EluRyng Etonogestrel and Ethinyl Estradiol .12 mg/d; .015 mg/d Ring
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Progestin class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Estrogen and progestin vaginal ring contraceptives are used to prevent pregnancy. Estrogen (ethinyl estradiol) and progestin (etonogestrel or segesterone) are two female sex hormones. Estrogen and progestin are in a class of medications called combination hormonal contraceptives (birth control medications). Combinations of estrogen and progestin work by preventing ovulation (the release of eggs from the ovaries). They also change the lining of the uterus (womb) to prevent pregnancy from developing and change the mucus at the cervix (opening of the uterus) to prevent sperm (male reproductive ce...
Read the full MedlinePlus article ↗- No exact position is needed — the ring just needs to be inside the vagina, wherever feels comfortable. Compress it between your fingers and slide it in. You wear it continuously fo...
- How exactly do I use this ring — do I need to place it in a specific spot?
- Rinse it with cool water and reinsert it as soon as you can. How long it was out matters, so check the detailed instructions that came with your specific product — they'll tell you...
- The most common ones — vaginal discomfort, headaches, mood changes, nausea, and breast tenderness — are unpleasant but not dangerous. Spotting or irregular bleeding is also common,...
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII 8ILA5X28VS
A synthetic plastic material made from ethylene and vinyl acetate monomers. It functions as a binder to hold ingredients together and as a film-former to create coatings on tablets or capsules.
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UNII 4OKC630HS6
A plastic-like polymer made from ethylene and vinyl acetate that acts as a binder and film-former in medications. It helps hold tablet ingredients together and can create protective coatings on pills.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
3 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $47.172 | $2,971.81 / 63 ds |
| Medicaid paysCMS SDUD · 12 mo | $54.26 | $3,418.59 / 63 ds |
| Medicare drug plans payPart D · Q2 2026 | $82.72 | $5,211.21 / 63 ds |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Etonogestrel and Ethinyl Estradiol .12 mg/d; .015 mg/d 00093-7679-02 | Teva | 3 pouches | $47.172 | AB | Availability likely | — |
| Etonogestrel and Ethinyl Estradiol Vaginal Ring .015 mg/d; .12 mg/d 16714-0029-03 | Northstar | 3 pouches | $47.172 | AB | Availability likely | — |
| EluRyng .12 mg/d; .015 mg/dthis 65162-0469-35 | Amneal | 3 pouches | $47.172 | AB | Availability likely | — |
| Etonogestrel/Ethinyl Estradiol .12 mg/d; .015 mg/d 66993-0605-36 | Prasco | 3 pouches | $47.172 | AB | Availability likely | — |
| EnilloRing .015 mg/d; .12 mg/d 70700-0156-91 | Xiromed, | 3 pouches | $47.172 | AB | Availability likely | — |
| NuvaRing .12 mg/d; .015 mg/d 78206-0146-03 | Organon | 3 pouches | $155.703 | AB | Availability likely | +230% |
| Etonogestrel and Ethinyl Estradiol Vaginal .015 mg/d; .12 mg/d 42291-0478-03 | AvKARE | 3 pouches | — | AB | FDA listed | — |
| Nuvaring .12 mg/d; .015 mg/d 50090-5611-00 | A-S | 3 pouches | — | AB | FDA listed | — |
| Nuvaring .12 mg/d; .015 mg/d 50090-7663-00 | A-S | 1 pouch | — | AB | FDA listed | — |
| NuvaRing .12 mg/d; .015 mg/d 59212-0146-03 | Advanz | 3 pouches | — | AB | FDA listed | — |
| Etonogestrel/Ethinyl Estradiol .12 mg/d; .015 mg/d 50090-5959-00 | A-S | 1 pouch | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 65162-0469-35 You're viewing this | 3 POUCH in 1 CARTON (65162-469-35) / 21 d in 1 POUCH (65162-469-32) | 2019-12-16 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including EluRyng, should not be used by women who are over 35 years of age and smoke [see Contraindications (4) ].
