Indications

Ulipristal Acetate is used before surgery to treat moderate to severe symptoms of uterine fibroids, which are noncancerous (benign) tumors of the womb (uterus). Ulipristal Acetate is used in adult women who have not yet reached menopause.

Therapeutic Class

Drugs acting on the Uterus

Pharmacology

Ulipristal acetate is a selective progesterone receptor modulator. It acts by blocking the receptor of a hormone in the body called progesterone, which is involved in controlling the growth of the lining of the womb. In some women, progesterone may promote the growth of fibroids, which may cause symptoms such as heavy uterine bleeding, anaemia and abdominal pain. When progesterone activity is blocked, fibroid cells stop dividing and eventually die which reduces the size of the fibroids and reduces the symptoms caused by them.

Dosage & Administration

Ulipristal acetate is taken by mouth and the recommended dose is one tablet (5 mg) a day for up to three months. The three month treatment can be repeated but only once. Treatment should always be started during the first week of the menstrual cycle (period bleeding).

Contraindications

Contraindicated in patients with-

Hypersensitivity to the active substance or to any of the excipients.

Pregnancy and breastfeeding.

Genital bleeding of unknown aetiology or for reasons other than uterine fibroids.

Uterine, cervical, ovarian or breast cancer.

Side Effects

Common side effects are Endometrial thickening, Hot flush, Headache, Uterine haemorrhage

Pregnancy & Lactation

Pregnancy Category X. Ulipristal acetate is contraindicated during pregnancy. Ulipristal acetate is excreted in human milk and is not recommended.

Precautions & Warnings

Ulipristal acetate should only be prescribed after careful diagnosis and Pregnancy should be precluded prior to treatment.

Contraception: Concomitant use of progestagen-only pills, a progestagen releasing intrauterine device or combined oral contraceptive pills is not recommended. Although a majority of women taking a therapeutic dose of ulipristal acetate have anovulation, a non-hormonal contraceptive method is recommended during treatment.

Endometrial Changes: Endometrial Thickening or Progesterone receptor modulator Associated Endometrial Changes (PAEC). Ulipristal acetate has a specific pharmacodynamic action on the endometrium. An increase in thickness of the endometrium may occur. The thickness of the endometrium decreases to baseline levels upon treatment cessation. If the endometrial thickening persists beyond 3 months following the end of treatment and return of menstruations, this may need to be investigated as per usual clinical practice to exclude underlying conditions.

Bleeding Pattern: Patients should be informed that treatment with ulipristal acetate usually leads to a significant reduction in menstrual blood loss or amenorrhea within the first 10 days of treatment. Should the excessive bleeding persist, patients should notify their physician.

Asthma Patients: Use in women with severe asthma insufficiently controlled by oral glucocorticoids is not recommended.

Use in Special Populations

Hepatic Impairment: Ulipristal acetate is not recommended in patients with severe hepatic impairment unless the patient is closely monitored.

Renal Impairment: Renal impairment is not expected to significantly alter the elimination of ulipristal acetate. In the absence of specific studies, ulipristal acetate is not recommended for patients with moderate and severe renal impairment unless the patient is closely monitored.

Overdose Effects

Experience with ulipristal acetate overdose is limited. Single doses up to 200 mg and daily doses of 50 mg for 10 consecutive days were administered to a limited number of subjects, and no severe or serious adverse reactions were reported.

Storage Conditions

Keep protected from light & moisture, store below 25° C. Keep out of reach of children.