ADALIMUMAB & METHOTREXATE COMBINATION THERAPY
Date:
RE:
Dear Doctor
This patient has …..................................................................................and is
being commenced on Adalimumab (Humira) in combination with methotrexate
therapy. Adalimumab is an anti-TNF therapy given by subcutaneous injection,
once a fortnight (occasionally weekly). Most patients, who are willing to, are
being taught to inject themselves, but some will require practice or district
nurse input for administration. If this is not going to be possible please let
us know as soon as possible.
ALL prescriptions for Adalimumab will be supplied by the Rheumatology
Department
I recommend commencing Methotrexate at
mg / week.
For safety please prescribe Methotrexate 2.5mg tablets only.
Folic acid should be prescribed at a dose of 5mg to be taken:
daily except on methotrexate day / once a week on day after
methotrexate.
Your patient has been screened for contraindications to Adalimumab &
Methotrexate and counselled on the drugs and possible side effects.
Written information about the drugs and monitoring requirements has
been issued.
While taking Adalimumab & Methotrexate your patient will require
FORTNIGHTLY FBC & Liver function for 3 months after starting Adalimumab
& / or until 6 weeks after last dose increase of Methotrexate, monthly
thereafter (If monitoring is normal) for the first year. If monitoring &
methotrexate dose remains stable in the second year, FBC & Liver function
can be reduced to 3 monthly.
RENAL FUNCTION should be checked 6 – 12 monthly if no abnormality
detected.
Your patient may experience nausea with their Methotrexate. If this occurs the
dose of Methotrexate can be divided over the 24 hours or if necessary over 2
consecutive days. In some circumstances patients will be switched to s/c
injection prescribed by the Rheumatology unit at the present time.
Other potential side effects include: rash, mouth ulcers, headache and
breathlessness.
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PTO
Adalimumab can cause any of the following side effects: injection site
reaction, headache, joint flare, ‘flu-like’ symptoms, abdominal pain, dyspepsia,
rash, sepsis.
Treatment should be withheld and the Rheumatology Department contacted
if:

Neutrophils < 1.5 x 109

new/increasing dyspnoea or cough

Platelets < 100 x 109

MCV > 105 fl

unexplained fall in serum ALBUMIN


rash or oral ulceration

deterioration in renal function
(reduce dose)
abnormal bruising/sore throat
(urgent FBC)
sepsis

>2 fold increase in ALT
(from upper limit of reference range)

Please note that live vaccines should not be given to patients taking
Adalimumab and Methotrexate.
Pregnancy and fatherhood should be avoided in all patients taking these
drugs, as Methotrexate is teratogenic. Breastfeeding should also be
avoided.
If your patient is in close skin contact with chickenpox or shingles, then
Adalimumab & Methotrexate should be stopped for 2 weeks and:
 Varicella Zoster antibody IgG levels checked (after discussion with
Rheumatology or Microbiology)
 If negative your patient should receive 1gm IM immunoglobulin – via
pharmacy at Victoria Hospital Kirkcaldy or Queen Margaret Hospital
Dunfermline.
If your patient develops chickenpox or shingles then Adalimumab &
Methotrexate must be stopped and high dose anti-virals should be
commenced as soon as possible.
The use of NSAID’s in a standard dose with Methotrexate is NOT
contraindicated. Once stable most patients will be able to reduce or stop their
NSAID.
Please note that Adalimumab should be stopped for 4 weeks before surgery
and restarted 2 weeks following surgery if clear of infection.
There is an increased risk of certain infections – urine, chest and soft tissue
infections. Prompt treatment with antibiotics (with specimens sent to
microbiology, where possible) and withholding the anti-TNF therapy until
infection cleared is recommended.
For full SPC please refer to Fife ADTC website.
Yours Sincerely
General enquiries: 01592 648193
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Updated October 2012 Version 1 due for review October 2013