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NuvaRing (Organon Usa)
- Drugs index
delivers 0.120 mg/0.015 mg per day
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
FOR VAGINAL USE ONLY
NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring) is a non-biodegradable, flexible, transparent, colorless to almost colorless, combination contraceptive vaginal ring containing two active components, a progestin, etonogestrel (13-ethyl-17-hydroxy-11-methylene-18,19-dinor-17(alpha)-pregn-4-en-20-yn-3-one) and an estrogen, ethinyl estradiol (19-nor-17(alpha)-pregna-1,3,5(10)-trien-20-yne-3, 17-diol). When placed in the vagina, each ring releases on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol over a three-week period of use. NuvaRing® is made of ethylene vinylacetate copolymers (28% and 9% vinyl acetate) and magnesium stearate and contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol. NuvaRing® has an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. The molecular weights for etonogestrel and ethinyl estradiol are 324.46 and 296.40, respectively. The structural formulas are as follows:
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).
Receptor binding studies, as well as studies in animals, have shown that etonogestrel, the biologically active metabolite of desogestrel, combines high progestational activity with low intrinsic androgenicity. The relevance of this later finding in humans is unknown.
Etonogestrel: Etonogestrel released by NuvaRing® is rapidly absorbed. Bioavailability of etonogestrel after vaginal administration is approximately 100%. The serum etonogestrel and ethinyl estradiol concentrations (pg/mL) observed during three weeks of NuvaRing® use are summarized in Table I.
Ethinyl estradiol: Ethinyl estradiol released by NuvaRing® is rapidly absorbed. Bioavailability of ethinyl estradiol after vaginal administration is approximately 55.6%, which is comparable to that with oral administration of ethinyl estradiol. The serum ethinyl estradiol concentrations observed during three weeks of NuvaRing® use are summarized in Table I.
The pharmacokinetic profile of etonogestrel and ethinyl estradiol during use of NuvaRing® is shown in Figure 1.
The pharmacokinetic parameters of etonogestrel and ethinyl estradiol were determined during one cycle of NuvaRing® use in 16 healthy female subjects and are summarized in Table II.
Etonogestrel: Etonogestrel is approximately 32% bound to sex hormone binding globulin (SHBG) and approximately 66% bound to albumin in blood.
Ethinyl estradiol: Ethinyl estradiol is highly but not specifically bound to serum albumin (approximately 98.5%) and induces an increase in the serum concentrations of SHBG.
In vitro data shows that both etonogestrel and ethinyl estradiol are metabolized in liver microsomes by the cytochrome P450 3A4 isoenzyme. Ethinyl estradiol is primarily metabolized by aromatic hydroxylation, but a wide variety of hydroxylated and methylated metabolites are formed. These are present as free metabolites and as sulfate and glucuronide conjugates. The hydroxylated ethinyl estradiol metabolites have weak estrogenic activity. The biological activity of etonogestrel metabolites is unknown.
Etonogestrel and ethinyl estradiol are primarily eliminated in urine, bile and feces.
No formal studies were conducted to evaluate the effect of race on the pharmacokinetics of NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring).
No formal studies were conducted to evaluate the effect of hepatic disease on the pharmacokinetics, safety, and efficacy of NuvaRing®. However, steroid hormones may be poorly metabolized in patients with impaired liver function (see PRECAUTIONS ).
No formal studies were conducted to evaluate the effect of renal disease on the pharmacokinetics, safety, and efficacy of NuvaRing®.
Interactions between contraceptive steroids and other drugs have been reported in the literature (see PRECAUTIONS ) . The pharmacokinetics of NuvaRing® were evaluated in one cycle in 24 healthy female subjects randomized to a single-dose vaginal administration on Day 8 of 100 mg of a non-oxynol-9 spermicide gel or a 1200 mg miconazole nitrate antimycotic capsule. In this study, it was determined that the vaginally-administered, oil-based miconazole nitrate capsule increased the serum concentrations of etonogestrel and ethinyl estradiol by approximately 17% and 16%, respectively. The clinical significance of these findings is unknown; however, the contraceptive effectiveness of NuvaRing® is not expected to change. It was determined that the single dose of 100 mg vaginally-administered, water-based non-oxynol-9 gel did not affect the serum concentrations of etonogestrel or ethinyl estradiol. The effects of chronic administration of either of these products with NuvaRing® are unknown.
