Cyclophosphamide Injection

— THERAPEUTIC CATEGORIES —
  • Breast cancer
  • CNS cancers
  • Eye cancer
  • Gynecologic cancers
  • Leukemias, lymphomas, and other hematologic cancers

Cyclophosphamide Injection Generic Name & Formulations

General Description

Cyclophosphamide 500mg, 1g, 2g; per vial; pwd for inj after reconstitution; preservative-free.

Pharmacological Class

Alkylating agent.

See Also

How Supplied

Contact supplier

Mechanism of Action

Cyclophosphamide is biotransformed principally in the liver to active alkylating metabolites by a mixed function microsomal oxidase system. These metabolites interfere with the growth of susceptible rapidly proliferating malignant cells. The mechanism of action is thought to involve cross-linking of tumor cell DNA.

Cyclophosphamide Injection Indications

Indications

Carcinoma of the breast.

Cyclophosphamide Injection Dosage and Administration

Adult

Initially 40–50mg/kg IV in divided doses over 2–5 days; or 10–15mg/kg IV every 7–10 days; or 3–5mg/kg IV twice weekly.

Children

See full labeling.

Cyclophosphamide Injection Contraindications

Contraindications

Urinary outflow obstruction.

Cyclophosphamide Injection Boxed Warnings

Not Applicable

Cyclophosphamide Injection Warnings/Precautions

Warnings/Precautions

Risk for myelosuppression, immunosuppression, bone marrow failure, infections. Monitor CBCs during treatment. Do not initiate therapy if neutrophils ≤1,500/mm3 and platelets <50,000/mm3. Interrupt or reduce dose if serious infection occurs; consider using G-CSF to reduce risk. Increased risk for severe myelosuppression if pretreated with and/or receiving concomitant chemotherapy and/or radiation therapy. Exclude or correct any urinary tract obstructions prior to initiation; check urinary sediment regularly for signs of urotoxicity and/or nephrotoxicity. Active urinary tract infections. Monitor in patients with risk factors for cardiotoxicity and with pre-existing cardiac disease. Monitor for pulmonary toxicity. May interfere with wound healing. May contain alcohol. Severe renal or hepatic impairment: monitor. Elderly. Embryo-fetal toxicity. Advise to use effective contraception during and for up to 1 year (females of reproductive potential) and for 4 months (males w. female partners) after completion of therapy. Pregnancy. Nursing mothers: not recommended (during and for 1 week after the last dose).

Cyclophosphamide Injection Pharmacokinetics

Distribution

Volume of distribution: 30 to 50 L. Approximately 20% protein bound.

Metabolism

Hepatic (CYP2A6, CYP2B6, CYP3A4, CYP3A5, CYP2C9, CYP2C18, CYP2C19).

Elimination

Renal. Half-life: 3–12 hours. Total body clearance: 4 to 5.6 L/h.

Cyclophosphamide Injection Interactions

Interactions

Increased risk for hematotoxicity and/or immunosuppression with ACE inhibitors, natalizumab, paclitaxel, thiazide diuretics, zidovudine. Increased risk for cardiotoxicity with anthracyclines, cytarabine, pentostatin, radiation therapy of the cardiac region, trastuzumab. Increased risk for pulmonary toxicity with amiodarone, G-CSF, GM-CSF. Increased risk for nephrotoxicity with amphotericin B, indomethacin. Increased risk for hepatotoxicity with azathioprine. Increased risk for hepatic veno-occlusive disease and mucositis with busulfan. Increased risk for mucositis with protease inhibitors. Increased risk for hemorrhagic cystitis with radiation treatment. May affect warfarin. May antagonize cyclosporine. Potentiates depolarizing muscle relaxants (eg, succinylcholine). Potentiated by metronidazole.

Cyclophosphamide Injection Adverse Reactions

Adverse Reactions

Neutropenia, febrile neutropenia, fever, alopecia, nausea, vomiting, diarrhea; urinary tract and renal toxicity, cardiotoxicity, pulmonary toxicity, secondary malignancies (eg, urinary tract cancer, myelodysplasia, acute leukemias, lymphomas, thyroid cancer, sarcomas), veno-occlusive liver disease, infertility, hyponatremia.

