Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
GMMMG Interface Prescribing Subgroup Shared Care Protocol Shared Care Guideline for Reference Number Hydroxycarbamide in Adult Sickle Cell Disease Version: 1 Replaces: n/a Author(s)/Originator(s): (please state author name and department) Dr Kate Ryan- Lead Consultant Haematologist, CMFT Liz Davies – Lead Haematology Pharmacist, CMFT Date approved by Interface Prescribing Group: 11/06/2015 Date approved by Commissioners: dd/mm/yyyy Issue date: 16/07/02015 To be read in conjunction with the following documents: Current Summary of Product characteristics (http://www.medicines.org.uk) BNF Date approved by Greater Manchester Medicines Management Group: 16/07/2015 Review Date: 16/07/2017 Please complete all sections 1. Name of Drug, Brand Name, Form and Strength 2. Licensed Indications Hydroxycarbamide 500mg capsules. The 500mg hydroxycarbamide capules are not licensed for use Sickle Cell Disease. Hydrea® is licensed only for CML. Medac® is licensed for CML and additionally for essential thrombocythemia or polycythemia vera. 3. Criteria for shared Prescribing responsibility will only be transferred when care 4. Therapeutic use & background Version: 1 Date: 16/07/2015 Review: 16/07/2017 Treatment is for the specified indication of sickle cell disease and duration. Treatment has been initiated and established by the secondary care specialist. The patient’s initial reaction to and progress on the drug is satisfactory. The GP has agreed in writing in each individual case that shared care is appropriate. The patient’s general physical, mental and social circumstances are such that he/she would benefit from shared care arrangements This shared care protocol applies to adults only. Hydroxycarbamide has been shown to be beneficial in sickle cell disease by reducing the frequency and severity of painful crises and preventing acute sickle lung syndrome and blood transfusion requirements (Charache et al 1994). There is now extensive worldwide use of this drug for over 15 years in sickle cell disease and it appears safe with no reported long term side effects (Lanzkron, et al 2008). Shared Care Guideline for Hydroxycarbamide in Sickle Cell Disease Current version is held on GMMMG Website Check with internet that this printed copy of the latest issue Page 1 of 13 Hydroxycarbamide is myelosuppressive, therefore requires monitoring of blood counts. These effects are not always predictable and individual variation exists. However, once a stable dose has been achieved, the risk of myelosuppression is low. Monitoring and dosing advice is undertaken by the haematology department at the hospital. 5. Contraindications (please note this does not replace the SPC or BNF and should be read in conjunction with it). 6. Prescribing in pregnancy and lactation 7. Dosage regimen for continuing care Severe Bone Marrow Depression Severe Anaemia Pregnancy, breast feeding or not practising contraception. Men under therapy are advised to use safe contraceptive measures during and for at least 3 months after therapy. Active hepatitis. Hypersensitivity to Hydroxycarbamide. Severe hepatic impairment (Child-Pugh classification C) Severe renal impairment (creatinine clearance < 30 ml/min) Blood dyscrasias (marked leucopenia wbc<2.5.x109/L, thrombocytopenia <100x109/L, severe anaemia) Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Risk of secondary leukaemia associated with long-term hydroxycarbamide use. This drug cannot be prescribed in the pregnant/breastfeeding patient. Under these circumstances prescribing should be the responsibility of the specialist. An effective method of contraception is strongly recommended in women of childbearing potential and men during therapy and for 3 months after therapy. Route of administration: Oral Preparations available: Hydroxycarbamide 500mg capsules. In the hospital setting, the brand used depends on the current purchasing contract as there is no clinical difference between the products and brands are often prescribed outside their exact license. It is suggested that the GP prescribe generically, but either brand is acceptable. Please prescribe: In adults commence at 15mg/kg to nearest 500 mg. Doses are based on real or ideal bodyweight of the patient, whichever is the less. Is titration required Yes by the initiating hospital In adults dosage to be increased every 12 weeks. Maintenance dosage up to a maximum of 30mg/kg/day. Typical doses range from 500mg to 1500mg daily. A small number of patients may require variable dosing e.g. alternate day dosing or doses may be different during week compared to weekends. Patients will only be eligible for shared care once dose titration has been accomplished and the patient is established on a stable dose. Adjunctive treatment regime: Patients with sickle cell disease also required supplementation with folic acid. Version: 1 Date: 16/07/2015 Review: 16/07/2017 Shared Care Guideline for Hydroxycarbamide in Sickle Cell Disease Current version is held on GMMMG Website Check with internet