INDICATIONS AND USAGE
NuvaRing® is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Like oral contraceptives, NuvaRing® is highly effective if used as recommended in this label.
In two large clinical trials of 13 cycles of NuvaRing® use, pregnancy rates were between one and two per 100 women-years of use. Table III lists the pregnancy rates for users of various contraceptive methods.
NuvaRing® should not be used in women who currently have the following conditions:
NuvaRing® and other contraceptives that contain both an estrogen and a progestin are called combination hormonal contraceptives. There is no epidemiologic data available to determine whether safety and efficacy with the vaginal route of administration of combination hormonal contraceptives would be different than the oral route. Practitioners prescribing NuvaRing® should be familiar with the following information relating to these risks.
The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases signficantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity, and diabetes.
The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with formulations of higher doses of estrogens and progestogens than those in common use today. The effect of long-term use of oral contraceptives with lower doses of both estrogens and progestogens remains to be determined.
Throughout this labeling, epidemiologic studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of a disease, namely, a ratio of the incidence of a disease among oral contraceptive users to that among non-users. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between oral contraceptive users and non-users. The attributable risk does provide information about the actual occurrence of a disease in the population. For further information, the reader is referred to a text on epidemiologic methods.
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
2. PHYSICAL EXAMINATION AND FOLLOW-UP
It is good medical practice for women using NuvaRing®, as for all women, to have an annual medical evaluation including physical examination and relevant laboratory tests. The physical examination should include special reference to blood pressure, breasts, abdomen, pelvic organs and vagina (including cervical cytology). In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a family history of breast cancer or who have breast nodules should be monitored with particular care.
3. LIPID DISORDERS
Women who are being treated for hyperlipidemias should be followed closely if they elect to use NuvaRing®. Some progestogens may elevate LDL lev-els and may render the control of hyperlipidemias more difficult.
If jaundice develops in any woman using NuvaRing®, product use should be discontinued. The hormones in NuvaRing® may be poorly metabolized in patients with impaired liver function.
5. FLUID RETENTION
Steroid hormones like those in NuvaRing®, may cause some degree of fluid retention. NuvaRing® should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention.
6. EMOTIONAL DISORDERS
Women who become significantly depressed while using combination hormonal contraceptives, such as NuvaRing®, should stop the medication and use another method of contraception in an attempt to determine whether the symptom is drug related. Women with a history of depression should be carefully observed and NuvaRing® discontinued if significant depression occurs.
7. CONTACT LENSES
Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.
8. DRUG INTERACTIONS
Changes in Contraceptive Effectiveness Associated with Co-Administration of Other Drugs
Contraceptive effectiveness may be reduced when hormonal contraceptives are co-administered with some antibiotics, antifungals, anticonvulsants, and other drugs that increase metabolism of contraceptive steroids. This could result in unintended pregnancy or breakthrough bleeding. Examples include barbiturates, griseofulvin, rifampin, phenylbutazone, phenytoin, carbamazepine, felbamate, oxcarbazepine, topiramate and possibly with ampicillin and tetracyclines. Women may need to use an additional contraceptive method when taking medications which may make hormonal contraceptives less effective.
Several of the anti-HIV protease inhibitors have been studied with co-administration of oral combination hormonal contraceptives; significant changes (increase and decrease) in the mean AUC of the estrogen and progestin have been noted in some cases. The efficacy and safety of oral contraceptive products may be affected; it is unknown whether this applies to NuvaRing®. Healthcare providers should refer to the label of the individual anti-HIV protease inhibitors for further drug-drug interaction information.
