Indication:Licensed indications: Chronic myeloid leukaemia (CML), thrombocythemia or polycythemia vera. Unlicensed indication: Sickle Cell Syndrome
In patients receiving long-term therapy with hydroxycarbamide for myeloproliferative disorders, such as polycythemia, secondary leukaemia has been reported. It is unknown whether this leukaemogenic effect is secondary to hydroxycarbamide or associated with the patients’ underlying disease. Skin cancer has also been reported in patients receiving long-term hydroxyurea. Patients should be advised to protect skin from sun exposure, conduct self-inspection of the skin and be screened for secondary malignancies during routine follow-up visits.
EMC SPC June 2012
When prescribed for the unlicensed indication of Sickle Cell sydrome hydroxycarbamide must not be prescribed as the brand Siklos as this is not funded.
Yorkshire and the Humber Specialiised Commissioning Group
Doctors, nurses, pharmacists and their staff must be made aware that the prescribing, dispensing and administering of oral anti-cancer medicines should be carried out and monitored to the same standard as injected therapy. This requires that:
* Healthcare organisations should prepare local policies and procedures that describe the safe use of these oralmedicines.
* Treatment should be initiated by a cancer specialist.
* All oral anti-cancer medicines should be prescribed only in the context of a written protocol and treatment plan.
* Non-specialists who prescribe or administer on-going oral anti-cancer medication should have ready access to appropriate written protocols and treatment plans including guidance on monitoring and treatment of toxicity.
* Staff dispensing oral anti-cancer medicines should be able to confirm that the prescribed dose is appropriate for the patient, and that the patient is aware of the required monitoring arrangements, by having access to information in the written protocol and treatment plan from the hospital where treatment is initiated and advice from a pharmacist with experience in cancer treatment in that hospital.
* Patients should be fully informed and receive verbal and up-to-date written information about their oral anticancer therapy from the initiating hospital. This information should include contact details for specialist advice, which can be shared with non-specialist practitioners. Written information, including details of the intended oral anti cancer regimen, treatment plan and arrangements for monitoring, taken from the original protocol should be given to the patient. When shared with pharmacists and dispensing staff, this would enable the above dispensing requirements to be satisfied.
* Full use should also be made of NHS cancer centre web sites to provide information for healthcare staff, patients and carers to ensure the safe use of oral anti-cancer medicines.
Risks of incorrect dosing of oral anti-cancer medicines – NPSA January 2008