Cyclophosphamide Injection Clinical Trials

See Literature

Cyclophosphamide Injection Note

Notes

Formerly known under the brand name Cytoxan.

Cyclophosphamide Injection Patient Counseling

See Literature

Cyclophosphamide Injection Generic Name & Formulations

General Description

Cyclophosphamide 500mg, 1g, 2g; per vial; pwd for inj after reconstitution; preservative-free.

Pharmacological Class

Alkylating agent.

See Also

How Supplied

Contact supplier

Mechanism of Action

Cyclophosphamide is biotransformed principally in the liver to active alkylating metabolites by a mixed function microsomal oxidase system. These metabolites interfere with the growth of susceptible rapidly proliferating malignant cells. The mechanism of action is thought to involve cross-linking of tumor cell DNA.

Cyclophosphamide Injection Indications

Indications

Neuroblastoma (disseminated disease).

Cyclophosphamide Injection Dosage and Administration

Adult

Initially 40–50mg/kg IV in divided doses over 2–5 days; or 10–15mg/kg IV every 7–10 days; or 3–5mg/kg IV twice weekly.

Children

See full labeling.

Cyclophosphamide Injection Contraindications

Contraindications

Urinary outflow obstruction.

Cyclophosphamide Injection Boxed Warnings

Not Applicable

Cyclophosphamide Injection Warnings/Precautions

Warnings/Precautions

Risk for myelosuppression, immunosuppression, bone marrow failure, infections. Monitor CBCs during treatment. Do not initiate therapy if neutrophils ≤1,500/mm3 and platelets <50,000/mm3. Interrupt or reduce dose if serious infection occurs; consider using G-CSF to reduce risk. Increased risk for severe myelosuppression if pretreated with and/or receiving concomitant chemotherapy and/or radiation therapy. Exclude or correct any urinary tract obstructions prior to initiation; check urinary sediment regularly for signs of urotoxicity and/or nephrotoxicity. Active urinary tract infections. Monitor in patients with risk factors for cardiotoxicity and with pre-existing cardiac disease. Monitor for pulmonary toxicity. May interfere with wound healing. May contain alcohol. Severe renal or hepatic impairment: monitor. Elderly. Embryo-fetal toxicity. Advise to use effective contraception during and for up to 1 year (females of reproductive potential) and for 4 months (males w. female partners) after completion of therapy. Pregnancy. Nursing mothers: not recommended (during and for 1 week after the last dose).

Cyclophosphamide Injection Pharmacokinetics

Distribution

Volume of distribution: 30 to 50 L. Approximately 20% protein bound.

Metabolism

Hepatic (CYP2A6, CYP2B6, CYP3A4, CYP3A5, CYP2C9, CYP2C18, CYP2C19).

Elimination

Renal. Half-life: 3–12 hours. Total body clearance: 4 to 5.6 L/h.

Cyclophosphamide Injection Interactions

Interactions

Increased risk for hematotoxicity and/or immunosuppression with ACE inhibitors, natalizumab, paclitaxel, thiazide diuretics, zidovudine. Increased risk for cardiotoxicity with anthracyclines, cytarabine, pentostatin, radiation therapy of the cardiac region, trastuzumab. Increased risk for pulmonary toxicity with amiodarone, G-CSF, GM-CSF. Increased risk for nephrotoxicity with amphotericin B, indomethacin. Increased risk for hepatotoxicity with azathioprine. Increased risk for hepatic veno-occlusive disease and mucositis with busulfan. Increased risk for mucositis with protease inhibitors. Increased risk for hemorrhagic cystitis with radiation treatment. May affect warfarin. May antagonize cyclosporine. Potentiates depolarizing muscle relaxants (eg, succinylcholine). Potentiated by metronidazole.

Cyclophosphamide Injection Adverse Reactions

Adverse Reactions

Neutropenia, febrile neutropenia, fever, alopecia, nausea, vomiting, diarrhea; urinary tract and renal toxicity, cardiotoxicity, pulmonary toxicity, secondary malignancies (eg, urinary tract cancer, myelodysplasia, acute leukemias, lymphomas, thyroid cancer, sarcomas), veno-occlusive liver disease, infertility, hyponatremia.

