Ethinylestradiol/etonogestrel

What is Ethinylestradiol/etonogestrel?

• Ethinylestradiol/etonogestrel (NuvaRing), is an estrogen/progestin combination hormonal contraceptive (CHC).

Ethinylestradiol

Etonogestrel

What are the uses of this medicine?

• Ethinylestradiol/etonogestrel (NuvaRing), Vaginal Ring is a flexible birth control vaginal ring used to prevent pregnancy.
• Etonogestrel/Ethinyl Estradiol Vaginal Ring contains a combination of a progestin and estrogen, 2 kinds of female hormones.
• Birth control methods that contain both an estrogen and a progestin are called combination hormonal contraceptives (CHCs).

How does this medicine work?

• 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).

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• smoke
• are pregnant or think you are pregnant
• recently had a baby
• recently had a miscarriage or abortion
• have a family history of breast cancer
• have or have had breast nodules, fibrocystic disease, an abnormal breast x-ray, or abnormal mammogram
• use tampons and have a history of toxic shock syndrome
• have been diagnosed with depression
• have had liver problems including jaundice during pregnancy
• have or have had elevated cholesterol or triglycerides
• have or have had gallbladder, liver, heart, or kidney disease
• have diabetes
• have a history of jaundice (yellowing of the skin or eyes) caused by pregnancy (also called cholestasis of pregnancy)
• have a history of scanty or irregular menstrual periods
• have any condition that makes the vagina become irritated easily
• have or have had high blood pressure
• have or have had migraines or other headaches or seizures
• are scheduled for surgery. Etonogestrel/Ethinyl Estradiol Vaginal Ring may increase your risk of blood clots after surgery. You should stop using Etonogestrel/Ethinyl Estradiol Vaginal Ring at least 4 weeks before you have surgery and not restart it until at least 2 weeks after your surgery.
• are scheduled for any laboratory tests. Certain blood tests may be affected by hormonal birth control methods.
• are breastfeeding or plan to breastfeed. Hormonal birth control methods that contain estrogen, like Etonogestrel/Ethinyl Estradiol Vaginal Ring, may decrease the amount of milk you make. A small amount of hormones from Etonogestrel/Ethinyl Estradiol Vaginal Ring may pass into your breast milk. Consider another non-hormonal method of birth control until you are ready to stop breastfeeding.
• have (or have ever had) an allergic reaction while using Etonogestrel/Ethinyl Estradiol Vaginal Ring, including hives, swelling of the face, lips, tongue, and/or throat causing difficulty in breathing or swallowing (anaphylaxis and/or angioedema).

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• certain anti-seizure medicines (such as barbiturates, carbamazepine, felbamate, oxcarbazepine, phenytoin, rufinamide and topiramate)
• medicine to treat fungal infections (griseofulvin)
• certain combinations of HIV medicines, (such as nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir)
• certain hepatitis C (HCV) medicines (such as boceprevir and telaprevir)
• non-nucleoside reverse transcriptase inhibitors (such as efavirenz and nevirapine)
• medicine to treat tuberculosis (such as rifampicin and rifabutin)
• medicine to treat high blood pressure in the vessels of the lung (bosentan)
• medicine to treat chemotherapy-induced nausea and vomiting (aprepitant)
• St John's wort

Some medicines and grapefruit juice may increase the level of ethinyl estradiol in your blood if used together, including:

• the pain reliever acetaminophen
• ascorbic acid (vitamin C)
• medicines that affect how your liver breaks down other medicines (such as itraconazole, ketoconazole, voriconazole, fluconazole, clarithromycin, erythromycin, and diltiazem)
• certain HIV medicines (atazanavir/ritonavir and indinavir)
• non-nucleoside reverse transcriptase inhibitors (such as etravirine)
• medicines to lower cholesterol such as atorvastatin and rosuvastatin
• Hormonal birth control methods may interact with lamotrigine, a medicine used for seizures. This may increase the risk of seizures, so your healthcare provider may need to adjust your dose of lamotrigine.
• Women on thyroid replacement therapy may need increased doses of thyroid hormone.

Is this medicine FDA approved?

• The combination was approved for medical use in the United States in 2001.
• It is available as a generic medication in the United Kingdom.
• In 2020, it was the 194th most commonly prescribed medication in the United States, with more than 2 million prescriptions.

How should this medicine be used?

