Description
Etonogestrel and ethinyl estradiol combination is used to prevent pregnancy. It is a flexible birth control vaginal ring that contains two types of hormones, etonogestrel and ethinyl estradiol. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization (pregnancy) is prevented.
No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than vaginal rings. Discuss your options for birth control with your doctor.
This medicine will not prevent HIV infection or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Insert, Extended Release
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of etonogestrel and ethinyl estradiol combination in teenagers. This medicine may be used for birth control in teenage females but should not be used before the start of menstruation.
Geriatric
Appropriate studies on the relationship of age to the effects of etonogestrel and ethinyl estradiol combination have not been performed in the geriatric population. This medicine is not recommended for use in elderly women.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Dasabuvir
- Fezolinetant
- Ombitasvir
- Paritaprevir
- Ritonavir
- Tranexamic Acid
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Alclometasone
- Aldosterone
- Amcinonide
- Amifampridine
- Amobarbital
- Amoxicillin
- Ampicillin
- Amprenavir
- Anagrelide
- Apalutamide
- Aprepitant
- Armodafinil
- Artemether
- Bacampicillin
- Beclomethasone
- Belzutifan
- Betamethasone
- Bexarotene
- Boceprevir
- Bosentan
- Budesonide
- Bupropion
- Butabarbital
- Butalbital
- Carbamazepine
- Carbenicillin
- Cefaclor
- Cefadroxil
- Cefdinir
- Cefditoren
- Cefixime
- Cefpodoxime
- Cefprozil
- Ceftazidime
- Ceftibuten
- Cefuroxime
- Cenobamate
- Ceritinib
- Chlortetracycline
- Ciclesonide
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amitriptyline
- Atazanavir
- Atorvastatin
- Clomipramine
- Diazepam
- Doxepin
- Efavirenz
- Etoricoxib
- Ginseng
- Imipramine
- Lamotrigine
- Leflunomide
- Levothyroxine
- Licorice
- Liothyronine
- Lorazepam
- Parecoxib
- Roflumilast
- Selegiline
- Temazepam
- Teriflunomide
- Tipranavir
- Triazolam
- Valdecoxib
- Voriconazole
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.
- Tobacco
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Caffeine
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Abnormal or unusual vaginal bleeding or
- Blood clots (eg, deep vein thrombosis, pulmonary embolism), or history of or
- Blood disorder (eg, hypercoagulopathy), acquired or inherited or
- Breast cancer, or history of or
- Diabetes with kidney, eye, nerve, or blood vessel damage or
- Heart attack, history of or
- Heart or blood vessel disease (eg, coronary artery disease, heart valve problems), or history of or
- Heart rhythm problems or
- Hypertension (high blood pressure), uncontrolled or
- Jaundice during pregnancy or from using hormonal therapy in the past or
- Liver disease (eg, hepatitis), including tumors or cancer or
- Major surgery in near future, with prolonged periods of immobilization or
- Migraine headache or
- Stroke, history of or
- Tumors (estrogen-dependent), known or suspected—Should not be used in patients with these conditions.
- Angioedema (swelling of the face, tongue, or throat), inherited or
- Chloasma gravidarum (skin disorder during pregnancy), history of or
- Cholestasis (bile problem) during pregnancy, history of or
- Cervical cancer or
- Depression, history of or
- Gallbladder disease or
- Hypertension (high blood pressure) or
- Toxic shock syndrome, history of or
- Vaginal or cervical erosion or ulcers—Use with caution. May make these conditions worse.
- Diabetes or
- Hyperlipidemia (high cholesterol or fats in the blood), or family history of or
- Kidney disease or
- Obesity, or history of—Use with caution. These conditions may increase the risk for more serious side effects.
Proper Use
Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects.
This medicine is to be used only in the vagina. This combination medicine is contained in a ring that is placed into your vagina. The ring will slowly release small amounts of the medicine for your body to absorb.
This medicine comes with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
NuvaRing® is used in a 4 week cycle. You may start using the vaginal ring on the first day of your menstrual period or between the second and fifth day, keeping it in place for 3 weeks.
Once the ring is in place inside your vagina, you should not be able to feel it. If you feel uncomfortable, the ring may not be inserted far enough. Gently push the ring farther into your vagina. If you feel pain, talk to your doctor.
Check for the presence of the ring inside your vagina regularly (including before and after having sex).
The ring may move down into the lower part of your vagina accidently. This can happen if you strain to have a bowel movement. Use your finger to gently push the ring back into place. If the ring comes all the way out of your vagina, rinse it off with warm water and put it back in. Call your doctor if the ring comes out several times.
Remove the vaginal ring after 3 weeks on the same day of the week and time it was inserted. During the 1-week break, you will usually have your menstrual period. Another ring will be inserted after a week.
While using this medicine, you may need to use an additional form of birth control method (eg, condom, spermicide) during the first 7 days to prevent pregnancy. Do not use a vaginal diaphragm because the ring may affect how the diaphragm fits.
If you need to remove the ring, hook your finger through it and pull it out.
If you are switching from a combination hormonal method (eg, pills, patch) to NuvaRing®, start using this medicine on any day. Do not start using this medicine any later than the day you would start your next birth control pill or patch.
If you are switching from a progestin-only method (eg, progestin-only pill, implant, injection, intrauterine system) to NuvaRing®, start using it on the day after you used your last progestin-only pill, or on the day your implant or IUD is removed, or on the day you would have your next injection. You must also use an additional barrier method of birth control (eg, male condom with spermicide) for the first 7 days.
Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For vaginal dosage form (ring):
- For contraception (to prevent pregnancy):
- Adults—One ring inserted into the vagina for 3 weeks, followed by a 1 week ring-free interval. Then, a new ring is inserted 1 week after the last ring was removed.