Herbal products containing St. John's Wort (hypericum perforatum) may induce hepatic enzymes (cytochrome P450) and p-glycoprotein transporter and may reduce the effectiveness of contraceptive steroids. This may also result in breakthrough bleeding.
Increase in Plasma Hormone Levels Associated with Co-Administered Drugs
Co-administration of atorvastatin and certain oral contraceptives containing ethinyl estradiol increase AUC values for ethinyl estradiol by approximately 20%. Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol levels, possibly by inhibition of conjugation. CYP 3A4 inhibitors such as itraconazole or ketoconazole may increase plasma hormone levels.
Changes in Plasma Levels of Co-Administered Drugs
Combination hormonal contraceptives containing some synthetic estrogens (e.g., ethinyl estradiol) may inhibit the metabolism of other compounds. Increased plasma concentrations of cyclosporine, prednisolone, and theophylline have been reported with concomitant administration of oral contraceptives. In addition, oral contraceptives may induce the conjugation of other compounds. Decreased plasma concentrations of acetaminophen and increased clearance of temazepam, salicylic acid, morphine and clofibric acid have been noted when these drugs were administered with oral contraceptives.
9.INTERACTIONS WITH LABORATORY TESTS
Certain endocrine and liver function tests and blood components may be affected by combined hormonal contraceptives:
10. CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
In a 24-month carcinogenicity study in rats with subdermal implants releasing 10 and 20 µg etonogestrel per day, (approximately 0.3 and 0.6 times the systemic steady state exposure of women using NuvaRing®), no drug-related carcinogenic potential was observed. Etonogestrel was not genotoxic in the in-vitro Ames/Salmonella reverse mutation assay, the chromosomal aberration assay in Chinese hamster ovary cells or in the in-vivo mouse micronucleus test. Fertility returned after withdrawal from treatment. See WARNINGS .
Pregnancy Category X (see CONTRAINDICATIONS and WARNINGS) .
Teratology studies have been performed in rats and rabbits using the oral route of administration at doses up to 130 and 260 times, respectively, the human NuvaRing® dose (based on body surface area) and have revealed no evidence of harm to the fetus due to etonogestrel.
12. NURSING MOTHERS
The effects of NuvaRing® in nursing mothers have not been evaluated and are unknown. Small amounts of contraceptive steroids have been identified in the milk of nursing mothers and a few adverse effects on the child have been reported, including jaundice and breast enlargement. In addition, contraceptive steroids given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. Long-term follow-up of children whose mothers used combination hormonal contraceptives while breast feeding has shown no deleterious effects on infants. However, women who are breast feeding should be advised not to use NuvaRing® but to use other forms of contraception until the child is weaned.
13. PEDIATRIC USE
Safety and efficacy of NuvaRing® have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of this product before menarche is not indicated.
14. GERIATRIC USE
This product has not been studied in women over 65 years of age and is not indicated in this population.
15. VAGINAL USE
NuvaRing® may not be suitable for women with conditions that make the vagina more susceptible to vaginal irritation or ulceration. Some women are aware of the ring at random times during the 21 days of use or during intercourse. During intercourse some sexual partners may feel NuvaRing® in the vagina. However, clinical studies revealed that 90% of couples did not find this to be a problem.
If NuvaRing® has been removed or expelled during the three-week use period, it should be rinsed with cool to lukewarm (not hot) water and reinserted as soon as possible, but at the latest within three hours of removal or expulsion. If NuvaRing® is lost, a new vaginal ring should be inserted and the regimen should be continued without alteration. If the ring has been out of the vagina for more than three hours, contraceptive effectiveness may be reduced and an additional method of contraception, such as male condoms or spermicide, must be used until the ring has been used continuously for seven days . NuvaRing® may interfere with the correct placement and position of a diaphragm. A diaphragm is therefore not recommended as a backup method with NuvaRing® use.
