Published: 5 March 2020

Publications

Acitretin: Changes to pregnancy prevention requirements

Prescriber Update 41(1): 7-8
March 2020

Key Messages

  • Acitretin is contraindicated in women of childbearing potential unless all of the conditions of the Pregnancy Prevention Programme are met.
  • The period during which effective contraception must be used has increased from two to three years after the end of treatment.


Acitretin is a teratogenic medicine used to treat several skin conditions, including psoriasis. It is contraindicated in women of childbearing potential unless they follow all of the conditions of the Pregnancy Prevention Programme1. Recently, there has been a change to the requirements to take effective contraception following completion of treatment: women must now use effective contraception for three years (36 months). The change has occurred since the formation of etretinate in the presence of alcohol has been discovered. The half-life of etretinate is 120 days1, resulting in the increased post-treatment contraception requirements.

Prescribers are asked to remind women of childbearing potential of the Pregnancy Prevention Programme requirements. In particular, any woman requiring treatment should understand that she must consistently and correctly use one highly effective method of contraception (ie, a user-independent form) or two complementary user-dependent forms of contraception, for at least one month prior to starting treatment, throughout the treatment period and for at least three years (36 months) after cessation of treatment. Oral progesterone-only contraceptives are not considered an effective form of contraception during treatment with acitretin2.

Novatretin is the only approved acitretin product currently available in New Zealand. The pregnancy warning on the Novatretin package label and foils has been updated from 24 to 36 months (Figure 1).

Figure 1: Image of the Novatretin (acitretin) package foils

Figure 1

References

  1. Douglas Pharmaceuticals Ltd. 2019. Novatretin New Zealand Data Sheet 8 October 2019. URL: medsafe.govt.nz/profs/Datasheet/n/novatretincap.pdf (accessed 17 December 2019).
  2. New Zealand Formulary. 2020. New Zealand Formulary v91: Acitretin 1 January 2020. URL: nzf.org.nz/nzf_6379 (accessed 30 January 2020).
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