Download Amber Drug Guidance (women and men

Leeds
Denosumab (Prolia®): Amber Drug Guidance for the treatment
of Osteoporosis in; postmenopausal women and men at
increased risk of fractures
Amber Drug Level 3 (amber drug with monitoring requirements)
Amber Level 3 ‘Medicines that should be initiated by a
specialist, and which require specific drug related monitoring
on an ongoing basis. After a successful initiation period,
including assessment of efficacy, a transition to GP care can
take place. Relevant disease monitoring should be
undertaken. The amber drug guidance will outline the
specialist and GP responsibilities (including monitoring
requirements and specific details of follow up) and basic
prescribing information’, this can be accessed via Leeds
Health Pathways.
We have started your patient on Denosumab for the treatment of osteoporosis in
postmenopausal women or men at increased risk of fractures. We will continue to
see the patient and prescribe Denosumab until the patient (and their condition) is
stable. After this period the GP will be asked to take over prescribing and
monitoring responsibilities within this amber drug protocol. This drug requires
ongoing monitoring which does include blood tests.
This guideline outlines the specific responsibilities of the Specialist, GP, and patient
when Denosumab is prescribed.
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The link to Denosumab on the Leeds formulary can be found here
The link to the protocol for rapid Vitamin D replacement before scheduled IV
bisphosphonate and SC denosumab in osteoporosis can be found here
The link to the advice on the management of adults over 18 years with
Vitamin D deficiency or insufficiency in primary and secondary care can be
found here
Indication for therapy:
Osteoporosis in postmenopausal women and
men at increased risk of fractures
Classification:
Amber Level 3
Monitoring:
Required
The advice in the following alerts have been incorporated into our guidance
MHRA Drug Safety Update September 2014 Link and Drug Safety Update on
denosumab July 2015 - link
Baseline Tests:
Prior to treatment each patient will have:
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A DXA bone scan,
spinal x-ray (right lateral mid dorsal and lumbar
spine),
Denosumab Amber Drug Guideline
Date prepared: October 2015
1
Review date: October 2018
Leeds
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Vitamin D (if low correct before administration)
PTH,
Ca bone profile (if hypocalcaemia correct before
administration),
U&Es, ,
CRP,
FBC
fasting plasma b-CTX (a specific indicator of bone
resorption)
Prior to starting treatment the hospital specialist
will evaluate the patient for risks of osteonecrosis
of the jaw. The specialist will recommend the
patient has a dental examination and preventative
dentistry prior to treatment in patients who have
concomitant risk factors for osteonecrosis of the
jaw.
If the patient hasn’t had a dental check up in
the last year they will also advise they get one
before starting treatment
The specialist will provide patients they see in
hospital with a reminder card from the
manufacturer of denosumab which contains
information about the risk of osteonecrosis of the
jaw with denosumab and the precautions to take
before and during treatment - these cards can be
obtained directly from the manufacturer, and the
information in these can be found in the following
link
Patients will receive their first and second doses of
their six monthly injections at LTHT
Routine Tests/Monitoring:
In patients who are pre-disposed to hypocalcaemia
(e.g. severe renal impairment, creatinine clearance
<30mL/min). calcium levels will be re-checked
within 2 weeks of the initial dose by the hospital
At three months:
fasting plasma b-CTX will be done at LTHT. This is
to monitor if bone turnover has been suppressed,
which would indicate a positive treatment
response.
Six monthly :
 Calcium
 vitamin D
Low levels must be corrected prior to each dose of
denosumab. This would be done by the hospital
prior to the first 2 doses for subsequent doses this
will be the responsibility of the GP
Denosumab Amber Drug Guideline
Date prepared: October 2015
2
Review date: October 2018
Leeds
Calcium levels should be re-checked if the patient
presents with suspected symptoms of
hypocalcaemia at any time during treatment with
denosumab®.
The specialist will review the patient at 6 months,
and issue advice at that time to the GP about
further management, and the follow up they
recommend for each patient.
Disease Monitoring:
For patients discharged to primary care the
specialist will advise the GP on recommendations
regarding duration of treatment, monitoring of bone
bone density and criteria for re-referral
To monitor the osteoporosis a repeat DXA bone
scan may be advised in some patients at 18 to 24
months
Prescribing
Information
The following is a summary of prescribing information only.
Consult the BNF and SPC for full and current prescribing information.
Dose: the usual dose is 60mg administered as a single subcutaneous injection
once every 6 months into the thigh, abdomen or upper arm.
Formulation:
Adverse drug reactions:
Denosumab 60mg/mL solution for injection in a
prefilled syringe
Denosumab should be stored at 2ºC to 8ºC (in a
refrigerator). To avoid discomfort at injection
site, allow the injection to come to room
temperature prior to injection.
Denosumab may be stored at room temperature
(up to 25ºC) for up to 30 days in its original
container. Once removed from the refrigerator it
must be used within this 30 day period.
Musculoskeletal pain, pain in extremity,
constipation, hypocalcaemia, UTI, upper
respiratory tract infection, sciatica, cataracts,
rash, eczema, abdominal discomfort, less
commonly; diverticulitis, cellulitis (urgent
medical attention required), ear infection, rarely;
osteonecrosis of the jaw, atypical femoral
fractures
Cautions/Contra-indications:
Hypocalcaemia, hypersensitivity to any of the
ingredients.
Precautions for use:
Hypocalcaemia and vitamin D insufficiency /
deficiency must be corrected by adequate
intake of calcium and vitamin D before initiating
therapy. For further information on
hypocalcaemia see the monitoring section.
