PATIENT INFORMATION Can I use vaginal medications?
® Use of spermicides or vaginal yeast products will not reduce the contraceptive efficacy of NuvaRing®.
What should I do if my NuvaRing® disconnects?
only There have been reported cases of NuvaRing® disconnecting at the weld joint causing the ring to change shape and straight-
en out. This is not expected to affect the contraceptive effectiveness of NuvaRing®. If NuvaRing® disconnects, expulsion
(slipping out) is more likely to occur (see “If NuvaRing® slips out”). If you discover the ring has disconnected, you should
discard the ring and replace it with a new ring.
delivers 0.120 mg/0.015 mg per day
Overdose
NuvaRing® is unlikely to cause an overdose because the ring holding the medicine releases a steady amount of contracep-
Read this leaflet carefully before you use NuvaRing® so that you understand the benefits and risks of using this form of
tive hormones. Do not use more than one ring at a time. Overdose of combination hormonal contraceptives may cause
birth control. The leaflet gives you information about the possible serious side effects of NuvaRing®. This leaflet will also
nausea, vomiting, or vaginal bleeding.
tell you how to use NuvaRing® properly so that it will give you the best possible protection against pregnancy. Read the
® information you get whenever you get a new prescription or refill, because there may be new information. This informa- What should I avoid while using NuvaRing
Cigarette smoking increases the risk of serious cardiovascular side effects when you use combination oral contraceptives,
tion does not take the place of talking with your healthcare provider.
including Nuva Ring®. This risk increases even more if you are over age 35 and if you smoke 15 or more cigarettes a day.
What is NuvaRing® Women who use combination hormonal contraceptives, like Nuva Ring®, are strongly advised not to smoke. Do not breast-
NuvaRing® (NEW-vah-ring) is a flexible combined contraceptive vaginal ring. It is used to prevent pregnancy. It does not feed while using NuvaRing®. Some of the medicine may pass through the milk to the baby and could cause yellowing of
protect against HIV infection (AIDS) and other sexually transmitted diseases (S TD’s) such as chlamydia, genital herpes, the skin (jaundice) and breast enlargement in your baby. NuvaRing® could also decrease the amount and quality of your
genital warts, gonorrhea, hepatitis B, and syphilis. NuvaRing® contains a combination of a progestin and estrogen, two breast milk. The hormones in NuvaRing® can interact with many other medicines and herbal supplements. Tell your health-
kinds of female hormones. You insert the ring in your vagina and leave it there for three weeks. After the ring is inserted,
care provider about any medicines you are taking, including prescription medicines, over-the-counter medicines, herbal
it releases a continuous low dose of hormones into your body. You then remove it for a one-week ring-free period. remedies, and vitamins. The blood levels of the hormones released by NuvaRing® were increased when women used a
Contraceptives that contain both an estrogen and a progestin are called combination hormonal contraceptives. Most stud- vaginal medication (miconazole nitrate) for a yeast infection while NuvaRing® was in place. The pregnancy protection of
ies on combination contraceptives have used oral (taken by mouth) contraceptives. NuvaRing® may have the same risks NuvaRing® is not likely to be changed by use of these products. The blood levels of these hormones were not changed
that have been found for combination oral contraceptives. This leaflet will tell you about risks of taking combination oral when women used vaginal, water-based spermicides (nonoxynol or N- 9 products) along with NuvaRing®. Certain drugs
contraceptives that may also apply to NuvaRing® users. In addition, it will tell you how to use NuvaRing® properly so that
and herbal supplements may interact with combined hormonal contraceptives to make them less effective in preventing
it will give you the best possible protection against pregnancy.
pregnancy or cause an increase in breakthrough bleeding. Such drugs include rifampin, drugs used for epilepsy such as
Who should not use NuvaRing®?