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)
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE FOR VAGINAL USE ONLY EluRyng™ is indicated for use by females of reproductive age to prevent pregnancy. EluRyng is an estrogen/progestin combination hormonal contraceptive (CHC) indicated for use by women to prevent pregnancy. (1)
⏱️ Dosage and Administration ▾
2 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)
2.1How to Use EluRyng To achieve maximum contraceptive effectiveness, EluRyng must be used as directed [see Dosage and Administration (2.2) ] . One EluRyng is inserted in the vagina. The ring is to remain in place continuously for three weeks.
It is removed for a one-week break, during which a withdrawal bleed usually occurs. A new ring is inserted one week after the last ring was removed. The user can choose the insertion position that is most comfortable to her, for example, standing with one leg up, squatting, or lying down.
The ring is to be compressed and inserted into the vagina. The exact position of EluRyng inside the vagina is not critical for its function. The vaginal ring must be inserted on the appropriate day and left in place for three consecutive weeks.
This means that the ring should be removed three weeks later on the same day of the week as it was inserted and at about the same time. EluRyng can be removed by hooking the index finger under the forward rim or by grasping the rim between the index and middle finger and pulling it out. The used ring should be placed in the foil pouch and discarded in a waste receptacle out of the reach of children and pets (do not flush in toilet).
After a one-week break, during which a withdrawal bleed usually occurs, a new ring is inserted on the same day of the week as it was inserted in the previous cycle. The withdrawal bleed usually starts on Day 2 to 3 after removal of the ring and may not have finished before the next ring is inserted. In order to maintain contraceptive effectiveness, the new ring must be inserted exactly one week after the previous one was removed even if menstrual bleeding has not finished.
2.2How to Start Using EluRyng IMPORTANT: Consider the possibility of ovulation and conception prior to the first use of EluRyng . No Hormonal Contraceptive Use in the Preceding Cycle: The woman should insert EluRyng on the first day of her menstrual bleeding. EluRyng may also be started on Days 2 to 5 of the woman’s cycle, but in this case a barrier method, such as male condoms with spermicide, should be used for the first seven days of EluRyng use in the first cycle.
Changing From a CHC: The woman may switch from her previous CHC on any day, but at the latest on the day following the usual hormone-free interval, if she has been using her hormonal method consistently and correctly, or if it is reasonably certain that she is not pregnant. Changing From a Progestin-Only Method (progestin-only pill [POP], Implant, or Injection or a Progestin-Releasing Intrauterine System [IUS]): The woman may switch from the POP on any day; instruct her to start using EluRyng on the day after she took her last POP.
She should switch from an implant or the IUS on the day of its removal, and from an injectable on the day when the next injection would be due. In all of these cases, the woman should use an additional barrier method such as a male condom with spermicide, for the first seven days. Use After Abortion or Miscarriage: The woman may start using EluRyng within the first five days following a complete first trimester abortion or miscarriage, and she does not need to use an additional method of contraception.
If use of EluRyng is not started within five days following a first trimester abortion or miscarriage, the woman should follow the instructions for “No Hormonal Contraceptive Use in the Preceding Cycle.” In the meantime, she should be advised to use a non-hormonal contraceptive method. Start EluRyng no earlier than four weeks after a second trimester abortion or miscarriage, due to the increased risk of thromboembolism [see Contraindications (4) and Warnings and Precautions (5.1) ]. Following Childbirth: The use of EluRyng may be initiated no sooner than four weeks postpartum in women who elect not to br…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS EluRyng (etonogestrel and ethinyl estradiol vaginal ring) is a non-biodegradable, flexible, transparent to translucent, colorless to almost colorless, combination contraceptive vaginal ring, with an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. It is made of ethylene vinylacetate copolymers and magnesium stearate, and contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol, USP. When placed in the vagina, each ring releases on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol, USP over a three-week period of use.
