Cyclophosphamide

Cyclophosphamide
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

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Overview

Cyclophosphamide is a antineoplastic, immunosuppressive agent that is FDA approved for the treatment of malignant diseases, minimal change nephrotic syndrome in pediatric patients. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Acute myeloid leukemia

• Dosing Information

• Single agent: 40 to 50 mg/kg IV in divided doses over 2 to 5 days OR 10 to 15 mg/kg IV every 7 to 10 days OR 3 to 5 mg/kg IV twice weekly.
• Single agent: oral cyclophosphamide is usually administered at dosages in the range of 1 to 5 mg/kg/day for both initial and maintenance dosing.

Breast cancer

• Dosing Information

• Single agent: 40 to 50 mg/kg IV in divided doses over 2 to 5 days OR 10 to 15 mg/kg IV every 7 to 10 days OR 3 to 5 mg/kg IV twice weekly.
• Single agent: 1 to 5 mg/kg/day ORALLY, for both initial and maintenance dosing.

Burkitt's lymphoma

• Dosing Information

• Single agent: 40 to 50 mg/kg IV in divided doses over 2 to 5 days OR 10 to 15 mg/kg IV every 7 to 10 days OR 3 to 5 mg/kg IV twice weekly.
• Single agent: oral cyclophosphamide is usually administered at dosages in the range of 1 to 5 mg/kg/day for both initial and maintenance dosing.

Chronic lymphoid leukemia

• Dosing Information

• Chronic lymphoid leukemia: (single agent) 40 to 50 mg/kg IV in divided doses over 2 to 5 days OR 10 to 15 mg/kg IV every 7 to 10 days OR 3 to 5 mg/kg IV twice weekly.

• Chronic lymphoid leukemia: (single agent) oral cyclophosphamide is usually administered at dosages in the range of 1 to 5 mg/kg/day for both initial and maintenance dosing.

Chronic myeloid leukemia

• Dosing Information

• Chronic myeloid leukemia: (single agent) 40 to 50 mg/kg IV in divided doses over 2 to 5 days OR 10 to 15 mg/kg IV every 7 to 10 days OR 3 to 5 mg/kg IV twice weekly.

• Chronic myeloid leukemia: (single agent) oral cyclophosphamide is usually administered at dosages in the range of 1 to 5 mg/kg/day for both initial and maintenance dosing.

Hodgkin's disease, Stages III and IV (Ann Arbor staging system)

• Dosing Information

• Hodgkin's disease, Stages III and IV (Ann Arbor staging system): (single agent) 40 to 50 mg/kg IV in divided doses over 2 to 5 days OR 10 to 15 mg/kg IV every 7 to 10 days OR 3 to 5 mg/kg IV twice weekly.
• Hodgkin's disease, Stages III and IV (Ann Arbor staging system): (single agent) oral cyclophosphamide is usually administered at dosages in the range of 1 to 5 mg/kg/day for both initial and maintenance dosing.

Malignant histiocytosis (clinical)

• Dosing Information

• Malignant histiocytosis (clinical): (single agent) 40 to 50 mg/kg IV in divided doses over 2 to 5 days OR 10 to 15 mg/kg IV every 7 to 10 days OR 3 to 5 mg/kg IV twice weekly.
• Malignant histiocytosis (clinical): (single agent) oral cyclophosphamide is usually administered at dosages in the range of 1 to 5 mg/kg/day for both initial and maintenance dosing.

Malignant lymphoma - mixed small and large cell

• Dosing Information

• Malignant lymphoma - mixed small and large cell: (single agent) 40 to 50 mg/kg IV in divided doses over 2 to 5 days OR 10 to 15 mg/kg IV every 7 to 10 days OR 3 to 5 mg/kg IV twice weekly.
• Malignant lymphoma - mixed small and large cell: (single agent) oral cyclophosphamide is usually administered at dosages in the range of 1 to 5 mg/kg/day for both initial and maintenance dosing.

Malignant lymphoma - small lymphocytic, Nodular or diffuse

• Dosing Information

• Malignant lymphoma - small lymphocytic, Nodular or diffuse: (single agent) 40 to 50 mg/kg IV in divided doses over 2 to 5 days OR 10 to 15 mg/kg IV every 7 to 10 days OR 3 to 5 mg/kg IV twice weekly.
• Malignant lymphoma - small lymphocytic, Nodular or diffuse: (single agent) oral cyclophosphamide is usually administered at dosages in the range of 1 to 5 mg/kg/day for both initial and maintenance dosing.

Mantle cell lymphoma, Stages III and IV (Ann Arbor staging system)

• Dosing Information

• Mantle cell lymphoma, Stages III and IV (Ann Arbor staging system): (single agent) 40 to 50 mg/kg IV in divided doses over 2 to 5 days OR 10 to 15 mg/kg IV every 7 to 10 days OR 3 to 5 mg/kg IV twice weekly.
• Mantle cell lymphoma, Stages III and IV (Ann Arbor staging system): (single agent) oral cyclophosphamide is usually administered at dosages in the range of 1 to 5 mg/kg/day for both initial and maintenance dosing.

