CYCLOPHOSPHAMIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

CYCLOPHOSPHAMIDE

Composition:

CYCLOPHOSPHAMIDE ANHYDROUS 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cyclophosphamide Capsules are indicated for the treatment of: Cyclophosphamide Capsules, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs. Cyclophosphamide Capsules are indicated for the treatment of biopsy proven minimal change nephrotic syndrome in pediatric patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy. Limitations of Use: The safety and effectiveness of Cyclophosphamide Capsules for the treatment of nephrotic syndrome in adults or other renal disease has not been established. Cyclophosphamide Capsules are contraindicated in patients with: Risk Summary Based on its mechanism of action and published reports of effects in pregnant patients or animals, Cyclophosphamide Capsules can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) and Nonclinical Toxicology (13.1)] . Exposure to cyclophosphamide during pregnancy may cause feta

Product summary:

Cyclophosphamide Capsules, USP 25 mg, supplied as a blue/blue opaque capsule with “54 006” printed in black ink on the cap and body, containing a white to off-white powder. NDC 0054-0382-13: Bottle of 30 Capsules NDC 0054-0382-25: Bottle of 100 Capsules 50 mg, supplied as a blue/blue opaque capsule with “54 881” printed in black ink on the cap and body, containing a white to off-white powder. NDC 0054-0383-13: Bottle of 30 Capsules NDC 0054-0383-25: Bottle of 100 Capsules Storage Store at 20°C to 25°C (68°F to 77°F); with excursions permitted between 15ºC to 30ºC (59°F to 86°F). [See USP Controlled Room Temperature.] Cyclophosphamide is an antineoplastic product. Follow special handling and disposal procedures.1

Authorization status:

New Drug Application

Summary of Product characteristics

CYCLOPHOSPHAMIDE- CYCLOPHOSPHAMIDE CAPSULE
HIKMA PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CYCLOPHOSPHAMIDE
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CYCLOPHOSPHAMIDE
CAPSULES.
CYCLOPHOSPHAMIDE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1959
INDICATIONS AND USAGE
Cyclophosphamide is an alkylating drug indicated for treatment of:
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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
During or immediately after the administration, administer adequate
amounts of fluid to reduce the risk of
urinary tract toxicity (2.1).
MALIGNANT DISEASES: ADULT AND PEDIATRIC PATIENTS (2.2)
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MINIMAL CHANGE NEPHROTIC SYNDROME IN PEDIATRIC PATIENTS (2.3)
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DOSAGE FORMS AND STRENGTHS
Capsules: 25 mg and 50 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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)
Oral: Usually 1 mg per kg per day to 5 mg per kg orally once daily for
both initial and maintenance
dosing.
Recommended oral dose: 2 mg per kg once daily for 8 to 12 weeks
(maximum cumulative dose 168
mg per kg). Treatment beyond 90 days increases the probability of
sterility in males.
Hypersensitivity to cyclophosphamide (4)
Urinary outflow obstruction (4)
Myelosuppression, Immunosuppression, Bone Marrow Failure and
Infections – Severe
immunosuppression may lead to serious and sometimes fatal in