NuvaRing® can be accidentally expelled, for example, when it has not been inserted properly, or while removing a tampon, moving the bowels, straining, or with severe constipation. If this occurs, the vaginal ring can be rinsed with cool to lukewarm (not hot) water and re-inserted promptly (see VAGINAL USE above and INFORMATION FOR THE PATIENT , DOSAGE AND ADMINISTRATION ). If NuvaRing® is lost, a new vaginal ring should be inserted and the regimen should be continued without alteration. If the ring has been out of the vagina for more than three hours, contraceptive effectiveness may be reduced and an additional method of contraception, such as male condoms or spermicide, MUST be used until NuvaRing® has been used continuously for seven days. Vaginal stenosis, cervical prolapse, rectoceles, and cystoceles are conditions that under some circumstances may make expulsion more likely to occur.
INFORMATION FOR THE PATIENT
The patient should be instructed regarding the proper use of NuvaRing® (see Patient Information printed below).
The most common adverse events reported by 5 to 14% of women using NuvaRing® in clinical trials (n=2501) were the following: vaginitis, headache, upper respiratory tract infection, leukorrhea, sinusitis, weight gain, and nausea.
The most frequent system-organ class adverse events leading to discontinuation in 1 to 2.5% of women using NuvaRing® in the trials included the following: device related events (foreign body sensation, coital problems, device expulsion), vaginal symptoms (discomfort/vaginitis/leukorrhea), headache, emotional lability, and weight gain.
Listed below are adverse reactions that have been associated with the use of combination hormonal contraceptives. These are also likely to apply to combination vaginal hormonal contraceptives, such as NuvaRing®.
An increased risk of the following serious adverse reactions has been associated with the use of combination hormonal contraceptives (see CONTRAINDICATIONS and WARNINGS ):
There is evidence of an association between the following conditions and the use of combination hormonal contraceptives:
The following additional adverse reactions have been reported in users of combination hormonal contraceptives and are believed to be drug-related:
The following additional adverse reactions have been reported in users of combination hormonal contraceptives and a causal association has been neither confirmed nor refuted:
Overdosage of combination hormonal contraceptives may cause nausea, vomiting, vaginal bleeding, or other menstrual irregularities. Given the nature and design of NuvaRing® it is unlikely that overdosage will occur. If NuvaRing® is broken, it does not release a higher dose of hormones. Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. There are no antidotes and further treatment should be symptomatic.
DOSAGE AND ADMINISTRATION
To achieve maximum contraceptive effectiveness, NuvaRing® must be used as directed (see When to Start NuvaRing® below) . One NuvaRing® is inserted in the vagina by the woman herself. The ring is to remain in place continuously for three weeks. It is removed for a one-week break, during which a withdrawal bleed usually occurs. A new ring is inserted one week after the last ring was removed.
The user can choose the insertion position that is most comfortable to her, for example, standing with one leg up, squatting, or lying down. The ring is to be compressed and inserted into the vagina. The exact position of NuvaRing® inside the vagina is not critical for its function. The vaginal ring must be inserted on the appropriate day and left in place for three consecutive weeks. This means that the ring is removed three weeks later on the same day of the week as it was inserted and at about the same time. NuvaRing® can be removed by hooking the index finger under the forward rim or by grasping the rim between the index and middle finger and pulling it out. The used ring should be placed in the sachet (foil pouch) and discarded in a waste receptacle out of the reach of children and pets (do not flush in toilet). After a one-week break, during which a withdrawal bleed usually occurs, a new ring is inserted on the same day of the week as it was inserted in the previous cycle. The withdrawal bleed usually starts on day 2-3 after removal of the ring and may not have finished before the next ring is inserted. In order to maintain contraceptive effectiveness, the new ring must be inserted one week after the previous one was removed even if menstrual bleeding has not finished.
When to Start NuvaRing®
IMPORTANT: The possibility of ovulation and conception prior to the first use of NuvaRing® should be considered.
No preceding hormonal contraceptive use in the past month
Counting the first day of menstruation as "Day 1". NuvaRing® should be inserted on or prior to Day 5 of the cycle, even if the patient has not finished bleeding. During the first cycle, an additional method of contraception, such as male condoms or spermicides, is recommended until after the first seven days of continuous ring use.
