Download Methotrexate subcutaneous injection - airedale

DOCUMENT
TITLE:
METHOTREXATE SUBCUTANEOUS INJECTION (LICENSED) RHEUMATOLOGY GUIDE
FILENAME
PHA_Medicines management_Shared Care
Guideline_Methotrexate Subcutaneous injection (licensed)
Rheumatology Shared Care Guideline
VERSION №
6
DATE OF ISSUE
01/11/2007
REVIEW INTERVAL
2 Years
AUTHORISED BY
Drug and Therapeutics Committee
AUTHOR
Dr Shabina Sultan – Consultant Rheumatologist
Linda Stewart – Pharmacist
Linda Sigsworth – Rheumatology Nurse Specialist
EMAIL ADDRESS OF AUTHOR
[email protected]
COPY №
2
LOCATION OF COPIES
1. SHAREPOINT
2. AIREDALE NHS FOUNDATION TRUST WEBSITE
ASSOCIATED WORKING INSTRUCTIONS
N/A
LOCATION OF WORKING INSTRUCTIONS
N/A
TO BE VIEWED
TRUST WIDE
X
PHARMACY ONLY
DOCUMENT REVIEW HISTORY
REVIEW DATE
REVIEWED BY
CHANGES
October 2008
June 2008
Dr K. Lindsay – Locum Consultant Rheumatologist
Linda Stewart - Pharmacist
Sarah Redfern - Riley Locum Rheumatology Nurse
20/7/2009
Linda Stewart
Expiry date extended as we are
waiting for the New Yorkshire
Guidelines to come out later this
year
30/12/2009
Linda Stewart – Pharmacist
Dr S Sultan – Consultant Rheumatologist
Monitoring and live vaccine
information updated
31/01/2011
Linda Stewart and Dr Sultan
Expiry date extended whilst
document being reformatted
31/5/2011
Linda Stewart – Pharmacist
Dr Reddy – Consultant Rheumatologist
Dr Sultan – Consultant Rheumatologist
Document reformatted and
responsibilities of GP and consultant
added.
May 2013
Linda Stewart – Pharmacist
Dr Reddy – Consultant Rheumatologist
Dr Sultan – Consultant Rheumatologist
Document amended to take into
account the change to licensed
subcutaneous methotrexate and
updated.
September
2013
Linda Stewart – Pharmacist
Dr Sultan – Consultant Rheumatologist
Shingles vaccine added to ‘avoid live
vaccines section’
July 2014
Linda Stewart – Pharmacist
Dr Sultan – Consultant Rheumatologist
Frequency of monitoring of U&Es
amended
September
2015
Linda Stewart – Pharmacist
Dr Sultan – Consultant Rheumatologist
Kelly Hayes-Head – CNS Rheumatology
Removed contra-indication to
shingles vaccine
Blood cell ranges amended
September
2017
NB: ONLY SHAREPOINT VERSION OR NUMBERED COPIES IN STATED LOCATIONS
ARE VALID FOR OPERATIONAL USE
In keeping with Yorkshire Rheumatology Guidelines June 2009
In accordance with BSR/BHPR guidelines 2008
Revised September 2015, Review date September 2017
Agreed by DTC May 2013
METHOTREXATE SUBCUTANEOUS INJECTION RHEUMATOLOGY GUIDE
GENERAL
STATEMENTS
PHARMACOLOGICAL
SUMMARY
INDICATIONS FOR
THERAPY
CONTRAINDICATIONS
Methotrexate should be initiated in secondary care under
specialist supervision.
Prescribing and monitoring will be carried out by the
Rheumatology Department throughout the course of treatment.
Patients receive supplies of drug from hospital via home delivery
The full summary of product characteristics (SPC) should be
read before prescribing.
Methotrexate Subcutaneous Injection SPC
Methotrexate is a competitive inhibitor of dihydrofolate reductase and
thus interferes with the process of DNA synthesis and cell replication.
This may not account for its full action in rheumatoid arthritis.
N.B. at the doses used in rheumatology, methotrexate is classed as an
immunosuppressive drug and not a cytotoxic agent.

