Powder for solution for injection

Specialist use only

Concentrate for solution for infusion.

100mg

Pre-filled syringe 70mg, 140mg

Pre-filled pen 70mg, 140mg

Pre-filled pens/ pre-filled syringes 225mg/1.5ml solution for injection  

Solution for injection pre-filled pens  120mg/1ml

For NICE TA659: Galcanezumab for preventing migraine

Tablets 500micrograms, 1.5mg

**Under review**

See section 4.8.1

Unlicensed indication

In November 2023, due to known significant risk of serious harm to a baby after exposure to valproate the MHRA has stipulated that new regulatory measures will be put in place in January 2024 for oral valproate medicines as follows:

• Valproate must not be initiated in patients male or female under the age of 55 years, unless two specialists independently consider and document that there is no other effective or tolerated treatment and any use of valproate in women of childbearing potential should be in accordance with the Pregnancy Prevention Programme.
• At their next annual review females of childbearing potential will require the signature of a second specialist if valproate is to be continued

National Patient Safety Alert:  Valproate: organisations to prepare for new regulatory measures for oversight of prescribing to new patients and existing female patients https://assets.publishing.service.gov.uk/media/6565ddf162180b0012ce82fd/NatPSA-2023-013-MHRA.pdf

MHRA Drug Safety Update - Valproate medicines (Epilim▼, Depakote▼): contraindicated in women and girls of childbearing potential unless conditions of Pregnancy Prevention Programme are met https://www.gov.uk/drug-safety-update/valproate-medicines-epilim-depakote-contraindicated-in-women-and-girls-of-childbearing-potential-unless-conditions-of-pregnancy-prevention-programme-are-met?utm_source=eshot&utm_medium=email&utm_campaign=DSUApril2018Split2

**Under review**

Tablets 25mg, 50mg, 100mg, 200mg

Topiramate is now contraindicated in pregnancy and in women of childbearing potential unless the conditions of a Pregnancy Prevention Programme are fulfilled. This follows a review by the MHRA which concluded that the use of topiramate during pregnancy is associated with significant harm to the unborn child. Harms included a higher risk of congenital malformation, low birth weight and a potential increased risk of intellectual disability, autistic spectrum disorder and attention deficit hyperactivity disorder in children of mothers taking topiramate during pregnancy.

Capsules, 25mg. 50mg, 100mg

Approved for use in patients when at least 3 prior prophylactic treatments have failed and erenumab, galcanezumab and fremanezumab are being considered 

Capsules 5mg

Specialist consultant use only