barbiturates (for example, phenobarbital), carbamazepine, and phenytoin, primidone, topiramate, phenylbutazone,
modafinil, and some drugs used for HIV such as ritonavir. Pregnancies and breakthrough bleeding have been reported by
Cigarette smoking increases the risk of serious cardiovascular side effects when you use combination
users of combined hormonal contraceptives who also used the herbal supplement St. John’s Wort. You may need to use
oral contraceptives. This risk increases even more if you are over age 35 and if you smoke 15 or more
a non-hormonal method of contraception during any cycle in which you take drugs that can make oral contraceptives less
cigarettes a day. Women who use combination hormonal contraceptives, including NuvaRing®, are effective. Be sure to tell your healthcare provider if you are taking or start taking any other medications, including non-pre-
strongly advised not to smoke.
scription products or herbal products while using NuvaRing®. While using NuvaRing®, you should not rely upon a
Do not use NuvaRing® if you have any of the following conditions: • a history of heart attack or stroke • a history of diaphragm when you need a back-up method of birth control because NuvaRing® may interfere with the correct placement
blood clots in your legs (thrombophlebitis), lungs (pulmonary embolism), or eyes • a history of blood clots in the deep
and position of a diaphragm. If you are scheduled for any laboratory tests, tell your doctor or healthcare provider you are
veins of your legs • chest pain (angina pectoris) • severe high blood pressure • diabetes with complications of the using NuvaRing®. Contraceptive hormones may changecertain blood testsresults.
kidneys, eyes, nerves, or blood vessels • headaches with neurological symptoms • known or suspected breast cancer or What are the possible risks and side effects of NuvaRing®?
cancer of the lining of the uterus, cervix, or vagina (now or in the past) • unexplained vaginal bleeding (until a diagnosis • Blood clots The hormones in NuvaRing® may cause changes in your blood clotting system which may allow your blood
is reached by your healthcare provider) • yellowing of the whites of the eyes or of the skin (jaundice) during pregnancy to clot more easily. If blood clots form in your legs, they can travel to the lungs and cause a sudden blockage of a vessel
or during previous use of hormonal birth control of any kind (the pill, patch, vaginal ring, injection, or implant) • liver carrying blood to the lungs. Rarely, clots occur in the blood vessels of the eye and may cause blindness, double vision, or
tumor (benign or cancerous) • heart valve or heart rhythm disorders that may be associated with formation of blood other vision problems. The risk of getting blood clots may be greater with the type of progestin in NuvaRing® than with
clots • need for a long period of bed rest following major surgery • known or suspected pregnancy • active liver disease some other progestins in certain low-dose birth control pills. It is unknown if the risk of blood clots is different with
with abnormal liver function tests • an allergy or hypersensitivity to any of the components of NuvaRing®. NuvaRing® use than with the use of certain birth control pills. If you take hormonal contraceptives and need elective sur-
Tell your healthcare provider if you have ever had any of the conditions just listed. Your healthcare provider can suggest gery, need to stay in bed for a prolonged illness or have recently delivered a baby, you may be at risk of developing blood
another method of birth control. Talk with your healthcare provider about using NuvaRing® if you: • smoke • recently had clots. You should consult your doctor or healthcare provider about stopping hormonal contraceptives three to four weeks
a baby • recently had a miscarriage or abortion • are breast-feeding • are taking other medications. In addition, talk to your before surgery and not taking hormonal contraceptives for two weeks after surgery or during bed rest. You should also
healthcare provider about using NuvaRing® if you have any of the following conditions. Women with any of these condi- not take hormonal contraceptives soon after delivery of a baby. It is advisable to wait for at least four weeks after delivery
tions should be checked often by their doctor or healthcare provider if they choose to use NuvaRing®. • a family history of if you are not breast-feeding. If you are breast-feeding, you should wait until you have weaned your child before using the
breast cancer • breast nodules, fibrocystic disease, an abnormal breast x-ray, or abnormal mammogram • diabetes • ele- pill (see PRECAU TIONS, NURSING MO THERS). • Strokes and heart attacks Hormonal contraceptives may increase your
vated cholesterol or triglycerides • high blood pressure • migraine or other headaches or epilepsy • depression • gallblad- risk of strokes (blockage of blood flow to the brain) or heart attacks (blockage of blood flow to the heart). Any of these
der, liver, heart, or kidney disease • scanty or irregular menstrual periods • plan to have major surgery (You may need to conditions can cause death or serious disability. Smoking greatly increases the risk of having strokes and heart attacks.
