Clinical Information
Gen. Code and Des.
50464 etonogestrel/ethinyl estradiol VAGINAL VAG RING .12-.015MG
GCN and Des.
17528 etonogestrel/ethinyl estradiol VAGINAL VAG RING .12-.015MG
Strength
Dose Form
RING, VAGINAL
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
68120000 CONTRACEPTIVES
Active Ingredients
1286 ethinyl estradiol 57636
7906 etonogestrel 54048101
EluRyng (ethinyl estradiol/etonogestrel vaginal ring) is an estrogen/progestin combination hormonal contraceptive (CHC) indicated for use by women to prevent pregnancy.
EluRyng is the first approved generic version of NuvaRing. These highlights do not include all the information needed to use ELURYNG safely and effectively. See full prescribing information for ELURYNG.
ELURYNG� (etonogestrel and ethinyl estradiol vaginal ring)
Initial U.S. Approval: 2001
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
Women over 35 years old who smoke should not use EluRyng. (4)
Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use. (4)
RECENT MAJOR CHANGES
Dosage and Administration
Deviations from the Recommended Regimen (2.3) 12/2018
Warnings and Precautions
Hypersensitivity Reactions (5.6) 12/2018
INDICATIONS AND USAGE
EluRyng is an estrogen/progestin combination hormonal contraceptive (CHC) indicated for use by women to prevent pregnancy. (1)
DOSAGE AND ADMINISTRATION
One EluRyng is inserted in the vagina. The ring must remain in place continuously for three weeks, followed by a one-week ring-free interval. (2)
DOSAGE FORMS AND STRENGTHS
EluRyng is a polymeric vaginal ring containing 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol, USP, which releases on average 0.12 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol, USP. (3)
CONTRAINDICATIONS
A high risk of arterial or venous thrombotic diseases (4)
Breast cancer or other estrogen- or progestin-sensitive cancer (4)
Liver tumors or liver disease (4)
Undiagnosed abnormal uterine bleeding (4)
Pregnancy (4)
Hypersensitivity, including anaphylaxis and angioedema, to any of the components of Eluryng (4)
Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (4)
WARNINGS AND PRECAUTIONS
Vascular risks: Stop EluRyng use if a thrombotic event occurs. Stop EluRyng use at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. (5.1)
Toxic Shock Syndrome (TSS): If patient exhibits signs or symptoms of TSS, consider the possibility of this diagnosis and initiate appropriate medical evaluation and treatment. (5.2)
Liver disease: Discontinue EluRyng use if jaundice develops. (5.3)
High blood pressure: If used in women with well-controlled hypertension, monitor blood pressure and stop EluRyng use if blood pressure rises significantly. (5.5)
Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia. (5.9)
Headache: Evaluate significant change in headaches and discontinue EluRyng use if indicated. (5.10)
Uterine bleeding: Evaluate irregular bleeding or amenorrhea. (5.11)
ADVERSE REACTIONS
The most common adverse reactions (?2%) in clinical trials were: vaginitis, headache (including migraine), mood changes (e.g., depression, mood swings, mood altered, depressed mood, affect lability), device-related events (e.g., expulsion/discomfort/foreign body sensation), nausea/vomiting, vaginal discharge, increased weight, vaginal discomfort, breast pain/discomfort/tenderness, dysmenorrhea, abdominal pain, acne, and decreased libido. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Drugs or herbal products that induce certain enzymes, such as CYP3A4, may decrease the effectiveness of CHCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with CHCs. (7)
USE IN SPECIFIC POPULATIONS
Nursing mothers: Not recommended; can decrease milk production. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 5/2019