Recommended dosage:

• One Etonogestrel/Ethinyl Estradiol Vaginal Ring is inserted in the vagina. The ring must remain in place continuously for three weeks, followed by a one-week ring-free interval.

Administration:

• Use Etonogestrel/Ethinyl Estradiol Vaginal Ring exactly as your healthcare provider tells you to use it.
• Etonogestrel/Ethinyl Estradiol Vaginal Ring is used in a 4-week cycle.
• Insert 1 Etonogestrel/Ethinyl Estradiol Vaginal Ring in the vagina and keep it in place for 3 weeks (21 days). Regularly check that Etonogestrel/Ethinyl Estradiol Vaginal Ring is in your vagina (for example, before and after intercourse) to ensure that you are protected from pregnancy.
• Remove the Etonogestrel/Ethinyl Estradiol Vaginal Ring for a 1-week break (7 days). During the 1-week break (7 days), you will usually have your menstrual period.
• Note: Insert and remove Etonogestrel/Ethinyl Estradiol Vaginal Ring on the same day of the week and at the same time:
• For example, if you insert your Etonogestrel/Ethinyl Estradiol Vaginal Ring on a Monday at 8:00 am, you should remove it on the Monday 3 weeks later at 8:00 am.
• After your 1-week (7 days) break, you should insert a new Etonogestrel/Ethinyl Estradiol Vaginal Ring on the next Monday at 8:00 am.
• While using Etonogestrel/Ethinyl Estradiol Vaginal Ring, you should not use certain female barrier contraceptive methods such as a vaginal diaphragm, cervical cap or female condom as your back-up method of birth control because Etonogestrel/Ethinyl Estradiol Vaginal Ring may interfere with the correct placement and position of a diaphragm, cervical cap or female condom.
• Ring breakage has occurred when also using a vaginal product such as a lubricant or treatment for infection. Use of spermicides or vaginal yeast products will not make Etonogestrel/Ethinyl Estradiol Vaginal Ring less effective at preventing pregnancy.
• Use of tampons will not make Etonogestrel/Ethinyl Estradiol Vaginal Ring less effective or stop Etonogestrel/Ethinyl Estradiol Vaginal Ring from working.
• If Etonogestrel/Ethinyl Estradiol Vaginal Ring has been left inside your vagina for more than 4 weeks (28 days), you may not be protected from pregnancy and you should see your healthcare provider to be sure you are not pregnant. Until you know the results of your pregnancy test, you should use an extra method of birth control, such as male condoms with spermicide, until the new Etonogestrel/Ethinyl Estradiol Vaginal Ring has been in place for 7 days in a row.
• Do not use more than 1 Etonogestrel/Ethinyl Estradiol Vaginal Ring at a time. Too much hormonal birth control medicine in your body may cause nausea, vomiting, or vaginal bleeding.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a Vaginal Ring is a polymeric vaginal ring containing 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol, which releases on average 0.12 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol.

This medicine is available in fallowing brand namesː

• NuvaRing

What side effects can this medication cause?

The most common side effects of this medicine may include:

• tissue irritation inside your vagina or on your cervix
• headache (including migraine)
• mood changes (including depression, especially if you had depression in the past). Call your healthcare provider immediately if you have any thoughts of harming yourself.
• Etonogestrel/Ethinyl Estradiol Vaginal Ring problems, including the ring slipping out or causing discomfort
• nausea and vomiting
• vaginal discharge
• weight gain
• vaginal discomfort
• breast pain, discomfort, or tenderness
• painful menstrual periods
• abdominal pain
• acne
• less sexual desire
• Some women have spotting or light bleeding during Etonogestrel/Ethinyl Estradiol Vaginal Ring use.

• Other side effects seen with Etonogestrel/Ethinyl Estradiol Vaginal Ring include breast discharge; vaginal injury (including pain, discomfort, and bleeding) associated with broken rings; and penis discomfort of the partner (such as irritation, rash, itching).

Less common, but serious side effects may include:

• Blotchy darkening of your skin, especially on your face
• High blood sugar, especially in women who already have diabetes
• High fat (cholesterol, triglycerides) levels in the blood

What special precautions should I follow?

