CYCLOPHOSPHAMIDE 50 mg Tablets

Alkylating Cytotoxic Agent – Antineoplastic / Immunosuppressant

ATC Code: L01AA01 | Prescription Only | Cytotoxic

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Product Description:

Cyclophosphamide is a nitrogen mustard–derived alkylating agent widely used as both a chemotherapeutic and immunosuppressive drug. It is a prodrug, requiring hepatic activation by cytochrome P450 enzymes to form the active metabolites phosphoramide mustard and acrolein. These agents cross-link DNA strands, leading to cell-cycle arrest and apoptosis. Cyclophosphamide 50 mg oral tablets are frequently used in low-dose regimens for long-term therapy in cancer and autoimmune diseases, including lymphomas, leukemias, breast cancer, and vasculitis.

Available Presentation:

• Strength: 50 mg per tablet
• Formulation: Film-coated or uncoated tablets (white, round or oval, varies by manufacturer)
• Packaging: Bottle or blister pack with 50 tablets
• Route of Administration: Oral
• Storage Conditions: Store below 25°C; protect from moisture and light; handle with cytotoxic precautions

Uses:

• Oncology:
  • Part of multi-drug chemotherapy regimens for non-Hodgkin’s lymphoma
  • Chronic lymphocytic leukemia (CLL)
  • Multiple myeloma
  • Ovarian cancer
  • Breast cancer
• Autoimmune Disorders:
  • Systemic lupus erythematosus (SLE)
  • Vasculitis
  • Rheumatoid arthritis
  • Glomerulonephritis
• Pediatric Oncology:
  • Wilms’ tumor
  • Neuroblastoma
  • Ewing’s sarcoma
  • Rhabdomyosarcoma

Indications:

• Malignancies:
  • Lymphomas (NHL, Hodgkin’s)
  • Leukemias (CLL, AML, ALL)
  • Solid tumors (breast, ovarian, small-cell lung cancer)
• Immunosuppressive Therapy:
  • Lupus nephritis
  • ANCA-associated vasculitis
  • Immune thrombocytopenia
  • Systemic sclerosis
• Conditioning Regimens: Hematopoietic stem cell transplantation (HSCT) protocols

Regulatory and Safety Profile:

• ATC Code: L01AA01
• Pharmacologic Class: Alkylating agent
• Pregnancy Category: D – Contraindicated unless used for life-threatening indications
• Black Box Warnings: Myelosuppression, urotoxicity (hemorrhagic cystitis), secondary malignancies
• Common Adverse Effects: Nausea, vomiting, alopecia, leukopenia, mucositis
• Serious Risks: Hematuria, bladder fibrosis, cardiotoxicity, infertility, opportunistic infections
• Monitoring Parameters: CBC, renal and hepatic function, urinalysis for hematuria, hydration status during treatment