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Annovera

Last reviewed on RxList: 5/11/2020
Annovera Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Annovera?

Annovera (segesterone acetate and ethinyl estradiol vaginal system) is a progestin/estrogen combined hormonal contraceptive (CHC) indicated for use by females of reproductive potential to prevent pregnancy.

What Are Side Effects of Annovera?

Common side effects of Annovera include:

Dosage for Annovera

The dose of Annovera is one Annovera inserted in the vagina. The vaginal system must remain in place continuously for 3 weeks (21 days) followed by a 1-week (7-day) vaginal system-free interval. One Annovera vaginal system provides contraception for thirteen 28-day cycles (1 year).

What Drugs, Substances, or Supplements Interact with Annovera?

Annovera may interact with aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, topiramate, St. John's wort, protease inhibitors, lamotrigine, thyroid hormone replacement therapy, corticosteroid replacement therapy, acetaminophen, morphine, salicylic acid, temazepam, cyclosporine, prednisolone, theophylline, tizanidine, voriconazole, oil-based vaginal suppositories, oil-based (including silicone-based) vaginal lubricants, and HCV drug combinations containing ombitasvir/paritaprevir/ritonavir (with or without dasabuvir).

Annovera During Pregnancy and Breastfeeding

Tell your doctor all medications and supplements you use. Discontinue Annovera if pregnancy occurs, because there is no reason to use contraceptives during pregnancy. Annovera can reduce milk production in breastfeeding females. Other methods of contraception are recommended until breastfeeding is discontinued. Consult your doctor before breastfeeding.

Additional Information

Our Annovera (segesterone acetate and ethinyl estradiol vaginal system) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Which of the following are methods for contraception? See Answer
Annovera Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • very high blood pressure--severe headache, blurred vision, pounding in your neck or ears;
  • signs of a blood clot--sudden numbness or weakness (especially on one side of the body), sudden severe headache, problems with speech or vision, stabbing chest pain, feeling short of breath, pain or numbness in one or both legs;
  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • toxic shock syndrome--sudden fever, body aches, skin rash, vomiting, diarrhea, and feeling dizzy or light-headed;
  • new headaches, or a change in the pattern or severity of migraine headaches;
  • jaundice (yellowing of the skin or eyes); or
  • symptoms of depression--mood changes, thoughts about hurting yourself.

Common side effects may include:

  • headache;
  • nausea, vomiting, diarrhea, stomach pain;
  • vaginal itching or discharge;
  • menstrual pain, breast tenderness;
  • irregular vaginal bleeding; or
  • pain or burning when you urinate;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Annovera (Segesterone Acetate and Ethinyl Estradiol Vaginal System)

SLIDESHOW

Choosing Your Birth Control Method See Slideshow
Annovera Professional Information

SIDE EFFECTS

The following adverse reactions are described elsewhere in other sections of the labeling:

Clinical Trial Experience

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 the rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The clinical trials that evaluated the safety of ANNOVERA™ were obtained from three 13-cycle trials. One trial was conducted entirely in the U.S. (15 sites), and the other two were global studies that included 5 U.S. sites and 7 international sites (Australia, Brazil, Chile, Dominican Republic, Finland, Hungary, Sweden). All three trials were open label and enrolled healthy females, desiring contraception, 18 to 40 years of age. At about 50% enrollment, females with BMI >29 kg/m2 were excluded due to the occurrence of two VTEs in this subgroup. In total, 2,308 females contributed 21,590 cycles of exposure for safety evaluation and 999 completed 13 cycles; there were 209 subjects with BMI >29 kg/m2 who contributed 1,254 cycles of exposure with 36 subjects completing 13 cycles. The demographic profile for subjects was: mean age 26.7 years, mean BMI 24.1 (16.0-41.5) kg/m2; 67% were from the U.S. The racial distribution was 71% Caucasian, 14% African American, 4% Asian, and 11% Other; 30% of the population was Hispanic.

Most Common Adverse Reactions

Table 1 summarizes the most common adverse reactions reported by females using ANNOVERA™. This table shows adverse reactions reported in at least 5% of subjects. In addition, 25% of subjects reported at least 1 complete expulsion during their use of ANNOVERA™.

Table 1: Adverse Drug Reactions Reported by ≥ 5% of ANNOVERA™-treated Subjects

Adverse Reactions %
(N=2,308)
Headache, including migraine 38.6
Nausea/vomiting 25.0
Vulvovaginal mycotic infection/vaginal candidiasis 14.5
Abdominal pain/lower/upper 13.3
Dysmenorrhea 12.5
Vaginal Discharge 11.8
UTI/cystitis/pyelonephritis/genitourinary tract infection 10.0
Breast pain/tenderness/discomfort 9.5
Metrorrhagia/menstrual disorder 7.5
Diarrhea 7.2
Genital pruritus 5.5

Adverse Reactions Leading To Discontinuation

Among subjects using ANNOVERA™ for contraception, 12% discontinued from the clinical trials due to an adverse reaction. Table 2 summarizes the most common adverse reactions leading to discontinuation. In addition, 1.4% of subjects discontinued ANNOVERA™ use due to vaginal system expulsions.

Table 2: Adverse Reactions Leading to Discontinuation by ≥ 1% of ANNOVERA™ treated Subjects

Adverse Reactions %
(N=2,308)
Metrorrhagia/menorrhagia 1.7
Headache, including migraine 1.3
Vaginal discharge/vulvovaginal mycotic infections 1.3
Nausea/vomiting 1.2

Serious Adverse Reactions

Serious adverse reactions occurring in ≥2 subjects were: VTEs (deep venous thrombosis, cerebral vein thrombosis, pulmonary embolism); psychiatric events; drug hypersensitivity reactions; and spontaneous abortions.

Read the entire FDA prescribing information for Annovera (Segesterone Acetate and Ethinyl Estradiol Vaginal System)

Related Resources for Annovera

© Annovera Patient Information is supplied by Cerner Multum, Inc. and Annovera Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

QUESTION

Which of the following are methods for contraception? See Answer

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