stop using NuvaRing® for a while to reduce your chance of getting blood clots.) • any condition that makes the vagina get Furthermore, smoking and the use of combination hormonal contraceptives, like NuvaRing®, greatly increases the chances
irritated easily • prolapsed (dropped) uterus, dropped bladder (cystocele), or rectal prolapse (rectocele) • severe consti- of developing and dying of heart disease. If you use combination hormonal contraceptives, including NuvaRing®, you should
pation • history of toxic shock syndrome. not smoke. • High blood pressure and heart disease Combination hormonal contraceptives, including NuvaRing®, can wors-
How should I use NuvaRing®?
en conditions like high blood pressure, diabetes, and problems with cholesterol and triglycerides. • Cancer of the repro-
For the best protection from pregnancy, use NuvaRing® exactly as directed. Insert one NuvaRing® in the vagina and keep
ductive organs and breast Breast cancer has been diagnosed slightly more often in women who use the pill than in women
it in place for three weeks in a row. Remove it for a one-week break and then insert a new ring. During the one-week break,
of the same age who do not use the pill. This small increase in the number of breast cancer diagnoses gradually disap-
you will usually have your menstrual period. Your healthcare provider should examine you at least once a year to see if
pears during the 10 years after stopping use of the pill. It is not known whether the difference is caused by the pill. It may
there are any signs of side effects of NuvaRing® use.
be that women taking the pill are examined more often, so that breast cancer is more likely to be detected. You should
have regular breast examinations by a healthcare provider and examine your own breasts monthly. Tell your healthcare
When should I start NuvaRing®?
provider if you have a family history of breast cancer or if you have had breast nodules or an abnormal mammogram.
Follow the instructions in one of the sections below to find out when to start using NuvaRing®: If you did not use a hormon- Women who currently have or have had breast cancer should not use hormonal contraceptives, including NuvaRing®,
al contraceptive in the preceding cycle Insert NuvaRing® on the first day of your cycle, (i.e., the first day of menstrual bleed-
because breast cancer is usually a hormone-sensitive tumor. Some studies have found an increase in the incidence of can-
ing). NuvaRing® will work immediately, it is not necessary to use an additional contraceptive method. You may also start on
cer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use
days 2-5 of your cycle, but in this case make sure you also use an extra method of birth control (barrier method), such as
of oral contraceptives. There is insufficient evidence to rule out the possibility that pills may cause such cancers.
male condoms or spermicide for the first seven days of NuvaRing® use in the first cycle. If you are changing from a com-
• Gallbladder disease Combination hormonal contraceptive users may have a higher chance of having gallbladder disease.
