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Cyclophosphamide injection

Updated 2 Feb 2023 | Alkylating agents


Injection containing cyclophosphamide

Drugs List

  • cyclophosphamide 1g powder for solution for injection
  • cyclophosphamide 2g powder for solution for injection
  • cyclophosphamide 500mg powder for solution for injection
  • Therapeutic Indications


    Autoimmune disease
    Immunomodulatory effect in bone marrow transplantation
    Malignant neoplasms

    Cyclophosphamide may be used as a single agent or in combination with other cytotoxic drugs for the treatment of:
    Chronic lymphocytic leukaemia (CLL).
    Acute lymphocytic leukaemia (ALL).
    As conditioning for a bone marrow transplantation, in the treatment of acute lymphoblastic leukaemia, chronic myelogenous leukaemia and acute myelogenous leukaemia, in combination with whole body irritation or busulfan.
    Hodgkin's lymphoma, non-Hodgkin's lymphoma and multiple myeloma.
    Metastatic ovarian and breast carcinoma.
    Ewing's sarcoma.
    Small cell lung cancer.
    Advanced or metastatic neuroblastoma.
    Life-threatening autoimmune diseases such as severe progressive forms of lupus nephritis and Wegener's granulomatosis.

    Unlicensed Uses

    Idiopathic thrombocytopenic purpura
    Nephrotic syndrome - steroid sensitive
    Severe systemic rheumatoid arthritis

    Treatment of severe systemic rheumatoid arthritis and other connective tissue diseases.
    Treatment of steroid sensitive nephrotic syndrome in children.
    Treatment of idiopathic thrombocytopenic purpura (ITP).


    Due to the complexity and specialist nature of dosage regimens for the treatment of malignant disease, specific dosing information on this agent is not included.
    Doses may vary significantly if this agent is used as monotherapy or different combinations.
    When using this agent, specialist literature, national guidelines, cancer network protocols and Trust chemotherapy protocols should be consulted.


    One manufacturer suggests the following doses for the following indications:

    Bone marrow transplantation 2 days 60mg/kg or 4 days 50mg/kg body weight injected intravenously. If a busulfan-cyclophosphamide (Bu/Cy) regimen is applied, the first dose of cyclophosphamide must be administered at least 24 hours after the last dose of busulfan. Autoimmune diseases 500 to 1000mg/square metre of body surface area per month.

    Severe systemic rheumatoid arthritis (unlicensed)
    500mg to 1000mg initially at fortnightly intervals and then at monthly intervals, according to clinical response and haematological toxicity.


    The manufacturers do not suggest specific advice for cyclophosphamide use in children.
    Local protocols should be consulted.

    Steroid sensitive nephrotic syndrome (unlicensed):
    Children aged 3 months to 18 years
    500 mg/square metre by intravenous infusion once a month for 6 months.

    Patients with Renal Impairment

    Dose adjustment according to the renal drug handbook:
    GFR greater that 20 ml/minute: Dose as normal.
    GFR 10 to 20 ml/minute: 75 to 100% of the normal dose.
    GFR less than 10 ml/minute: 50 to 100% of the normal dose.

    Patients requiring dialysis should have a consistent interval between cyclophosphamide administration and dialysis as cyclophosphamide is highly dialysable.

    Patients with Hepatic Impairment

    The dose must be reduced in patients with severe hepatic impairment.
    Serum bilirubin concentrations of 3.1 to 5 mg/100 ml (0.053 to 0.086 mmol/l): Dose reduction of 25%.

    Additional Dosage Information

    Dose modification due to myelosuppression
    Leukocyte count between 2.5 x 10 to the power 9/L and 4 x 10 to the power 9/L and/ or platelet count between 50 x 10 to the power 9/L and 100 x 10 to the power 9/L
    Dose reduction of 50% of the planned dose.

    Leukocyte count below 2.5 x 10 to the power 9/L and platelet count below 50 x 10 to the power 9/L
    Interrupt treatment until values normalise.


    For intravenous injection or infusion.

    To be administered very slowly. Infusions should range from 30 minutes to 2 hours depending on volume and carrier fluid.

    Some products are also licensed for oral administration.


    Bone marrow aplasia
    Haemorrhagic cystitis
    Urinary obstruction
    Urinary tract infection

    Precautions and Warnings

    Concurrent radiotherapy
    Leucocyte count below 2.5 x 10 to the power of 9 / L
    Platelet count below 50 x 10 to the power of 9 / L
    Recent radiotherapy
    Recent surgery
    Adrenal insufficiency
    Cardiac disorder
    Diabetes mellitus
    Severe hepatic impairment
    Severe renal impairment