Multiple myeloma

• Dosing Information

• Multiple myeloma: (single agent) 40 to 50 mg/kg IV in divided doses over 2 to 5 days OR 10 to 15 mg/kg IV every 7 to 10 days OR 3 to 5 mg/kg IV twice weekly.
• Multiple myeloma: (single agent) oral cyclophosphamide is usually administered at dosages in the range of 1 to 5 mg/kg/day for both initial and maintenance dosing.

Mycosis fungoides, Advanced

• Dosing Information

• Mycosis fungoides, Advanced: (single agent) 40 to 50 mg/kg IV in divided doses over 2 to 5 days OR 10 to 15 mg/kg IV every 7 to 10 days OR 3 to 5 mg/kg IV twice weekly.
• Mycosis fungoides, Advanced: (single agent) oral cyclophosphamide is usually administered at dosages in the range of 1 to 5 mg/kg/day for both initial and maintenance dosing.

Neuroblastoma, Disseminated disease

• Dosing Information

• Neuroblastoma, Disseminated disease: (single agent) 40 to 50 mg/kg IV in divided doses over 2 to 5 days OR 10 to 15 mg/kg IV every 7 to 10 days OR 3 to 5 mg/kg IV twice weekly.
• Neuroblastoma, Disseminated disease: (single agent) oral cyclophosphamide is usually administered at dosages in the range of 1 to 5 mg/kg/day for both initial and maintenance dosing.

Non-Hodgkin's lymphoma

• Dosing Information

• Non-Hodgkin's lymphoma: (single agent) 40 to 50 mg/kg IV in divided doses over 2 to 5 days OR 10 to 15 mg/kg IV every 7 to 10 days OR 3 to 5 mg/kg IV twice weekly.
• Non-Hodgkin's lymphoma: (single agent) oral cyclophosphamide is usually administered at dosages in the range of 1 to 5 mg/kg/day for both initial and maintenance dosing.

Ovarian carcinoma

• Dosing Information

• Ovarian carcinoma: (single agent) 40 to 50 mg/kg IV in divided doses over 2 to 5 days OR 10 to 15 mg/kg IV every 7 to 10 days OR 3 to 5 mg/kg IV twice weekly.
• Ovarian carcinoma: (single agent) oral cyclophosphamide is usually administered at dosages in the range of 1 to 5 mg/kg/day for both initial and maintenance dosing.

Retinoblastoma

• Dosing Information

• Retinoblastoma: (single agent) 40 to 50 mg/kg IV in divided doses over 2 to 5 days OR 10 to 15 mg/kg IV every 7 to 10 days OR 3 to 5 mg/kg IV twice weekly.
• Retinoblastoma: (single agent) oral cyclophosphamide is usually administered at dosages in the range of 1 to 5 mg/kg/day for both initial and maintenance dosing.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Cyclophosphamide in adult patients.

Non–Guideline-Supported Use

Bone marrow transplant

• Dosing Information

• Dosage

Breast cancer

Pheochromocytoma, Malignant

Wegener's granulomatosis

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Acute lymphoid leukemia

• Dosing Information

• Dosage

Acute myeloid leukemia

Burkitt's lymphoma

Chronic lymphoid leukemia

Chronic myeloid leukemia

Hodgkin's disease, Stages III and IV (Ann Arbor staging system)

Malignant histiocytosis (clinical)

Malignant lymphoma - mixed small and large cell

Malignant lymphoma - small lymphocytic, Nodular or diffuse

Mantle cell lymphoma, Stages III and IV (Ann Arbor staging system)

Minimal change disease, In patients who fail to respond to or are unable to tolerate adrenocorticosteroid therapy

• Dosing Information

• Dosage

Multiple myeloma

Mycosis fungoides, Advanced

Neuroblastoma, Disseminated disease

Non-Hodgkin's lymphoma

Ovarian carcinoma

Retinoblastoma

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Cyclophosphamide in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Cyclophosphamide in pediatric patients.

Contraindications

• Condition1

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Cyclophosphamide in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Cyclophosphamide in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cyclophosphamide in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Cyclophosphamide during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Cyclophosphamide with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Cyclophosphamide with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Cyclophosphamide with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Cyclophosphamide with respect to specific gender populations.

Race

There is no FDA guidance on the use of Cyclophosphamide with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Cyclophosphamide in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Cyclophosphamide in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Cyclophosphamide in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Cyclophosphamide in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Cyclophosphamide in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Cyclophosphamide in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Cyclophosphamide in the drug label.

Pharmacology

There is limited information regarding Cyclophosphamide Pharmacology in the drug label.

Mechanism of Action

Structure

File:Cyclophosphamide01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Cyclophosphamide in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Cyclophosphamide in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Cyclophosphamide in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Cyclophosphamide in the drug label.

How Supplied

Storage

There is limited information regarding Cyclophosphamide Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Cyclophosphamide in the drug label.

Precautions with Alcohol

• Alcohol-Cyclophosphamide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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