Cyclophosphamide Injection Clinical Trials

See Literature

Cyclophosphamide Injection Note

Notes

Formerly known under the brand name Cytoxan.

Cyclophosphamide Injection Patient Counseling

See Literature

Cyclophosphamide Injection Generic Name & Formulations

General Description

Cyclophosphamide 500mg, 1g, 2g; per vial; pwd for inj after reconstitution; preservative-free.

Pharmacological Class

Alkylating agent.

See Also

How Supplied

Contact supplier

Mechanism of Action

Cyclophosphamide is biotransformed principally in the liver to active alkylating metabolites by a mixed function microsomal oxidase system. These metabolites interfere with the growth of susceptible rapidly proliferating malignant cells. The mechanism of action is thought to involve cross-linking of tumor cell DNA.

Cyclophosphamide Injection Indications

Indications

Retinoblastoma.

Cyclophosphamide Injection Dosage and Administration

Adult

Initially 40–50mg/kg IV in divided doses over 2–5 days; or 10–15mg/kg IV every 7–10 days; or 3–5mg/kg IV twice weekly.

Children

See full labeling.

Cyclophosphamide Injection Contraindications

Contraindications

Urinary outflow obstruction.

Cyclophosphamide Injection Boxed Warnings

Not Applicable

Cyclophosphamide Injection Warnings/Precautions

Warnings/Precautions

Risk for myelosuppression, immunosuppression, bone marrow failure, infections. Monitor CBCs during treatment. Do not initiate therapy if neutrophils ≤1,500/mm3 and platelets <50,000/mm3. Interrupt or reduce dose if serious infection occurs; consider using G-CSF to reduce risk. Increased risk for severe myelosuppression if pretreated with and/or receiving concomitant chemotherapy and/or radiation therapy. Exclude or correct any urinary tract obstructions prior to initiation; check urinary sediment regularly for signs of urotoxicity and/or nephrotoxicity. Active urinary tract infections. Monitor in patients with risk factors for cardiotoxicity and with pre-existing cardiac disease. Monitor for pulmonary toxicity. May interfere with wound healing. May contain alcohol. Severe renal or hepatic impairment: monitor. Elderly. Embryo-fetal toxicity. Advise to use effective contraception during and for up to 1 year (females of reproductive potential) and for 4 months (males w. female partners) after completion of therapy. Pregnancy. Nursing mothers: not recommended (during and for 1 week after the last dose).

Cyclophosphamide Injection Pharmacokinetics

Distribution

Volume of distribution: 30 to 50 L. Approximately 20% protein bound.

Metabolism

Hepatic (CYP2A6, CYP2B6, CYP3A4, CYP3A5, CYP2C9, CYP2C18, CYP2C19).

Elimination

Renal. Half-life: 3–12 hours. Total body clearance: 4 to 5.6 L/h.

Cyclophosphamide Injection Interactions

Interactions

Increased risk for hematotoxicity and/or immunosuppression with ACE inhibitors, natalizumab, paclitaxel, thiazide diuretics, zidovudine. Increased risk for cardiotoxicity with anthracyclines, cytarabine, pentostatin, radiation therapy of the cardiac region, trastuzumab. Increased risk for pulmonary toxicity with amiodarone, G-CSF, GM-CSF. Increased risk for nephrotoxicity with amphotericin B, indomethacin. Increased risk for hepatotoxicity with azathioprine. Increased risk for hepatic veno-occlusive disease and mucositis with busulfan. Increased risk for mucositis with protease inhibitors. Increased risk for hemorrhagic cystitis with radiation treatment. May affect warfarin. May antagonize cyclosporine. Potentiates depolarizing muscle relaxants (eg, succinylcholine). Potentiated by metronidazole.

Cyclophosphamide Injection Adverse Reactions

Adverse Reactions

Neutropenia, febrile neutropenia, fever, alopecia, nausea, vomiting, diarrhea; urinary tract and renal toxicity, cardiotoxicity, pulmonary toxicity, secondary malignancies (eg, urinary tract cancer, myelodysplasia, acute leukemias, lymphomas, thyroid cancer, sarcomas), veno-occlusive liver disease, infertility, hyponatremia.

Cyclophosphamide Injection Clinical Trials

See Literature

Cyclophosphamide Injection Note

Notes

Formerly known under the brand name Cytoxan.

