CYCLOPHOSPHAMIDE injection, powder, for solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Amneal Pharmaceuticals LLC

Uygulama yolu:

INTRAVENOUS

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Cyclophosphamide for injection 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 for injection 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 for injection, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs. Cyclophosphamide for injection is indicated for the treatment of biopsy proven minimal change nephrotic syn

Ürün özeti:

Cyclophosphamide for Injection, USP is a sterile white powder containing cyclophosphamide, USP and is supplied in vials for single dose use. It is available as follows: 500 mg/vial 1 Vial in Carton:                                   NDC 70121-1238-1 1 g/vial 1 Vial in Carton:                                   NDC 70121-1239-1 2 g/vial 1 Vial in Carton:                                   NDC 70121-1240-1 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

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

CYCLOPHOSPHAMIDE- CYCLOPHOSPHAMIDE INJECTION, POWDER, FOR SOLUTION
AMNEAL PHARMACEUTICALS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CYCLOPHOSPHAMIDE
FOR INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR
CYCLOPHOSPHAMIDE FOR INJECTION.
CYCLOPHOSPHAMIDE FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1959
INDICATIONS AND USAGE
Cyclophosphamide for injection 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, Im