    Advise ability to drive/operate machinery may be affected by side effects
    Give pre-treatment counselling and consideration of oocyte cryopreservation
    Give pre-treatment counselling and consideration of sperm cryopreservation
    Maintain adequate hydration of patient prior / during treatment
    Not all available brands are licensed for all routes of administration
    Prophylactic G-CSF should be considered
    Treatment to be initiated and supervised by a specialist
    Consult local policy on the safe use of anti-cancer drugs
    Staff: Not to be handled by breastfeeding staff
    Staff: Not to be handled by pregnant staff
    Perform urine analysis before and after each course of treatment
    Monitor closely patient at risk of cardiovascular disorders
    Monitor patient for signs of haematuria throughout treatment
    Monitor platelets and leucocytes frequently
    Monitor urine output
    Advise patient to report any new or worsening respiratory symptoms
    Advise patient to report signs or symptoms of cystitis
    Advise patient to report symptoms of infection immediately
    Advise patient to report unexplained fever, sore throat, bruising, bleeding
    Antimicrobial prophylaxis recommended if severe neutropenia occurs
    Consider hepatic veno-occlusive disease if hepatic impairment occurs
    Consider the use of anti-emetics before and during therapy
    Treatment may adversely affect wound healing
    Discontinue if severe haemorrhagic cystitis occurs
    Interrupt treatment if platelet count <50 x 10 to the power of 9/L
    Reduce dose if leukocyte count less than 4 x 10 to the power 9/L
    Reduce dose if platelet count below 100 X 10 to power 9/L
    Suspend treatment if leukocyte count less than 2.5 x 10 to the power 9/L
    Advise patient to avoid alcohol during treatment
    Male & female: May cause infertility
    Female: Contraception required during and for 1 year after treatment
    Male: Contraception required during and for 6 months after treatment

    Cyclophosphamide should be given early in the day and the bladder voided frequently. The patient should be well hydrated and maintained in fluid balance. Urotoxic effects may be reduced with concurrent administration of mesna.

    Urinary sediment should be checked regularly for the presence of erythrocytes.

    Use of haematopoiesis stimulating agents (colony stimulating factors and erythropoiesis stimulating agents) may be considered to reduce the risk of myelosuppressive complications and/or help facilitate the delivery of the intended dosing.

    Patients with adrenal insufficiency may require an increase in corticoid substitution dose when exposed to stress from toxicity due to cytostatics, including cyclophosphamide.

    Cyclophosphamide should not be administered to patients who had a surgery less than 10 days ago.

    In some patients, alcohol may increase cyclophosphamide-induced vomiting and nausea.

    When the leukocyte count drops below 3000 cells per microlitre, more frequent monitoring may be required in addition to the dose adjustment.
    The nadirs of the reduction in leukocyte count and thrombocyte count are usually reached in weeks 1 and 2 of treatment. The bone marrow recovers relatively quickly, and the levels of peripheral blood cell counts normalize, as a rule, after approximately 20 days.

    Cases of veno-occlusive liver disease have been reported in patients receiving cyclophosphamide, ensuring a time interval of at least 24 hours between the last busulfan dose and the first cyclophosphamide reduces the risk.

    Cases of pulmonary toxicity including fatal cases have been observed in patients receiving cyclophosphamide. Pneumonitis may develop even years after treatment.

    Pregnancy and Lactation


    Cyclophosphamide is contraindicated in pregnancy.

    There are very limited data from the use of cyclophosphamide in pregnant women. There are reports of serious multiple congenital aberrations after use during the first trimester. Animal studies have shown teratogenicity and other reproduction toxicity. Considering the data from human case reports, animal studies and the mechanism of action of cyclophosphamide, its use during pregnancy, in particular during the first trimester, is not recommended.

    The effect of concurrent therapies must also be considered.
    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Cyclophosphamide is contraindicated in breastfeeding.

    Cyclophosphamide passes into breast milk in large quantities. Most sources consider breastfeeding to be contraindicated during maternal antineoplastic drug therapy, especially alkylating agents such as cyclophosphamide. Neutropenia has been reported in 2 infants whose mothers breastfed them while receiving cyclophosphamide. Chemotherapy may adversely affect the normal microbiome and chemical makeup of breast milk.

    The effect of concurrent therapies must also be considered.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Bladder contracture
    Bladder fibrosis
    Cardiac failure
    Cardiac tamponade
    Change in carbohydrate metabolism
    Creatine phosphokinase increased
    Depression of the reticulo-endothelial system
    ECG changes
    Febrile neutropenia
    Fluid retention
    Haemolytic uraemic syndrome
    Haemorrhagic cystitis
    Hepatic impairment
    Inappropriate secretion of antidiuretic hormone
    Increase in AST level
    Increase in lactate dehydrogenase
    Increase in mean corpuscular volume (MCV)
    Intravascular coagulation (disseminated)
    Myelodysplastic syndrome
    Pericardial effusion
    Pigmentation of nails
    Pulmonary fibrosis
    Pulmonary toxicity
    Renal impairment
    Renal tubular necrosis
    Skin pigmentation changes
    Supraventricular arrhythmias
    Ulceration of mucous membrane
    Veno-occlusive disease
    Ventricular arrhythmias
    Water intoxication


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: August 2015

    Reference Sources

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Martindale: The Complete Drug Reference (online) London: Brayfield A (ed). Pharmaceutical Press. Accessed on 17 August 2015.

    Summary of Product Characteristics: Cyclophosphamide injection 1g. Baxter Healthcare Ltd. Revised December 2014.

    Summary of Product Characteristics: Cyclophosphamide injection 500mg. Baxter Healthcare Ltd. Revised December 2014.

    Summary of Product Characteristics: Cyclophosphamide injection 1g. Sandoz Limited. Revised August 2014.

    Summary of Product Characteristics: Cyclophosphamide injection 2g. Sandoz Limited. Revised August 2014.

    The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Cyclophosphamide. Last revised: 03 October 2014
    Last accessed: 7 August 2015.

    NICE Evidence Services Available at: Last accessed: 18 August 2017

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