Display Patient Information Leafelts

Esmya (ullipristal acetate) for fibroids

Date issued: August 2021

Review date: August 2023

Ref: A-475

PDF: Esmya (ullipristal acetate) for fibroids final August 2021.pdf [pdf] 187KB

This information leaflet is for women who have been offered treatment with Esmya for fibroids.

What is Esmya?

Esmya is a tablet taken orally once a day for a course of 3 months. It is a very effective treatment for women who have symptoms caused by fibroids. Fibroids are non-cancerous growths in the uterus. Symptoms from fibroids can include heavy menstrual bleeding (heavy periods), pelvic pain and pressure on other organs. Esmya can reduce the size of your fibroids and can also stop or reduce bleeding.

What are the risks of taking Esmya?

Rare but serious cases of liver injury, including cases of hepatic failure requiring liver transplantation, have been reported worldwide in women treated with Esmya for the symptoms of uterine fibroids. For this reason, you should not take Esmya if you have an existing liver condition.

Esmya makes hormonal contraception (such as the pill, the implant, the depo injection or the Mirena IUS) less effective. It is therefore advised that you use additional reliable barrier method such as condoms to prevent pregnancy whilst you take Esmya. You should discuss this with your doctor before starting treatment.

You should not take Esmya if you are pregnant or breastfeeding

Am I eligible for treatment with Esmya?

More than one course of Esmya can be taken by women of reproductive age with moderate to severe symptoms, when surgical procedures (including fibroid embolization) are not suitable or have failed.

Will I need monitoring whilst I take Esmya?

We will arrange close monitoring of your liver function whilst you take Esmya.

You will be in contact with Sarah Black CNS (Clinical Nurse Specialist). Sarah will monitor your blood tests, liaise with your consultant and arrange prescriptions. Please note prescriptions will only be available from the hospital.

Before the course

Before you start treatment with Esmya you will have a blood test to confirm your liver is functioning normally. You should not start taking Esmya until your doctor/CNS has confirmed the results with you.

Contact Sarah on (01752) 430089 when it has been confirmed you are going to commence treatment. Sarah will discuss with you the best form of contact and where to go for your blood tests.

During the course

Blood tests to check your liver function will be repeated monthly during the first 2 treatment courses. If you take more than 2 courses, blood tests will be taken before you start each course.

Sarah will only contact you if the results are abnormal. If, in the unlikely event that there are any abnormalities we may advise that you stop taking Esmya.

At the end of the course

Blood tests to check your liver function will be taken 2 to 4 weeks after you complete a course of Esmya.

When to stop Esmya

You should stop taking Esmya and contact your GP immediately if you experience any signs which may be caused by liver damage such as feeling of being sick (nausea or vomiting), fatigue, severe tiredness, jaundice (yellowing of the eyes or skin), dark urine, itching or upper stomach ache.

You can contact Sarah on 01752 430089 Mon-Fri 9-5

Further information

More information is available at:

www.nhs.uk/conditions/fibroids/treatment/

www.gov.uk/drug-safety-update/esmya-ulipristal-acetate-and-risk-of-serious-liver-injury-new-restrictions-to-use-and-requirements-for-liver-function-monitoring-before-during-and-after-treatment

www.rcog.org.uk/en/guidelines-research-services/guidelines/esmya-ulipristal-acetate---mhra-safety-alert/

 

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