Etonogestrel/Ethinyl Estradiol (Page 3 of 8)


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Includes low-dose COCs containing the following progestins: norgestimate, norethindrone, or levonorgestrel.

5.2 Toxic Shock Syndrome (TSS)

Cases of TSS have been reported by Etonogestrel/Ethinyl Estradiol Vaginal Ring users. TSS has been associated with tampons and certain barrier contraceptives, and, in some cases the Etonogestrel/Ethinyl Estradiol Vaginal Ring users were also using tampons. A causal relationship between the use of Etonogestrel/Ethinyl Estradiol Vaginal Ring and TSS has not been established. If a patient exhibits signs or symptoms of TSS, consider the possibility of this diagnosis and initiate appropriate medical evaluation and treatment.

5.3 Liver Disease

Impaired Liver Function

Do not use Etonogestrel/Ethinyl Estradiol Vaginal Ring in women with liver disease such as acute viral hepatitis or severe (decompensated) cirrhosis of the liver [see Contraindications (4)]. Acute or chronic disturbances of liver function may necessitate the discontinuation of CHC use until markers of liver function return to normal and CHC causation has been excluded [see Use in Specific Populations (8.6)]. Discontinue Etonogestrel/Ethinyl Estradiol Vaginal Ring use if jaundice develops.

Liver Tumors

Etonogestrel/Ethinyl Estradiol Vaginal Ring is contraindicated in women with benign and malignant liver tumors [see Contraindications (4)]. Hepatic adenomas are associated with CHC use. An estimate of the attributable risk is 3.3 cases per 100,000 CHC users. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage.

Studies have shown an increased risk of developing hepatocellular carcinoma in long term (>8 years) CHC users. However, the attributable risk of liver cancers in CHC users is less than one case per million users.

5.4 Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment

During clinical trials with the Hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with and without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications, such as CHCs. Discontinue Etonogestrel/Ethinyl Estradiol Vaginal Ring prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir [see Contraindications (4)]. Etonogestrel/Ethinyl Estradiol Vaginal Ring can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen.

5.5 High Blood Pressure

Etonogestrel/Ethinyl Estradiol Vaginal Ring is contraindicated in women with uncontrolled hypertension or hypertension with vascular disease [see Contraindications (4)]. For women with well-controlled hypertension, monitor blood pressure and stop Etonogestrel/Ethinyl Estradiol Vaginal Ring use if blood pressure rises significantly.

An increase in blood pressure has been reported in women using CHCs and this increase is more likely in older women and with extended duration of use. The incidence of hypertension increases with increasing concentrations of progestin.

5.6 Hypersensitivity Reactions

Hypersensitivity reactions of anaphylaxis and angioedema have been reported during use of Etonogestrel/Ethinyl Estradiol Vaginal Ring. If anaphylaxis and/or angioedema is suspected, Etonogestrel/Ethinyl Estradiol Vaginal Ring should be discontinued and appropriate treatment administered. [See Contraindications (4).]

5.7 Vaginal Use

Etonogestrel/Ethinyl Estradiol Vaginal Ring may not be suitable for women with conditions that make the vagina more susceptible to vaginal irritation or ulceration. Vaginal/cervical erosion or ulceration in women using Etonogestrel/Ethinyl Estradiol Vaginal Ring has been reported. In some cases, the ring adhered to vaginal tissue, necessitating removal by a healthcare provider and in some instances (i.e., when the tissue had grown over the ring), removal was achieved by cutting the ring without incising the overlying vaginal tissue.

Some women are aware of the ring on occasion during the 21 days of use or during intercourse, and sexual partners may feel Etonogestrel/Ethinyl Estradiol Vaginal Ring in the vagina.

5.8 Gallbladder Disease

Studies suggest a small increased relative risk of developing gallbladder disease among CHC users. Use of CHCs may also worsen existing gallbladder disease.

A past history of CHC-related cholestasis predicts an increased risk with subsequent CHC use. Women with a history of pregnancy-related cholestasis may be at an increased risk for CHC-related cholestasis.

5.9 Carbohydrate and Lipid Metabolic Effects

Carefully monitor prediabetic and diabetic women who are using Etonogestrel/Ethinyl Estradiol Vaginal Ring. CHCs may decrease glucose tolerance.

Consider alternative contraception for women with uncontrolled dyslipidemia. Some women will have adverse lipid changes while on CHCs.

Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using CHCs.

5.10 Headache

If a woman using Etonogestrel/Ethinyl Estradiol Vaginal Ring develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Etonogestrel/Ethinyl Estradiol Vaginal Ring if indicated.

Consider discontinuation of Etonogestrel/Ethinyl Estradiol Vaginal Ring in the case of an increased frequency or severity of migraine during CHC use (which may be prodromal of a cerebrovascular event) [see Contraindications (4)].

5.11 Bleeding Irregularities and Amenorrhea

Unscheduled Bleeding and Spotting

Unscheduled bleeding (breakthrough or intracyclic) bleeding and spotting sometimes occur in women using CHCs, especially during the first three months of use. If bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy. If pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different CHC.

Bleeding patterns were evaluated in three large clinical studies. In the North American study (US and Canada, N=1,177), the percentages of subjects with breakthrough bleeding/spotting ranged from 7.2% to 11.7% during cycles 1-13. In the two non-US studies, the percentages of subjects with breakthrough bleeding/spotting ranged from 2.6% to 6.4% (Europe, N=1,145) and from 2.0% to 8.7% (Europe, Brazil, Chile, N=512).

Amenorrhea and Oligomenorrhea

If scheduled (withdrawal) bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule, consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures.

Occasional missed periods may occur with the appropriate use of Etonogestrel/Ethinyl Estradiol Vaginal Ring. In the clinical studies, the percent of women who did not have withdrawal bleeding in a given cycle ranged from 0.3% to 3.8%.

If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy.

Some women may experience amenorrhea or oligomenorrhea after discontinuing CHC use, especially when such a condition was pre-existent.

5.12 Inadvertent Urinary Bladder Insertion

There have been reports of inadvertent insertions of Etonogestrel/Ethinyl Estradiol Vaginal Ring into the urinary bladder, which required cystoscopic removal. Assess for ring insertion into the urinary bladder in Etonogestrel/Ethinyl Estradiol Vaginal Ring users who present with persistent urinary symptoms and are unable to locate the ring.

5.13 Depression

Carefully observe women with a history of depression and discontinue Etonogestrel/Ethinyl Estradiol Vaginal Ring use if depression recurs to a serious degree.

5.14 Carcinoma of the Breasts and Cervix

Etonogestrel/Ethinyl Estradiol Vaginal Ring is contraindicated in women who currently have or have had breast cancer because breast cancer is a hormonally-sensitive tumor [see Contraindications (4)].

There is substantial evidence that CHCs do not increase the incidence of breast cancer. Although some past studies have suggested that CHCs might increase the incidence of breast cancer, more recent studies have not confirmed such findings.

Some studies suggest that CHCs are associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. However, there is controversy about the extent to which these findings may be due to differences in sexual behavior and other factors.

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