EluRyng is not made with natural rubber latex. 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 ▾
4 CONTRAINDICATIONS EluRyng is contraindicated in females who are known to have or develop the following conditions: A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1) ] Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1) ] Have cerebrovascular disease [see Warnings and Precautions (5.1) ] Have coronary artery disease [see Warnings and Precautions (5.1) ] Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1) ] Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1) ] Have uncontrolled hypertension [see Warnings and Precautions (5.5) ] Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.9) ] Have headaches with focal neurological symptoms or migraine headaches with aura [see Warnings and Precautions (5.10) ] Women over age 35 with any migraine headaches [see Warnings and Precautions (5.10) ] Liver tumors, benign or malignant or liver disease [see Warnings and Precautions (5.3) and Use in Specific Populations (8.6) ] Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.11) ] Pregnancy, because there is no reason to use CHCs during pregnancy [see Use in Specific Populations (8.1) ] Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see Warnings and Precautions (5.14) ] Hypersensitivity reactions, including anaphylaxis and angioedema, to any of the components of EluRyng [see Warnings and Precautions (5.6) and Adverse Reactions (6) ] Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations [see Warnings and Precautions (5.4) and Drug Interactions (7) ] .
A high risk of arterial or venous thrombotic diseases (4) Breast 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 Cautions ▾
5 WARNINGS AND PRECAUTIONS Vascular risks: Stop etonogestrel and ethinyl estradiol vaginal ring use if a thrombotic event occurs. Stop etonogestrel and ethinyl estradiol vaginal ring 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 etonogestrel and ethinyl estradiol vaginal ring use if jaundice develops. (5.3) High blood pressure: If used in women with well-controlled hypertension, monitor blood pressure and stop etonogestrel and ethinyl estradiol vaginal ring 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 etonogestrel and ethinyl estradiol vaginal ring use if indicated.
(5.10) Uterine bleeding: Evaluate irregular bleeding or amenorrhea. (5.11)
5.1Thromboembolic Disorders and Other Vascular Problems Stop etonogestrel and ethinyl estradiol vaginal ring use if an arterial thrombotic or venous thromboembolic event (VTE) occurs. Stop etonogestrel and ethinyl estradiol vaginal ring use if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately [see Adverse Reactions (6) ].
If feasible, stop etonogestrel and ethinyl estradiol vaginal ring at least four weeks before and through two weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism, and during and following prolonged immobilization. Start etonogestrel and ethinyl estradiol vaginal ring no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.
The use of CHCs increases the risk of VTE. Known risk factors for VTE include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of CHCs [see Contraindications (4) ] . Two epidemiologic studies 1, 2, 3 that assessed the risk of VTE associated with the use of etonogestrel and ethinyl estradiol vaginal ring are described below.
In these studies, which were required or sponsored by regulatory agencies, etonogestrel and ethinyl estradiol vaginal ring users had a risk of VTE similar to Combined Oral Contraceptives (COCs) users (see Table 1 for adjusted hazard ratios). A large prospective, observational study, the Transatlantic Active Surveillance on Cardiovascular Safety of etonogestrel and ethinyl estradiol vaginal ring (TASC), investigated the risk of VTE for new users, and women who were switching to or restarting etonogestrel and ethinyl estradiol vaginal ring or COCs in a population that is representative of routine clinical users.
The women were followed for 24 to 48 months. The results showed a similar risk of VTE among etonogestrel and ethinyl estradiol vaginal ring users (VTE incidence 8.3 per 10,000 WY) and women using COCs (VTE incidence 9.2 per 10,000 WY). For women using COCs that did not contain the progestins desogestrel (DSG) or gestodene (GSD), VTE incidence was 8.9 per 10,000 WY.
