Cyclophosphamide Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
Cyclophosphamide is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
1 INDICATIONS AND USAGE Cyclophosphamide capsules, USP is an alkylating drug indicated for treatment of: Malignant Diseases: malignant lymphomas: Hodgkin's disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma ( 1.1 ) Minimal Change Nephrotic Syndrome in Pediatric Patients: biopsy proven minimal change nephrotic syndrome in pediatric patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy ( 1.2 ) Limitations of Use: The safety and effectiveness for the treatment of nephrotic syndrome.
What should I know before taking it?
Cyclophosphamide capsules are contraindicated in patients with: 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. In patients with urinary outflow obstruction [see Warnings and Precautions ( 5.2 )] .
What important warnings are listed?
5 WARNINGS AND PRECAUTIONS Myelosuppression, Immunosuppression, Bone Marrow Failure and Infections – Severe immunosuppression may lead to serious and sometimes fatal infections. Close hematological monitoring is required. ( 5.1 ) Urinary Tract and Renal Toxicity – Hemorrhagic cystitis, pyelitis, ureteritis, and hematuria can occur. Exclude or correct any urinary tract obstructions prior to treatment. ( 5.2 ) Cardiotoxicity – Myocarditis, myopericarditis, pericardial effusion, arrythmias and congestive heart failure, which may be fatal, have been reported. Monitor patients, especially those with risk factors for cardiotoxicity or pre-existing cardiac disease. ( 5.3 ) Pulmonary Toxicity –.
How is this medication usually taken?
Each 25 mg capsule for oral administration contains 25 mg of cyclophosphamide. It is a white to off white blend filled hard gelatin capsule size 3, cap opaque white imprinted with "Cipla" in black ink and body opaque blue imprinted with "516 25 MG" with black ink. Each 50 mg capsule for oral administration contains 50 mg of cyclophosphamide. It is a white to off white blend filled in hard gelatin capsule size 1, cap opaque white imprinted with "Cipla" in black ink and body opaque blue imprinted with "517 50 MG" with black ink.
What side effects are listed?
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 and 8.4 )] Impaired Wound Healing [see.
What interactions are listed?
Cyclophosphamide is a pro-drug that is activated by cytochrome P450s [see Clinical Pharmacology ( 12.3 )]. An increase of the concentration of cytotoxic metabolites may occur with: Protease inhibitors: Concomitant use of protease inhibitors may increase the concentration of cytotoxic metabolites. Use of protease inhibitor-based regimens was found to be associated with a higher incidence of infections and neutropenia in patients receiving cyclophosphamide, doxorubicin, and etoposide (CDE) than use of a Non-Nucleoside Reverse Transcriptase Inhibitor-based regimen.Combined or sequential use of cyclophosphamide and other agents with similar toxicities can potentiate toxicities.Increased.
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0e1cb955-99c8-4fe5-89d1-399c8e52174e
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.