ella®

ulipristal acetate tablet 30 mg

Please see full Prescribing Information here.

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Prescription strength emergency contraceptive

  • Single-tablet dosing
  • Affordable product, reliable supply
  • Not an abortifacient
  • ella is contraindicated in women with a known or suspected pregnancy and should not replace a regular method of contraception
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ndc # package size order numbers
50102-911-01 Monocarton Containing 1-tablet Blister Pack
ndc # 50102-911-01
package size Monocarton Containing
1-tablet Blister Pack
order numbers

ORDER ella®

AmerisourceBergen

1-610-727-7000
www.amerisourcebergen.com
10153832

ANDA

1-800-331-2632 (Ext. 74591)
www.andanet.com
50102091101

ASD Healthcare

1-800-746-6273
www.asdhealthcare.com
46710

Cardinal

1-800-326-6457
www.cardinal.com
5029780

INDICATION

ella® is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. ella is not intended for routine use as a contraceptive.

Important Safety Information

The most common side effects of ella (ulipristal acetate) tablets include headache (18%), abdominal pain (12%), nausea (12%), dysmenorrhea (9%), fatigue (6%), and dizziness (5%). ella is contraindicated in women with a known or suspected pregnancy, and should not replace a regular method of contraception. ella is not indicated for termination of an existing pregnancy. Women who become pregnant or complain of lower abdominal pain after taking ella should be evaluated for ectopic pregnancy. ella may alter the next expected menses. If menses is delayed beyond 1 week, pregnancy should be ruled out. A rapid return of fertility is likely following treatment with ella, therefore, a reliable barrier method of contraception should be used with subsequent acts of intercourse in that same menstrual cycle. Because ella and the progestin component of hormonal contraceptives both bind to the progesterone receptor, using them together could reduce their contraceptive effectiveness. After using ella, if a woman wishes to use hormonal contraception, she should do so no sooner than 5 days after intake of ella. Repeated use of ella within the same menstrual cycle is not recommended. Drugs or herbal products that induce CYP3A4 decrease the effectiveness of ella. ella does not protect against STI/HIV.

Reference:
ella® [prescribing information]. Charleston, SC: Afaxys Pharma, LLC; May 2018.

Please see full Prescribing Information here.

To report SUSPECTED ADVERSE REACTIONS, call 1-855-888-2467 or report via the FDA MedWatch Program at www.fda.gov/medwatch or 1-800-FDA-1088.

References:

  1. Glasier A, Cameron S, et al. Ulipristal acetate versus levonorgestrel for emergency contraception: a randomized non-inferiority trial and meta analysis. The Lancet. 2010; 375: 555–562.
  2. Moreau C, Trussel J. Results from pooled Phase III studies of ulipristal acetate for emergency contraception. Contraception. 2012; 86: 673–680.
  3. Levy D, Jager M, et al. Ulipristal acetate for emergency contraception: postmarketing experience after use by more than 1 million women. Contraception. 2014; 89: 431–433.