Description

Bortezomib Injection (Generic Bortenat)

Healthy Inc is a specialized global supplier and exporter of high-value targeted oncology injectables. We provide high-purity Bortezomib Injection (2 mg / 3.5 mg), the bio-equivalent generic to Bortenat / Velcade. Sourced from WHO–GMP certified Cytotoxic facilities, this “Proteasome Inhibitor” is a top export to cancer institutes, hematology clinics, and government health ministries in Africa, LATAM, and Southeast Asia, offering a cost-effective gold standard for Multiple Myeloma therapy.

Product Overview

This formulation contains Bortezomib, a modified dipeptide boronic acid analogue. It acts as a reversible inhibitor of the chymotrypsin-like activity of the 26S proteasome.

The “Myeloma” Specialist:

• Mechanism (The “Trash Blockade”): Cancer cells (especially plasma cells) generate huge amounts of waste proteins. The 26S Proteasome acts as the cellular garbage disposal. Bortezomib blocks this disposal system.
• Apoptotic Cascade: By inhibiting the proteasome, toxic proteins accumulate within the cancer cell, causing “proteotoxic stress” and disrupting cell signaling pathways (specifically NF-kappaB). This forces the cancer cell to undergo apoptosis (programmed cell death).
• Bio-Equivalence: Our formulation uses the same Mannitol-Boronic Ester chemistry as the innovator (Bortenat/Velcade) to ensure identical stability, solubility, and therapeutic efficacy.

Product Composition & Strength

We supply this product as a Sterile Lyophilized Powder in glass vials. It must be reconstituted with Normal Saline (0.9% NaCl).

*Pack Sizes: Single Vial Box with protective Cytotoxic shrink-wrapping.

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.

• Containment Safety: Bortezomib is a potent cytotoxic. We manufacture in OEB-5 Isolators (highest containment level) to prevent cross-contamination and ensure operator safety.
• Esterification: Free Bortezomib is unstable. Our process lyophilizes it with excess Mannitol to form a stable Boronic Acid Ester, which hydrolyzes rapidly upon reconstitution to release the active drug.

Therapeutic Indications (Human Use)

Indicated for the treatment of hematological cancers:

• Multiple Myeloma: As monotherapy or in combination (e.g., with Dexamethasone, Thalidomide, or Lenalidomide) for untreated or relapsed patients.
• Mantle Cell Lymphoma: For patients who have received at least one prior therapy.

Dosage & Administration

Recommended Dosage (Strictly as per Oncologist):

• Standard Dose: 1.3 mg/m² body surface area administered twice weekly for 2 weeks (Days 1, 4, 8, 11) followed by a 10-day rest period (Day 12-21).
• Routes of Administration (CRITICAL):
  • Subcutaneous (SC): Preferred route. Reconstitute 3.5mg vial with 1.4 ml saline (2.5 mg/ml). Inject into thigh or abdomen. Causes less peripheral neuropathy.
  • Intravenous (IV): Reconstitute 3.5mg vial with 3.5 ml saline (1 mg/ml). Administer as a 3-5 second bolus.
• WARNING: NEVER administer Intrathecally (into the spine). Fatal.

Safety Warnings (CRITICAL):

• Peripheral Neuropathy: A major dose-limiting side effect characterized by burning, tingling, or numbness in hands and feet. SC administration significantly reduces this risk.
• Herpes Zoster (Shingles): Reactivation is common. Antiviral prophylaxis (Acyclovir) is mandatory during treatment.
• Thrombocytopenia: Causes a cyclic drop in platelet count. Monitor CBC before every dose.

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.