Ella Information
Ella (Ulipristal acetate) Indications And Usage
Ella (Ulipristal acetate) Dosage And Administration
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 intake, consideration should be given to repeating the dose.
Ella (Ulipristal acetate) Dosage Forms And Strengths
The tablet is supplied as a white to off-white, round, curved tablet containing 30 mg of ulipristal acetate and is marked “” on both sides.
Ella (Ulipristal acetate) Contraindications
Ella (Ulipristal acetate) Warnings And Precautions
Ella (Ulipristal acetate)
Ella (Ulipristal acetate) .
Ella (Ulipristal acetate)
Ella (Ulipristal acetate)
Ella (Ulipristal acetate)
After intake, menses sometimes occur earlier or later than expected by a few days. In clinical trials, cycle length was increased by a mean of 2.5 days but returned to normal in the subsequent cycle. Seven percent of subjects reported menses occurring more than 7 days earlier than expected, and 19% reported a delay of more than 7 days. If there is a delay in the onset of expected menses beyond 1 week, rule out pregnancy.
Nine percent of women studied reported intermenstrual bleeding after use of
Ella (Ulipristal acetate)
Ella (Ulipristal acetate) Adverse Reactions
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Ella (Ulipristal acetate)
The most common adverse reactions (≥ 10%) in the clinical trials for women receiving were headache (18% overall) and nausea (12% overall) and abdominal and upper abdominal pain (12% overall). Table 1 lists those adverse reactions that were reported in ≥ 5% of subjects in the clinical studies ().
Table 1: Adverse Reactions in ≥ 5% of Women (%) Receiving a Single Dose of Ella (Ulipristal acetate) (30 mg Ulipristal Acetate)
Ella (Ulipristal acetate) Drug Interactions
No drug interaction studies have been conducted for . However, data indicate that is predominantly metabolized by CYP3A4.
In vitro
Ella (Ulipristal acetate)
Ella (Ulipristal acetate) Use In Specific Populations
Pregnancy Category X. [ .]
Use of is contraindicated during an existing or suspected pregnancy. There are no adequate and well controlled studies in pregnant women.
Ulipristal acetate was administered repeatedly to pregnant rats and rabbits during the period of organogenesis. Embryofetal loss was noted in all pregnant rats and in half of the pregnant rabbits following 12 and 13 days of dosing, at daily drug exposures 1/3 and 1/2 the human exposure, respectively, based on body surface area (mg/m). There were no malformations of the surviving fetuses in these studies. Adverse effects were not observed in the offspring of pregnant rats administered ulipristal acetate during the period of organogenesis through lactation at drug exposures 1/24 the human exposure based on AUC. Administration of ulipristal acetate to pregnant monkeys for 4 days during the first trimester caused pregnancy termination in 2/5 animals at daily drug exposures 3 times the human exposure based on body surface area.
Ella (Ulipristal acetate) Overdosage
Experience with ulipristal acetate overdose is limited. In a clinical study, single doses equivalent to up to 4 times were administered to a limited number of subjects without any adverse reactions.
Ella (Ulipristal acetate) Description
The (ulipristal acetate) tablet for oral use contains 30 mg of a single active steroid ingredient, ulipristal acetate [17α-acetoxy-11β-(4-N,N-dimethylaminophenyl)-19-norpregna-4,9-diene-3,20-dione], a synthetic progesterone agonist/antagonist. The inactive ingredients are lactose monohydrate, povidone K-30, croscarmellose sodium and magnesium stearate.
Ulipristal acetate is a white to yellow crystalline powder which has a molecular weight of 475.6. The structural formula is:
CHNO
Ella (Ulipristal acetate) Clinical Pharmacology
Ulipristal acetate is a selective progesterone receptor modulator with antagonistic and partial agonistic effects (a progesterone agonist/antagonist) at the progesterone receptor. It binds the human progesterone receptor and prevents progesterone from occupying its receptor.
The pharmacodynamics of ulipristal acetate depends on the timing of administration in the menstrual cycle. Administration in the mid-follicular phase causes inhibition of folliculogenesis and reduction of estradiol concentration. Administration at the time of the luteinizing hormone peak delays follicular rupture by 5 to 9 days. Dosing in the early luteal phase does not significantly delay endometrial maturation but decreases endometrial thickness by 0.6 ± 2.2 mm (mean ± SD).
Absorption
Following a single dose administration of in 20 women under fasting conditions, maximum plasma concentrations of ulipristal acetate and the active metabolite, monodemethyl-ulipristal acetate, were 176 and 69 ng/ml and were reached at 0.9 and 1 hour, respectively.