A retrospective cohort study using data from 4 health plans in the US (FDA-funded Study in Kaiser Permanente and Medicaid databases) showed the VTE incidence for new users of etonogestrel and ethinyl estradiol vaginal ring to be 11.4 events per 10,000 WY, for new users of a levonorgestrel (LNG)-containing COC 9.2 events per 10,000 WY, and for users of other COCs available during the course of the study* 8.2 events per 10,000 WY. * Includes low-dose COCs cont…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions with the use of CHCs are discussed elsewhere in the labeling. Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions (5.1) ] Vascular events [see Warnings and Precautions (5.1) ] Liver disease [see Warnings and Precautions (5.3) ] Adverse reactions commonly reported by CHC users are: Irregular uterine bleeding Nausea Breast tenderness Headache 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.
6.1Clinical Trials 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 rates in the clinical trials of another drug and may not reflect the rates observed in practice. Trials with a duration of 6 to 13 28-day cycles provided safety data. In total, 2,501 women, aged 18 to 41 contributed 24,520 cycles of exposure.
Common Adverse Reactions (≥ 2%): vaginitis (13.8%), headache (including migraine) (11.2%), mood changes (e.g., depression, mood swings, mood altered, depressed mood, affect lability) (6.4%), device-related events (e.g., expulsion/discomfort/foreign body sensation) (6.3%), nausea/vomiting (5.9%), vaginal discharge (5.7%), increased weight (4.9%), vaginal discomfort (4.0%), breast pain/discomfort/tenderness (3.8%), dysmenorrhea (3.5%), abdominal pain (3.2%), acne (2.4%), and decreased libido (2.0%). Adverse Reactions (≥ 1%) Leading to Study Discontinuation: 13.0% of the women discontinued from the clinical trials due to an adverse reaction; the most common adverse reactions leading to discontinuation were device-related events (2.7%), mood changes (1.7%), headache (including migraine) (1.5%) and vaginal symptoms (1.2%).
Serious Adverse Reactions: deep vein thrombosis [see Warnings and Precautions (5.1) ] , anxiety, cholelithiasis, and vomiting.
6.2Post-marketing Experience Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 to 1.12 (Figure 2). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 2). One of these studies reported no association between breast cancer risk and COC use.
The other two studies found an increased relative risk of 1.19 to 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8 to10 years of COC use. Figure 2: RR = relative risk; OR = odds ratio; HR = hazard ratio. “ever COC” are females with current or past COC use; “never COC use” are females that never used COCs.
The following adverse reactions have been identified during post-approval use of etonogestrel and ethinyl estradiol vaginal ring. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune system disorders: hypersensitivity reactions, including anaphylaxis and angioedema Nervous system disorders: stroke/cerebrovascular accident Vascular disorders: arterial events (including arterial thromboembolism and myocardial i…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. 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)
7.1Effects of Other Drugs on CHCs Substances decreasing the plasma concentrations of CHCs and potentially diminishing the effectiveness of CHCs Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of CHCs and potentially diminish the effectiveness of CHCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include: phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St.
John's wort. Interactions between CHCs and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative non-hormonal method of contraception or a back-up method when enzyme inducers are used with etonogestrel and ethinyl estradiol vaginal ring, and to continue back-up non-hormonal contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.
Note: etonogestrel and ethinyl estradiol vaginal ring may interfere with the correct placement and position of certain female barrier methods such as a diaphragm or female condom. These methods are not recommended as back-up methods with etonogestrel and ethinyl estradiol vaginal ring use [see Dosage and Administration (2.5) ] . The serum concentrations of etonogestrel and ethinyl estradiol were not affected by concomitant administration of oral amoxicillin or doxycycline in standard dosages during 10 days of antibiotic treatment.
The effects of other antibiotics on etonogestrel or ethinyl estradiol concentrations have not been evaluated. Substances increasing the plasma concentrations of CHCs Co-administration of atorvastatin and certain CHCs containing ethinyl estradiol increase AUC values for ethinyl estradiol by approximately 20-25%. Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol concentrations, possibly by inhibition of conjugation.
