Etonogestrel-Ethinyl Estradiol

Etonogestrel-Ethinyl Estradiol is a vaginal ring combination hormone medication and is used to prevent pregnancy. 

• Etonogestrel-Ethinyl Estradiol is available under the following different brand names: NuvaRing, EluRyng

Common side effects of Etonogestrel-Ethinyl Estradiol include:

• Headache,
• Mood changes,
• Decreased sex drive,
• Vaginal irritation or discharge,
• Pain in the cervix,
• Menstrual cramps,
• Breast pain or tenderness,
• Nausea,
• Vomiting,
• Stomach pain,
• Acne, and
• Weight gain

Serious side effects of Etonogestrel-Ethinyl Estradiol include:

• Sudden numbness or weakness (especially on one side of the body),
• Sudden severe headache,
• Slurred speech,
• Problems with vision or balance,
• Sudden vision loss,
• Stabbing chest pain,
• Shortness of breath,
• Coughing up blood,
• Pain or warmth in one or both legs,
• Pain spreading to the jaw or shoulder,
• Nausea,
• Sweating,
• Sudden fever,
• Body aches,
• Skin rash,
• Vomiting,
• Diarrhoea,
• Lightheadedness,
• Mood changes,
• Thoughts of hurting yourself,
• Loss of appetite,
• Upper stomach pain,
• Tiredness,
• Dark urine, and
• Yellowing of your eyes or skin (jaundice)

Rare side effects of Etonogestrel-Ethinyl Estradiol include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Vaginal ring

• 0.12 mg/0.015 mg released per day

Contraception

Adult and pediatric dosage

• One NuvaRing is inserted in the vagina to remain in place for 3 weeks
• Remove for a one-week break; withdrawal bleed usually occurs, THEN
• Insert a new ring 1 week after the last ring removed

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Etonogestrel-Ethinyl Estradiol has severe interactions with the following drugs:
  • ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC)
  • tranexamic acid oral
• Etonogestrel-Ethinyl Estradiol has serious interactions with at least 71 other drugs.
• Etonogestrel-Ethinyl Estradiol has serious interactions with at least 186 other drugs.
• Etonogestrel-Ethinyl Estradiol has serious interactions with at least 28 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Documented hypersensitivity
• Arterial thromboembolic disease (stroke, MI), thrombophlebitis, DVT/PE, thrombogenic valvular disease
• Estrogen-dependent neoplasia (current or history of)
• Cerebrovascular disease, coronary artery disease
• Headaches with focal neurological symptoms
• Liver disease, liver tumors
• Undiagnosed abnormal vaginal bleeding
• Uncontrolled hypertension
• Women above 35 years who smoke
• Major surgery with prolonged immobilization
• Diabetes mellitus with vascular involvement, jaundice with prior oral contraceptive use
• Breast cancer or other estrogen-or progestin-sensitive cancer, now or in the past
• Use of hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Etonogestrel-Ethinyl Estradiol?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Etonogestrel-Ethinyl Estradiol?”

