CYCLOPHOSPHAMIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ingenus Pharmaceuticals, LLC

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. - Hypersensitivity Cyclophosphamide is contraindicated in patients who have a history of severe hypersensitivity reactions to it, any of its metaboli

Product summary:

Cyclophosphamide Injection is a 200 mg/mL sterile clear colorless solution ready-to-dilute solution containing cyclophosphamide, USP. Cyclophosphamide Injection Store the vials refrigerated at 2°C to 8°C (36°F to 46°F). Store diluted solutions of cyclophosphamide according to Table 1 [see Dosage and Administration (2.3)] Cyclophosphamide is an antineoplastic product. Follow special handling and disposal procedures1 .

Authorization status:

New Drug Application

Summary of Product characteristics

CYCLOPHOSPHAMIDE- CYCLOPHOSPHAMIDE INJECTION, SOLUTION
INGENUS PHARMACEUTICALS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CYCLOPHOSPHAMIDE
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CYCLOPHOSPHAMIDE
INJECTION.
CYCLOPHOSPHAMIDE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1959
RECENT MAJOR CHANGES
Dosage and Administration (2.3)
09/2021
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)
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.
DOSAGE FORMS AND STRENGTHS
Cyclophosphamide Injection: 200 mg/mL (500 mg/2.5 mL, 1 g/5 mL and 2
g/10 mL) in a multiple-dose vial
(3)
CONTRAINDICATIONS
Hypersensitivity to cyclophosphamide (4)
Urinary outflow obstruction (4)
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,
arrhythmias and congestive heart
failure, which may be fatal, have been reported. Monitor patients,
especially those with risk factors for
cardio toxicity or pre-existing cardiac disease. (5.3