Topiramate & Contraception

Contraception for individuals using Topiramate

Pregnancy MUST be avoided during use of Topiramate because it is a teratogen. Use of effective contraception is a requirement for prescription of Topiramate for any individual who has the potential to conceive.

Ideally, highly effective long-acting reversible contraception (LARC) should be used because short-acting contraception methods have a high contraceptive failure rate.

However, Topiramate is an enzyme inducer and so contraception options are limited to levonogestrel (LNG) and copper intrauterine contraception, sterilisation, and progestogen only injections (POI) plus condoms.

Background information regarding Topiramate and the pregnancy prevention programme

Pregnancy must be avoided during use of Topiramate.  Harms in the children of mothers taking Topiramate during pregnancy include:

• a higher risk of congenital malformation
• low birth weight
• a potential increased risk of intellectual disability
• autistic spectrum disorder
• attention deficit hyperactivity disorder.

It is extremely important, therefore, that pregnancy is avoided during use of Topiramate.

The UK Topiramate Pregnancy Prevention Programme aims to minimise exposure of pregnancies to Topiramate. It mandates that if Topiramate is the only suitable treatment option, the individual must use effective contraception during Topiramate use and for 4 weeks after the last dose.

Exclusion criteria for use of effective contraception during use of Topiramate include:-

• Hysterectomy
• Bilateral oophorectomy
• Aged >50 years and confirmed post-menopause (i.e. at least 12 months of natural amenorrhoea after age 50 or 12 months after a serum FSH >30 that was taken after age 50)
• No sexual partners who were assigned male at birth.

Consideration of any other potential exclusion criteria should be made by the specialist overseeing prescription of the Topiramate medicine.

Contraceptive options during use of Topiramate

Highly effective contraceptive methods should be recommended during use of Topiramate. These are methods that do not rely on the user to ensure correct use and are >99% effective for contraception. They include:-

• Copper intrauterine devices (Cu-IUD)
• Levonorgestrel-releasing intrauterine devices (LNG-IUD – available as LNG 52mg, 19.5mg and 13.5mg devices)
• Female sterilisation*
• Male sterilisation*

(Note that there is a wait for both female and male sterilisation procedures and that after male sterilisation the contraception should not be relied upon until follow up semen analysis is complete. Interim effective contraception is required).

• If these methods are not suitable depot medroxyprogesterone acetate (Depo Provera, Sayana Press) PLUS condoms can be used.

Topiramate is an enzyme inducer which means it may reduce contraceptive effectiveness of the combined hormonal contraception (CHC), progestogen only pills (POP) and etonogestrel implants (ENG-IMP).

Therefore, highly effective methods of contraception that are not affected by enzyme inducers (Cu- IUD, LNG-IUD, sterilisation) are recommended. If these methods are not suitable/acceptable, depot medroxyprogesterone acetate injections could be considered (their effectiveness is not affected by enzyme induction) but additional use of condoms should be recommended because the typical use failure rate of POI is much higher than LARC methods and sterilisation.

The typical use contraceptive failure rate of condoms, internal condoms and contraceptive diaphragms and caps, fertility awareness methods and apps is high. These methods should not be relied upon to prevent pregnancy during use of topiramate, and alternative, effective contraception should be offered.

If there is a risk of pregnancy because contraception has not been used/ has not been used correctly, or if an IUD has expired or cannot be located, a pregnancy test should be performed, and requirement for emergency contraception (EC) assessed and EC offered if indicated:

• If EC is indicated a copper IUD should be recommended if appropriate.
• Individuals should be advised that the effectiveness of oral EC could be reduced by Topiramate.
• A double (3mg) dose of LNG-EC can be considered but individuals should be informed that the effectiveness of this regimen is unknown. A double-dose of UPA-EC is not recommended

If an individual with potential to conceive is using Topiramate and wishes to discontinue their current effective contraception:-

• explain the importance of effective contraception during Topiramate use
• offer alternative effective contraception, and ensure immediate start of the new method
• if the individual declines effective alternative contraception, advise that discussion with the specialist overseeing their Topiramate use is required prior to stopping effective contraception, make an urgent referral to the Complex Contraception Clinic at Chalmers and inform their specialist and their GP of their wish to discontinue contraception.
• Effective contraception must be continued for 4 weeks after the last dose of Topiramate.

The individual’s GP and the specialist overseeing their Topiramate prescription MUST be made aware of any changes to contraception.