NUVARING- etonogestrel and ethinyl estradiol insert, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

etonogestrel (UNII: 304GTH6RNH) (etonogestrel - UNII:304GTH6RNH), ethinyl estradiol (UNII: 423D2T571U) (ethinyl estradiol - UNII:423D2T571U)

Available from:

Organon USA Inc.

INN (International Name):

etonogestrel

Composition:

etonogestrel 0.12 mg in 1 d

Administration route:

VAGINAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

FOR VAGINAL USE ONLY NuvaRing® is indicated for use by females of reproductive age to prevent pregnancy. Do not prescribe NuvaRing to women who are known to have or use the following: - A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)] Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)] Have cerebrovascular disease [see Warnings and Precautions (5.1)] Have coronary artery disease [see Warnings and Precautions (5.1)] Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)] Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)] Have uncontrolled hypertension [see Warnings and Precautions (5.5)] Have diabetes mellitus with vascular disease [see Wa

Product summary:

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 and discarded in a waste receptacle out of the reach of children and pets. It should not be flushed down the toilet. 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.

Authorization status:

New Drug Application

Summary of Product characteristics

NUVARING- ETONOGESTREL AND ETHINYL ESTRADIOL INSERT, EXTENDED RELEASE
ORGANON USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NUVARING SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR NUVARING.
NUVARING (ETONOGESTREL/ETHINYL ESTRADIOL VAGINAL RING)
INITIAL U.S. APPROVAL: 2001
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WOMEN OVER 35 YEARS OLD WHO SMOKE SHOULD NOT USE NUVARING. (4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM COMBINATION HORMONAL
CONTRACEPTIVE (CHC) USE. (4)
INDICATIONS AND USAGE
NuvaRing is an estrogen/progestin combination hormonal contraceptive
(CHC) indicated for use by women to prevent
pregnancy. (1)
DOSAGE AND ADMINISTRATION
One NuvaRing is inserted in the vagina. The ring must remain in place
continuously for three weeks, followed by a one-
week ring-free interval. (2)
DOSAGE FORMS AND STRENGTHS
NuvaRing is a polymeric vaginal ring containing 11.7 mg etonogestrel
and 2.7 mg ethinyl estradiol, which releases on
average 0.12 mg/day of etonogestrel and 0.015 mg/day of ethinyl
estradiol. (3)
CONTRAINDICATIONS
A high risk of arterial or venous thrombotic diseases (4)
Breast cancer or other estrogen- or progestin-sensitive cancer (4)
Liver tumors or liver disease (4)
Undiagnosed abnormal uterine bleeding (4)
Pregnancy (4)
Hypersensitivity, including anaphylaxis and angioedema, to any of the
components of NuvaRing (4)
Co-administration with Hepatitis C drug combinations containing
ombitasvir/paritaprevir/ritonavir, with or without
dasabuvir (4)
WARNINGS AND PRECAUTIONS
Vascular risks: Stop NuvaRing use if a thrombotic event occurs. Stop
NuvaRing use at least 4 weeks before and through
2 weeks after major surgery. Start no earlier than 4 weeks after
delivery, in women who are not breastfeeding. (5.1)
Toxic Shock Syndrome (TSS): If patient exhibits signs or symptoms of
TSS, consider the possibility of thi