Cyclophosphamide Injection Patient Counseling

See Literature

Cyclophosphamide Injection Generic Name & Formulations

General Description

Cyclophosphamide 500mg, 1g, 2g; per vial; pwd for inj after reconstitution; preservative-free.

Pharmacological Class

Alkylating agent.

See Also

How Supplied

Contact supplier

Mechanism of Action

Cyclophosphamide is biotransformed principally in the liver to active alkylating metabolites by a mixed function microsomal oxidase system. These metabolites interfere with the growth of susceptible rapidly proliferating malignant cells. The mechanism of action is thought to involve cross-linking of tumor cell DNA.

Cyclophosphamide Injection Indications

Indications

Adenocarcinoma of the ovary.

Cyclophosphamide Injection Dosage and Administration

Adult

Initially 40–50mg/kg IV in divided doses over 2–5 days; or 10–15mg/kg IV every 7–10 days; or 3–5mg/kg IV twice weekly.

Children

See full labeling.

Cyclophosphamide Injection Contraindications

Contraindications

Urinary outflow obstruction.

Cyclophosphamide Injection Boxed Warnings

Not Applicable

Cyclophosphamide Injection Warnings/Precautions

Warnings/Precautions

Risk for myelosuppression, immunosuppression, bone marrow failure, infections. Monitor CBCs during treatment. Do not initiate therapy if neutrophils ≤1,500/mm3 and platelets <50,000/mm3. Interrupt or reduce dose if serious infection occurs; consider using G-CSF to reduce risk. Increased risk for severe myelosuppression if pretreated with and/or receiving concomitant chemotherapy and/or radiation therapy. Exclude or correct any urinary tract obstructions prior to initiation; check urinary sediment regularly for signs of urotoxicity and/or nephrotoxicity. Active urinary tract infections. Monitor in patients with risk factors for cardiotoxicity and with pre-existing cardiac disease. Monitor for pulmonary toxicity. May interfere with wound healing. May contain alcohol. Severe renal or hepatic impairment: monitor. Elderly. Embryo-fetal toxicity. Advise to use effective contraception during and for up to 1 year (females of reproductive potential) and for 4 months (males w. female partners) after completion of therapy. Pregnancy. Nursing mothers: not recommended (during and for 1 week after the last dose).

Cyclophosphamide Injection Pharmacokinetics

Distribution

Volume of distribution: 30 to 50 L. Approximately 20% protein bound.

Metabolism

Hepatic (CYP2A6, CYP2B6, CYP3A4, CYP3A5, CYP2C9, CYP2C18, CYP2C19).

Elimination

Renal. Half-life: 3–12 hours. Total body clearance: 4 to 5.6 L/h.

Cyclophosphamide Injection Interactions

Interactions

Increased risk for hematotoxicity and/or immunosuppression with ACE inhibitors, natalizumab, paclitaxel, thiazide diuretics, zidovudine. Increased risk for cardiotoxicity with anthracyclines, cytarabine, pentostatin, radiation therapy of the cardiac region, trastuzumab. Increased risk for pulmonary toxicity with amiodarone, G-CSF, GM-CSF. Increased risk for nephrotoxicity with amphotericin B, indomethacin. Increased risk for hepatotoxicity with azathioprine. Increased risk for hepatic veno-occlusive disease and mucositis with busulfan. Increased risk for mucositis with protease inhibitors. Increased risk for hemorrhagic cystitis with radiation treatment. May affect warfarin. May antagonize cyclosporine. Potentiates depolarizing muscle relaxants (eg, succinylcholine). Potentiated by metronidazole.

Cyclophosphamide Injection Adverse Reactions

Adverse Reactions

Neutropenia, febrile neutropenia, fever, alopecia, nausea, vomiting, diarrhea; urinary tract and renal toxicity, cardiotoxicity, pulmonary toxicity, secondary malignancies (eg, urinary tract cancer, myelodysplasia, acute leukemias, lymphomas, thyroid cancer, sarcomas), veno-occlusive liver disease, infertility, hyponatremia.

Cyclophosphamide Injection Clinical Trials

See Literature

Cyclophosphamide Injection Note

Notes

Formerly known under the brand name Cytoxan.