- Children—Use and dose must be determined by your doctor.
- For contraception (to prevent pregnancy):
Missed Dose
Call your doctor or pharmacist for instructions.
If NuvaRing® has slipped out of the vagina and it has been out less than 3 hours, you should still be protected from pregnancy.
If NuvaRing® has been out of the vagina for more than 3 hours:
- During Weeks 1 and 2: You may not be protected from pregnancy. Reinsert the ring as soon as you remember. Use another form of birth control (condoms or spermicide) until the ring has been in place for 7 days in a row.
- During Week 3: Throw the NuvaRing® away, do not reinsert. Use another form of birth control (condoms or spermicide) until the new ring has been used for 7 days in a row, following these options. You may only choose option 2 if you used the ring for 7 days in a row prior to it falling out.
- Option 1: Insert a new ring right away to start your next 21 day cycle. You may not have your regular period, but you may have spotting or vaginal bleeding.
- Option 2: Insert a new ring no later than 7 days from the time the previous ring was removed. During this time, you may have your period.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store this medicine for up to 4 months after you receive it.
Place the used NuvaRing® in the re-sealable foil pouch and throw it in the trash where children and pets cannot get to it. Do not flush the ring down the toilet.
Precautions
It is very important that your doctor check your progress at regular annual visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects. Your doctor may also want to check your blood pressure while using this medicine.
Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away. You may start using this medicine 4 weeks after giving birth and if you are not breastfeeding.
Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when lighter, or breakthrough bleeding when heavier.
- If this should occur, continue using NuvaRing®.
- The bleeding usually stops within 1 week. Check with your doctor if the bleeding continues for more than 1 week.
- If the bleeding continues after you have been taking hormonal contraceptives on schedule and for more than 3 months, check with your doctor.
You may be pregnant if:
- You missed a period and NuvaRing® was out of the vagina for more than 3 hours during the 3 weeks of ring use.
- You missed a period and waited longer than 1 week to insert a new ring.
- You missed two periods in a row.
- You have left NuvaRing® in place for longer than 4 weeks.
If you suspect that you may be pregnant, stop using this medicine and check with your doctor right away.
Do not use this medicine together with medicine to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (Technivie®, Viekira Pak®).
Do not use this medicine if you smoke cigarettes or if you are over 35 years of age. If you smoke while using NuvaRing®, you increase your risk of having a blood clot, heart attack, or stroke. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you have overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.
Using this medicine may increase your risk of having blood clotting problems. Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty with breathing, a sudden, severe headache, slurred speech, a sudden, trouble breathing, a sudden loss of coordination, or vision changes while using this medicine.
Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want an eye doctor (ophthalmologist) to check your eyes.
Toxic shock syndrome (TSS) may occur while using this medicine. Call your doctor right away if you have any of the following symptoms: sudden high fever, diarrhea, dizziness, fainting, vomiting, muscle aches, or a sunburn-like rash.
Check with your doctor right away if you have pain or tenderness in the upper stomach, dark urine, pale stools, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Your blood pressure might get too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away.
This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, puffiness or swelling of the eyelids, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.
This medicine may increase your risk of having gallbladder disease. Check with your doctor if you start to have stomach pains, nausea, and vomiting.
Using this medicine may increase your risk of breast cancer or cervical cancer. Talk with your doctor about this risk. Check with your doctor immediately if you experience abnormal vaginal bleeding.
This medicine may cause skin discoloration. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.
Make sure any doctor or dentist who treats you knows that you are using this medicine. The results of some medical tests may be affected by this medicine. You may also need to stop using this medicine at least 4 weeks before and 2 weeks after having major surgery.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Incidence not known
- Blurred vision
- changes in skin color
- chest pain or discomfort
- confusion
- constipation
- diarrhea
- dizziness
- gaseous stomach pain
- headache
- inability to speak
- nausea
- nervousness
- numbness of the hands
- pain in the chest, groin, or legs, especially calves of the legs
- pain or discomfort in the arms, jaw, back, or neck
- pounding in the ears
- prominent superficial veins over the affected area with tenderness and warmth
- recurrent fever
- seizures
- severe headache of sudden onset
- slow or fast heartbeat
- stomach fullness
- stomach pain or tenderness usually after eating a meal
- sudden loss of coordination
- sudden onset of slurred speech
- sudden vision changes
- sudden and severe weakness in the arm or leg on one side
- sweating
- swelling of the foot or leg on one side of the body
- temporary blindness
- vomiting with or without blood
- yellow eyes or skin
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Menstrual changes
- nausea
- vaginal bleeding
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Chest tightness
- cough
- fever
- itching of the vagina or genital area
- pain during sexual intercourse
- pain or tenderness around the eyes and cheekbones
- sore throat
- stuffy or runny nose
- thick, white vaginal discharge with or without a mild odor
- weight gain
Less common
- Crying
- depersonalization
- false or unusual sense of well-being
- hoarseness
- mental depression
- paranoia
- quick to react or overreact emotionally
- rapidly changing moods, mild feeling of sadness or discouragement that come and go
Incidence not known
- Absent, missed, or irregular menstrual periods
- bloody vaginal discharge
- brown, blotchy spots on exposed skin
- chills
- clay-colored stools
- contact lens intolerance
- dark urine
- decreased amount or quality of milk
- dry mouth
- dry skin
- fruit-like or unpleasant breath odor
- increased hunger
- increased thirst
- increased urination
- loss of appetite
- medium to heavy, irregular vaginal bleeding between regular monthly periods, which may require the use of a pad or a tampon
- rash
- soreness, swelling, or discharge from the breast or breasts
- trouble getting pregnant
- unexplained weight loss
- unusual tiredness or weakness
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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