Ulipristal acetate

What is Ulipristal acetate?

• Ulipristal acetate (ella) is a progesterone agonist/antagonist emergency contraceptive used for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure.

What are the uses of this medicine?

• Ulipristal acetate (ella) is a prescription emergency contraceptive that reduces your chance of becoming pregnant if your birth control fails or you have unprotected sex.

Limitations of use:

• ella should not be used as your regular birth control.
• It is very important that you have a reliable form of birth control that is right for you.
• ella will not protect you against HIV infection (AIDS) and other sexually transmitted diseases (STDs).

How does this medicine work?

• An orally bioavailable, acetate ester of ulipristal, a selective progesterone receptor modulator with anti-progesterone activity.
• Ulipristal binds to the progesterone receptor (PR), thereby inhibiting PR-mediated gene expression, and interfering with progesterone activity in the reproductive system.
• As a result, this agent may suppress the growth of uterine leiomyomatosis.
• Furthermore, by inhibiting or delaying ovulation and effecting endometrial tissue, ulipristal can be used as an emergency contraception.
• When taken immediately before ovulation is to occur, ella postpones follicular rupture.
• The likely primary mechanism of action of ulipristal acetate for emergency contraception is therefore inhibition or delay of ovulation; however, alterations to the endometrium that may affect implantation may also contribute to efficacy.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• in the case of known or suspected pregnancy.

What drug interactions can this medicine cause?

Drugs or herbal products that induce CYP3A4 decrease the effectiveness of ella which includes:

• barbiturates
• bosentan
• carbamazepine
• felbamate
• griseofulvin
• oxcarbazepine
• phenytoin
• rifampin
• St. John's Wort
• topiramate
• Avoid co-administration of ella and hormonal contraceptives.
• CYP3A4 inhibitors such as itraconazole or ketoconazole increase plasma concentrations of ella.

Is this medicine FDA approved?

• Ulipristal acetate was approved for medical use in the United States in 2010.

How should this medicine be used?

Recommended dosage:

• One tablet taken orally as soon as possible, within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure.

Administration:

• Take ella as soon as possible within 5 days (120 hours) after unprotected sex or if you had a birth control failure.
• ella can be taken with or without food.
• Contact your healthcare provider right away if you vomit within 3 hours of taking ella. Your healthcare provider may prescribe another dose of ella for you.
• ella can be taken at any time during the menstrual cycle.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 30 mg tablet

This medicine is available in fallowing brand namesː

• ELLA

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• nausea
• stomach (abdominal) pain
• menstrual pain (dysmenorrhea)
• tiredness
• dizziness

What special precautions should I follow?

• ella is not indicated for termination of an existing pregnancy.
• A history of ectopic pregnancy is not a contraindication to use of this emergency contraceptive method. Women who become pregnant or complain of lower abdominal pain after taking ella should be evaluated for ectopic pregnancy.
• ella is for occasional use as an emergency contraceptive. It should not replace a regular method of contraception. Repeated use of ella within the same menstrual cycle is not recommended, as safety and efficacy of repeat use within the same cycle has not been evaluated.
• ella should not be administered with CYP3A4 inducers
• Subsequent acts of intercourse should be protected by a reliable barrier method until next menstrual period. If a woman wishes to use hormonal contraception, she should do so no sooner than 5 days after intake of ella.
• ella may alter the next expected menses. If menses is delayed beyond 1 week, pregnancy should be ruled out.
• ella does not protect against HIV infection (AIDS) or other sexually transmitted infections (STIs).

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Experience with ulipristal acetate overdose is limited.

Can this medicine be used in pregnancy?

• ella is contraindicated for use during an existing or suspected pregnancy.

Can this medicine be used in children?

• Safety and efficacy of ella have been established in women of reproductive age.
• Use of ella before menarche is not indicated.

What are the active and inactive ingredients in this medicine?

• Active ingredients: ulipristal acetate, 30 mg
• Inactive ingredients: lactose monohydrate, povidone, croscarmellose sodium, and magnesium stearate

Who manufactures and distributes this medicine?

• Manufactured for :

Afaxys Pharma LLC, Charleston, SC, USA

• Under License From:

Laboratoire HRA Pharma Paris, France

ella® is a registered trademark of Laboratoire HRA Pharma

• Manufactured by:

Cenexi,Osny, France, or Laboratorios León Farma S.A., León, Spain or Delpharm Lille SAS,Lys-Lez-Lannoy, France

What should I know about storage and disposal of this medication?

• Store ella at 68-77°F (20-25°C).
• Protect ella from light.
• Keep ella in the blister card inside the original box until you are ready to take it.

• Dailymed label info on Ulipristal acetate
• FDA Ulipristal acetate

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