Figure 1: Mean (± SD) Plasma Concentration-time Profile of Ulipristal Acetate and Monodemethyl-ulipristal Acetate Following Single Dose Administration of 30 mg Ulipristal Acetate
Table 2: Pharmacokinetic Parameter Values Following Administration of Ella (Ulipristal acetate) Tablet 30 mg to 20 Healthy Female Volunteers under Fasting Conditions
C = maximum concentrationAUC = area under the drug concentration curve from time 0 to time of last determinable concentration AUC = area under the drug concentration curve from time 0 to infinity t = time to maximum concentration t = elimination half-life * Median (range)
Effect of food: Administration of together with a high-fat breakfast resulted in approximately 40-45% lower mean C, a delayed t (from a median of 0.75 hours to 3 hours) and 20-25% higher mean AUC of ulipristal acetate and monodemethyl-ulipristal acetate compared with administration in the fasting state. These differences are not expected to impair the efficacy or safety of to a clinically significant extent; therefore, can be taken with or without food.
Distribution
Ulipristal acetate is highly bound (> 94%) to plasma proteins, including high density lipoprotein, alpha-l-acid glycoprotein, and albumin.
Metabolism
Ulipristal acetate is metabolized to mono-demethylated and di-demethylated metabolites. data indicate that this is predominantly mediated by CYP3A4. The mono-demethylated metabolite is pharmacologically active.
Excretion
The terminal half-life of ulipristal acetate in plasma following a single 30 mg dose is estimated to 32.4 ± 6.3 hours.
Ella (Ulipristal acetate) Clinical Studies
Two multicenter clinical studies evaluated the efficacy and safety of . An open-label study provided the primary data to support the efficacy and safety of ulipristal acetate for emergency contraception when taken 48 to 120 hours after unprotected intercourse. A single-blind comparative study provided the primary data to support the efficacy and safety of ulipristal acetate for emergency contraception when taken 0 to 72 hours after unprotected intercourse and provided supportive data for ulipristal acetate for emergency contraception when taken > 72 to 120 hours after unprotected intercourse. Women in both studies were required to have a negative pregnancy test prior to receiving emergency contraception. The primary efficacy analyses were performed on subjects less than 36 years of age who had a known pregnancy status after taking study medication.
Ella (Ulipristal acetate) How Supplied/storage And Handling
NDC 52544-238-54 (1 tablet unit of use package)
Store at 20-25°C (68-77°F). [See USP controlled room temperature.]
Keep the blister in the outer carton in order to protect from light. .
Ella (Ulipristal acetate) Patient Counseling Information
See "Who should not take ?" Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Using other medicines may affect how works. These include St. John's Wort, phenytoin, rifampin, phenobarbital, and carbamazepine. Talk to your healthcare provider if you are currently using these medications. Talk to your healthcare provider if you use hormonal birth control. Using may make your regular hormonal birth control method less effective. After using , you should use a reliable barrier method of birth control (such as a condom with spermicide) during any other times that you have sex in that same menstrual cycle. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
If is taken as directed, it will reduce the chance that you will get pregnant. is not effective in every case. is only to be used for a single episode of unprotected intercourse. Be sure to use a regular birth control method the next time you have sex. and other emergency contraceptives may be less effective in women with a body mass index (BMI) > 30 kg/m.
After taking , your next menstrual period may begin a few days earlier or later than expected. If your period is more than 7 days later than expected, you may be pregnant. You should get a pregnancy test and follow up with your healthcare provider. If you have severe lower stomach (abdominal) pain about 3 to 5 weeks after taking , you may have a pregnancy outside of the uterus (womb), which is called an ectopic or tubal pregnancy. An ectopic pregnancy is a serious condition that needs medical treatment right away. Call your healthcare provider or go to the nearest emergency room right away if you think you may have an ectopic pregnancy.
The most common side effects of include:
Some women taking may have their next period earlier or later than expected. If your period is more than a week late, you should get a pregnancy test. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of . For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA 1-800-FDA-1088.
Store at 68-77°F (20-25°C). Protect from light. Keep in the blister card inside the original box until you are ready to take it. Do not use if the package is torn or broken. Keep and all medicines out of the reach of children.
Medicines are sometimes prescribed for purposes other than those in a Patient Information Leaflet. Do not use for a condition for which it was not prescribed. Do not give to other people, even if they have the same symptoms that you have. It may harm them. In the case of an overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Overdose experience with is limited.
This Patient Information Leaflet summarizes the most important information about If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about that is written for health professionals.
For more information, go to or you can contact Watson Medical Communications at 1-800-272-5525.
Address medical inquiries to:WATSONMedical CommunicationsP.O. Box 1953Morristown, NJ 07962-1953800-272-5525
Distributed By:Watson Pharma, Inc.Morristown, NJ 07962 USA
Under License From:Laboratoire HRA Pharma75003 Paris, France
Manufactured By:Osny Pharma, 95520 Osny, France; orLeón Farma S.A., 24008 León, Spain
Ella (Ulipristal acetate) Principal Display Panel
Ella (Ulipristal acetate) ® (ulipristal acetate) tablet 30 mgNDC 52544-238-54Carton x 1 tablet
