BORTEZOMIB SPC 3.5 mg Powder for Solution for Infusion 3.5 mg powder for solution for injection 10ml Vial

Product Overview

Bortezomib 3.5 mg Powder for Solution for Infusion is a highly specialized, prescription-only antineoplastic agent. This medication is primarily indicated for the treatment of multiple myeloma and mantle cell lymphoma, two types of blood cancer. As a proteasome inhibitor, Bortezomib works by blocking the action of proteasomes within cancer cells, disrupting their normal function and leading to programmed cell death. Its precise mechanism of action contributes to its efficacy in managing these complex hematological malignancies, offering a targeted approach to therapy. This product is intended for administration by qualified healthcare professionals in a clinical setting.

Key Benefits

• Targets and inhibits proteasomes, crucial for cancer cell survival and growth.
• Induces programmed cell death in multiple myeloma and mantle cell lymphoma cells.
• Offers a targeted therapeutic option for specific hematological cancers.
• Integral component of various treatment regimens for these conditions.

How to Use

1. Bortezomib 3.5 mg is supplied as a powder and must be reconstituted with the appropriate diluent before administration.
2. It is administered via intravenous infusion by a trained healthcare professional.
3. The dosage, frequency, and duration of treatment are determined by the prescribing physician based on the patient's specific condition, response to therapy, and overall treatment plan.
4. Strict adherence to aseptic techniques and proper handling procedures is required during preparation and administration.

Caution & Warnings

• Peripheral Neuropathy: Patients should be monitored for new or worsening peripheral neuropathy, which can be severe.
• Myelosuppression: May cause thrombocytopenia, neutropenia, and anemia; regular blood count monitoring is essential.
• Cardiac Toxicity: Cases of acute heart failure and other cardiac events have been reported.
• Hepatotoxicity: Liver function tests should be monitored, as liver injury can occur.
• Gastrointestinal Toxicity: Nausea, diarrhea, constipation, and vomiting are common; supportive care may be needed.
• Hypotension: Orthostatic/postural hypotension can occur; patients should be advised to move slowly.
• Tumor Lysis Syndrome: Risk of tumor lysis syndrome, especially in patients with high tumor burden.
• Pregnancy & Lactation: Not recommended during pregnancy or breastfeeding due to potential fetal harm. Effective contraception should be used.
• Administration: Must be administered by healthcare professionals experienced in the use of antineoplastic agents. Not for intrathecal administration.

Ingredients

Bortezomib 3.5 mg powder contains Bortezomib (active ingredient) and mannitol (excipient).

Product Details

• Active Ingredient: Bortezomib
• Strength: 3.5 mg per vial
• Form: Powder for Solution for Infusion
• Administration Route: Intravenous (IV) Infusion
• Packaging: Single-dose vial
• Therapeutic Class: Antineoplastic agent, Proteasome Inhibitor
• Legal Status: Prescription Only Medicine (POM)