Concomitant administration of strong or moderate CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma estrogen and/or progestin concentrations. Co-administration of vaginal miconazole nitrate and etonogestrel and ethinyl estradiol vaginal ring increases the serum concentrations of etonogestrel and ethinyl estradiol by up to 40% [see Clinical Pharmacology (12.3) ] . Human immunodeficiency virus (HIV) / Hepatitis C Virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors Significant changes in the plasma concentrations of the estrogen and /or progestin have been noted in some cases of co-administration with HIV protease inhibitors (decrease [e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir] or increase [e.g., indinavir and atazanavir/ritonavir]) /HCV protease inhibitors (decrease [e.g., boceprevir and telaprevir]) or with non-nucleoside reverse transcriptase inhibitors (decrease [e.g., efavirenz, nevirapine] or increase [e.g., etravirine]).
These changes may be clinically relevant in some cases.
7.2Effects of CHCs on Other Drugs CHCs containing ethinyl estradiol may inhibit the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations. CHCs have been shown to decrease plasma concentrations of acetaminophen…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Nursing mothers: Not recommended; can decrease milk production. (8.2)
8.1Pregnancy Risk Summary etonogestrel and ethinyl estradiol vaginal ring is contraindicated during pregnancy because there is no need for pregnancy prevention in a woman who is already pregnant. Epidemiologic studies and meta-analyses have not shown an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following maternal exposure to low dose CHCs prior to conception or during early pregnancy. No adverse developmental outcomes were observed in pregnant rats and rabbits with the administration of etonogestrel during organogenesis at doses approximately 300 times the anticipated daily vaginal human dose (~0.002 mg/kg/day).
No adverse developmental outcomes were observed in pregnant rats and rabbits with the co-administration of the combination desogestrel/ethinyl estradiol during organogenesis at desogestrel/ethinyl estradiol doses at least 2/5 times, respectively, the anticipated daily vaginal human dose (~0.002 desogestrel/0.00025 ethinyl estradiol mg/kg/day). Discontinue etonogestrel and ethinyl estradiol vaginal ring use if pregnancy is confirmed. Data Animal Data In rats and rabbits at dosages up to 300 times the anticipated dose, etonogestrel is neither embryotoxic nor teratogenic.
Co-administration of a maternally toxic dose of desogestrel/ethinyl estradiol to pregnant rats was associated with embryolethality and wavy ribs at a desogestrel/ethinyl estradiol dose that was 40/130 times, respectively, the anticipated vaginal human dose (0.002 desogestrel/0.00025 ethinyl estradiol mg/kg/day). No adverse embryofetal effects were observed when the combination was administered to pregnant rats at a desogestrel/ethinyl estradiol dose that was 4/13 times, respectively, the anticipated vaginal human dose.
When desogestrel/ethinyl estradiol was given to pregnant rabbits, pre-implantation loss was observed at a desogestrel/ethinyl estradiol dose that was 3/10 times, respectively, the anticipated vaginal human dose. No adverse embryofetal effects were observed when the combination was administered to pregnant rabbits at a desogestrel/ethinyl estradiol dose that was 2/5 times the anticipated vaginal human dose.
8.2Lactation Risk Summary Small amounts of contraceptive steroids and/or metabolites, including etonogestrel and ethinyl estradiol are transferred to human milk. Harmful effects have not been observed in breastfed infants exposed to CHCs through breast milk. CHCs can reduce milk production in breastfeeding mothers.
This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. When possible, advise the nursing mother to use non-estrogen-containing contraception until she has completely weaned her child. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for etonogestrel and ethinyl estradiol vaginal ring and any potential adverse effects on the breastfed child from etonogestrel and ethinyl estradiol vaginal ring or from the underlying maternal condition.