that this printed copy of the latest issue Page 2 of 13 Conditions requiring dose reduction: Myelotoxicity e.g. Neutrophils < 2.0 x 109/L. Platelets <80 x 109/L, or Reticulocytes <1%, or Haemoglobin drop >3g/dl from baseline If myelotoxicity, stop the Hydroxycarbamide until the blood count (FBC) has recovered – Restart at 2.5 mg/kg or 1 capsule (500mg) daily lower dose. This is the maximum tolerated dose. Usual recovery time generally 1-2 weeks – check the FBC weekly. Renal and hepatic impairment – refer to specialist for advice. NB. All dose adjustments will be the responsibility of the initiating specialist care unless directions have been specified in the medical letter to the GP. Usual response time : Assessment of response prior to transfer to shared care Duration of treatment: Long term Treatment to be terminated by: The initiating hospital. However, in the event of adverse reactions to the medication, termination of treatment may be required prior to the next Hospital appointment. 8.Drug Interactions For a comprehensive list consult the BNF or Summary of Product Characteristics 9. Adverse drug reactions The following drugs must not be prescribed without consultation with the specialist: Clozapine Didanosine Stavudine Live vaccines e.g. oral polio, MMR, BCG, yellow fever Other cytotoxic and immunsuppressant drugs Concomitant use of hydroxycarbamide with a live virus vaccine may potentiate the replication of the vaccine virus and/or may increase the adverse reaction of the vaccine virus, because normal defence mechanisms may be suppressed by hydroxycarbamide therapy. Vaccination with a live vaccine in a patient taking hydroxycarbamide may result in severe infections. Generally, the patient's antibody response to vaccines may be decreased. Treatment with hydroxycarbamide and concomitant immunisation with live virus vaccines should only be performed if benefits clearly outweigh potential risks and after discussion with hospital specialist. Specialist to detail below the action to be taken upon occurrence of a particular adverse event as appropriate. Most serious toxicity is seen with long-term use and may therefore present first to GPs. For a comprehensive list (including rare and very rare adverse effects), or if significance of possible adverse event uncertain, consult Summary of Product Characteristics or BNF Version: 1 Date: 16/07/2015 Review: 16/07/2017 Shared Care Guideline for Hydroxycarbamide in Sickle Cell Disease Current version is held on GMMMG Website Check with internet that this printed copy of the latest issue Page 3 of 13 Adverse event System – symptom/sign Action to be taken Include whether drug should be stopped prior to contacting secondary care specialist By whom Bone marrow suppression Neutrophils <2x109/l ± Platelets <80 x 109/l ± Reticulocytes < 1 % Haemoglobin > 3g/dl below baseline a) Stop hydroxycarbamide b) Recheck FBC twice weekly and restart Hydroxycarbamide at 500mg lower daily dose than previously once neutrophils >2 x 109/L and platelets and reticulocytes are in the normal range. c) Consider GCSF or blood transfusion on discussion with specialist centre staff GP to stop hydroxycarbamide. Refer to the specialist centre to advise on the adjustment of hydroxycarbamide or any further action to be required Rise in haemoglobin >3g/dl above baseline Refer to specialist centre for advice GP GI Disturbances; Nausea, Vomiting and Diarrhoea. Stop on patient’s request and refer to specialist centre for advice GP to Stop Refer to the specialist centre for further action Hyperpigmentation of nails Stop on patient’s request and refer to specialist centre for advice GP to Stop Refer to the specialist centre for further action Alopecia Stop on patient’s request and refer to specialist centre for advice GP to Stop Refer to the specialist centre for further action Skin rash Stop on patient’s request and refer to specialist centre for advice GP to Stop Refer to the specialist centre for further action Fever and hepatitis Stop and discuss with specialist GP Development of gout or, at worst, uric acid nephropathy Monitor uric acid levels regularly and advise patient to maintain a high fluid intake during treatment. GP Oral ulceration and/or sore throat Stop and discuss with specialist GP The patient should be advised to report any of the following signs or symptoms to their GP without delay: Bruising, petechiae, or frank bleeding. Feeling generally unwell and infections. Version: 1 Date: 16/07/2015 Review: 16/07/2017 Shared Care Guideline for Hydroxycarbamide in Sickle Cell Disease Current version is held on GMMMG Website Check with internet that this printed copy of the latest issue Page 4 of 13 Other important co morbidities (e.g. Chickenpox exposure). Include advice on management and prevention and who will be responsible for this in each case: If the patient is concerned about infection exposure they should be instructed to contact the specialist centre for advice. The specialist centre will be responsible for providing advice on any further action required. Pneumococcal Vaccination In those with Sickle Cell disease, check the patient has had one dose of unconjugated Polysaccharide Pneumococcal vaccine, prior to starting treatment. Influenza Vaccination. Administer influenza vaccine annually (N.B. Do not use a live vaccine) Chickenpox Exposure Passive immunisation using Varicella immunoglobulin (VZIG) should be considered in non -immune patients if exposed to chicken pox or shingles in line with advice in Chapter 34 of the Green Book on Varicella. Contact virology for advice if exposure is suspected. Any adverse reaction to a black triangle drug or serious reaction to an established drug should be reported to the MHRA via the “Yellow Card” scheme. 