ella®

ulipristal acetate tablet 30 mg

back to all products
Next-Generation Prescription Strength Emergency Contraceptive

  • The only 30 mg ulipristal acetate tablet currently available
  • The only emergency contraceptive product that is FDA approved for use up to 5 days after unprotected sex or a known contraceptive failure1,2
  • Safety and tolerability established in more than 1.4 million women worldwide3
  • Convenient, single-tablet dosing
  • Affordable product, reliable supply
  • Not an abortifacient
Product Gallery
ndc # package size pi order numbers product info sheet
50102-911-01 Monocarton Containing
1-tablet Blister Pack

ORDER ella®

AmerisourceBergen

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

ANDA

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

Cardinal

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

McKesson

1-800-793-9875
www.mckesson.com
3470556

MCKESSON MEDICAL SURGICAL

1-866-625-2679
mms.mckesson.com
989953

Morris & Dickson

1-888-376-7409
www.morrisdickson.com/
602680

Pharmedix

1-800-486-1811
www.pharmedixrx.com
---

R&S Northeast

1-800-262-7770
www.rsnortheast.com
091101

Seacoast Medical LLC

1-877-410-0811
www.seacoastmedical.com/afaxys
500033

Smith Medical Partners LLC

1-800-292-9653
340B 1-877-445-7970 www.smpspecialty.com
5264-882

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. ella is not recommended for use in breastfeeding women. 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, Inc. March 2015.

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.