Veltezo 3.5 mg Ingredients and Usage

The active ingredient is Bortezomib. The 3.5 mg vial is supplied as a lyophilized powder that must be reconstituted with sterile saline before being administered.

Veltezo is clinically indicated for the treatment of adult patients with:

• Multiple Myeloma: Used in combination with other agents (e.g., Dexamethasone, Melphalan) for both newly diagnosed and relapsed/refractory disease.
• Mantle Cell Lymphoma (MCL): Used for patients who have received at least one prior therapy.

How Does Veltezo Work?

Bortezomib is the first-in-class proteasome inhibitor. The proteasome is an enzyme complex that breaks down unneeded or damaged proteins in the cell. Bortezomib’s mechanism specifically targets this process:

1. Proteasome Inhibition: Bortezomib reversibly inhibits the chymotrypsin-like activity of the 20S core subunit of the 26S proteasome.
2. Protein Accumulation: By blocking the proteasome, key regulatory and damaged proteins (e.g., IκB, p53) accumulate within the cancer cell.
3. Apoptosis Induction: This toxic accumulation disrupts the cell’s internal signaling, leading to endoplasmic reticulum (ER) stress, activation of caspases, and ultimately, the programmed cell death (apoptosis) of the malignant plasma cells (Myeloma) or lymphocytes (MCL).

Veltezo 3.5 mg Side Effects and Warnings

Bortezomib is associated with significant, serious side effects, requiring frequent monitoring and supportive care.

Black Box Warnings and Critical Precautions:

1. Peripheral Neuropathy (PN): This is the most common and dose-limiting toxicity. It manifests as tingling, numbness, and pain in the hands and feet. The risk of PN is generally lower with subcutaneous (SC) administration compared to intravenous (IV) administration.
2. Thrombocytopenia and Neutropenia: Severe reductions in platelets (thrombocytopenia, increasing bleeding risk) and white blood cells (neutropenia, increasing infection risk) are common. Frequent blood counts are mandatory.
3. Hepatotoxicity: Liver damage, including acute liver failure, has been reported.
4. Pulmonary Toxicity: Acute respiratory distress syndrome (ARDS) and other severe, acute pulmonary reactions have occurred.
5. Herpes Zoster Reactivation: Antiviral prophylaxis (e.g., Acyclovir) is typically required during treatment to prevent the reactivation of the dormant chickenpox virus.

Veltezo 3.5 mg Storage Conditions

Bortezomib is a lyophilized powder requiring careful handling:

• Store the unopened vials at controlled room temperature, typically between 15°C and 30°C (59°F and 86°F). Protect from light.
• Reconstitution: The 3.5 mg powder must be reconstituted only with 0.9% Sodium Chloride solution (NaCl) to the concentration specified for the route of administration (IV or SC).
• Handling: Because it is a cytotoxic agent, it must be prepared and administered by qualified personnel using appropriate protective measures.
• Stability: The reconstituted solution should be used promptly, typically within 8 hours if stored at room temperature or refrigerated.