CYCLOPHOSPHAMIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

ANI Pharmaceuticals, Inc.

INN (International Name):

CYCLOPHOSPHAMIDE

Composition:

CYCLOPHOSPHAMIDE ANHYDROUS 50 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 fetal

Product summary:

Cyclophosphamide Capsules 25 mg, dark green opaque/white opaque capsule, #3, imprinted “AMG” on the cap and “307” on the body in black ink. NDC 43975-307-10: Bottle of 100 capsules. 50 mg, dark green opaque/dark green opaque capsules, #1, imprinted “AMG” on the cap and “308” on the body in black ink. NDC 43975-308-10: Bottle of 100 capsules Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Cyclophosphamide is an antineoplastic product. Follow special handling and disposal procedures.¹

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYCLOPHOSPHAMIDE- CYCLOPHOSPHAMIDE CAPSULE
ANI PHARMACEUTICALS, 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.
INITIAL U.S. APPROVAL: 1959
RECENT MAJOR CHANGES
Warnings and Precautions, Embryo-Fetal Toxicity 09/2019
INDICATIONS AND USAGE
Cyclophosphamide is an alkylating drug indicated for treatment of:
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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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ADVERSE REACTIONS
Adverse reactions reported most often include neutropenia, febrile
neutropenia, fever, alopecia, nausea, vomiting, and
diarrhea. (6.1)
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)
Limitations of Use: The safety and effectiveness for the treatment of
nephrotic syndrome in adults or other renal
disease has not been established.
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 cyclophosph