CYCLOPHOSPHAMIDE 1,000 mg Vial

Alkylating Antineoplastic Agent – Cytotoxic Chemotherapy

ATC Code: L01AA01 | Prescription Only | Cytotoxic

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Product Description:

Cyclophosphamide is a bifunctional alkylating agent of the nitrogen mustard class, used in the treatment of a wide range of hematologic malignancies, solid tumors, and autoimmune conditions. It is a prodrug, activated hepatically by cytochrome P450 enzymes to form phosphoramide mustard (the active cytotoxic compound) and acrolein (a urotoxic byproduct). Cyclophosphamide interferes with DNA replication and RNA transcription by forming cross-links between and within DNA strands, leading to apoptosis of rapidly dividing cells. The 1,000 mg vial presentation is commonly used in high-dose chemotherapy protocols, including conditioning regimens prior to hematopoietic stem cell transplantation (HSCT), pulse immunosuppressive therapy, and oncology regimens.

Available Presentation:

• Strength: 1,000 mg per vial
• Formulation: Lyophilized powder for solution for injection or infusion
• Packaging: Single-dose Type I glass vial in individual carton
• Route of Administration: Intravenous (IV) infusion
• Reconstitution: Typically with sterile water or 0.9% sodium chloride solution
• Storage Conditions: Store below 25°C; protect from moisture and light

Uses:

• Oncology: Lymphomas, leukemias, multiple myeloma, breast, ovarian, small-cell lung, and neuroblastoma
• Hematopoietic Stem Cell Transplantation (HSCT): Pre-conditioning regimens
• Immunosuppressive Therapy: SLE, vasculitis, glomerulonephritis, autoimmune hemolytic anemia

Indications:

• Lymphomas (Hodgkin and Non-Hodgkin)
• Leukemias: CLL, AML, ALL
• Solid Tumors: Breast, ovarian, small-cell lung, neuroblastoma
• Multiple Myeloma
• Autoimmune Diseases: Off-label use in lupus nephritis, ANCA-associated vasculitis, etc.
• Stem Cell Transplantation: Conditioning regimens

Regulatory and Safety Profile:

• ATC Code: L01AA01
• Pharmacologic Class: Alkylating Agent / Nitrogen Mustard Derivative
• Pregnancy Category: D – Contraindicated unless life-saving
• Common Side Effects: Nausea, vomiting, leukopenia, alopecia, anorexia
• Serious Risks: Hemorrhagic cystitis, bone marrow suppression, infertility, secondary malignancies, cardiotoxicity
• Monitoring Parameters: CBC, renal and liver function, urinalysis, hydration status, cardiac monitoring (high-dose use)
• Supportive Measures: Adequate hydration and use of mesna recommended in high-dose protocols

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For pricing, tender participation, or regulatory support documentation, please contact info@panamfarma.com.