10.Baseline investigations At outset: FBC U&Es Liver function Serum ferritin Quantitative electrophoresis Reticulocytes Haemaglobin F% Every 14 days until maximum tolerated dose Every 14 days at maximum tolerated dose until stable (minimum 8 weeks).i.e. HbF, MCV have reached plateau: Once stable every 8-12 weeks: 11. Ongoing monitoring requirements to be undertaken by GP Is monitoring required? Monitoring Version: 1 Date: 16/07/2015 Review: 16/07/2017 Yes - Blood count monitoring is usually performed on an 8-12 weekly basis for stable patients. However the exact monitoring plan will be agreed and communicated individually between the Hospital Specialist and the GP. The GP should have access to blood results prior to prescribing. Blood tests will therefore need to be performed at the GP surgery or if performed at the Hospital, the GP will need to be able to access pathology results via their available online system. Frequency Results Action By whom Serum creatinine Every 8-12 weeks. >150 µmol/L Stop & seek advice GP Haemoglobin Every 8-12 weeks. <4.5 g/dl (limit applicable to sickle cell anaemia patients only) Stop & seek advice GP Shared Care Guideline for Hydroxycarbamide in Sickle Cell Disease Current version is held on GMMMG Website Check with internet that this printed copy of the latest issue Page 5 of 13 Neutrophils Every 8-12 weeks. <2.0 x 109/L Stop & seek advice GP Reticulocytes Every 8-12 weeks. Stop & seek advice GP Platelets Every 8-12 weeks. <80 x109/L if the haemoglobin concentration < 9 g/dl <80 x 109/L Stop & seek advice GP Serial rise over 3 visits >TWICE upper limit of normal Indication of compliance Stop & seek advice GP None unless symptoms worsening Hospital Stop & seek advice GP LFTs (AST, ALT GGT) Haemaglobin F% (Sickle cell disease only) U&Es 12. Pharmaceutical aspects Every 3 months Every 8-12 weeks. Serial rise over 3 visits Hydroxycarbamide is a medicinal product that must be handled with care. People who are not taking Hydroxycarbamide and in particular pregnant women should avoid being in contact with hydroxycarbamide. Anyone handling Hydroxycarbamide should wash their hands before and after contact with the tablets. Any unused product or waste material should be disposed of in accordance with local requirements. 13. Patients excluded from shared care 14. Responsibilities of initiating specialist Version: 1 Date: 16/07/2015 Review: 16/07/2017 Hydroxycarbamide should not be dispensed in any Nomad/ Multiple Dose Units due to the cytotoxic nature of the drug. Unstable disease state Patient does not consent to shared care. Patient does not meet criteria for shared care specified in section 3. Patients <18yrs old. Initiate treatment and prescribe until dose is stable Undertake baseline monitoring. Dose adjustments. Monitor patient’s initial reaction to and progress on the drug. Ensure that the patient has an adequate supply of medication until GP supply can be arranged. Patients will be considered suitable for transfer to GP prescribing ONLY when they meet the criteria listed in section 3 above. The consultant team will write formally to the GP to request shared care using the Shared Care Agreement Form (Appendix 2) which must be fully completed. Failure to supply all the required information will result in the refusal of the request until all information has been supplied. Patients will only be transferred to the GP once the GP has agreed via signing copies of the Shared Care Agreement Form (Appendix 2). Continue to monitor and supervise the patient according to this protocol, while the Shared Care Guideline for Hydroxycarbamide in Sickle Cell Disease Current version is held on GMMMG Website Check with internet that this printed copy of the latest issue Page 6 of 13 15. Responsibilities of the GP Version: 1 Date: 16/07/2015 Review: 16/07/2017 patient remains on this drug, and agree to review the patient promptly if contacted by the GP Provide GP with diagnosis, relevant clinical information and baseline results, treatment to date and treatment plan, duration of treatment before consultant review. Provide GP with details of outpatient consultations, ideally within 14 days of seeing the patient or inform GP if the patient does not attend appointment. To stop the drug or provide GP with advice on when to stop this drug. Act upon communication from the GP in a timely