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Basic Drug Info
Drug Name:Cyclophosphamide
Manufacturer:Roxane Laboratories, Inc.
Other Info:

Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs, NIH Publication No.

83-2621.

For sale by the Superintendent of Documents, US Government Printing Office, Washington, DC 20402.AMA Council Report.

Guidelines for Handling Parenteral Antineoplastics.

JAMA 1985; March 15.National Study Commission on Cytotoxic Exposure - Recommendations for Handling Cytotoxic Agents.

Available from Louis P.

Jeffrey, ScD, Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Science, 179 Longwood Ave., Boston, Massachusetts 02115.Clinical Oncological Society of Australia: Guidelines and Recommendations for Safe Handling of Antineoplastic Agents.

Med J Australia 1983; 1:426-428.Jones RB, et al: Safe handling of chemotherapeutic agents: A report from the Mount Sinai Medical Center.

CA - A Cancer Journal for Clinicians 1983; (Sept/Oct) 258-263.American Society of Hospital Pharmacists Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs.

Am J Hosp Pharm 1990; 47:1033-1049.Controlling Occupational Exposure to Hazardous Drugs.

(OSHA WORK PRACTICE GUIDELINES).

Am J Health-Syst Pharm 1996; 53:1669-1685. 4047200//01April 2001Roxane Laboratories, Inc.Columbus, Ohio 43216© RLI, 2001



Clinical Trials:


Indications and Usage

Cyclophosphamide tablets, although effective alone in susceptible malignancies, are more frequently used concurrently or sequentially with other antineoplastic drugs.

The following malignancies are often susceptible to cyclophosphamide treatment:Malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin’s disease, lyphocytic 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 in children (cyclophosphamide 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.
Malignant Neoplasms -- A term for diseases in which abnormal cells divide without control. Cancer cells can invade nearby tissues and can spread through the bloodstream and lymphatic system to other parts of the body.

Lymphoma -- A general term for various neoplastic diseases of the lymphoid tissue.

Hodgkins Disease -- A malignant disease characterized by progressive enlargement of the lymph nodes, spleen, and general lymphoid tissue. In the classical variant, giant usually multinucleate Hodgkin's and REED-STERNBERG CELLS are present; in the nodular lymphocyte predominant variant, lymphocytic and histiocytic cells are seen.

Diffuse Mixed Cell Lymphoma -- An antiquated term referring to non-Hodgkin lymphomas with a mixed cellular composition. This term applies to both B- and T- cell non-Hodgkin lymphomas.

Diffuse Large B-Cell Lymphoma -- Malignant lymphoma composed of large B lymphoid cells whose nuclear size can exceed normal macrophage nuclei, or more than twice the size of a normal lymphocyte. The pattern is predominantly diffuse. Most of these lymphomas represent the malignant counterpart of B-lymphocytes at midstage in the process of differentiation.

Reticulosarcoma -- rare type of nonHodgkin's lymphoma of intermediate to high malignancy, characterized by the presence of large tumor cells that resemble histiocytes morphologically but are considered to be of lymphoid origin.

Burkitt Lymphoma -- A form of undifferentiated malignant LYMPHOMA usually found in central Africa, but also reported in other parts of the world. It is commonly manifested as a large osteolytic lesion in the jaw or as an abdominal mass. B-cell antigens are expressed on the immature cells that make up the tumor in virtually all cases of Burkitt lymphoma. The Epstein-Barr virus (HERPESVIRUS 4, HUMAN) has been isolated from Burkitt lymphoma cases in Africa and it is implicated as the causative agent in these cases; however, most non-African cases are EBV-negative.

Multiple Myeloma -- A malignancy of mature PLASMA CELLS engaging in monoclonal immunoglobulin production. It is characterized by hyperglobulinemia, excess Bence-Jones proteins (free monoclonal IMMUNOGLOBULIN LIGHT CHAINS) in the urine, skeletal destruction, bone pain, and fractures. Other features include ANEMIA; HYPERCALCEMIA; and RENAL INSUFFICIENCY.

Myeloid Leukemia, Chronic -- chronic leukemia in which myeloid progenitor cells predominate; the hallmark of CML, the Philadelphia chromosome, is a reciprocal translocation between chromosomes 9 and 22 which activates the proto- oncogene c-abl.

Blast Phase -- An advanced phase of chronic myelogenous leukemia, characterized by a rapid increase in the proportion of immature white blood cells (blasts) in the blood and bone marrow to greater than 30%.

Stem Cell Leukemia -- A leukemia originating from a precursor bone marrow cell which is in an earlier developmental stage compared to lymphoblasts and myeloblasts. -- 2003

Central neuroblastoma --

Neuroblastoma -- A common neoplasm of early childhood arising from neural crest cells in the sympathetic nervous system, and characterized by diverse clinical behavior, ranging from spontaneous remission to rapid metastatic progression and death. This tumor is the most common intraabdominal malignancy of childhood, but it may also arise from thorax, neck, or rarely occur in the central nervous system. Histologic features include uniform round cells with hyperchromatic nuclei arranged in nests and separated by fibrovascular septa. Neuroblastomas may be associated with the opsoclonus-myoclonus syndrome. (From DeVita et al., Cancer: Principles and Practice of Oncology, 5th ed, pp2099-2101; Curr Opin Oncol 1998 Jan;10(1):43-51)

Adenocarcinoma -- A malignant epithelial tumor with a glandular organization.