bined hormonal contraceptive pill or patch (containing both progestin and estrogen) Switch from your previous combined • Liver tumors In rare cases, combination hormonal contraceptives, like NuvaRing®, can cause non-cancerous (benign)
hormonal contraceptive on any day, but at the latest on the day following the usual hormone-free interval by inserting
but dangerous liver tumors. These benign liver tumors can break and cause fatal internal bleeding. In addition, it is pos-
NuvaRing®. If you have been using your hormonal contraceptive method consistently and correctly, no extra birth control sible that women who use combination hormonal contraceptives, like NuvaRing®, have a higher chance of getting liver
method should be needed. If you are changing from a progestagen-only method (minipill, implant or injection) or from a
cancer. Ho wever, liver cancers are extremely rare. • Lipid metabolism and inflammation of the pancreas In women with
progestagen-releasing intrauterine system (IUS) You may switch on any day from a minipill. You should switch from an
inherited defects of lipid metabolism, there have been reports of significant elevations of plasma triglycerides during estro-
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 gen therapy. This has led to pancreatitis in some cases. The common side effects reported by NuvaRing® users are: • vagi-
of these cases, you should use an extra method of birth control, such as a male condom or spermicide, for the first seven
nal infections and irritation • vaginal secretion • headache • weight gain • nausea. In addition to the risks and side effects
days of ring use. Following first trimester abortion or miscarriage If you start using NuvaRing® within five days after a com-
listed above, users of combination hormonal contraceptives have reported the following side effects: • vomiting • change
plete first trimester abortion or miscarriage, you do not need to use an extra method of contraception. If NuvaRing® is not
in appetite • abdominal cramps and bloating • breast tenderness or enlargement • irregular vaginal bleeding or spotting •
started within five days after a first trimester abortion or miscarriage, begin NuvaRing® at the time of your next menstrual
changes in menstrual cycle • temporary infertility after treatment • fluid retention (edema) • spotty darkening of the skin,
period. Counting the first day of your menstrual period as “Day 1”, insert NuvaRing® on or before Day 5 of the cycle, even
particularly on the face • rash • weight changes • depression • intolerance to contact lenses • nervousness • dizziness •
if you have not finished bleeding. During this first cycle, use an extra method of birth control, such as male condoms or
loss of scalp hair. Call your healthcare provider right a way if you get any of the symptoms listed below. They may be signs
spermicide, for the first seven days of ring use.
of a serious problem: • sharp chest pain, coughing blood, or sudden shortness of breath (possible clot in the lung) • pain
When do I insert a new ring? in the calf (back of lower leg; possible clot in the leg) • crushing chest pain or heaviness in the chest (possible heart attack)
After no more than a one-week ring-free break, insert a new ring on the same day of the week as it was removed in the • sudden severe headache or vomiting, dizziness or fainting, problems with vision or speech, weakness, or numbness in
last cycle. If the ring-free interval has been extended beyond one week, the possibility of pregnancy should be considered, an arm or leg (possible stroke) • sudden partial or complete loss of vision (possible clot in the eye) • yellowing of the skin
and an extra method of birth control, such as male condoms or spermicide, MUS T be used until NuvaRing® has been used or whites of the eyes (jaundice), especially with fever, tiredness, loss of appetite, dark colored urine, or light colored bowel
continuously for seven days. movements (possible liver problems) • severe pain, swelling, or tenderness in the abdomen (gallbladder or liver problems)
• sudden fever (usually 102°F or more), vomiting, diarrhea, dizziness, fainting, or a sunburn-like rash on the face or body
If NuvaRing® slips out:
(very rarely, toxic shock syndrome) • breast lumps (possible breast cancer or benign breast disease) • irregular vaginal
NuvaRing® can accidentally slip out of the vagina while removing a tampon, during intercourse, or straining during a bowel
bleeding or spotting that happens in more than one menstrual cycle or lasts for more than a few days • urgent, frequent,
movement. If NuvaRing® slips out of the vagina and it has been out for less than three hours, you should still be protect-
® ed from pregnancy. NuvaRing® can be rinsed with cool to lukewarm (not hot) water and reinserted as soon as possible, burning and/or painful urination, and cannot locate the ring in the vagina (rarely, inadvertent insertions of NuvaRing into
the urinary bladder) • swelling (edema) of your fingers or ankles • difficulty in sleeping, weakness, lack of energy, fatigue,
and at the latest within three hours of removal or expulsion (slipping out). If NuvaRing® is out of the vagina for more than
or a change in mood (possible severe depression)
three continuous hours: During Weeks 1 and 2: If the ring has been out of the vagina for more than three continuous hours
during the 1st or 2nd week of use, contraceptive effectiveness may be reduced. Reinsert ring as soon as you remember How effective is NuvaRing®?
