This site is intended for UK healthcare professionals
Medscape UK Univadis Logo
Medscape UK Univadis Logo

Treosulfan capsules

Updated 2 Feb 2023 | Alkylating agents


Oral formulations of treosulfan

Drugs List

  • treosulfan 250mg capsules
  • Therapeutic Indications


    Treatment of carcinoma of the ovary

    Treatment of all types of ovarian cancer either supplementary to surgery or palliatively.

    Uncontrolled studies have shown treosulfan may be useful in other refractory neoplasms.


    For use only by physicians experienced in cancer chemotherapy

    Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.


    Total dose of 21 g to 28 g in the initial 8 weeks.

    The following regimes have been indicated:
    Regimen A:
    1 g daily in four divided doses for 4 weeks followed by 4 weeks off therapy.

    Regimen B:
    1 g daily in four divided doses for 2 weeks followed by 2 weeks off therapy.

    Regimen C:
    1.5 g daily in three divided doses for 1 week, followed by 3 weeks off therapy. If no evidence of haematological toxicity at this dose in this regimen, increase to 2 g daily in four divided doses for one week for the second and subsequent courses.

    The cycles should be repeated with the dose being adjusted if necessary according to the effect on the peripheral blood counts.


    (See Dosage; Adult)

    Patients with Renal Impairment

    The renal drug handbook suggests the following dose reductions:
    Creatinine clearance greater than or equal to 30 ml/minute: Dose as normal.
    Creatinine clearance less than 30 ml/minute: Reduce dose by 60%

    Additional Dosage Information

    Present evidence suggests regimens B and C are less myelosuppressive than regimen A, whilst retaining maximum cytotoxic efficacy.

    Dose modifications
    Suspend treatment if white blood cell count is less than 3 x 10 to the power 9/L and/or platelet count is less than 100 x 10 to the power 9/L, repeat blood count after 1 to 2 weeks. Treatment can be restarted if haematological parameters are satisfactory, reducing dose as follows:

    Regimen A: Reduce from 1 g daily for 4 weeks to 0.75 g daily for 4 weeks and, if necessary, to 0.5 g daily for 4 weeks

    Regimen B: Reduce from 1 g daily for 2 weeks to 0.75 g for 2 weeks and, if necessary, to 0.5 g daily for 2 weeks

    Regimen C: Reduce from 2 g daily for 1 week to 1.5 g daily for 1 week and, if necessary, to 1 g daily for 1 week


    Children under 18 years
    Leucocyte count below 3 x 10 to the power of 9 / L
    Platelet count below 100 x 10 to the power of 9/ L
    Severe myelosuppression

    Precautions and Warnings

    Renal impairment - creatinine clearance below 30 ml/minute

    Administration of live vaccines is not recommended
    Advise ability to drive/operate machinery may be affected by side effects
    Treatment to be prescribed under the supervision of a specialist
    Consult local policy on the safe use of oral anti-cancer drugs
    Ensure patient has adequate fluid intake
    Staff: Not to be handled by pregnant staff
    Monitor full blood count regularly
    Advise patient to report signs or symptoms of cystitis
    Increased risk of myelodysplastic syndrome & non-lymphocytic leukaemia
    Oversuppression of immune system may increase susceptibility to infection
    Reduce dose in patients with haematological toxicity
    Discontinue if pulmonary toxicity occurs
    Suspend treatment if leukocyte count falls below 3000/microlitre
    Suspend treatment if platelets fall below 100,000/cubic mm
    Female: Ensure adequate contraception during treatment

    Blood counts usually reach their baseline level after 28 days. As bone marrow suppression is cumulative, blood counts should be monitored at shorter intervals from the 3rd treatment cycle onwards.

    Pregnancy and Lactation


    Treosulfan is contraindicated in pregnancy.

    At the time of writing there is no published experience concerning the use of treosulfan during pregnancy. Like other cytostatic agents with alkylating properties, treosulfan has a mutagenic potential and therefore should not be given during pregnancy.

    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 ( ).


    Treosulfan is contraindicated in breastfeeding

    At the time of writing it is unknown whether treosulfan is excreted in human breast milk, a risk to neonates cannot be excluded.

    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

    Allergic alveolitis
    Allergic reaction
    Exacerbation of Addison's disease
    Exacerbation of psoriasis
    Haemorrhagic cystitis
    Influenza-like syndrome
    Multiple myeloma
    Myelodysplastic syndrome
    Non-lymphocytic leukaemia (acute)
    Pulmonary fibrosis
    Skin pigmentation changes


    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 During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press. Accessed on 3 August 2015.

    Summary of Product Characteristics. Treosulfan Capsules 250mg. Medac GmbH. Revised January 2015.

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

    Access the full UK drug database with a FREE Medscape UK Account
    It takes just a few minutes, and you’ll get unlimited access to information on over 11,000 UK drugs.
    Register for Free

    Already a member? Log in

    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

    FDB Logo

    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.