Download Hydroxycarbamide for sickle cell disease

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