Cyclophosphamide (6 brand names, 5 dosage forms, 4 routes)
Available dosage forms: CAPSULE, INJECTABLE, SOLUTION, TABLET, INJECTION.
Routes of administration: ORAL, INJECTION, INTRAVENOUS, SOLUTION.
Brand Names
- CYCLOPHOSPHAMIDE
- CYTOXAN
- CYTOXAN (LYOPHILIZED)
- FRINDOVYX
- LYOPHILIZED CYTOXAN
- NEOSAR
Contraindications
Hypersensitivity Cyclophosphamide for Injection is contraindicated in patients who have a history of severe hypersensitivity reactions to cyclophosphamide, any of its metabolites, or to other components of the product. Anaphylactic reactions including death have been reported with cyclophosphamide. Cross-sensitivity with other alkylating agents can occur. Urinary Outflow Obstruction Cyclophosphamide for Injection is contraindicated in patients with urinary outflow obstruction [see Warnings and Precautions (5.2)].
Adverse Reactions
The following adverse reactions are discussed in more detail in other sections of the labeling. •Hypersensitivity [see Contraindications (4)] •Myelosuppression, Immunosuppression, Bone Marrow Failure, and Infections [see Warnings and Precautions (5.1)] •Urinary Tract and Renal Toxicity [see Warnings and Precautions (5.2)] •Cardiotoxicity [see Warnings and Precautions (5.3)] •Pulmonary Toxicity [see Warnings and Precautions (5.4)] •Secondary Malignancies [see Warnings and Precautions (5.5)] •Veno-occlusive Liver Disease [see Warnings and Precautions (5.6)] •Infertility [see Warnings and Precautions (5.8) and Use in Specific Populations (8.3, 8.4)] •Impaired Wound Healing [see Warnings and Precautions (5.9)] •Hyponatremia [see Warnings and Precautions (5.10)]
Mechanism of Action
The mechanism of action has not been fully characterized. However, cross-linking of tumor cell DNA may be involved. The active alkylating metabolites of cyclophosphamide interfere with the growth of susceptible rapidly proliferating malignant cells.
Overdosage
No specific antidote for cyclophosphamide is known. Overdosage should be managed with supportive measures, including appropriate treatment for any concurrent infection, myelosuppression, or cardiac toxicity should it occur. Serious consequences of overdosage include manifestations of dose dependent toxicities such as myelosuppression, urotoxicity, cardiotoxicity (including cardiac failure), veno-occlusive hepatic disease, and stomatitis [see Warnings and Precautions (5.1, 5.2, 5.3 , and 5.6)]. Patients who received an overdose should be closely monitored for the development of toxicities, and hematologic toxicity in particular. Cyclophosphamide and its metabolites are dialyzable. Therefore, rapid hemodialysis is indicated when treating any suicidal or accidental overdose or intoxication [see Clinical Pharmacology (12.3)]. Cystitis prophylaxis with mesna may be helpful in preventing or limiting urotoxic effects with cyclophosphamide overdose.