CYCLOPHOSPHAMIDE injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CYCLOPHOSPHAMIDE (UNII: 8N3DW7272P) (CYCLOPHOSPHAMIDE ANHYDROUS - UNII:6UXW23996M)

Available from:

Sandoz Inc.

INN (International Name):

CYCLOPHOSPHAMIDE

Composition:

CYCLOPHOSPHAMIDE ANHYDROUS 500 mg in 25 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cyclophosphamide is indicated for the treatment of: - malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin's disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma - multiple myeloma - leukemias: Chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration) - mycosis fungoides (advanced disease) - neuroblastoma (disseminated disease) - adenocarcinoma of the ovary - retinoblastoma - carcinoma of the breast Cyclophosphamide, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs.    Cyclophosphamide is indicated for the treatment of biopsy proven minimal change nephrotic syndrome in pediatrics patients who failed to adequately

Product summary:

Cyclophosphamide for Injection, USP is a sterile white powder containing cyclophosphamide and is supplied in vials for single dose use. Cyclophosphamide for Injection, USP NDC 0781-3233-94        500 mg vial, carton of 1 NDC 0781-3244-94        1 g vial, carton of 1 NDC 0781-3255-94        2 g vial, carton of 1 Store vials at or below 25°C (77°F). During transport or storage of cyclophosphamide vials, temperature influences can lead to melting of the active ingredient, cyclophosphamide. [see Dosage and Administration ( 2.3)] . Cyclophosphamide is an antineoplastic product. Follow special handling and disposal procedures. 1 

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYCLOPHOSPHAMIDE- CYCLOPHOSPHAMIDE INJECTION, POWDER, FOR SOLUTION
SANDOZ INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CYCLOPHOSPHAMIDE
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CYCLOPHOSPHAMIDE.
CYCLOPHOSPHAMIDE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1959
INDICATIONS AND USAGE
Cyclophosphamide 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 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
in adults or other renal disease
has not been established.
DOSAGE AND ADMINISTRATION
MALIGNANT DISEASES: ADULT AND PEDIATRIC PATIENTS ( 2.1)
Intravenous: Initial course for patients with no hematologic
deficiency: 40 mg per kg to 50 mg per kg in
divided doses over 2 to 5 days. Other regimens include 10 mg per kg to
15 mg per kg given every 7 to
10 days or 3 mg per kg to 5 mg per kg twice weekly.
Oral: Usually 1 mg per kg per day to 5 mg per kg per day for both
initial and maintenance dosing.
MINIMAL CHANGE NEPHROTIC SYNDROME IN PEDIATRIC PATIENTS ( 2.2)
Recommended oral dose: 2 mg per kg daily for 8 to 12 weeks (maximum
cumulative dose 168 mg per
kg). Treatment beyond 90 days increases the probability of sterility
in males.
DOSAGE FORMS AND STRENGTHS
Injection, sterile white powder: 500 mg,1 g, and 2 g ( 3)
CONTRAINDICATIONS
Hypersensitivity to cyclophosphamide ( 4)
Urinary outflow obstruction ( 4)
WARNINGS AND PRECAUTIONS
Myelosuppression, Immunosuppression, Bone Marrow Failure and
Infections - Sev