8.4Pediatric Use Safety and efficacy of etonogestrel and ethinyl estradiol vaginal ring have been established in women of reproductive age. Efficacy is expected to be the same for postpubertal adolescents under the age of 18 and for users 18 years and older. Use of this product before menarche is not indicated.
8.5Geriatric Use Etonogestrel and ethinyl estradiol vaginal ring has not been studied in postmenopausal women and is not indicated in this population.
8.6Hepatic Impairment The effect of hepatic impairment on the pharmacokinetics of etonogestrel and ethinyl estradiol vaginal ring has not been studied. Steroid hormones may be poorly metabolized in patients with impaired liver function. Acute or chronic disturbances of liver function may necessitate the discontinuation of CHC use until markers o…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary etonogestrel and ethinyl estradiol vaginal ring is contraindicated during pregnancy because there is no need for pregnancy prevention in a woman who is already pregnant. Epidemiologic studies and meta-analyses have not shown an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following maternal exposure to low dose CHCs prior to conception or during early pregnancy. No adverse developmental outcomes were observed in pregnant rats and rabbits with the administration of etonogestrel during organogenesis at doses approximately 300 times the anticipated daily vaginal human dose (~0.002 mg/kg/day).
No adverse developmental outcomes were observed in pregnant rats and rabbits with the co-administration of the combination desogestrel/ethinyl estradiol during organogenesis at desogestrel/ethinyl estradiol doses at least 2/5 times, respectively, the anticipated daily vaginal human dose (~0.002 desogestrel/0.00025 ethinyl estradiol mg/kg/day). Discontinue etonogestrel and ethinyl estradiol vaginal ring use if pregnancy is confirmed. Data Animal Data In rats and rabbits at dosages up to 300 times the anticipated dose, etonogestrel is neither embryotoxic nor teratogenic.
Co-administration of a maternally toxic dose of desogestrel/ethinyl estradiol to pregnant rats was associated with embryolethality and wavy ribs at a desogestrel/ethinyl estradiol dose that was 40/130 times, respectively, the anticipated vaginal human dose (0.002 desogestrel/0.00025 ethinyl estradiol mg/kg/day). No adverse embryofetal effects were observed when the combination was administered to pregnant rats at a desogestrel/ethinyl estradiol dose that was 4/13 times, respectively, the anticipated vaginal human dose.
When desogestrel/ethinyl estradiol was given to pregnant rabbits, pre-implantation loss was observed at a desogestrel/ethinyl estradiol dose that was 3/10 times, respectively, the anticipated vaginal human dose. No adverse embryofetal effects were observed when the combination was administered to pregnant rabbits at a desogestrel/ethinyl estradiol dose that was 2/5 times the anticipated vaginal human dose.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and efficacy of etonogestrel and ethinyl estradiol vaginal ring have been established in women of reproductive age. Efficacy is expected to be the same for postpubertal adolescents under the age of 18 and for users 18 years and older. Use of this product before menarche is not indicated.
🧓 Geriatric Use ▾
8.5Geriatric Use Etonogestrel and ethinyl estradiol vaginal ring has not been studied in postmenopausal women and is not indicated in this population.
🆘 Overdosage ▾
10 OVERDOSAGE There have been no reports of serious ill effects from overdose of CHCs. Overdosage may cause withdrawal bleeding in females and nausea. If the ring breaks, it does not release a higher dose of hormones. In case of suspected overdose, all EluRyng rings should be removed and symptomatic treatment given.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Combination hormonal contraceptives act by suppression of gonadotropins. Although the primary effect of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation).
12.3Pharmacokinetics Absorption Etonogestrel: Etonogestrel released by EluRyng is rapidly absorbed. The bioavailability of etonogestrel after vaginal administration is approximately 100%. The serum etonogestrel and ethinyl estradiol concentrations observed during three weeks of EluRyng use are summarized in Table 2.
