Bortezomib Injection

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Bortezomib injection is an antineoplastic (cancer) medication supplied as a sterile lyophilised powder (freeze-dried cake) for reconstitution. It is most commonly known by the brand name Velcade.

Description

Bortezomib Injection

Healthy Inc is a specialized global supplier and exporter of targeted proteasome inhibitors. We provide high-purity Bortezomib Injection (2 mg / 3.5 mg), sourced from WHO–GMP certified Oncology (Cytotoxic) facilities. This “Myeloma Game-Changer” is a top export to cancer institutes, hematology wards, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the first-line therapy for Multiple Myeloma and Mantle Cell Lymphoma.


Product Overview

This formulation contains Bortezomib, a modified dipeptide boronic acid analogue that revolutionized the treatment of plasma cell malignancies.

The “Cellular Trash Compactor” Blocker:

  • Mechanism (Proteasome Inhibition): Cancer cells, especially Myeloma cells, produce vast amounts of proteins (immunoglobulins). They rely on the 26S Proteasome (the cell’s “garbage disposal”) to break down misfolded proteins. Bortezomib binds to and inhibits this proteasome.
  • Apoptosis Trigger: When the proteasome is blocked, toxic proteins accumulate inside the cancer cell. This “proteotoxic stress” disrupts cell signaling (specifically the NF-kappaB pathway) and forces the cancer cell to commit suicide (apoptosis).
  • Targeted Action: Because Myeloma cells are “protein factories,” they are much more sensitive to proteasome inhibition than normal cells, providing a therapeutic window.

Product Composition & Strength

We supply this product as a Sterile Lyophilized Powder in glass vials. It contains Mannitol, which forms a stable boronic ester with Bortezomib for shelf stability.

Active IngredientVial StrengthPrimary Use
Bortezomib (as Mannitol Boronic Ester)2 mg / VialSingle Dose / Low BSA
Bortezomib (as Mannitol Boronic Ester)3.5 mg / VialStandard Adult Dose
ExcipientsMannitol (Sterile)Stabilizer / Bulking Agent

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


Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Distributors.

HS Code3004.90.99 (Antineoplastic medicaments)
Dosage FormPowder for Injection (Lyophilized)
PackagingType I Glass Vial with Teflon-coated Stopper
StorageStore below 25°C. Protect from Light. Stable in vial for 24 months.
CertificatesWHO-GMP, COPP, Free Sale Certificate

Manufacturing Authority

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

  • Boronic Ester Stability: Free Bortezomib is prone to oxidation. Our lyophilization process creates a Bortezomib-Mannitol Ester, which is chemically stable. Upon reconstitution with saline, this ester hydrolyzes back into active Bortezomib.
  • Containment: Manufactured in high-containment OEB-5 isolators to prevent operator exposure to this potent cytotoxic agent.

Therapeutic Indications (Human Use)

Indicated for the treatment of hematological cancers:

  • Multiple Myeloma: First-line treatment (often with Dexamethasone/Lenalidomide) and for relapsed/refractory cases.
  • Mantle Cell Lymphoma: For patients who have received at least one prior therapy.

Dosage & Administration

Recommended Dosage (Strictly as per Hematologist):

  • Routes (CRITICAL DISTINCTION):
    • Subcutaneous (SC): Preferred route. Significantly lowers the risk of peripheral neuropathy. Requires high concentration (2.5 mg/ml).
    • Intravenous (IV): Rapid bolus (3-5 secs). Requires low concentration (1 mg/ml).
  • Standard Schedule: 1.3 mg/m² body surface area on Days 1, 4, 8, and 11 of a 21-day cycle.
  • Reconstitution Warning:
    • For SC use: Add 1.4 ml saline to 3.5 mg vial (Final Conc: 2.5 mg/ml).
    • For IV use: Add 3.5 ml saline to 3.5 mg vial (Final Conc: 1 mg/ml).
  • Intrathecal Use: FATAL. NEVER inject into the spine.

Safety Warnings (CRITICAL):

  • Peripheral Neuropathy: Causes severe burning/numbness in hands and feet. SC administration reduces this risk compared to IV.
  • Herpes Zoster Reactivation (Shingles): Bortezomib suppresses T-cell immunity against viruses. Antiviral prophylaxis (e.g., Acyclovir) is MANDATORY for all patients during treatment.
  • Hypotension: Can cause sudden drops in blood pressure; adjust antihypertensive meds.

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.

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