Important Education for Patients Regarding a Long-Lasting Reversible Contraceptive

Pharmacy Times, June 2020, Volume 88, Issue 6

This article is sponsored by TherapeuticsMD, Inc.

ANNOVERA® (segesterone acetate and ethinyl estradiol vaginal system) is a progestin/estrogen combined hormonal contraceptive indicated for use by females of reproductive potential to prevent pregnancy. ANNOVERA is the only FDA-approved long-lasting reversible contraceptive that does not require a procedure. It is inserted for 21 continuous days and removed for 7 days each cycle for 13 cycles. ANNOVERA contains a novel progestin, segesterone acetate.1 Unlike other progestins, segesterone acetate has demonstrated no androgenic activity.2a The 13 mcg ethinyl estradiol daily dose is one of the lowest doses on the market. A single ANNOVERA prescription provides fertility and menstruation control for 13 consecutive 28-day cycles (1 year), and pharmacists can provide counseling support with just a single conversation, either during the initial pharmacy visit or over the phone if the prescription is not used immediately. Pharmacists have an important role in counseling patients on birth control. Patient understanding should be confirmed prior to dispensing self-administered birth control. Counseling can involve answering patient questions and educating on product-specific features, administration, storage, and expiration.1

DOSING AND ADMINISTRATION

ANNOVERA is a nonbiodegradable, soft, flexible ring that patients can fold into a size no wider than a tampon for the simple, 6-step insertion and removal process (

TABLE

). It is inserted for 21 continuous days and removed for 7 days each cycle for 13 cycles. Counsel on the 6-step insertion and removal process and the 28-day cycle, emphasizing the importance of maintaining a calendar of insertion and removal dates to optimize adherence.1,3

EXPIRATION

The first insertion of ANNOVERA must be prior to the 18-month expiration date that is printed on the packaging. Show patients where the expiration date is printed. Advise them that if the first insertion of ANNOVERA is prior to the date of expiration, contraception will be provided for a full 13 cycles (1 year).1 Offer availability to answer future questions via phone.

STORAGE

Counsel patients that, before and after each use, ANNOVERA should be washed and dried. During each 7-day vaginal system-free interval, ANNOVERA should be stored in its black compact case at 20°C to 25°C (68°F to 77°F). Excursions are permitted to 15°C to 30°C (59°F to 86°F). It should not be stored in direct sunlight, exposed to excessive heat, or put in the refrigerator or freezer. After 13 cycles of use, ANNOVERA should be discarded in its case via a drug take-back option if possible. By counseling on ANNOVERA, pharmacists can help patients adhere to guidelines for optimal efficacy.1

a Based on pharmacological studies in animals and in vitro studies. The clinical significance of these data is not known.

IMPORTANT SAFETY INFORMATION

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

See full prescribing information for complete boxed warning.

  • Females over 35 years old who smoke should not use ANNOVERA.
  • Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive use.

CONTRAINDICATIONS

ANNOVERA is contraindicated and should not be used in women with a high risk of arterial or venous thrombotic diseases; current or history of breast cancer or other estrogen- or progestin-sensitive cancer; liver tumors, acute hepatitis, or severe (decompensated) cirrhosis; undiagnosed abnormal uterine bleeding; hypersensitivity to any of the components of ANNOVERA; and use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

WARNINGS AND PRECAUTIONS

  • Stop ANNOVERA if a thrombotic or thromboembolic event occurs, and at least 4 weeks before and through 2 weeks after major surgery. Start ANNOVERA no earlier than 4 weeks after delivery, in females who are not breastfeeding. Consider cardiovascular risk factors before initiating in all females, particularly those over 35 years.
  • Discontinue if jaundice occurs.
  • Stop ANNOVERA prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir. ANNOVERA can be restarted 2 weeks following completion of this regimen.
  • Do not prescribe ANNOVERA for females with uncontrolled hypertension or hypertension with vascular disease. Monitor blood pressure and stop use if blood pressure rises significantly in females with well-controlled hypertension.
  • Monitor glucose in pre-diabetic or diabetic females taking ANNOVERA. Consider an alternate contraceptive method for females with uncontrolled dyslipidemias.
  • Patients using ANNOVERA who have a significant change in headaches or irregular bleeding or amenorrhea should be evaluated. ANNOVERA should be discontinued if indicated.
  • Other warnings include: gallbladder disease; depression; cervical cancer; increased serum concentrations of binding globulins; hereditary angioedema; chloasma (females who tend to develop chloasma should avoid exposure to the sun or UV radiation while using ANNOVERA); toxic shock syndrome (TSS) (if a patient exhibits symptoms of TSS, remove ANNOVERA, and initiate appropriate medical treatment); vaginal use (ANNOVERA may not be suitable for females with conditions that make the vagina more susceptible to vaginal irritation or ulceration).

ADVERSE REACTIONS

The most common adverse reactions reported in at least 5% of women who received ANNOVERA were: headache/migraine, nausea/vomiting, vulvovaginal mycotic infection/candidiasis, lower/upper abdominal pain, dysmenorrhea, vaginal discharge, urinary tract infection, breast pain/tenderness/discomfort, bleeding irregularities including metrorrhagia, diarrhea, and genital pruritus.

DRUG INTERACTIONS

Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of ANNOVERA or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with ANNOVERA.

INDICATION

ANNOVERA is a progestin/estrogen combination hormonal contraceptive indicated for use by females of reproductive potential to prevent pregnancy.

Limitations of Use: ANNOVERA has not been adequately studied in females with a body mass index >29 kg/m2.

REFERENCES

1. ANNOVERA [Prescribing Information]. Boca Raton, Florida: TherapeuticsMD, Inc; 2020. 2. Kumar N, Koide SS, Tsong Y, Sundaram K. Nestorone: a progestin with a unique pharmacological profile. Steroids. 2000;65(10-11):629-636. doi:10.1016/s0039-128x(00)00119-7 3. Carlin EP, Spielmann HM, inventors; The Proctor & Gamble Company, assignee. Tampon. US Patent 7,338,483 B2. March 4, 2008.

Please note that this information is not comprehensive. The Full Prescribing Information, including Boxed Warning, for ANNOVERA is available at ANNOVERA.com/pi.pdf.

ANNOVERA is a registered trademark licensed to TherapeuticsMD, Inc.

© 2020 TherapeuticsMD, Inc. All rights reserved. ANVA-20272 06/2020