Download Cyclophosphamide injections - airedale

DOCUMENT
TITLE:
CYCLOPHOSPHAMIDE INTRAVENOUS INJECTION RHEUMATOLOGY
GP INFORMATION
FILENAME
PHA_Medicines Management_Shared care
Guideline_Cyclophosphamide Intravenous Injection
Rheumatology GP information
VERSION №
6
DATE OF ISSUE
26/10/2007
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 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
26/10/2007
Karen Lindsay Rheumatology Nurse
and Linda Stewart Pharmacist
Live vaccines to be avoided
Contact details
17/12/2009
Linda Stewart – Pharmacist
Dr S Sultan – Consultant Rheumatologist
Live vaccine, screening and monitoring
information updated
31/01/2011
Linda Stewart and Dr Sultan
Expiry date extended whilst document
being reformatted
31/05/2011
Linda Stewart – Pharmacist
Dr Reddy – Consultant Rheumatologist
Dr Sultan – Consultant Rheumatologist
Document reformatted and responsibilities
of GP and consultant added
31/5/2013
Linda Stewart
Review date extended. Sent to consultants for
consultation
30/9/2013
Linda Stewart – Pharmacist
Dr Sultan – Consultant Rheumatologist
DTC September 2013
Shingles vaccine added to the ‘avoid live
vaccine’ section.
30/9/2015
Linda Stewart – Pharmacist
Dr Sultan – Consultant Rheumatologist
APC – 17th December 2015
Monitoring section reviewed in line with
Yorkshire Rheumatology Guidelines for
monitoring DMARDs (May 2014) and SPC
Pregnancy and breastfeeding moved to a
separate new section
17/12/2017
NB: ONLY SHAREPOINT VERSION OR NUMBERED COPIES IN
STATED LOCATIONS ARE VALID FOR OPERATIONAL USE
In keeping with Yorkshire Rheumatology Guidelines May 2014
In accordance with BSR/BHPR guidelines 2008
Revised December 2015 Review date December 2017
Agreed by DTC September 2013
Page: 1 of 5
CYCLOPHOSPHAMIDE INTRAVENOUS INJECTION RHEUMATOLOGY
GP INFORMATION
GENERAL
STATEMENTS
 Cyclophosphamide should be initiated in secondary care
under specialist supervision.
 Prescribing, administration and monitoring will be carried
out by the Rheumatology Department throughout the course
of treatment.
The full summary of product characteristics (SPC) should be read
before prescribing.
Baxter UK - IV Solutions & Medication Delivery Systems
PHARMACOLOGIC
AL SUMMARY
INDICATIONS FOR
THERAPY
CONTRAINDICATIONS
PREGNANCY AND
BREASTFEEDING
Cyclophosphamide is an antineoplastic agent which is
converted in the body to an active alkylating metabolite. It also
possesses marked immunosuppressant properties.
Cyclophosphamide is used in the treatment of systemic
vasculitis and in certain organ or life threatening
manifestations of other rheumatological conditions such as
SLE, Scleroderma.
Hypersensitivity and haemorrhagic cystitis
Porphyria
AVOID LIVE VACCINATIONS
(BCG, MMR, Poliomyelitis (live oral vaccine), Rotavirus (live
oral vaccine), Typhoid (live oral vaccine), Varicella-Zoster
vaccine, Shingles and Yellow Fever))
For more detail see Vaccinations Rheumatology Share Care
Guideline




The Rheumatologist will discuss with the patient the
potential effects on fertility before commencing therapy.
Pregnancy should be avoided during treatment and for
3 months after discontinuation of treatment.
Breastfeeding not recommended
Contraception should be used for at least 3 months after
treatment in both sexes. May affect sperm count in
males.
In keeping with Yorkshire Rheumatology Guidelines May 2014
In accordance with BSR/BHPR guidelines 2008
Revised December 2015 Review date December 2017
Agreed by DTC September 2013
Page: 2 of 5
CYCLOPHOSPHAMIDE INTRAVENOUS INJECTION RHEUMATOLOGY
GP INFORMATION
CAUTIONS
POTENTIAL DRUG
INTERACTIONS
INITIAL
SCREENING
PRESCRIBING

