Norelgestromin

Norelgestromin
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alara E.Dagsali

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Black Box Warning

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI ≥ 30 kg/m Norelgestromin and ethinyl estradiol transdermal system is contraindicated in women over 35 years old who smoke. Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use. Norelgestromin and ethinyl estradiol transdermal system is contraindicated for use in women with a BMI ≥ 30 kg/m . Women with a BMI ≥ 30 kg/m who use norelgestromin and ethinyl estradiol transdermal system may have a higher risk of venous thromboembolic events compared with women with a lower BMI. See full prescribing information for complete Boxed Warning.

Overview

Norelgestromin is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the prevention of Norelgestromin and ethinyl estradiol transdermal system is indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m for whom a combined hormonal contraceptive is appropriate.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include The following serious adverse reactions with the use of combination hormonal contraceptives, including norelgestromin and ethinyl estradiol, are discussed elsewhere in the labeling: Serious cardiovascular events and stroke Vascular events, including venous and arterial thromboembolic events Liver disease

Adverse reactions commonly reported by users of combination hormonal contraceptives are: Irregular uterine bleeding Nausea Breast tenderness Headache 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 drug and may not reflect the rates observed in clinical practice.

The data described below reflect exposure to norelgestromin and ethinyl estradiol transdermal system in 3,330 sexually active women (3,322 of whom had safety data) who participated in three Phase 3 clinical trials designed to evaluate contraceptive efficacy and safety. These subjects received six or 13 cycles of contraception (norelgestromin and ethinyl estradiol transdermal system or an oral contraceptive comparator in 2 of the trials). The women ranged in age from 18 to 45 years and were predominantly white (91%).

The most common adverse reactions (≥ 5%) reported during clinical trials were breast symptoms, nausea/vomiting, headache, application site disorder, abdominal pain, dysmenorrhea, vaginal bleeding and menstrual disorders, and mood, affect and anxiety disorders. The most common events leading to discontinuation were application site reaction, breast symptoms (including breast discomfort, engorgement and pain), nausea and/or vomiting, headache and emotional lability..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

To achieve maximum contraceptive effectiveness, norelgestromin and ethinyl estradiol transdermal systems must be used exactly as directed. Complete instructions to facilitate patient counseling on proper system usage may be found in the FDA-Approved Patient Labeling. The norelgestromin and ethinyl estradiol transdermal system uses a 28-day (four-week) cycle. A new patch is applied each week for three weeks (21 total days). Week Four is patch-free. Withdrawal bleeding is expected during this time. Every new patch should be applied on the same day of the week. This day is known as the “Patch Change Day.” For example, if the first patch is applied on a Monday, all subsequent patches should be applied on a Monday. Only one patch should be worn at a time. Do not cut, damage or alter the norelgestromin and ethinyl estradiol transdermal patch in any way. If the norelgestromin and ethinyl estradiol transdermal patch is cut, damaged or altered in size, contraceptive efficacy may be impaired. On the day after Week Four ends, a new four-week cycle is started by applying a new patch. Under no circumstances should there be more than a seven-day patch-free interval between dosing cycles.

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Norelgestromin FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Contraindications

There is limited information regarding Norelgestromin Contraindications in the drug label.

Warnings

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI ≥ 30 kg/m Norelgestromin and ethinyl estradiol transdermal system is contraindicated in women over 35 years old who smoke. Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use. Norelgestromin and ethinyl estradiol transdermal system is contraindicated for use in women with a BMI ≥ 30 kg/m . Women with a BMI ≥ 30 kg/m who use norelgestromin and ethinyl estradiol transdermal system may have a higher risk of venous thromboembolic events compared with women with a lower BMI. See full prescribing information for complete Boxed Warning.

There is limited information regarding Norelgestromin Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Norelgestromin Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Norelgestromin Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Norelgestromin Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Norelgestromin in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Norelgestromin in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Norelgestromin during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Norelgestromin in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Norelgestromin in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Norelgestromin in geriatric settings.

Gender

There is no FDA guidance on the use of Norelgestromin with respect to specific gender populations.

Race

There is no FDA guidance on the use of Norelgestromin with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Norelgestromin in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Norelgestromin in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Norelgestromin in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Norelgestromin in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Norelgestromin Administration in the drug label.

Monitoring

There is limited information regarding Norelgestromin Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Norelgestromin and IV administrations.

Overdosage

There is limited information regarding Norelgestromin overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Norelgestromin Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Norelgestromin Mechanism of Action in the drug label.

Structure

There is limited information regarding Norelgestromin Structure in the drug label.

Pharmacodynamics

There is limited information regarding Norelgestromin Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Norelgestromin Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Norelgestromin Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Norelgestromin Clinical Studies in the drug label.

How Supplied

There is limited information regarding Norelgestromin How Supplied in the drug label.

Storage

There is limited information regarding Norelgestromin Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Norelgestromin Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Norelgestromin interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Norelgestromin Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Norelgestromin Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.