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Bortlee 2 Lyophilized Injection

Generic Name – Bortezomib
Drug Class – Antineoplastic agent
Bortezomib is a proteasome inhibitor, approved by FDA for the treatment of refractory multiple myelomas and mantle cell lymphomas. It acts by inhibiting 26-S proteosome complex which regulates protein degradation. Blocking this proteosome complex disrupts various cell signaling pathways leading to cell cycle arrest, inhibition of angiogenesis and apoptosis. It also increases sensitivity of cancer cells to traditional anticancer agents (e.g., gemcitabine, cisplatin, paclitaxel, irinotecan, and radiation).

Product Description

Bortlee 2 (Bortezomib for injection) is a sterile lyophilized powder for injection. Lyophilized form improves the stability of injection by avoiding moisture content. Bortlee 2 lyophilized injection provides a stable and therapeutically effective formulation with extended shelf life.

Indications and Usage

Bortezomib is indicated for:
• Treatment of multiple myeloma
• Treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy

Limitations of use:
• Bortezomib is not indicated for the treatment of solid tumors, as its efficacy in solid tumors is lacking

Dosage and Administration

•Dosage Regimen for Previously Untreated Multiple Myeloma

Bortezomib, Melphalan and Prednisone (VMP) Regimen
Bortezomib 1.3 mg/m2, IV, twice weekly on weeks 1,2,4 and 5 of cycle 1-4 and once weekly on weeks 1,2,4 and 5 of cycle 5-9
Melphalan 9 mg/m2, oral, once daily on days 1-4
Prednisone 60 mg/m2, oral, once daily on days 1-4

• Dosage Regimen for Relapsed Multiple Myeloma and Mantle Cell Lymphoma

Bortezomib monotherapy
Bortezomib 1.3 mg/m2 administered as a 3 to 5 second bolus IV injection twice weekly for 2 weeks followed by a 10-day rest period

• Dose may be adjusted to manage adverse events that occur during treatment

Dosage Form and Strength
• Supplied as a single use sterile lyophilized powder for intravenous infusion
• Available as 2mg vial for injection

Clinical Efficacy

• Shows significant clinical efficacy in patients with both newly diagnosed and relapsed multiple myeloma treatment
• Improves the response rate and survival outcome in multiple myeloma patients when combined with other chemotherapeutic agents
• Produces good clinical outcomes with less toxic effects in relapsed and refractory MCL, while sparing the toxic effects of cytarabine-based regimens in younger patients
• Effective in patients previously refractory to other more conventional treatments as well as in patients with high risk disease as defined by cytogenetics

Adverse reactions
• The most common adverse effects of bortezomib includes diarrhea, constipation, nausea, vomiting, decreased appetite, peripheral neuropathy, thrombocytopenia, neutropenia, neuralgia, leucopenia, skin rashes and anemia
• Other serious adverse events such as cardiac disorders, hepatic events, tumor lysis syndrome and reversible posterior leukoencephalopathy syndrome may also occur in some patients

Contraindications
• It is contraindicated in patients with a known hypersensitivity to boron, mannitol and bortezomib

Special Precautions

• Patients should be regularly monitored for signs of neuropathy, if signs of neuropathy occurs, the dose of bortezomib should be modified or discontinued
• Patients with preexisting severe neuropathy should be treated with bortezomib only after careful risk-benefit assessment
• Bortezomib use can cause hypotension, therefore caution should be used while treating patients with a history of hypertension, syncope and those who are dehydrated
• Patients with risk factors for an existing heart disease, acute diffuse infiltrative pulmonary disease, and hepatic disease should be closely monitored
• Blood glucose levels and complete blood counts should be monitored regularly in patients with diabetes and a risk of thrombocytopenia and neutropenia respectively
• Patients should be advised to use antiemetic, ant diarrheal medications and fluid replacement, if gastrointestinal side effects and dehydration occurs
• Women treated with bortezomib should use birth control measures to avoid pregnancy
• Use of bortezomib is not recommended in pregnant and breast feeding mothers

Bortlee 2 Lyophilized Injection - ADMAC Life Science