Active rheumatoid arthritis in adult patients

Steroid sparing agent in Polymyalgia rheumatica,
Temporal arteritis

Immunosuppressant in vasculitis

Known hypersensitivity to methotrexate
Pregnancy or planned pregnancy (stop at least 6/12 before
considering conception, for both male and female patients)
Breastfeeding





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Severe immunodeficiency.
Serious infection.
Severe renal (CrCl <20ml/min)
Severe hepatic impairment
pre-existing blood dyscrasias, such as bone marrow
hypoplasia, leukopenia, thrombocytopenia, or significant
anaemia,
 AVOID LIVE VACCINATIONS
(BCG, MMR, Poliomyelitis (live oral vaccine), Rotavirus (live
oral vaccine), Typhoid (live oral vaccine), Varicella-Zoster
vaccine (Zostavax@) and Yellow Fever)
 Zostavax® is a live attenuated vaccine. Caution needs to
be exercised in the use of live vaccines in people who
may be immunosuppressed. However the DH guidelines
for the use of Zostavax® state:
“Therapy with low-doses of methotrexate (<0.4 mg/Kg/week),
for treatment of rheumatoid arthritis, psoriasis, polymyositis,
sarcoidosis, inflammatory bowel disease, and other
conditions are not considered sufficiently immunosuppressive
and are not contraindications for administration of zoster
vaccine”.
 For more detail see Vaccinations Rheumatology Shared
Care Guideline
In keeping with Yorkshire Rheumatology Guidelines June 2009
In accordance with BSR/BHPR guidelines 2008
Revised May 2013, Review date September 2015
Agreed by DTC May 2013
1 of 5
METHOTREXATE SUBCUTANEOUS INJECTION RHEUMATOLOGY GUIDE
CAUTIONS
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Renal impairment: inform specialist if GFR falls below
30ml/min as increased risk of toxicity
Alcohol consumption must not exceed national
recommendations (BSR)
Intercurrent infection: Methotrexate use is associated with a
small increased risk of infection.

Chicken pox/varicella zoster can be fatal in
immunosuppresed patients: varicella zoster
immunoglobulin should be given to susceptible patients
(not known to be immune to chicken pox) where contact
occurs, preferably within 3 days but up to 10 days after
exposure. Systemic antivirals should be given if infection
is suspected
 In the presence of significant infection requiring antibiotics
DMARDs should be stopped . They can be restarted
when clear of infection and /or the antibiotic course has
been completed.
POTENTIAL DRUG
INTERACTIONS
INITIAL SCREENING
PRESCRIBING
NSAID USE: May increase the bioavailability of methotrexate by
slowing renal excretion. This is rarely of clinical significance and
only very rarely causes toxicity.
Folate antagonists e.g. phenytoin, trimethoprim, co-trimoxazole,
penicillins
tolbutamide
See BNF for full list of interactions
CXR in last 6 months, FBC, LFTs and U&E checked in rheumatology
Clinic
Pulmonary function tests in patients with RA and if underlying chest
disease/ smoker . Hepatitis B and C serology
If TLCO < 70% or clinical concern – HRCT lungs advisable
If patient is unsure if they have had chicken pox need to check
Varicella Zoster Virus IgGs
Methotrexate subcutaneous injection should be given given
ONCE weekly.
The starting dose is usually 10mg but can vary.
Increased as appropriate by 2.5- 5 mg every 2-4 weeks.
Usual maximum dose 25mg/ week.
Prescribe folic acid supplements - 5mg weekly the day after
methotrexate to reduce toxicity.
Analgesics and NSAIDs are not contra-indicated with
methotrexate and are often needed.
Pneumovax and annual ‘flu vaccine should be given
In keeping with Yorkshire Rheumatology Guidelines June 2009
In accordance with BSR/BHPR guidelines 2008
Revised September 2015, Review date September 2017
Agreed by DTC May 2013 2 of 5
METHOTREXATE SUBCUTANEOUS INJECTION RHEUMATOLOGY GUIDE
MONITORING
FBC, LFTs: 2 weekly for 2 months, then monthly for 4 months, then 3
monthly (assuming dose stable).
U&Es, ESR or CRP 3 monthly.
If any increase in dose, monitor FBC, LFTs every 2 weeks for 2
months, then revert to patient’s usual monitoring arrangements
If the bloods are abnormal BUT above the specified
values below, consider the trend. If the patient is well,
simply repeat count in one week but continue
DMARD. If persistently low CONTACT AGH as dose
adjustment may be required
If any of the following apply please contact AGH
urgently and withhold DMARDs
WCC
Neutrophils
Platelets
AST/ALT/AlkPhos
<3.0 x 109/l
<1.5 x 109/l
<100 x 109/l
>2 x upper limit of normal
Unusual bruising, fever, sore throat (check FBC first
and if the above apply: contact AGH)
Breathlessness and/ or cough unexplained by infection
or persistent despite antibiotics
Unexplained fall in albumin (increased risk of
methotrexate toxicity)
Significant deterioration in renal function or if GFR falls
below 30ml/min
ADVERSE EVENTS