and use an extra method of birth control, such as male condoms or spermicide, until the ring has been used continuous- If NuvaRing® is used according to the directions, your chance of getting pregnant is about 1 to 2% a year. This means that,
ly for seven days. During Week 3: If NuvaRing® slips out of the vagina for more than three continuous hours during the for every 100 women who use NuvaRing® for a year, one or two will become pregnant. Your chance of getting pregnant
3rd week of the three-week use period, throw the ring away and choose one of the following two options. 1. Insert a new increases if NuvaRing® is not used exactly according to the directions. By comparison, the chances of getting pregnant in
ring immediately. Inserting a new ring will start the next three-week use period. You may not experience a period from your the first year of typical use (not always following directions exactly) of other methods of birth control are as follo ws: No birth
previous cycle. However, breakthrough spotting or bleeding may occur. 2. Have your period and insert a new ring no later control method: 85%; Spermicides alone: 26%; Periodic abstinence methods (calendar, ovulation, thermometer): 25%;
than seven days (7x24 hours) from the time the previous ring was removed or expelled. This option should only be cho- Withdrawal: 19%; Cervical Cap with spermicides: 20 to 40%; Vaginal sponge: 20 to 40%; Diaphragm with spermicides:
sen if the ring was used continuously for the preceding seven days. In addition, a barrier method such as condoms or 20%; Condom alone(male):14%; Condom alone (female): 21%;Oral contraceptives: 5%; IUD: less than 1 to 2%;Implants:
spermicides must be used until the ring has been used continuously for seven days. Women with conditions affecting the less than 1%; Injection: less than 1%; Sterilization: less than 1%.
vagina, such as a prolapsed (dropped) uterus, may be more likely to have NuvaRing® slip out of the vagina. If NuvaRing®
Other Information
slips out repeatedly, you should consult with your healthcare provider. • Store NuvaRing® at room temperature, 25°C ( 77°F). Temperatures can be from 59–86°F ( 15–30°C). Avoid direct
If NuvaRing® is in your vagina too long: sunlight or storing above 86°F ( 30°C). • Medicines are sometimes prescribed for conditions that are not mentioned
If NuvaRing® has been left in your vagina for an extra week or less (four weeks total or less), you will remain protected. in patient information leaflets. Do not use NuvaRing® for a condition for which it was not prescribed. Do not give
Remove NuvaRing® and insert a new ring after a one-week ring-free break. If NuvaRing® has been left in place for more NuvaRing® to anyone else who may want to use it. • Place the used ring in the reclosable foil pouch and properly
than four weeks, you may not be adequately protected from pregnancy and you must check to be sure you are not preg- dispose of it in a waste receptacle out of the reach of children and pets. This leaflet summarizes the most impor-
nant. You MUS T use an extra method of birth control, such as male condoms or spermicide, until the new NuvaRing® has tant information about NuvaRing®. If you would like more information, talk with your healthcare provider. You can
been in place for seven days in a row. ask your pharmacist or healthcare provider for information about NuvaRing® that is written for health professionals.
If you miss a menstrual period:
You must check to be sure that you are not pregnant if: 1. you miss a period and NuvaRing® was out of the vagina for You are encouraged to report negative side effects of prescription drugs to the FDA.
more than three hours during the three weeks of ring use. 2. you miss a period and waited longer than one week to Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
insert a new ring. 3. you have followed the instructions and you miss two periods in a row. 4. you have left NuvaRing® in
place for longer than four weeks. Manufactured for Organon USA Inc.
Can I use tampons when using NuvaRing®?
Roseland, NJ 07068
Use of tampons will not reduce the contraceptive efficacy of NuvaRing®. Insert NuvaRing® before inserting a tampon. You by N. V. Organon, Oss, The Netherlands
should pay particular attention when removing a tampon to be sure that the ring is not accidentally pulled out. If this should