manner. Provide patient with relevant drug information to enable Informed consent to therapy. Provide patient with relevant drug information to enable understanding of potential side effects and appropriate action. Provide patient with relevant drug information to enable understanding of the role of monitoring. Provide patient with monitoring booklet. The consultant team will ensure the patient has been fully counselled on the benefits of hydroxycarbamide, the monitoring requirements and what will happen if the patient fails to attend for monitoring, the signs and symptoms of toxicity and what to do if they are experienced. Be available to provide patient specific advice and support to GPs as necessary. Continue treatment as directed by the specialist. Prescribe folic acid supplementation as directed by the specialist. Notify the consultant team of any circumstances that may preclude the use of hydroxycarbamide, for example, the use of illicit drugs/excessive drinking or contraindications to treatment. Act upon communication from the specialist in a timely manner. To formally reply to the request for shared care from the specialist. Ensure no drug interactions with concomitant medicines. To monitor and prescribe in collaboration with the specialist according to this protocol. To ensure monitoring is carried out as per this shared care protocol. Formally reply to the consultant’s request to shared care within 14 days of receipt, using the shared care agreement forms (Appendix 2). NB the GP should only agree to the transfer of prescribing if all details of the form have been completed. If the GP does not feel it is appropriate to take on the prescribing then the prescribing responsibilities will remain with the specialist. The GP should indicate the reason for declining. Enter a READ code on to the patient record to highlight the existence of shared care for the patient. Undertake more frequent tests if there is evidence of clinical deterioration, abnormal results, or symptoms suggesting abnormal hepatic function or other risk factors. Contact consultant team for advice on monitoring in these circumstances if required. Check all monitoring results prior to issuing a repeat prescription to ensure it is safe to do so. If a patient fails to attend for monitoring: Only issue a 28 day prescription and send them the next available appointment for a blood test. If they fail to attend a second blood test then contact the consultant team for advice and to discuss suitability for continued shared care before supplying further prescriptions. Monitor the patient’s general wellbeing. Reinforce the importance of continued contraception with women and men of child bearing age as necessary. Shared Care Guideline for Hydroxycarbamide in Sickle Cell Disease Current version is held on GMMMG Website Check with internet that this printed copy of the latest issue Page 7 of 13 16. Responsibilities of the patient 17.Additional Responsibilities e.g. Failure of patient to attend for monitoring, Intolerance of drugs, Monitoring parameters outside acceptable range, Treatment failure, Communication failure 18. Supporting documentation 19. Patient monitoring booklet (may not be applicable for all drugs) 20. Shared care agreement form 21. Contact details Version: 1 Date: 16/07/2015 Review: 16/07/2017 Seek urgent advice from secondary care if: The patient becomes pregnant whilst taking hydroxycarbamide Non compliance is suspected The GP feels a dose change is required There is marked deterioration hepatic and renal function The GP feels the patient is not benefiting from the treatment The shared care agreement will cease to exist, and prescribing responsibility will return to secondary care, where: The clinical situation deteriorates such that the shared care criterion of stability is not achieved. The clinical situation requires a major change in therapy. GP feels it to be in the best stated clinical interest of the patient for prescribing responsibility to transfer back to the consultant team. The consultant team will accept such a transfer within a timeframe appropriate to the clinical circumstances. There must be discussion between the consultant team and GP on this matter and agreement from the consultant team to take back full prescribing responsibility for the treatment of the patient. The consultant team should be given 14 days’ notice in which to take back prescribing responsibilities from primary care. To ensure that the monitoring and dosage record is kept up to date (if applicable). To undertake vaccination as directed by the initiating consultant, the BNF or Green Book. Symptoms or results are appropriately actioned, recorded and communicated to secondary care when necessary. To take medication as directed by the prescriber, or to contact the GP if not taking medication To attend hospital and GP clinic appointments, bring monitoring booklet (if issued) Failure to attend will result in medication being stopped (on specialist advice). To report adverse effects to their Specialist or GP. List any special Action required By whom Date considerations Nil The SCG must be accompanied by a patient information leaflet.