Can cause infertility in women of childbearing age with
the younger persons at higher risk
 Hepatic and renal impairment
 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
 Contact the rheumatology consultant urgently if any
queries about a patient on regular IV
cyclophosphamide.
 In the presence of significant infection, treatment should
be withheld, FBC, U&E, LFTs and CRP sent, and
prompt therapy instituted. and inform specialist team
Oral hypoglycaemic agents may be potentiated by
cyclophosphamide.
See BNF for full list of interactions
FBC, LFT's, CRP, U&E, urinalysis, eGFR checked in
Rheumatology clinic, dose reduced if reduced eGFR
Consider hepatitis B and C in high risk groups
Administration, and monitoring will be carried out by
Rheumatology Department.
The decision to use cyclophosphamide should be made by the
Consultant Rheumatologist responsible for the patient’s care
and its planned use should be outlined in the management
plan and filed in the patient’s case notes. Patients typically
have severe connective tissue disease with organ
involvement, resistant rheumatoid arthritis or vasculitides.
Pulsed therapy on Surgical Day Ward
10 -15mg/kg plus 10mg/kg methylprednisolone.
Usual dose of 3 pulses every 2 weeks, then 3 pulses every 3
weeks and then reassess. Oral Mesna (or iv mesna) should be
given to protect the bladder from cystitis. A high fluid intake is
encouraged throughout treatment day.
Pneumovax and annual ‘flu vaccine should be given
In keeping with Yorkshire Rheumatology Guidelines May 2014
In accordance with BSR/BHPR guidelines 2008
Revised December 2015 Review date December 2017
Agreed by DTC September 2013
Page: 3 of 5
CYCLOPHOSPHAMIDE INTRAVENOUS INJECTION RHEUMATOLOGY
GP INFORMATION
MONITORING
FBC U&E LFT CRP and ESR/ CRP 7-10 days after each pulse
Urinalysis: each visit, with all results reviewed prior to
administering the drug
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
Significant deterioration in renal function or if GFR falls
below 30ml/min
ADVERSE EVENTS








Bone marrow depression, neutropenia and lymphopenia
more likely than anaemia and thrombocytopaenia
Amenorrhoea and azoospermia during treatment,
usually reversible on stopping treatment
Can induce permanent sterility in children
Haematuria (haemorrhagic cystitis)
Hair loss, which may be total, although generally
reversible;
Mucosal ulceration;
Anorexia, nausea and vomiting (may need to consider
ondansetron or equivalent)
Increased risk of certain malignancies on prolonged
use.
See BNF or SPC for full details
In keeping with Yorkshire Rheumatology Guidelines May 2014
In accordance with BSR/BHPR guidelines 2008
Revised December 2015 Review date December 2017
Agreed by DTC September 2013
Page: 4 of 5
CYCLOPHOSPHAMIDE INTRAVENOUS INJECTION RHEUMATOLOGY
GP INFORMATION
RESPONSIBILITY
OF THE
SPECIALIST
INITIATING
TREATMENT
SUMMARY








RESPONSIBILITY
OF OTHER
PRESCRIBERS
SUMMARY


To monitor the patients overall health and wellbeing.
To ensure that there are no interactions with any other
medications initiated

To refer back to the hospital specialist if the patient’s
condition deteriorates.
To identify adverse events if the patient presents with
any signs 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).

CONTACTS
To assess the suitability of the patient for this treatment
To perform the baseline tests
To inform the patient of the side effects of cyclophosphamide
and long term monitoring required before initiating treatment
To initiate treatment and provide 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).
A patient information leaflet has been issued to your
patient
If any problems occur please contact:
Dr Sultan, Consultant
rheumatologist’s secretary:
Dr Reddy, Consultant
rheumatologist’s secretary:
Rheumatology Nurse specialist/
advice line:
Pharmacy:
01535 292067
01535 292080
01535 292084
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 May 2014
In accordance with BSR/BHPR guidelines 2008
Revised December 2015 Review date December 2017
Agreed by DTC September 2013
Page: 5 of 5