Retinoblastoma -- A malignant tumor arising from the nuclear layer of the retina that is the most common primary tumor of the eye in children. The tumor tends to occur in early childhood or infancy and may be present at birth. The majority are sporadic, but the condition may be transmitted as an autosomal dominant trait. Histologic features include dense cellularity, small round polygonal cells, and areas of calcification and necrosis. An abnormal pupil reflex (leukokoria); NYSTAGMUS, PATHOLOGIC; STRABISMUS; and visual loss represent common clinical characteristics of this condition. (From DeVita et al., Cancer: Principles and Practice of Oncology, 5th ed, p2104)

Carcinoma -- A malignant neoplasm made up of epithelial cells tending to infiltrate the surrounding tissues and give rise to metastases. It is a histological type of neoplasm but is often wrongly used as a synonym for "cancer." (From Dorland, 27th ed)

Contraindications

Continued use of cyclophosphamide is contraindicated in patients with severely depressed bone marrow function.

Cyclophosphamide is contraindicated in patients who have demonstrated a previous hypersensitivity to it.

See WARNINGS and PRECAUTIONS sections.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

Second malignancies have developed in some patients treated with cyclophosphamide used alone or in association with other antineoplastic drugs and/or modalities.

Most frequently, they have been urinary bladder, myeloproliferative, or lymphoproliferative malignancies.

Second malignancies most frequently were detected in patients treated for primary myeloproliferative or lymphoproliferative malignancies or nonmalignant disease in which immune processes are believed to be involved pathologically.

In some cases, the second malignancy developed several years after cyclophosphamide treatment had been discontinued.

In a single breast cancer trial utilizing two to four times the standard dose of cyclophosphamide in conjunction with doxorubicin a small number of cases of secondary acute myeloid leukemia occurred within two years of treatment initiation.

Urinary bladder malignancies generally have occurred in patients who previously had hemorrhagic cystitis.

In patients treated with cyclophosphamide-containing regimens for a variety of solid tumors, isolated case reports of secondary malignancies have been published.

One case of carcinoma of the renal pelvis was reported in a patient receiving long-term cyclophosphamide therapy for cerebral vasculitis.

The possibility of cyclophosphamide-induced malignancy should be considered in any benefit-to-risk assessment for use of the drug.Cyclophosphamide can cause fetal harm when administered to a pregnant woman and such abnormalities have been reported following cyclophosphamide therapy in pregnant women.

Abnormalities were found in two infants and a six-month old fetus born to women treated with cyclophosphamide.

Ectrodactylia was found in two of the three cases.

Normal infants have also been born to women treated with cyclophosphamide during pregnancy, including the first trimester.

If this drug is used during pregnancy, or if the patient becomes pregnant while taking (receiving) this drug, the patient should be apprised of the potential hazard to the fetus.

Women of childbearing potential should be advised to avoid becoming pregnant.Cyclophosphamide interferes with oogenesis and spermatogenesis.

It may cause sterility in both sexes.

Development of sterility appears to depend on the dose of cyclophosphamide, duration of therapy, and the state of gonadal function at the time of treatment.

Cyclophosphamide-induced sterility may be irreversible in some patients.Amenorrhea associated with decreased estrogen and increased gonadotropin secretion develops in a significant proportion of women treated with cyclophosphamide.

Affected patients generally resume regular menses within a few months after cessation of therapy.

Girls treated with cyclophosphamide during prepubescence generally develop secondary sexual characteristics normally and have regular menses.

Ovarian fibrosis with apparently complete loss of germ cells after prolonged cyclophosphamide treatment in late prepubescence has been reported.

Girls treated with cyclophosphamide during prepubescence subsequently have conceived.Men treated with cyclophosphamide may develop oligospermia or azoospermia associated with increased gonadotropin but normal testosterone secretion.

Sexual potency and libido are unimpaired in these patients.

Boys treated with cyclophosphamide during prepubescence develop secondary sexual characteristics normally, but may have oligospermia or azoospermia and increased gonadotropin secretion.

Some degree of testicular atrophy may occur.

Cyclophosphamide-induced azoospermia is reversible in some patients, though the reversibility may not occur for several years after cessation of therapy.

Men temporarily rendered sterile by cyclophosphamide have subsequently fathered normal children.
Branded Drugs
The following US Branded drugs contain Cyclophosphamide


CYTOXAN -- BAXTER HEALTHCARE CORP

LYOPHILIZED CYTOXAN -- BAXTER HEALTHCARE CORP

NEOSAR -- TEVA PARENTERAL MEDICINES INC


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