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Ulipristal Acetate

Drug Class: Commonly Known As: Category:
Progestin Receptor Modulator Esmya® Adult

Ulipristal Acetate - What is it for

Fibroids are the most common form of non-cancerous, benign growth in women of reproductive age that grow in the muscles of the uterus (womb). The majority are very small and do not cause symptoms at all. However, when they become very large, they can cause heavy menstrual bleeding, pelvic pain and discomfort. The causes of uterine fibroids are not yet fully understood, however, they seem to be stimulated by the female hormone, progesterone.

Esmya® is used to treat moderate to severe symptoms of uterine fibroids by modifying the activity of progesterone. A single course of Esmya® can be used in women who are about to have surgery for their fibroids. It can be used for more than one course only in women who cannot have surgery.

Ulipristal Acetate - Side Effects, Precautions, and Contraindications

What side effects can Ulipristal Acetate cause?

Side effects may occur when taking Esmya®, but the majority of these tend to resolve spontaneously. Common side effects include:

  • Reduced or absence of menstrual bleeding - see special precautions
  • Thickening of the lining of the womb
  • Dizziness - do not drive or operate machines if you experience these symptoms
  • Hot flushes
  • Headache
  • Stomach discomfort e.g. nausea, vomiting, abdominal pain
  • Acne
  • Muscle pain
  • Fatigue
  • Breast tenderness

Consult your doctor about any symptoms that becomes bothersome.

Esmya® will not be prescribed to you if you have liver problems. In order to prevent rare but serious liver injury:

  • Blood tests will be done to find out how well your liver is working. Depending on the result of these tests, your doctor will decide if Esmya® is suitable for you.
  • You will also have blood tests to check your liver function during treatment with Esmya®. In addition, an additional check will be done after stopping treatment.
  • You should stop treatment and contact your doctor immediately if you develop symptoms of liver injury (such as tiredness, yellowing of the skin, darkening of the urine, nausea and vomiting).

Before taking Ulipristal Acetate, what precautions must I follow?

What food or medicine must I avoid when I take Ulipristal Acetate?

Ulipristal Acetate - Dosage and How to Use

How should Ulipristal Acetate be used?

  • Esmya® may be started on the first week of menstruation. Other hormonal treatments (e.g. combined oral hormonal treatment, progestogens-only pills, progestogen releasing devices) should be stopped before initiation of Esmya®.
  • It is usually administered as one tablet daily for treatment courses of up to 3 months each.  It can be taken with or without food.
  • If you have been prescribed several courses of Esmya® 3-month treatment, you should start each course at the earliest during the second menstrual bleeding following the previous treatment completion.

What should I do if I miss a dose?

If you miss a dose by less than 12 hours, take it as soon as you remember. If you miss a dose by more than 12 hours, skip the missed tablet. Resume the next dose and take only a single tablet as usual at the regular timing. Do not take a double dose to make up for a forgotten tablet.

What should I do if I overdose?

Ulipristal Acetate - Handling and Storage

How should I handle Ulipristal Acetate safely?

How should I store Ulipristal Acetate?

Keep away from children;#Keep in a cool, dry place, away from direct sunlight;#Store at room temperature;#

How should I dispose of Ulipristal Acetate safely?

Ulipristal Acetate - Additional Information

  • Bleeding patterns

  • Esmya® leads to a significant reduction in menstrual blood loss and may even stop your menstrual bleeding within the first 10 days of treatment. If excessive bleeding persists, you should inform your doctor. Menstrual periods will generally return within 4 weeks after the end of the treatment course.

  • Interactions with other medications

  • Check with your doctor or pharmacist if you are taking any other medicines or herbal supplements as they may interact with this medication and cause undesirable effects. You should avoid drinking grapefruit juice while on treatment with Esmya®.

  • Contraception​​

  • Esmya® is likely to make some hormonal contraceptives less effective. Women taking Esmya® as treatment for uterine fibroids are advised to use non-hormonal contraception (e.g barrier-method such as a condom) as a precaution to prevent pregnancy.

  • Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. 

  • Updated on Friday, August 17, 2018
  • This article is contributed by Department of Pharmacy KK Women's and Children's Hospital, Singapore General Hospital

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