Acitretin

Red

Brand Name(s):Neotigason

Indication:Psoriasis (severe and extensive)

Rationale:1,2

Considered:Apr-07

Review Date:Jul-24

Comments:
Drug Safety Update
Oral retinoid medicines: revised and simplified pregnancy prevention educational materials for healthcare professionals and women
June 2019
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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
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Refer to NICE clinical guideline 153 – October 2012