Switching from a combination oral contraceptive
NuvaRing® may be inserted anytime within seven days after the last combined (estrogen plus progestin) oral contraceptive tablet and no later than the day that a new cycle of pills would have been started. No backup method is needed.
Switching from a progestin-only method
There are several types of progestin-only methods. Women should insert the first NuvaRing® as follows:
In all of these cases, the patient should be advised to use an additional method of contraception, such as male condoms or spermicide, for the first seven days after insertion of the ring.
Following complete first trimester abortion
The patient may start using NuvaRing® within the first five days following a complete first trimester abortion and does not need to use an additional method of contraception. If use of NuvaRing® is not started within five days following a first trimester abortion, the patient should follow the instructions for "No preceding hormonal contraceptive use in the past month." In the meantime she should be advised to use a non-hormonal contraceptive method.
Following delivery or second trimester abortion
The use of NuvaRing® for contraception may be initiated four weeks postpartum in women who elect not to breast feed. Women who are breast feeding should be advised not to use NuvaRing® but to use other forms of contraception until the child is weaned. NuvaRing® use may be initiated four weeks after a second trimester abortion. When NuvaRing® is used postpartum or postabortion, the increased risk of thromboembolic disease must be considered. (See CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease. See PRECAUTIONS for "Nursing Mothers".) If the patient begins using NuvaRing® postpartum, and has not yet had a period, the possibility of ovulation and conception occurring prior to initiation of NuvaRing® should be considered, and she should be instructed to use an additional method of contraception, such as male condoms or spermicide, for the first seven days.
Deviations from the Recommended Regimen
To prevent loss of contraceptive efficacy patients should not deviate from the recommended regimen.
Inadvertent removal, expulsion, or prolonged ring-free interval
If NuvaRing® has been out of the vagina during the three-week use period, it can be rinsed with cool to lukewarm (not hot) water and should be reinserted as soon as possible, at the latest within three hours. If the ring has been out of the vagina for more than three hours, contraceptive effectiveness may be reduced and an additional method of contraception, such as male condoms or spermicide, MUST be used until NuvaRing® has been used continuously for seven days.
If the ring-free interval has been extended beyond one week, the possibility of pregnancy should be considered, and an additional method of contraception, such as male condoms or spermicide, MUST be used until NuvaRing® has been used continuously for seven days.
Prolonged Use of NuvaRing®
If NuvaRing® has been left in place for up to one extra week (i.e., up to four weeks total), it should be removed and the patient should insert a new ring after the one-week ring-free interval. The mean serum etonogestrel concentration during the fourth week of continuous use of NuvaRing® was 1272 ± 311 pg/mL compared to a mean concentration range of 1578 ± 408 to 1374 ± 328 pg/mL during weeks one to three. The mean serum ethinyl estradiol concentration during the fourth week of continuous use of NuvaRing® was 16.8 ± 4.6 pg/mL compared to a mean concentration range of 19.1 ± 4.5 to 17.6 ± 4.3 pg/mL during weeks one to three. If NuvaRing® has been left in place for longer than four weeks, pregnancy should be ruled out, and an additional method of contraception, such as male condoms or spermicide, MUST be used until a new NuvaRing® has been used continuously for seven days.
In the event of a missed menstrual period
Each NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring) is individually packaged in a reclosable aluminum laminate sachet consisting of three layers, from outside to inside: polyester, aluminum foil, and low-density polyethylene. The ring should be replaced in this reclosable sachet after use for convenient disposal.
Prior to dispensing to the user, store refrigerated 2-8°C (36-46°F). After dispensing to the user, NuvaRing® can be stored for up to 4 months at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Avoid storing NuvaRing® in direct sunlight or at temperatures above 30°C (86°F). For the Dispenser: When NuvaRing® is dispensed to the user, place an expiration date on the label. The date should not exceed either 4 months from the date of dispensing or the expiration date, whichever comes first.