• Do not use Etonogestrel/Ethinyl Estradiol Vaginal Ring if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from combination hormonal contraceptives (CHCs), including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.
• Cases of Toxic Shock Syndrome (TSS) have been reported by Etonogestrel/Ethinyl Estradiol Vaginal Ring users. If patient exhibits signs or symptoms of TSS, consider the possibility of this diagnosis and initiate appropriate medical evaluation and treatment.
• 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
• Etonogestrel/Ethinyl Estradiol Vaginal Ring is contraindicated in women with uncontrolled hypertension or hypertension with vascular disease. If used in women with well-controlled hypertension, monitor blood pressure and stop Etonogestrel/Ethinyl Estradiol Vaginal Ring use if blood pressure rises significantly.
• 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.
• Etonogestrel/Ethinyl Estradiol Vaginal Ring may not be suitable for women with conditions that make the vagina more susceptible to vaginal irritation or ulceration.
• Studies suggest a small increased relative risk of developing gallbladder disease among CHC users. Use of CHCs may also worsen existing gallbladder disease.
• Monitor prediabetic and diabetic women. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia.
• 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.
• Unscheduled bleeding (breakthrough or intracyclic) bleeding and spotting sometimes occur in women using CHCs, especially during the first three months of use. Evaluate irregular bleeding or amenorrhea.
• Carefully observe women with a history of depression and discontinue Etonogestrel/Ethinyl Estradiol Vaginal Ring use if depression recurs to a serious degree.
• Etonogestrel/Ethinyl Estradiol Vaginal Ring is contraindicated in females who currently have or have had breast cancer because breast cancer may be hormonally sensitive.
• The estrogen component of CHCs may raise the serum concentrations of thyroxine-binding globulin, sex hormone-binding globulin, and cortisol-binding globulin. The dose of replacement thyroid hormones or cortisol therapy may need to be increased.
• A woman who is using Etonogestrel/Ethinyl Estradiol Vaginal Ring should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated healthcare.
• Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while using Etonogestrel/Ethinyl Estradiol Vaginal Ring.
• Inform patients that they need to use a barrier method of contraception when the ring is out for more than three continuous hours until Etonogestrel/Ethinyl Estradiol Vaginal Ring has been used continuously for at least seven days.
• Inform patients that CHCs may reduce breast milk production. This is less likely to occur if breastfeeding is well established.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Overdosage may cause withdrawal bleeding in females and nausea.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• If the ring breaks, it does not release a higher dose of hormones.
• In case of suspected overdose, all Etonogestrel/Ethinyl Estradiol Vaginal Ring rings should be removed and symptomatic treatment given.

Can this medicine be used in pregnancy?

• Inform patients that Etonogestrel/Ethinyl Estradiol Vaginal Ring is not to be used during pregnancy.
• If pregnancy is planned or occurs during treatment with Etonogestrel/Ethinyl Estradiol Vaginal Ring, instruct the patient to discontinue Etonogestrel/Ethinyl Estradiol Vaginal Ring use.

Can this medicine be used in children?

• Safety and efficacy of Etonogestrel/Ethinyl Estradiol Vaginal Ring have been established in women of reproductive age.
• Use of this product before menarche is not indicated.

What are the active and inactive ingredients in this medicine?

• Active ingredients: etonogestrel and ethinyl estradiol
• Inactive ingredients: ethylene vinylacetate copolymers (28% and 9% vinylacetate) and magnesium stearate.
• Etonogestrel/Ethinyl Estradiol Vaginal Ring is not made with natural rubber latex.

Who manufactures and distributes this medicine?

• Manufactured for: Prasco Laboratories, Mason, OH, USA
• Manufactured by: N.V. Organon, Oss, The Netherlands, a subsidiary of
• Organon & Co., Jersey City, NJ, USA

What should I know about storage and disposal of this medication?

• Store Etonogestrel/Ethinyl Estradiol Vaginal Ring at room temperature between 68°F to 77°F (20°C to 25°C).
• Store Etonogestrel/Ethinyl Estradiol Vaginal Ring at room temperature for up to 4 months after you receive it. Throw Etonogestrel/Ethinyl Estradiol Vaginal Ring away if the expiration date on the label has passed.
• Do not store Etonogestrel/Ethinyl Estradiol Vaginal Ring above 86°F (30°C).
• Avoid direct sunlight.
• Place the used Etonogestrel/Ethinyl Estradiol Vaginal Ring in the re-closable foil pouch and properly throw it away in your household trash out of the reach of children and pets. Do not flush your used Etonogestrel/Ethinyl Estradiol Vaginal Ring down the toilet.

• Dailymed label info on Ethinylestradiol/etonogestrel
• FDA Ethinylestradiol/etonogestrel

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