Folic acid 5mg should be prescribed once a week the day after
the methotrexate dose. However the rheumatology team may
suggest increasing this dose to 5mg every day, except on the
day of methotrexate, if significant side effects occur e.g. where
mouth ulcers or hair loss become problematic.
 Common: Nausea, anorexia, oral ulcers, hair loss, abdominal
pain, diarrhoea and headaches, drowsiness, blurred vision
 Uncommon: Rash, thrombocytopenia, and neutropenia.
 Rare: Hepatotoxicity, Pulmonary toxicity (acute pneumonitis or
chronic pulmonary fibrosis).
See BNF for full list of adverse events
In keeping with Yorkshire Rheumatology Guidelines June 2009
In accordance with BSR/BHPR guidelines 2008
Revised September 2015, Review date September 2017
Agreed by DTC May 2013 3 of 5
METHOTREXATE SUBCUTANEOUS INJECTION RHEUMATOLOGY GUIDE
RESPONSIBILITY OF
THE SPECIALIST
INITIATING
TREATMENT
SUMMARY

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
RESPONSIBILITY OF
OTHER
PRESCRIBERS
To assess the suitability of the patient for this treatment
To perform the baseline tests
To inform the patient of the side effects of methotrexate
and long term monitoring required before initiating
treatment
To ensure that the patient is aware that they must use
reliable contraception
To initiate treatment and supply a METHOTREXATE
monitoring booklet and patient information leaflet
To assess and monitor the patient’s response to
treatment
To adjust treatment as clinically necessary.
Supporting and advising GPs
To monitor the patient for adverse events and report to
the GP, and where appropriate, the Commission on
Human Medicines / MHRA (Yellow card scheme).
SUMMARY
The General Practitioner:

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To monitor the patient’s overall health and wellbeing.
Monitor the patient for adverse drug reactions and remain
vigilant to the risk of potential drug interaction.
To ensure that the patient is using reliable contraception
Prescribe folic acid therapy as recommended by the
hospital specialist.
Ensure methotrexate is included on the electronic patient
record in order to minimise the chances of prescribing
other drugs that would interact with methotrexate.
Report adverse events to the specialist service, and
where appropriate, the Commission on Human Medicines
/ MHRA (Yellow card scheme).
To stop treatment on the advice of the hospital specialist
or if the GP feels it is clinically indicated (If in doubt STOP
the treatment and contact the Specialist as soon as
possible).
In keeping with Yorkshire Rheumatology Guidelines June 2009
In accordance with BSR/BHPR guidelines 2008
Revised September 2015, Review date September 2017
Agreed by DTC May 2013 4 of 5
METHOTREXATE SUBCUTANEOUS INJECTION RHEUMATOLOGY GUIDE
CONTACTS
A patient information leaflet has been issued to your patient
If any problems occur please contact:
Dr Sultan, Consultant rheumatologist’s
01535 292067
secretary:
Dr Reddy, Consultant rheumatologist’s
01535 292080
secretary:
Rheumatology Nurse specialist/ advice line: 01535 292084
Pharmacy:
01535 293503
Access to shared care guidelines is available via the
internet at Airedale NHS Trust:
http://www.airedale-trustformulary.nhs.uk/default.asp
In keeping with Yorkshire Rheumatology Guidelines June 2009
In accordance with BSR/BHPR guidelines 2008
Revised September 2015, Review date September 2017
Agreed by DTC May 2013 5 of 5