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Denosumab Amber Drug Guideline
Date prepared: October 2015
Review date: October 2018
Leeds
Patients receiving denosumab may develop skin
infections (predominantly cellulitis) leading to
hospitalisation. Patients should be advised to
seek prompt medical attention if they develop
symptoms of cellulitis .
Osteonecrosis of the jaw has been reported with
denosumab. Appropriate pre-treatment dental
examinations and preventative dental treatment
is recommended prior to treatment in patients
who have concomitant risk factors.
Atypical fractures have been reported with
denosumab. Discontinuation of therapy in
patients suspected to have an atypical femur
fracture should be considered pending
evaluation of the patient based on an individual
risk benefit assessment
The needle cover of the pre-filled syringe
contains dry natural rubber (a derivative of
latex) which may cause allergic reactions.
Communication
Interactions:
No interactions have been identified by the
manufacturer of Prolia®, though there have only
been a small number of interaction studies
undertaken with denosumab.
Pregnancy/breast-feeding:
Used in postmenopausal women only
Contact Names and Details
Leeds Teaching Hospitals NHS Trust
Medicines Information phone number and e-mail: 0113 2064344
[email protected]
Medicines Information Patient Helpline phone number: 0113 2064376
Specialist who makes request via switchboard: LGI 0113 2432799
SJUH 0113 2433144
Prepared by:
Responsibilities
of Specialist
Nicola Butler and Claire Sanderson
Dr Afroze Abbas
Responsibilities specific to Denosumab for the treatment of osteoporosis in
postmenopausal women and men at increased risk of fractures
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Diagnosis of the condition and ensuring other treatment options have been
fully explored
To assess the suitability of the patient for this treatment
To discuss the benefits and side effects of treatment with the patient/carer and
Denosumab Amber Drug Guideline
Date prepared: October 2015
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Review date: October 2018
Leeds
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Responsibilities
of GP
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where applicable the need for long term monitoring
Checking for allergies, interactions and contra-indications
To perform baseline tests and correct any hypocalcaemia and evaluate the risk
of osteonecrosis of the jaw in patients prior to starting therapy
The specialist will provide patients they see in hospital with a reminder card
from the manufacturer of denosumab which contains information about the risk
of osteonecrosis of the jaw with denosumab and the precautions to take before
and during treatment (see page 2 for a link to this)
To advise patients on the symptoms of hypocalcaemia and inform them to
report symptoms that may indicate hypocalcaemia
Patients will be advised to seek prompt medical attention if they develop
symptoms of cellulitis
To initiate treatment
To advise that the medication should be prescribed by brand. Only the Prolia®
brand of denosumab is licensed for treatment of osteoporosis
To assess and monitor the patients response to treatment for 6 months
To ask the GP whether they are willing to take over the prescribing and
monitoring responsibilities under this amber drug guidance
To advise the GP on the dose to be prescribed
To advise GP what routine monitoring will be completed by the specialist and
what monitoring the GP will be responsible for
To forward results of monitoring to GP
Outlining to the GP when therapy may be stopped assuming no relapse in
patient’s condition. Review periods to be agreed
Responding to issues raised by GP
To monitor the patient for adverse events and report to the GP and where
appropriate Commission on Human Medicines/MHRA (Yellow card scheme)
To check for allergies
To ensure all required monitoring is up to date before prescribing
To provide patients who are prescribed denosumab by their GP with a
reminder card from the manufacturer of denosumab which contains information
about the risk of osteonecrosis of the jaw with denosumab and the precautions
to take before and during treatment (see page 2 for a link to this), if this has not
already been done by the hospital.
To prescribe and arrange for administration of denosumab injection (the Prolia
brand)following initiation and stabilisation by the specialist
To perform routine monitoring as agreed with specialist
Calcium levels and vitamin D levels should be checked by the GP surgery ,
and any low levels corrected prior to each dose of denosumab after the GP
has taken over the prescribing of it
If a patient presents with suspected symptoms of hypocalcaemia during
treatment to check their calcium levels
To refer back to the specialist if the patient’s condition deteriorates, and in line
with specialist recommendations
To identify adverse events if the patient presents with any signs and symptoms
and liaise with the hospital specialist where necessary.
To report adverse events to the specialist and where appropriate the
Commission on Human Medicines/MHRA (Yellow card scheme).
To stop treatment on the advice of the specialist
Denosumab Amber Drug Guideline
Date prepared: October 2015
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Review date: October 2018
Leeds
Responsibilities
of patient/carer
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To tell their doctor if they have any problems with their mouth or teeth before
starting treatment; and if they wear dentures they should make sure their
dentures fit properly before starting treatment
To take responsibility for having denosumab injected as prescribed.
To attend for blood tests/disease monitoring on time (if appropriate).
To understand potential for adverse events and report these to the Specialist
and/or GP.
To seek medical attention if they develop signs of cellulitis (skin
infections)
To maintain good oral hygiene and get routine dental check-ups during
treatment
To inform dentists and other healthcare professionals that they are on
denosumab
To tell their doctor and dentist immediately if they have any problems with their
mouth or teeth during treatment (eg loose teeth, pain, swelling, non-healing
sores or discharge)
To contact the GP, Specialist or Medicines Information patient helpline if
further information or advice is needed about denosumab.
Denosumab Amber Drug Guideline
Date prepared: October 2015
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Review date: October 2018