(Available from http://www.medicines.org.uk/emc OR http://www.mhra.gov.uk/spc-pil/) The patient must receive a monitoring booklet from the specialist upon initiation of treatment. The patient must bring this booklet to all specialist and GP appointments where it will be updated by the health professional conducting the appointment. The patient must also produce the booklet to any health professional involved in other aspects of their care e.g. pharmacists and dentists. Attached below See Appendix 1 Shared Care Guideline for Hydroxycarbamide in Sickle Cell Disease Current version is held on GMMMG Website Check with internet that this printed copy of the latest issue Page 8 of 13 Appendix 1 – Local Contact Details Lead author contact information Name: [insert text here] Email: [insert text here] Contact number: [insert text here] Organisation: [insert text here] Commissioner contact information Name: [insert text here] Email: [insert text here] Contact number: [insert text here] Organisation: [insert text here] Secondary care contact information If stopping medication or needing advice please contact: Dr [insert text here] Contact number: [insert text here] Fax:[insert text here] Hospital: [insert text here] Version: 1 Date: 16/07/2015 Review: 16/07/2017 Shared Care Guideline for Hydroxycarbamide in Sickle Cell Disease Current version is held on GMMMG Website Check with internet that this printed copy of the latest issue Page 9 of 13 Shared Care Agreement Form Specialist request *IMPORTANT: ACTION NEEDED Dear Dr [insert Doctors name here] Patient name: [insert Patients name here] Date of birth: [insert date of birth] NHS Number: [insert NHS Number] Diagnosis: [insert diagnosis here] This patient is suitable for treatment with HYDROXYCARBAMIDE for the treatment of SICKLE CELL DISEASE. This drug has been accepted for Shared Care according to the enclosed protocol (as agreed by Trust / CCG / GMMMG). I am therefore requesting your agreement to share the care of this patient. The patient has been fully counselled on the medication. Treatment was started on [insert date started] [insert dose]. If you are in agreement, please undertake monitoring and treatment from [insert date] NB: date must be at least 1 month from initiation of treatment. Baseline tests: [insert information] Next review with this department: [insert date] You will be sent a written summary within 14 days. The medical staff of the department are available at all times to give you advice. The patient will not be discharged from outpatient follow-up while taking [insert text here]. The patient will also require folic acid supplementation as directed by the specialist. Please use the reply slip overleaf and return it as soon as possible. Thank you. Yours [insert Specialist name] Version: 1 Date: 16/07/2015 Review: 16/07/2017 Shared Care Guideline for Hydroxycarbamide in Sickle Cell Disease Current version is held on GMMMG Website Check with internet that this printed copy of the latest issue Page 10 of 13 Shared Care Agreement Form GP Response Dear Dr [insert Doctors name] Patient [insert Patients name] NHS Number [insert NHS Number] Identifier [insert patient date of birth/address] I have received your request for shared care of this patient who has been advised to start HYDROXYCARBAMIDE A I am willing to undertake shared care for this patient as set out in the protocol B I wish to discuss this request with you C I am unable to undertake shared care of this patient. My reasons for not accepting are: (Please complete this section) GP signature Date GP address/practice stamp Version: 1 Date: 16/07/2015 Review: 16/07/2017 Shared Care Guideline for Hydroxycarbamide in Sickle Cell Disease Current version is held on GMMMG Website Check with internet that this printed copy of the latest issue Page 11 of 13 Shared Care Guideline Summary: HYDROXYCARBAMIDE FOR THE TREATMENT OF ADULT SICKLE CELL DISEASE Drug Indication Hydroxycarbamide 500mg capsules Overview Hydroxycarbamide has been shown to be beneficial in sickle cell disease by reducing the frequency and severity of painful crises and preventing acute sickle lung syndrome and blood transfusion requirements (Charache et al 1994). There is now extensive worldwide use of this drug for over 15 years in sickle cell disease and it appears safe with no reported long term side effects (Lanzkron, et al 2008). Initial investigations: Assessment of the patient and diagnosis of Sickle Cell Disease. Discuss benefits and side-effects of treatment with the patient. FBC, U&Es, LFTs, Serum ferritin, quantitative electrophoresis and reticulocytes should be measured on initiation by specialist. Initial regimen: Commence at 15 mg/kg/day rounded to the nearest 500mg. In adults dosage to be increased every 12 weeks. Maintenance dosage up to a maximum of 30mg/kg/day. Typical doses range from 500mg to 1500mg daily. A small number of patients may require variable dosing e.g. alternate