Cyclophosphamide Injection Patient Counseling

See Literature

Cyclophosphamide Injection Generic Name & Formulations

General Description

Cyclophosphamide 500mg, 1g, 2g; per vial; pwd for inj after reconstitution; preservative-free.

Pharmacological Class

Alkylating agent.

See Also

How Supplied

Contact supplier

Mechanism of Action

Cyclophosphamide is biotransformed principally in the liver to active alkylating metabolites by a mixed function microsomal oxidase system. These metabolites interfere with the growth of susceptible rapidly proliferating malignant cells. The mechanism of action is thought to involve cross-linking of tumor cell DNA.

Cyclophosphamide Injection Indications

Indications

Malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin's disease, lymphocytic 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).

Cyclophosphamide Injection Dosage and Administration

Adult

Initially 40–50mg/kg IV in divided doses over 2–5 days; or 10–15mg/kg IV every 7–10 days; or 3–5mg/kg IV twice weekly.

Children

See full labeling.

Cyclophosphamide Injection Contraindications

Contraindications

Urinary outflow obstruction.

Cyclophosphamide Injection Boxed Warnings

Not Applicable

Cyclophosphamide Injection Warnings/Precautions

Warnings/Precautions

Risk for myelosuppression, immunosuppression, bone marrow failure, infections. Monitor CBCs during treatment. Do not initiate therapy if neutrophils ≤1,500/mm3 and platelets <50,000/mm3. Interrupt or reduce dose if serious infection occurs; consider using G-CSF to reduce risk. Increased risk for severe myelosuppression if pretreated with and/or receiving concomitant chemotherapy and/or radiation therapy. Exclude or correct any urinary tract obstructions prior to initiation; check urinary sediment regularly for signs of urotoxicity and/or nephrotoxicity. Active urinary tract infections. Monitor in patients with risk factors for cardiotoxicity and with pre-existing cardiac disease. Monitor for pulmonary toxicity. May interfere with wound healing. May contain alcohol. Severe renal or hepatic impairment: monitor. Elderly. Embryo-fetal toxicity. Advise to use effective contraception during and for up to 1 year (females of reproductive potential) and for 4 months (males w. female partners) after completion of therapy. Pregnancy. Nursing mothers: not recommended (during and for 1 week after the last dose).

Cyclophosphamide Injection Pharmacokinetics

Distribution

Volume of distribution: 30 to 50 L. Approximately 20% protein bound.

Metabolism

Hepatic (CYP2A6, CYP2B6, CYP3A4, CYP3A5, CYP2C9, CYP2C18, CYP2C19).

Elimination

Renal. Half-life: 3–12 hours. Total body clearance: 4 to 5.6 L/h.

Cyclophosphamide Injection Interactions

Interactions

Increased risk for hematotoxicity and/or immunosuppression with ACE inhibitors, natalizumab, paclitaxel, thiazide diuretics, zidovudine. Increased risk for cardiotoxicity with anthracyclines, cytarabine, pentostatin, radiation therapy of the cardiac region, trastuzumab. Increased risk for pulmonary toxicity with amiodarone, G-CSF, GM-CSF. Increased risk for nephrotoxicity with amphotericin B, indomethacin. Increased risk for hepatotoxicity with azathioprine. Increased risk for hepatic veno-occlusive disease and mucositis with busulfan. Increased risk for mucositis with protease inhibitors. Increased risk for hemorrhagic cystitis with radiation treatment. May affect warfarin. May antagonize cyclosporine. Potentiates depolarizing muscle relaxants (eg, succinylcholine). Potentiated by metronidazole.

Cyclophosphamide Injection Adverse Reactions

Adverse Reactions

Neutropenia, febrile neutropenia, fever, alopecia, nausea, vomiting, diarrhea; urinary tract and renal toxicity, cardiotoxicity, pulmonary toxicity, secondary malignancies (eg, urinary tract cancer, myelodysplasia, acute leukemias, lymphomas, thyroid cancer, sarcomas), veno-occlusive liver disease, infertility, hyponatremia.

Cyclophosphamide Injection Clinical Trials

See Literature

Cyclophosphamide Injection Note

Notes

Formerly known under the brand name Cytoxan.

Cyclophosphamide Injection Patient Counseling

See Literature