Usual Adult Dose for Contraception

Insert 1 ring into the vagina and leave in place continuously for 3 weeks, then remove for 1 week and insert a new ring 1 week after the last ring was removed

Comments:

• During the 1 week ring-free period, withdrawal bleeding usually occurs, generally on day 2 or 3 after removal.
• Reinsertion should occur on the same day of the week exactly 1 week after the previous one was removed, even if menstrual bleeding has not finished.

Use: For females of reproductive age to prevent pregnancy

Usual Pediatric Dose for Contraception

Postpubertal adolescents:

Insert 1 ring into the vagina and leave in place continuously for 3 weeks, then remove for 1 week and insert a new ring 1 week after the last ring was removed

Comments:

• During the 1 week ring-free period, withdrawal bleeding usually occurs, generally on day 2 or 3 after removal.
• Reinsertion should occur on the same day of the week exactly 1 week after the previous one was removed, even if menstrual bleeding has not finished.

Use: For females of reproductive age to prevent pregnancy

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Contraindicated in patients with liver tumors or liver disease

Dose Adjustments

Device Expulsion:

• If the ring is out of the vagina for less than 3 hours, contraceptive efficacy is not reduced and the ring should be washed with lukewarm water and reinserted immediately.
• If the ring is out of the vagina for more than 3 continuous hours, contraceptive efficacy may be reduced.
• If during weeks 1 and 2, the ring is out of the vagina for more than 3 continuous hours, reinsert the ring immediately and use barrier methods such as condoms with spermicide until the ring is used continuously for 7 days.
• If during week 3, the ring is out of the vagina for more than 3 continuous hours, discard the ring and either reinsert a new ring immediately which will start the next 3 week use period, or insert a new ring no later than 7 days from the time the previous ring was removed/expelled; a barrier method should be used until the ring is in place continuously for 7 days in either case.

Broken Rings: If the ring breaks, it should be discarded and replaced with a new one.

Prolonged Ring-Free Interval: If the ring-free interval has been extended beyond 1 week, consider the possibility of pregnancy, and an additional method of contraception, such as male condoms with spermicide, must be used until this drug has been used continuously for 7 days.

Prolonged Use: If the ring has been left in place for up to 1 extra week (i.e., up to 4 weeks total), the woman will remain protected.

• The ring should be removed and a new ring inserted after a 1 week ring-free interval.
• If the ring has been left in place for longer than 4 weeks, instruct the woman to remove the ring, and rule out pregnancy; if pregnancy is ruled out, a new ring may be restarted, and an additional method of contraception, such as male condoms with spermicide, must be used until a new ring has been used continuously for 7 days.

Precautions

US BOXED WARNING: CIGARETTE SMOKING SERIOUS CARDIOVASCULAR ADVERSE EFFECTS:

• Cigarette smoking increases the risk of serious cardiovascular side effects 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 this drug, should not be used by women over 35 years of age and smoke.

CONTRAINDICATIONS:

• Hypersensitivity reactions including anaphylaxis and angioedema to any components of this product
• Pregnancy
• Liver tumors, benign or malignant or liver disease
• Undiagnosed abnormal uterine bleeding
• Breast cancer or other estrogen or progestin sensitive cancer, now or in the past
• Concomitant use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations
• High risk of arterial or venous thrombotic disease including:
• Smokers over 35 years old
• Deep vein thrombosis or pulmonary embolism, now or in the past
• Cerebrovascular disease, now or in the past
• Coronary artery disease, now or in the past
• Thrombogenic valvular or thrombogenic rhythm disease of the heart, e.g., subacute bacterial endocarditis with valvular disease or atrial fibrillation
• Inherited or acquired hypercoagulopathies
• Uncontrolled hypertension
• Diabetes mellitus with vascular disease
• Headaches with focal neurological symptoms or migraine headaches with aura
• Women over 35 years with any migraine headache

Safety and efficacy have been established in female patients of reproductive age; use prior to menarche is not indicated.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration Advice:

• For vaginal use only.
• To achieve maximum contraceptive effectiveness, this drug should be used as directed.
• If the ring is out of the vagina for an unknown period of time, the possibility of pregnancy should be considered and a pregnancy test performed prior to inserting a new ring.
• The ring may interfere with the correct placement and position of certain female barrier methods such as a diaphragm or female condom and should not be used as back-up methods with ethinyl estradiol-etonogestrel vaginal ring use.
• If the patient has not adhered to the prescribed regimen, consider the possibility of pregnancy at the time of the first missed period and discontinue this drug if pregnancy is confirmed.
• If the patient has adhered to the prescribed regimen and misses 2 consecutive periods, rule out pregnancy.
• If the patient has retained 1 ring for longer than 4 weeks, rule out pregnancy.
• The manufacturer product information should be consulted for further insertion technique information.

No Hormonal Contraceptive Use in Preceding Cycle:

• Insert the ring on first day of menstrual bleeding.
• May also be inserted on days 2 through 5 of the woman's cycle, however, a barrier method (e.g., male condoms with spermicide), should be used for the first 7 days of use in the first cycle.

Changing from a Combined Hormonal Contraceptive (CHC):

• May switch from previous CHC on any day, but at the latest on the day following the usual hormone-free interval if it has been used consistently and it is reasonably certain she is not pregnant.

Changing From a Progestin-Only Method (progestin-only pill [POP], Implant, or Injection or a Progestin-Releasing Intrauterine System [IUS]):

• May switch from the POP on any day and start using this drug on the day after taking the last POP.
• May switch from an 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 of the above cases, an additional barrier method such as a male condom with spermicide, should be used for the first 7 days.

Use After Abortion or Miscarriage:

• May start using this drug within the first 5 days following a complete first trimester abortion or miscarriage; no need to use an additional method of contraception.
• If use of this drug is not started within 5 days following a first trimester abortion or miscarriage, the woman should follow the instructions for "No Hormonal Contraceptive Use in the Preceding Cycle" and in the meantime, she should be advised to use a non-hormonal contraceptive method.
• Begin this drug no earlier than 4 weeks after a second trimester abortion or miscarriage, due to the increased risk of thromboembolism.

Following Childbirth:

• May be initiated no sooner than 4 weeks postpartum in women who elect not to breastfeed, due to the increased risk of thromboembolism in the postpartum period; other forms of contraception until the child is weaned.
• If a woman begins using this drug postpartum, an additional method of contraception, such as male condoms with spermicide, should be used for the first 7 days; if the patient has not yet had a period, consider the possibility of ovulation and conception occurring prior to initiation of this drug.

Storage Requirements:

• Prior to dispensing, store in the refrigerator at 2C to 8C (36F to 46F); after dispensing to patient, may be store for up to 4 months at controlled room temperature.
• Avoid storing in direct sunlight or at temperatures above 30C (86F).

Reconstitution/Preparation Techniques:

• An expiration date should be placed on the label with a date that does not exceed either 4 months from the date of dispensing or the expiration date, whichever comes first.

Monitoring:

• Cardiovascular: Regularly monitor blood pressure throughout therapy.
• General: A complete medical history and physical examination should occur prior to initiation or reinstitution of this drug.
• Women using this drug should have a yearly visit with a healthcare provider for a blood pressure check and other indicated healthcare.

Patient Advice:

• Patient should be instructed to read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
• To prevent loss of contraceptive efficacy, do not deviate from the recommended regimen.
• This drug should be left in the vagina for a continuous period of 3 weeks, removed for 1 week, and a new ring inserted 1 week after the last ring was removed.
• Regularly check for the presence of the ring in the vagina (for example, before and after intercourse).

Frequently asked questions

• What is the name of the generic NuvaRing?