NuvaRing

NuvaRing is a birth control medication used to prevent pregnancy. It is a single product containing 2 kinds of female hormones: etonogestrel, a progestin, and ethinyl estradiol, an estrogen. NuvaRing works by preventing ovulation (the release of an egg from the ovaries). It also changes the lining of the uterus (womb) to prevent pregnancy from developing and changes the mucus at the cervix (opening of the uterus) to prevent sperm from entering.

This medication comes as a flexible vaginal ring and is inserted and left in place for 3 weeks. After 3 weeks, it is removed for a 1-week break, then a new ring is inserted.

Common side effects of NuvaRing include headache, mood changes, and weight gain.

NuvaRing is a prescription birth control medication used to prevent pregnancy.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Organon Pharmaceuticals USA

Serious side effects have been reported with NuvaRing. See the "NuvaRing Precautions" section.

Common side effects of NuvaRing include the following:

• 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.
• NuvaRing 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
• spotting or light bleeding. If these symptoms occur, do not stop using NuvaRing. The problem will usually go away. If it doesn't go away, check with your healthcare provider
• allergic reaction
• hives
• breast discharge
• penis discomfort of the partner (such as irritation, rash, itching)

This is not a complete list of NuvaRing side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines and herbal products may make hormonal birth control less effective, including, but not limited to:

• certain anti-seizure medicines (such as barbiturates, carbamazepine, felbamate, oxcarbazepine, phenytoin, rufinamide, topiramate)
• medicine to treat fungal infections (griseofulvin)
• certain combinations of HIV medicines (such as nelfinavir, ritonavir, darunavir/ritonavir, fosamprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir)
• certain hepatitis C (HCV) medicines (such as boceprevir, telaprevir)
• non-nucleoside reverse transcriptase inhibitors (such as 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

Use an additional birth control method (such as a male condom with spermicide) when you take medicines that may make NuvaRing less effective. Continue back-up birth control for 28 days after stopping the medicine to help prevent you from becoming pregnant.

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

• acetaminophen
• ascorbic acid (vitamin C)
• medicines that affect how your liver breaks down other medicines (such as itraconazole, ketoconazole, voriconazole, and fluconazole)
• certain HIV medicines (atazanavir/ritonavir, 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.

This is not a complete list of NuvaRing drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with NuvaRing including the following:

• Blood clots. Like pregnancy, combination hormonal birth control methods increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age greater than 35. This increased risk is highest when you first start using a combination hormonal birth control method or when you restart the same or different combination hormonal birth control method after not using it for a month or more. Talk with your healthcare provider about your risk of getting a blood clot before using NuvaRing or before deciding which type of birth control is right for you. It is possible to die or be permanently disabled from a problem caused by a blood clot, such as heart attack or stroke. Some examples of serious blood clots are blood clots in the:
  • legs (deep vein thrombosis)
  • lungs (pulmonary embolism)
  • eyes (loss of eyesight)
  • heart (heart attack)
  • brain (stroke)
• Call your healthcare provider right away if you have:
  • leg pain that does not go away
  • sudden shortness of breath
  • sudden blindness, partial or complete
  • severe pain or pressure in your chest
  • sudden, severe headache unlike your usual headaches
  • weakness or numbness in an arm or leg, or trouble speaking
  • yellowing of the skin or eyeballs

Other serious risks include:

• Toxic Shock Syndrome (TSS). Some of the symptoms are much the same as the flu, but they can become serious very quickly. Call your healthcare provider or get emergency treatment right away if you have the following symptoms:
  • sudden high fever
  • vomiting
  • diarrhea
  • a sunburn-like rash
  • muscle aches
  • dizziness
  • fainting or feeling faint when standing up
• liver problems, including liver tumors
• high blood pressure
• gallbladder problems
• accidental insertion into bladder
• symptoms of a problem called angioedema if you already have a family history of angioedema

Do not use NuvaRing if you:

• smoke and are over 35 years old
• have or have had blood clots in your arms, legs, eyes, or lungs
• have an inherited problem with your blood that makes it clot more than normal
• have had a stroke
• have had a heart attack
• have certain heart valve problems or heart rhythm problems that can cause blood clots to form in the heart
• have high blood pressure that medicine can't control
• have diabetes with kidney, eye, nerve, or blood vessel damage
• have certain kinds of severe migraine headaches with aura, numbness, weakness, or changes in vision, or have any migraine headaches if you are over age 35
• have liver disease, including liver tumors
• have unexplained vaginal bleeding
• are pregnant or think you may be pregnant. NuvaRing is not for pregnant women
• have or have had breast cancer or any cancer that is sensitive to female hormones
• are allergic to etonogestrel, ethinyl estradiol or any of the ingredients in NuvaRing

Grapefruit and grapefruit juice may interact with NuvaRing and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before using NuvaRing, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have any medical conditions
• 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 triglycerides or cholesterol
• 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 that 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. NuvaRing may increase your risk of blood clots after surgery. You should stop using NuvaRing 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 NuvaRing, may decrease the amount of milk you make. A small amount of hormones from NuvaRing may pass into your breast milk. Consider another non-hormonal method of birth control until you are ready to stop breastfeeding.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

NuvaRing falls into category X. It has been shown that women using NuvaRing during pregnancy may have babies born with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women.

Tell your doctor if you are breastfeeding or plan to breastfeed.

The effects of NuvaRing in nursing mothers have not been established and are unknown. When possible, the nursing mother should be advised to use other forms of contraception until she has completely weaned her child. Combination hormonal contraceptives 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. Small amounts of contraceptive steroids and/or metabolites are present in breast milk.

Use NuvaRing exactly as prescribed.

NuvaRing is used in a 4 week cycle. Insert 1 NuvaRing in the vagina and keep it in place for 3 weeks (21 days). Remove the NuvaRing for a 1 week break (7 days). During the 1-week break, you will usually have your menstrual period. Insert and remove NuvaRing on the same day of the week and at the same time.

When using NuvaRing, you should not use a vaginal diaphragm as your back-up method of birth control because NuvaRing may interfere with the correct placement and position of a diaphragm. Use of spermicides or vaginal yeast products will not make NuvaRing less effective at preventing pregnancy. Use of tampons will not make NuvaRing less effective or stop NuvaRing from working.

If NuvaRing 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 NuvaRing has been in place for 7 days in a row.

Do not use more than 1 NuvaRing at a time. Too much hormonal birth control medicine in your body may cause nausea, vomiting, or vaginal bleeding.

Use this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

NuvaRing is a non-biodegradable, flexible, transparent, colorless to almost colorless, combination contraceptive vaginal ring. It contains 11.7mg of etonogestrel and 2.7mg of ethinyl estradiol. When placed in the vagina, each ring releases on average 0.120mg/day of etonogestrel and 0.015mg/day of ethinyl estradiol over a three-week period of use.

If you use too much NuvaRing, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store NuvaRing at room temperature between 68 and 77 degrees Fahrenheit.
• Store NuvaRing at room temperature for up to 4 months after you receive it. Throw NuvaRing away if the expiration date on the label has passed
• Do not store NuvaRing above 86 degrees Fahrenheit.
• Avoid direct sunlight
• Place the used NuvaRing 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 NuvaRing down the toilet.
• Keep this and all medicines out of the reach of children

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 NuvaRing, should not be used by women who are over 35 years of age and smoke.