Ethinyl estradiol: Ethinyl estradiol released by EluRyng is rapidly absorbed. The bioavailability of ethinyl estradiol after vaginal administration is approximately 56%, which is comparable to that with oral administration of ethinyl estradiol. The serum ethinyl estradiol concentrations observed during three weeks of EluRyng use are summarized in Table 2.
Table 2: Mean (SD) Serum Etonogestrel and Ethinyl Estradiol Concentrations (n=16) 1 week 2 weeks 3 weeks etonogestrel (pg/mL) 1578 (408) 1476 (362) 1374 (328) ethinyl estradiol (pg/mL) 19.1 (4.5) 18.3 (4.3) 17.6 (4.3) The pharmacokinetic profile of etonogestrel and ethinyl estradiol during use of EluRyng is shown in Figure 3. Figure 3: Mean Serum Concentration-Time Profile of Etonogestrel and Ethinyl Estradiol during Three Weeks of EluRyng Use The pharmacokinetic parameters of etonogestrel and ethinyl estradiol were determined during one cycle of EluRyng use in 16 healthy female subjects and are summarized in Table 3.
Table 3: Mean (SD) Pharmacokinetic Parameters of EluRyng (n=16) Hormone C max pg/mL T max hr t 1/2 hr CL L/hr etonogestrel 1716 (445) 200.3 (69.6) 29.3 (6.1) 3.4 (0.8) ethinyl estradiol 34.7 (17.5) 59.3 (67.5) 44.7 (28.8) 34.8 (11.6) C max - maximum serum drug concentration T max - time at which maximum serum drug concentration occurs t 1/2 - elimination half-life, calculated by 0.693/K elim CL - apparent clearance Prolonged use of EluRyng: The mean serum etonogestrel concentration at the end of the fourth week of continuous use of EluRyng was 1272 ± 311 pg/mL compared to a mean concentration range of 1578 ± 408 to 1374 ± 328 pg/mL at the end of weeks one to three.
The mean serum ethinyl estradiol concentration at the end of the fourth week of continuous use of EluRyng was 16.8 ± 4.6 pg/mL compared to a mean concentration range of 19.1 ± 4.5 to 17.6 ± 4.3 pg/mL at the end of weeks one to three. Distribution Etonogestrel: Etonogestrel is approximately 32% bound to sex hormone-binding globulin (SHBG) and approximately 66% bound to albumin in blood. Ethinyl estradiol: Ethinyl estradiol is highly but not specifically bound to serum albumin (98.5%) and induces an increase in the serum concentrations of SHBG.
Metabolism In vitro data shows that both etonogestrel and ethinyl estradiol are metabolized in liver microsomes by the cytochrome P450 3A4 isoenzyme. Ethinyl estradiol is primarily metabolized by aromatic hydroxylation, but a wide variety of hydroxylated and methylated metabolites are formed. These are present as free metabolites and as sulfate and glucuronide conjugates.
The hydroxylated ethinyl estradiol metabolites have weak estrogenic activity. The biological activity of etonogestrel metabolites is unknown. Excretion Etonogestrel and ethinyl estradiol are primarily eliminated in urine, bile and feces.
Drug Interactions [See also Drug Interactions (7) .] The drug interactions of EluRyng were evaluated in several studies. A single-dose vaginal administration of an oil-based 1200-mg miconazole nitrate capsule increased the serum concentrations of etonogestrel and ethinyl estradiol by approximately 17% and 16%, respectively. Following multiple doses of 200 mg miconazole nitrate by vaginal suppository or vaginal cream, the mean serum concentrations of etonogestrel and ethinyl es…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Combination hormonal contraceptives act by suppression of gonadotropins. Although the primary effect of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation).
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Each EluRyng (etonogestrel and ethinyl estradiol vaginal ring) is individually packaged in a reclosable aluminum laminate pouch consisting of four layers, from outside to inside: polyester, LDPE-EAA coex (low density polyethylene/ethylene acryclic acid copolymer coextrudate laminate), aluminum foil, and EAA-LLDPE coex (ethylene acryclic acid copolymer/ low low density polyethylene coextrudate laminate). The ring should be replaced in this reclosable pouch after use and discarded in a waste receptacle out of the reach of children and pets.
