Indication:Eczema – refractory chronic hand (severe)
Drug Safety Update
Oral retinoid medicines: revised and simplified pregnancy prevention educational materials for healthcare professionals and women
All women should be made aware of the teratogenic risks before starting treatment
Pregnancy must be excluded before treatment with oral retinoids
Pregnancy test results (with a minimum sensitivity of 25 mIU/mL) must be documented 3 days or less before the prescription is issued
Women of childbearing potential should be on at least one, or preferably two, complementary forms of effective contraception (eg, barrier and hormonal)
Contraception should start 1 month before treatment, and should continue throughout oral retinoid treatment and after until the retinoids have left the patient’s system-ie:
At least 1 month after stopping treatment with isotretinoin or alitretinoin
At least 2 years after stopping treatment with acitretin
Females should undergo a pregnancy assessment every 4 weeks at follow-up appointments
Specialist advice from a physician specialised in teratology must be sought immediately if a pregnancy occurs
Prescription of oral retinoids should be limited to 30 days’ treatment
The prescription must be dispensed within 7 days of issue
Available data suggest that maternal exposure from the semen of patients receiving an oral retinoid is not associated with teratogenic effects
further information at:http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON287004
Drug Safety Update June 2013
Alitretinoin is recommended, within its licensed indication, as a treatment option for adults with severe chronic hand eczema that has not responded to potent topical corticosteroids if the person has:
* severe disease, as defined by the physician’s global assessment (PGA) and
* a dermatology life quality index (DLQI) score of 15 or more.
Alitretinoin treatment should be stopped:
* as soon as an adequate response (hands clear or almost clear) has been achieved or
* if the eczema remains severe (as defined by the PGA) at 12 weeks or
* if an adequate response (hands clear or almost clear) has not been achieved by 24 weeks.
Only dermatologists, or physicians with experience in both managing severe chronic hand eczema and the use of systemic retinoids, should start and monitor treatment with alitretinoin.
When using the DLQI, healthcare professionals should take into account any physical, sensory or learning disabilities, or other communication difficulties that could affect the responses to the DLQI. In such cases, healthcare professionals should ensure that the DLQI continues to be a sufficiently accurate measure.
NICE TA 177
Alitretinoin for the treatment of severe chronic hand eczema August 2009