Description

Fulvestrant Injection

Healthy Inc is a specialized global supplier and exporter of advanced hormonal oncology therapies. We provide high-purity Fulvestrant Injection (250 mg / 5 ml), sourced from WHO–GMP certified sterile cytotoxic facilities. This “SERD” specialist is a top export to oncology centers, breast cancer clinics, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the definitive second-line and maintenance therapy for Hormone Receptor-Positive (HR+) Metastatic Breast Cancer in postmenopausal women.

Product Overview

This formulation contains Fulvestrant, a pure anti-estrogen that acts as a Selective Estrogen Receptor Degrader (SERD).

The “Receptor Destroyer” Specialist:

• Mechanism (SERD Action): Unlike Tamoxifen (which just blocks the receptor), Fulvestrant binds to the Estrogen Receptor (ER) with very high affinity and triggers its physical degradation. By reducing the number of ER receptors on the cancer cell surface (“downregulation”), it completely shuts off the estrogen signaling pathway that fuels tumor growth.
• Pure Antagonist: It has no agonist effects (unlike Tamoxifen, which can stimulate the uterus). This makes it safer regarding endometrial cancer risk.
• Resistance Breaker: It is highly effective in patients whose cancer has progressed after treatment with Tamoxifen or Aromatase Inhibitors (Letrozole/Anastrozole).

Product Composition & Strength

We supply this product as a Sterile Oily Solution in Prefilled Syringes (PFS) or Vials. (Note: This is a high-viscosity injection).

*Pack Sizes: Box of 1 PFS (with safety needles) or Box of 2 PFS (for 500mg dose).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Distributors.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• Viscosity Management: Fulvestrant requires a specific mixture of alcohol, benzyl benzoate, and castor oil to remain soluble. Our formulation is rigorously tested for viscosity to ensure it can be injected through a standard 21G needle without excessive force, while maintaining stability at cold temperatures.
• Syringe Integrity: We use siliconized glass syringes to ensure smooth plunger movement during the slow injection process required for this drug.

Therapeutic Indications (Human Use)

Indicated for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer in postmenopausal women:

• First-Line: For advanced/metastatic disease not previously treated with endocrine therapy.
• Second-Line: For disease progression following therapy with other anti-estrogens (Tamoxifen/Letrozole).
• Combination Therapy: Often used with CDK4/6 inhibitors (Palbociclib/Ribociclib).

Dosage & Administration

Recommended Dosage (Strictly as per Oncologist):

• Route: Slow Intramuscular (IM) Injection ONLY. (Gluteal muscle).
• Standard Dose: 500 mg administered intramuscularly.
• Administration Protocol:
  • Administer as TWO 5 ml injections (250 mg each), one in each buttock.
  • Injection Rate: Inject SLOWLY (1-2 minutes per injection) because the solution is thick and oily.
  • Frequency: Days 1, 15, 29, and once monthly thereafter.

Safety Warnings (CRITICAL):

• Sciatic Nerve Injury: Because of the large volume (5ml) and gluteal injection site, care must be taken to avoid the sciatic nerve. Dorsogluteal site is preferred.
• Injection Site Pain: Pain and inflammation are common due to the castor oil vehicle. Administering slowly reduces pain.
• Bleeding Risk: Use with caution in patients with bleeding diathesis or on anticoagulants (due to deep IM route).
• Hepatic Impairment: Dose adjustment (250 mg) required in moderate liver failure.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Sterile Injectables, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.