Medicines

Here you will find the recommendations we have made about the use of individual medicines in Lancashire.

Ulipristal acetate

Brand: Esmya ®
NICE TA: 
Indication: Pre-surgical treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age
Disease category: Genito-urinary system
Commissioning responsibility: CCG
PbR excluded: No

Background

The LMMG supports the MHRA advice (August 2018) that:
• Ulipristal treatment is to be initiated and supervised by physicians experienced in the diagnosis and treatment of uterine fibroids
• Ulipristal is contraindicated in women with underlying liver disorders

Liver function monitoring
• Before initiation of each treatment course: perform liver function tests; do not initiate ulipristal in women with baseline alanine transaminase (ALT) or aspartate aminotransferase (AST) more that 2‑times the upper limit of normal [ULN]
• During the first 2 treatment courses: perform liver function tests every month
• For further treatment courses: perform liver function tests once before each new course and when clinically indicated
• At the end of each treatment course: perform liver function tests after 2–4 weeks
• Stop ulipristal treatment and closely monitor women with ALT or AST more than 3‑times ULN; consider the need for specialist hepatology referral

Discuss the risk of liver damage with ulipristal with women and report any suspected adverse drug reactions
• Before initiating ulipristal, discuss with women the rare risk of liver damage and the need for liver function testing before, during, and after treatment courses
• Pharmacists should provide the new patient card to women when dispensing ulipristal; copies of this card were included in the letter sent by post from Gedeon Richter on 1 August 2018 and are available online by searching medicines.org.uk/emc for ulipristal and selecting Risk Materials; this will only be required until packs with the pre-inserted patient card reach the market
• Advise women to seek urgent medical attention if they develop any symptoms or signs of liver injury (such as unusual tiredness, yellowing of the skin, darkening of the urine, nausea and vomiting)
• Report any suspected adverse drug reaction to ulipristal on a Yellow Card without delay

Recommendation

LMMG recommendation: Red
Click here to find the definitions for the colour classifications

Reason for decision:  Specialist medicine

Supporting documents:

MHRA Aug 2018 Update - Ulipristal (107.8 KiB)

Decisions of Lancashire local decision making groups:

NHS Blackburn With Darwen CCG and NHS East Lancashire CCG NHS Blackpool CCG NHS Chorley and South Ribble CCG and NHS Greater Preston CCG NHS Fylde and Wyre CCG NHS Morecambe Bay CCG NHS West Lancashire CCG

Red

Red

Red

Red

Red

Red