REFERENCES FURNISHED UPON REQUEST
NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring)
Read this leaflet carefully before you use NuvaRing® so that you understand the benefits and risks of using this form of birth control. The leaflet gives you information about the possible serious side effects of NuvaRing®. This leaflet will also 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 information does not take the place of talking with your healthcare provider.
What is NuvaRing®?
NuvaRing® (NEW-vah-ring) is a flexible combined contraceptive vaginal ring. It is used to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases (STD's) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.
NuvaRing® contains a combination of a progestin and estrogen, two kinds of female hormones. You insert the ring in your vagina and leave it there for three weeks. You then remove it for a one-week ring-free period. After the ring is inserted, it releases a continuous low dose of hormones into your body.
Contraceptives that contain both an estrogen and a progestin are called combination hormonal contraceptives. Most studies on combination contraceptives have used oral (taken by mouth) contraceptives. NuvaRing® may have the same risks that have been found for combination oral contraceptives. This leaflet will tell you about risks of taking combination oral contraceptives that may also apply to NuvaRing® users. In addition it will tell you how to use NuvaRing® properly so that it willl give you the best possible protection against pregnancy.
Who should not use NuvaRing®?
Do not use NuvaRing® if you have any of the following conditions:
Tell your healthcare provider if you have ever had any of the conditions just listed. Your healthcare provider can suggest another method of birth control.
Talk with your healthcare provider about when to start NuvaRing® if you are recovering from the birth of a child or a second trimester miscarriage or abortion or if you are breast feeding.
In addition, talk to your healthcare provider about using NuvaRing® if you have any of the following conditions. Women with any of these conditions should be checked often by their doctor or healthcare provider if they choose to use NuvaRing®.
How should I use NuvaRing®?
For the best protection from pregnancy, use NuvaRing® exactly as directed. Insert one NuvaRing® in the vagina and keep 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, you will usually have your menstrual period. Your healthcare provider should examine you at least once a year to see if there are any signs of side effects of NuvaRing® use.
When should I start NuvaRing®?
Follow the instructions in one of the sections below to find out when to start using NuvaRing®.
If you did not use a hormonal contraceptive in the past month
Counting the first day of your menstrual period as "Day 1", insert your first NuvaRing® between Day 1 and Day 5 of the cycle, but at the latest on Day 5, even if you have not finished bleeding. During this first cycle, use an extra method of birth control, such as male condoms or spermicide, for the first seven days of ring use.
If you are switching from a combination oral contraceptive (birth control pill containing both progestin and estrogen)
Insert NuvaRing® anytime during the first seven days after the last combined (estrogen and progestin) oral contraceptive tablet and no later than the day when you would have started a new pill cycle. No extra birth control method is needed.
If you are switching from a progestin-only contraceptive (mini-pill, implant, injection, or IUD)
When you are switching from a progestin-only contraceptive, use an extra method of birth control, such as male condoms or spermicide, for the first seven days after inserting NuvaRing®.
Following first trimester abortion or miscarriage
If you start using NuvaRing® within five days after a complete first trimester abortion or miscarriage, you do not need to use an extra method of contraception.
If NuvaRing® is not started within five days after a first trimester abortion or miscarriage, begin NuvaRing® at the time of your next menstrual period. Counting the first day of your menstrual period as "Day 1", insert NuvaRing® on or before Day 5 of the cycle, even if you have not finished bleeding. During this first cycle, use an extra method of birth control, such as male condoms or spermicide, for the first seven days of ring use.
How do I insert NuvaRing®?
How do I remove NuvaRing®?
When do I insert a new ring?
After a one-week ring-free break, insert a new ring on the same day of the week as it was inserted in the last cycle. For example, if NuvaRing® was inserted on a Sunday at about 10:00 PM, after the one-week break you should insert a new ring on a Sunday at about 10:00 PM.
If NuvaRing® slips out:
Rarely, NuvaRing® can slip out of the vagina if it has not been inserted properly, or while removing a tampon, moving the bowels, straining, or with severe constipation.