Cautions

• Avoid using the diaphragm concomitantly; may interfere with ring placement
• Family history of breast cancer and or DVT/PE
• Use caution in current/history of depression, endometriosis, DM, HTN, bone mineral density changes, renal/hepatic impairment, bone metabolic disease, SLE; conditions exacerbated by fluid retention (. g, migraine, asthma, epilepsy)
• Known risk factors for VTE include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate the use of CHCs; stop use if arterial thrombotic or venous thromboembolic event (VTE) occurs or if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions; evaluate for retinal vein thrombosis immediately
• The risk of VTE is highest during the first year of CHC use and after restarting a CHC following a break of at least four weeks; the risk of VTE due to CHCs gradually disappears after use is discontinued
• Discontinue if the following develop jaundice, visual problems (may cause contact lens intolerance), migraine with unusual severity, significant blood pressure increase, severe depression, increased risk of thromboembolic complications after surgery
• Discontinue 4 weeks before major surgery or prolonged immobilization
• Discontinue if an arterial thrombotic or venous thromboembolic event occurs
• Estrogens may cause retinal vascular thrombosis; discontinue therapy if visual disturbances occur including migraine, loss of vision, diplopia, or proptosis
• Patients on warfarin, oral anticoagulants (increase in anticoagulant dose may be warranted)
• Increased risk of cervical cancer with OCP use, however, HPV remains the main risk factor for this cancer, evidence suggests long-term use of OCPs, 5 or more years, may be associated with increased risk
• Increased risk of liver cancer with OCP use; risk increases with longer duration of OCP use
• Combination of hormonal contraceptives may affect lipoprotein levels and serum triglycerides
• Use of CHCs may worsen existing gallbladder disease; history of CHC-related cholestasis predicts an increased risk with subsequent CHC use; women with a history of pregnancy-related cholestasis may be at increased risk for CHC-related cholestasis
• Use caution in patients with diseases that may be exacerbated by fluid retention including migraine, diabetes, renal dysfunction, and epilepsy
• CDC guidelines recommend waiting at least 4 weeks following vaginal birth, in women who are not breastfeeding, or 6 weeks after cesarean section to decrease the risk for venous thromboembolism before initiating combined hormonal contraceptives; women with additional risk factors for VTE (besides postpartum) should not use combined hormonal contraceptives (MMWR July 7, 2011)
• The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week
• 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 reported; in some cases, the ring adhered to vaginal tissue, necessitating removal by a healthcare provider and in some instances (. e, when tissue had grown over ring), removal was achieved by cutting the ring without incising the overlying vaginal tissue
• Cases of toxic shock syndrome (TSS) have been reported by NuvaRing users; TSS has been associated with tampons and certain barrier contraceptives, and, in some cases, the patients were also using tampons; a causal relationship between the use of product 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
• Do not use the product in women with liver disease such as acute viral hepatitis or severe (decompensated) cirrhosis of the liver; 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; discontinue use if jaundice develops
• Risk of liver enzyme elevations with concomitant hepatitis C treatment reported; discontinue use before starting therapy with combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; the drug can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen
• Increase in blood pressure reported in women using CHCs; this increase is more likely in older women and with extended duration of use; incidence of hypertension increases with increasing concentrations of progestin; for women with well-controlled hypertension, monitor blood pressure and stop use if blood pressure rises significantly
• Hypersensitivity reactions of anaphylaxis and angioedema reported; if anaphylaxis and/or angioedema suspected, discontinue use and administer appropriate treatment
• Carefully monitor prediabetic and diabetic women who are using the product; 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 increased risk of pancreatitis when using CHCs
• If a woman develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue if indicated
• Consider discontinuation in the case of an increased frequency or severity of migraine during CHC use (which may be prodromal of a cerebrovascular event)
• Breast cancer
  • Epidemiology studies have not found a consistent association between the use of combined oral contraceptives (COCs) and breast cancer risk; studies do not show an association between every (current or past) use of COCs and the risk of breast cancer
  • Some studies report a small increase in the risk of breast cancer among current or recent users (below 6 months since last use) and current users with longer duration of COC use
  • A woman's risk depends on conditions where naturally high hormone levels persist for long periods including early-onset menstruation before age 12, late-onset menopause, after age 55, first child after age 30, nulliparity

Pregnancy and Lactation

• Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives before pregnancy; studies also do not suggest a teratogenic effect, particularly insofar as cardiac anomalies and limb reduction defects are concerned, when taken inadvertently during early pregnancy
• Administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy; oral contraceptives should not be used during pregnancy to treat threatened or habitual abortion
• It is recommended that for any patient who has missed two consecutive periods, pregnancy should be ruled out before continuing oral contraceptive use; if the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of first missed period; oral contraceptive use should be discontinued if pregnancy is confirmed
• Lactation
  • Small amounts of oral contraceptive steroids were identified in the milk of nursing mothers, and a few adverse effects on child reported, including jaundice and breast enlargement; in addition, oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk
  • If possible, the nursing mother should be advised not to use oral contraceptives but to use other forms of contraception until she has completely weaned her child