multiple approved manufacturers for best fit in import country
- Network of audited, compliant manufacturers across India
- Customizable & flexible branding, packaging & formulation options
- End-to-end logistics support with flexibility
- Deep expertise in exporting specialty injectables & all pharma products
Contact Details
- Email: hello@pharmet.io
- Phone/WhatsApp: +91 9999091881
- Website: www.pharmet.io
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