day dosing or doses may be different during week compared to weekends. Clinical monitoring: Specialist review to ensure continuing benefit. Haemaglobin F% Frequency: Baseline and then every 3 months Safety monitoring: FBC, U&Es, LFTs, Serum ferritin Frequency: Every 14 days until maximum tolerated dose Every 14 days at maximum tolerated dose until stable (minimum 8 weeks). Once stable every 8-12 weeks Prescribing details: Specialist initiated. Titrate the dose and transferred to GP once stabilised. To stop the drug or provide GP with advice on when to stop this drug. Documentation: Patients will only be transferred to the GP once the GP has agreed via signing copies of the Shared Care Agreement Form. Provide GP with diagnosis, relevant clinical information, treatment plan, duration of treatment with 14 days of seeing the patient or inform GP if the patient does not attend appointment. Maintenance prescription: Prescribe hydroxycarbamide in accordance with the specialist’s recommendations. Maintenance dosage up to a maximum of 30mg/kg/day. Clinical monitoring: Blood count monitoring is usually performed on an 8-12 weekly basis for stable patients. However the exact monitoring plan will be agreed and communicated individually between the Hospital Specialist and the GP. The GP should have access to blood results prior to prescribing. Safety monitoring: FBC, U&Es, LFTs, Serum ferritin Frequency: Once stable every 8-12 weeks Duration of treatment: Lifelong. Stop or adjust treatment on advice of, or in consultant with specialist. Re-referral criteria: Seek urgent advice from secondary care if: The patient becomes pregnant whilst taking hydroxycarbamide Non compliance is suspected The GP feels a dose change is required There is marked deterioration hepatic and renal function The GP feels the patient is not benefiting from the treatment Specialist’s Responsibilities GP’s Responsibilities Sickle Cell Disease The 500mg hydroxycarbamide capules are not licensed for use Sickle Cell Disease. Version: 1 Date: 16/07/2015 Review: 16/07/2017 Shared Care Guideline for Hydroxycarbamide in Sickle Cell Disease Current version is held on GMMMG Website Check with internet that this printed copy of the latest issue Page 12 of 13 Documentation: Formally reply to the consultant’s request to shared care within 14 days of receipt, using the shared care agreement forms. Adverse Events Adverse events Bone marrow suppression Neutrophils <2x109/l ± Platelets <80 x 109/l ± Reticulocytes < 1 % Haemoglobin > 3g/dl below baseline Rise in haemoglobin >3g/dl above baseline Action Stop hydroxycarbamide. Refer to the specialist centre to advise on the adjustment of hydroxycarbamide or any further action to be required Refer to specialist centre for advice GI Disturbances; Nausea, Vomiting and Diarrhoea Hyperpigmentation of nails Stop on patient’s request and refer to specialist centre for advice Stop on patient’s request and refer to specialist centre for advice Stop on patient’s request and refer to specialist centre for advice Stop on patient’s request and refer to specialist centre for advice Stop and discuss with specialist Monitor uric acid levels regularly and advise patient to maintain a high fluid intake during treatment. Stop and discuss with specialist Alopecia Skin rash Fever and hepatitis Development of gout or, at worst, uric acid nephropathy Oral ulceration and/or sore throat Contraindications Cautions Drug Interactions Other Information Please refer to the BNF and/or SPC for information Contact Details Hydrea® is licensed only for CML. Medac® is licensed for CML and additionally for essential thrombocythemia or polycythemia vera. There is no clinical difference between the two products and brands are often prescribed outside their exact license. It is suggested that the GP prescribe generically, but either brand listed above is acceptable. Folic acid supplementation is required in patients receiving hydroxycarbamide for sickle cell disease. Hydroxycarbamide is a medicinal product that must be handled with care. People who are not taking Hydroxycarbamide and in particular pregnant women should avoid being in contact with hydroxycarbamide. Anyone handling Hydroxycarbamide should wash their hands before and after contact with the tablets. Any unused product or waste material should be disposed of as cytotoxic waste.. Hydroxycarbamide should not be dispensed in any Nomad/ Multiple Dose Units due to the cytotoxic nature of the drug. Doses are rounded to the nearest 500mg and are based on real or ideal bodyweight of the patient, whichever is the less. An effective method of contraception is strongly recommended in women of childbearing potential and men during therapy and for 3 months after therapy. Name: [insert text here] Address: [insert text here] Telephone: [insert text here] Version: 1 Date: 16/07/2015 Review: 16/07/2017 Shared Care Guideline for Hydroxycarbamide in Sickle Cell Disease Current version is held on GMMMG Website Check with internet that this printed copy of the latest issue Page 13 of 13