Etonogestrel - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Etonogestrel. This is the same information dispensing pharmacists read.
\u26a0\ufe0f Boxed Warning (Highest FDA Alert)
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events 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 NuvaRing, should not be used by women who are over 35 years of age and smoke. [See Contraindications .] 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. Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use.
5 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.
Toxic Shock Syndrome (TSS): If patient exhibits signs or symptoms of TSS, consider the possibility of this diagnosis and initiate appropriate medical evaluation and treatment.
Liver disease: Discontinue NuvaRing use if jaundice develops.
High blood pressure: If used in women with well-controlled hypertension, monitor blood pressure and stop NuvaRing use if blood pressure rises significantly.
Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women.
Consider an alternate contraceptive method for women with uncontrolled dyslipidemia.
Headache: Evaluate significant change in headaches and discontinue NuvaRing use if indicated.
Uterine bleeding: Evaluate irregular bleeding or amenorrhea.
5.1 Thromboembolic Disorders and Other Vascular Problems Stop NuvaRing use if an arterial thrombotic or venous thromboembolic event (VTE) occurs.
Stop NuvaRing use if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions.
Evaluate for retinal vein thrombosis immediately. [See Adverse Reactions .] If feasible, stop NuvaRing at least four weeks before and through two weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism, and during and following prolonged immobilization.
Start NuvaRing no earlier than 4 weeks after delivery, in women who are not breastfeeding.
The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.
The use of CHCs increases the risk of VTE.
Known risk factors for VTE include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of CHCs [see Contraindications ].
Two epidemiologic studies 1, 2, 3 that assessed the risk of VTE associated with the use of NuvaRing are described below.
In these studies, which were required or sponsored by regulatory agencies, NuvaRing users had a risk of VTE similar to Combined Oral Contraceptives (COCs) users (see Table 1 for adjusted hazard ratios).
A large prospective, observational study, the Transatlantic Active Surveillance on Cardiovascular Safety of NuvaRing (TASC), investigated the risk of VTE for new users, and women who were switching to or restarting NuvaRing or COCs in a population that is representative of routine clinical users.
The women were followed for 24 to 48 months.
The results showed a similar risk of VTE among NuvaRing users (VTE incidence 8.3 per 10,000 WY) and women using COCs (VTE incidence 9.2 per 10,000 WY).
For women using COCs that did not contain the progestins desogestrel (DSG) or gestodene (GSD), VTE incidence was 8.9 per 10,000 WY.
A retrospective cohort study using data from 4 health plans in the US (FDA-funded Study in Kaiser Permanente and Medicaid databases) showed the VTE incidence for new users of NuvaRing to be 11.4 events per 10,000 WY, for new users of a levonorgestrel (LNG)-containing COC 9.2 events per 10,000 WY, and for users of other COCs available during the course of the study Includes low-dose COCs containing the following progestins: norgestimate, norethindrone, or levonorgestrel.
8.2 events per 10,000 WY.
Applies to YOU?
Some warnings apply only to specific age groups, health conditions, or other medicines. Ask GoDavaii AI to filter which of these 106+ warnings apply to your profile.
Ask Health AI \u2192