XULANE Patch (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Mylan Pharmaceuticals Inc.

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BOXED WARNING SECTION

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI ≥30 kg/m² Cigarette Smoking and Serious Cardiovascular Events Cigarette smoking increases the risk ...

1. Indications and Usage

Xulane is indicated for the prevention of pregnancy in women with a body mass index (BMI) <30 kg/m2 for whom a transdermal delivery system is an appropriate method of contraception. Limitations ...

2. Dosage and Administration

To achieve maximum contraceptive effectiveness, Xulane must be used exactly as directed. Complete instructions to facilitate patient counseling on proper system usage may be found in the FDA-Approved Patient ...

3. Dosage Forms and Strengths

Xulane (norelgestromin and ethinyl estradiol transdermal system) is available in one strength of 150 mcg/day norelgestromin (NGMN) and 35 mcg/day ethinyl estradiol (EE). Xulane is a 14 cm² peach, transdermal ...

4. Contraindications

Xulane is contraindicated in women with the following conditions: At high risk of arterial or venous thromboembolic events. Examples include women who:Smoke, if over age 35 [see Boxed Warning, and ...

5. Warnings and Precautions

5.1 Thromboembolic Disorders and Other Vascular Conditions Stop Xulane if an arterial or venous thromboembolic event (VTE) occurs. Stop Xulane if there is unexplained loss of vision, proptosis, diplopia, ...

6. Adverse Reactions

The following serious adverse reactions with the use of combination hormonal contraceptives, including Xulane, are discussed elsewhere in the labeling: Serious cardiovascular events and stroke [see ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions (Table 3) have been identified during postapproval use of norelgestromin and ethinyl estradiol transdermal system. Because these reactions are reported voluntarily from ...

7. Drug Interactions

Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. 7.1 Effects of Other Drugs on Combined ...

8. Use in Specific Populations

8.8 BMI and Weight Considerations Xulane is contraindicated in women with a BMI ≥30 kg/m2 because of the potential increased risk of VTE [see Contraindications (4) and Warnings and Precautions ...

8.1. Pregnancy

There is little or no increased risk of birth defects in women who inadvertently use hormonal contraceptives during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased ...

8.3. Nursing Mothers

The effects of Xulane in nursing mothers have not been evaluated and are unknown. When possible, advise the nursing mother to use other forms of contraception until she has completely weaned her child. ...

8.4. Pediatric Use

Safety and efficacy of norelgestromin and ethinyl estradiol transdermal system have been established in women of reproductive age. Efficacy is expected to be the same for post-pubertal adolescents under ...

8.5. Geriatric Use

Xulane has not been studied in postmenopausal women and is not indicated in this population.

8.6. Hepatic Impairment

No studies with Xulane have been conducted in women with hepatic impairment. However, steroid hormones may be poorly metabolized in patients with impaired liver function. Acute or chronic disturbances ...

8.7. Renal Impairment

No studies with Xulane have been conducted in women with renal impairment.

10. Overdosage

Overdosage may cause nausea and vomiting, and withdrawal bleeding may occur in women. In case of suspected overdose, all Xulane patches should be removed and symptomatic treatment given.

11. Description

Xulane is a transdermal system with a contact surface area of 14 cm². It contains 4.86 mg norelgestromin, USP (NGMN) and 0.53 mg ethinyl estradiol, USP (EE), and its delivery rate is approximately 150 ...

12.1. Mechanism of Action

NGMN is the active progestin largely responsible for the progestational activity that occurs in women following application of norelgestromin and ethinyl estradiol transdermal system. NGMN is also the ...

12.2. Pharmacodynamics

One clinical trial assessed the return of hypothalamic-pituitary-ovarian axis function post-therapy and found that follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estradiol mean values, ...

12.3. Pharmacokinetics

Absorption The systemic delivery rate of NGMN and EE from norelgestromin and ethinyl estradiol transdermal system is approximately 150 mcg of NGMN and 35 mcg of EE per day based on a comparative analysis ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

See Warnings and Precautions (5.3, 5.12) and Use in Specific Populations (8.1). Norelgestromin was tested in in vitro mutagenicity assays (bacterial plate incorporation mutation assay, CHO/HGPRT ...

14. Clinical Studies

In 3 large clinical trials lasting 12 months, in North America, Europe and South Africa, 3,330 women (ages 18 to 45) completed 22,155 cycles of norelgestromin and ethinyl estradiol transdermal system use, ...

16.1. How Supplied

Xulane (norelgestromin and ethinyl estradiol transdermal system) is available in one strength of 150 mcg/day NGMN and 35 mcg/day EE. Xulane is a 14 cm² peach, transdermal system printed with Xulane (norelgestromin ...

16.2. Storage and Handling

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Store patches in their protective pouches. Apply immediately upon removal from the protective pouch. Do not store in the refrigerator ...

17. Patient Counseling Information

Counsel patients about the following information: Cigarette smoking increases the risk of serious cardiovascular events from combined hormonal contraceptive use, and that women who are over 35 years old ...