Ulipristal Acetate

As the product Ulipristal Acetate (available in Canada and the US), Ulipristal Acetate is indicated for use as emergency contraception after unprotected intercourse or possible contraceptive failure when administered within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure. As the product Fibristal (available in Canada), Ulipristal Acetate is indicated for treatment of the signs and symptoms of uterine fibroids in adult women. (moderate Uterine fibroid; severe Uterine fibroid;)

Ulipristal Acetate is an emergency contraceptive. It works by stopping or delaying the release of an egg from an ovary. Ulipristal Acetate may also make it harder for a fertilized egg to attach to the uterus.

Ulipristal Acetate is used to prevent pregnancy after having sex without using a condom or other effective birth control method. Ulipristal Acetate is also used to prevent pregnancy after a regular form of birth control has failed. Ulipristal Acetate is not to be used as a regular form of daily, weekly, or monthly birth control.

Ulipristal Acetate SHOULD NOT BE USED TO TERMINATE AN EXISTING PREGNANCY.

Ulipristal Acetate may also be used for purposes not listed in this medication guide.

Instruct patients to take one tablet orally as soon as possible within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure.

The tablet can be taken with or without food.

If vomiting occurs within 3 hours of Ulipristal Acetate intake, consideration should be given to repeating the dose.

Ulipristal Acetate can be taken at any time during the menstrual cycle.

How supplied

Dosage Forms And Strengths

The Ulipristal Acetate tablet is supplied as a white to off-white, round, curved tablet containing 30 mg of Ulipristal Acetate and is marked “Ulipristal Acetate” on both sides.

Storage And Handling

Ulipristal Acetate (Ulipristal Acetate) tablet, 30 mg is supplied in a PVC-PE-PVDC-aluminum blister. The tablet is a white to off-white, round, curved tablet marked with “Ulipristal Acetate” on both sides.

NDC 50102-911-01 (1 tablet unit of use package)

Store at 20-25°C (68-77°F).

Keep the blister in the outer carton in order to protect from light. Keep out of reach of children.

For all medical inquiries contact: Afaxys, Inc. Health and Safety Team Charleston, SC, 29403, USA. 1-855-888-2467. Distributed By: Afaxys, Inc. Charleston, SC, 29403, USA. Revised: March 2015

See also:
What is the most important information I should know about Ulipristal Acetate?

Ulipristal Acetate: Pregnancy (known or suspected)

Canadian labeling: Additional contraindications (not in US labeling):Hypersensitivity to Ulipristal Acetate or any component of the formulation

Fibristal [Canadian product]: Hypersensitivity to Ulipristal Acetate or any component of the formulation; pregnancy; breastfeeding; genital bleeding of unknown etiology or for reasons other than uterine fibroids; cancer of the breast, cervix, uterus, or ovaries; hepatic disease (current or history of)

Use Ulipristal Acetate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Ulipristal Acetate. Talk to your pharmacist if you have questions about this information.
• Take Ulipristal Acetate by mouth with or without food.
• Keep Ulipristal Acetate in its original packaging until you are ready to take it. Do not take it if the package is torn or broken.
• Take Ulipristal Acetate as soon as possible after known or suspected birth control failure or after you have unprotected sexual intercourse. The dose must be taken within 120 hours (5 days), or as directed by your doctor.
• Ulipristal Acetate can be used any time during the menstrual cycle.
• If vomiting occurs within 3 hours after taking Ulipristal Acetate, talk with your health care provider to discuss whether to repeat that dose.
• If you are unsure about your general health or pregnancy status, a follow-up physical or pelvic exam may be needed after taking Ulipristal Acetate.
• If you miss a dose of Ulipristal Acetate, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Ulipristal Acetate.

Ulipristal Acetate is used in adult women of childbearing age to relieve moderate to severe symptoms of uterine fibroids (non-cancerous tumors of the womb) either before the surgery for fibroids or for long term treatment. It is also used as an emergency contraception to prevent pregnancy after unprotected sexual intercourse or known contraceptive failure.

See also:
What other drugs will affect Ulipristal Acetate?

Barbiturates: May decrease the serum concentration of Ulipristal Acetate. Avoid combination

Bosentan: May decrease the serum concentration of Ulipristal Acetate. Avoid combination

CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

CYP3A4 Inducers (Strong): May decrease the serum concentration of Ulipristal Acetate. Avoid combination

CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Ulipristal Acetate. Management: This is specific for when Ulipristal Acetate is being used for signs/symptoms of uterine fibroids (Canadian indication). When Ulipristal Acetate is used as an emergency contraceptive, patients receiving this combination should be monitored for Ulipristal Acetate toxicity. Avoid combination

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Ulipristal Acetate. Management: This is specific for when Ulipristal Acetate is being used for signs/symptoms of uterine fibroids (Canadian indication). When Ulipristal Acetate is used as an emergency contraceptive, patients receiving this combo should be monitored for Ulipristal Acetate toxicity. Avoid combination

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Consider therapy modification

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Efavirenz: May decrease the serum concentration of Ulipristal Acetate. Avoid combination

Erdafitinib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Felbamate: May decrease the serum concentration of Ulipristal Acetate. Avoid combination

Griseofulvin: May decrease the serum concentration of Ulipristal Acetate. Avoid combination

Ivosidenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

OXcarbazepine: May decrease the serum concentration of Ulipristal Acetate. Avoid combination

Progestins: Ulipristal Acetate may diminish the therapeutic effect of Progestins. Progestins may diminish the therapeutic effect of Ulipristal Acetate. Management: Ulipristal Acetate for uterine fibroids (Canadian indication): avoid progestins within 12 days of stopping Ulipristal Acetate; as emergency contraceptive (U.S. indication): avoid progestins within 5 days of stopping Ulipristal Acetate. Avoid combination

Sarilumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

St John's Wort: May decrease the serum concentration of Ulipristal Acetate. Avoid combination

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Topiramate: May decrease the serum concentration of Ulipristal Acetate. Avoid combination

See also:
What are the possible side effects of Ulipristal Acetate?

Abdominal pain, Dizziness, Pain during periods, Fatigue, Headache, Nausea, Intermenstrual bleeding

Ulipristal Acetate is a selective progesterone receptor modulator used for the purposes of emergency contraception (Ulipristal Acetate) and for the treatment of uterine fibroids (Fibristal). It is a derivative of 19-norprogesterone and has both antagonistic and partial agonist activity at the progesterone receptor. It also binds to glucocorticoid receptor, however compared to mifepristone (a progesterone receptor antagonist), Ulipristal Acetate is more tolerable and has lower glucocorticoid activity and better binding affinity. Ulipristal Acetate is currently recommended as first line therapy for emergency contraception, due to improved efficacy and similar side effect profile as compared to the traditional use of levonorgestrel or the Yuzpe regimen. The exact mechanism of action for Ulipristal Acetate is still currently debated, though there is evidence that it functions by inhibiting ovulation. A recent systematic review proclaimed that the majority of available evidence demonstrates an inhibitory effect on ovulation rather than a post-fertilization effect on the endometrium, which has been heavily debated due to ethical concerns related to abortion (Rosato et al, 2016).