If NuvaRing® slips out of the vagina, and it has been out less than three hours, you should still be protected from pregnancy. NuvaRing® can be rinsed with cool to lukewarm (not hot) water and should be reinserted as soon as possible, and at the latest within three hours. If you have lost NuvaRing®, you must insert a new NuvaRing® and use it on the same schedule as you would have used the lost ring. If NuvaRing® has been out of the vagina for more than three hours, you may not be adequately protected from pregnancy. NuvaRing® can be rinsed with cool to lukewarm (not hot) water and reinserted as soon as possible. You must use an extra method of birth control, such as male condoms or spermicide, until the NuvaRing® has been in place for seven days in a row.
Women with conditions affecting the vagina, such as prolapsed (dropped) uterus, may be more likely to have NuvaRing® slip out of the vagina. If NuvaRing® slips out repeatedly, you should consult with your healthcare provider.
If NuvaRing® is in your vagina too long:
If NuvaRing® has been left in your vagina for an extra week or less (four weeks total or less), remove it and insert a new ring after a one-week ring-free break.
If NuvaRing® has been left in place for more than four weeks, you may not be adequately protected from pregnancy and you must check to be sure you are not pregnant. You must use an extra method of birth control, such as male condoms or spermicide, until the new NuvaRing® has been in place for seven days in a row.
If you miss a menstrual period:
You must check to be sure that you are not pregnant if:
NuvaRing® is unlikely to cause an overdose because the ring holding the medicine releases a steady amount of contraceptive hormones. Do not use more than one ring at a time. Overdose of combination hormonal contraceptives may cause nausea, vomiting, or vaginal bleeding.
What should I avoid while using NuvaRing®?
Do not breast feed while using NuvaRing®. Some of the medicine may pass through the milk to the baby and could cause yellowing of the skin (jaundice) and breast enlargement. NuvaRing® could also decrease the amount and quality of your breast milk.
The hormones in NuvaRing® can interact with many other medicines and herbal supplements. Tell your healthcare provider about any medicines you are taking, including prescription medicines, over-the-counter medicines, herbal remedies, and vitamins.
The blood levels of the hormones released by NuvaRing® were increased when women used an oil-based vaginal medication (miconazole nitrate) for a yeast infection while NuvaRing® was in place. The pregnancy protection of NuvaRing® is not likely to be changed by use of these products. The blood levels of the hormones released by NuvaRing® were not changed when women used vaginal, water-based spermicides (nonoxynol or N-9 products) along with NuvaRing®.
While using NuvaRing®, you should not rely upon a diaphragm when you need a backup method of birth control because NuvaRing® may interfere with the correct placement and position of a diaphragm.
If you are scheduled for any laboratory tests, tell your doctor or healthcare provider you are using NuvaRing®. Contraceptive hormones may change certain blood tests results.
What are the possible risks and side effects of NuvaRing®?
The common side effects reported by NuvaRing® users are:
In addition to the risks and side effects listed above, users of combination hormonal contraceptives have reported the following side effects:
Call your healthcare provider right away if you get any of the symptoms listed below. They may be signs of a serious problem:
How effective is NuvaRing®?
If NuvaRing® is used according to the directions, your chance of getting pregnant is about 1 to 2% a year. This means that, for every 100 women who use NuvaRing® for a year, about one or two will become pregnant. Your chance of getting pregnant increases if NuvaRing® is not used exactly according to the directions.
By comparison, the chances of getting pregnant in the first year of typical use (not always following directions exactly) of other methods of birth control are as follows:
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use NuvaRing® for a condition for which it was not prescribed. Do not give NuvaRing® to anyone else who may want to use it.
This leaflet summarizes the most important information about NuvaRing®. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NuvaRing® that is written for health professionals.
Manufactured for Organon Usa Inc.
West Orange, NJ 07052
by N.V. Organon, Oss, The Netherlands
©2004 Organon Usa Inc. 5310220 10/04 13