It should not be flushed down the toilet. Carton of 3 pouches NDC 65162-469-35
16.1Storage Prior to dispensing to the user, store refrigerated 2° to 8°C (36° to 46°F). After dispensing to the user, EluRyng can be stored for up to 4 months at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Avoid storing EluRyng in direct sunlight or at temperatures above 30°C (86°F).
For the Dispenser: When EluRyng is dispensed to the user, place an expiration date on the label. The date should not exceed either 4 months from the date of dispensing or the expiration date, whichever comes first.
📋 Description ▾
11 DESCRIPTION EluRyng (etonogestrel and ethinyl estradiol vaginal ring) is a non-biodegradable, flexible, transparent to translucent , colorless to almost colorless, combination contraceptive vaginal ring containing two active components, a progestin, etonogestrel (13-ethyl-17-hydroxy-11-methylene-18,19-dinor-17α-pregn-4-en-20-yn-3-one) and an estrogen, ethinyl estradiol, USP (19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol). When placed in the vagina, each ring releases on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol, USP over a three-week period of use.
EluRyng is made of ethylene vinylacetate copolymers (28% and 9% vinylacetate) and magnesium stearate and contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol, USP. EluRyng is not made with natural rubber latex. EluRyng has an outer diameter of 54 mm and a cross-sectional diameter of 4 mm.
The molecular weights for etonogestrel and ethinyl estradiol, USP are 324.5 and 296.40, respectively. The structural formulas are as follows: formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ). Counsel patients regarding the following: Increased risk of cardiovascular events Advise patients that cigarette smoking increases the risk of serious cardiovascular events from use of EluRyng, and women who are over 35 years old and smoke should not use EluRyng [see Boxed Warning ] . Inform patients that the increased risk of VTE compared to non-users of CHCs is greatest after initially starting a CHC or restarting (following a 4-week or greater CHC-free interval) the same or a different CHC [see Warnings and Precautions (5.1) ] .
Use and administration Inform patients that EluRyng does not protect against HIV infection (AIDS) and other sexually transmitted infections. Advise patients on the proper usage of EluRyng and what to do if she does not comply with the labeled timing of insertion and removal [see Dosage and Administration (2) ] . Advise patients to regularly check for the presence of EluRyng in the vagina (for example, before and after intercourse) [see Dosage and Administration (2.3) ].
Pregnancy Inform patients that EluRyng is not to be used during pregnancy. If pregnancy is planned or occurs during treatment with EluRyng, instruct the patient to discontinue EluRyng use [see Use in Specific Populations (8.1) ] . Use of additional contraception Inform patients that they need to use a barrier method of contraception when the ring is out for more than three continuous hours until EluRyng has been used continuously for at least seven days [see Dosage and Administration (2.3) ] .
Advise patients to use a back-up or alternative method of contraception when enzyme inducers are used with EluRyng [see Drug Interactions (7.1) ] . Inform patients who start EluRyng postpartum and have not yet had a normal period that they should use an additional non-hormonal method of contraception for the first seven days [see Dosage and Administration (2.2) ] . Lactation Inform patients that CHCs may reduce breast milk production.
This is less likely to occur if breastfeeding is well established [see Use in Specific Populations (8.2) ] . Amenorrhea Inform patients that amenorrhea may occur. Rule out pregnancy in the event of amenorrhea if EluRyng has been out of the vagina for more than three consecutive hours, if the ring-free interval was extended beyond one week, if the woman has missed a period for two or more consecutive cycles, and if the ring has been retained for longer than four weeks [see Warnings and Precautions (5.11) ] .
Disposal Advise patients on the proper disposal of a used EluRyng [see How Supplied/Storage and Handling (16) ] . Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 01-2025-05