CYCLOPHOSPHAMIDE injection, powder, for solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Civica, Inc.

Administracija rute:

INTRAVENOUS

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Cyclophosphamide is indicated for the treatment of: 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 respond to or are unable to tolerate adrenocorticosteroid therapy. Limitations of Use: The safety and effectiveness for the treatment of nephrotic syndrome in adults or other renal disease has not been established. Pregnancy Category D Risk Summary Cyclophosphamide can cause fetal harm when administered to a pregnant woman based on its mechanism of action and published reports of effects in pregnant patients or animals. Exposure to cyclophosphamide during pregnancy may cause fetal malformations, miscarriage, fetal growth retardation, and toxic effects in the newborn. Cyclophosphamide is teratogenic and embryo-fetal toxic in mice, rats, rabbits and monke

Proizvod sažetak:

Cyclophosphamide for Injection, USP is a sterile white powder containing cyclophosphamide and is supplied in vials for single dose use. Cyclophosphamide for Injection, USP 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

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

CYCLOPHOSPHAMIDE- CYCLOPHOSPHAMIDE INJECTION, POWDER, FOR SOLUTION
CIVICA, INC.
----------
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 FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1959
INDICATIONS AND USAGE
Cyclophosphamide is an alkylating drug indicated for treatment of:
•
•
DOSAGE AND ADMINISTRATION
MALIGNANT DISEASES: ADULT AND PEDIATRIC PATIENTS (2.1)
•
•
MINIMAL CHANGE NEPHROTIC SYNDROME IN PEDIATRIC PATIENTS (2.2)
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
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.
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.
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.
Injection, sterile white powder: 500 mg, 1 g, and 2 g (3)
Hypersensitivity to cyclophosphamide (4)
Urinary outflow obstruction (4)
Myelosuppressi