Norelgestromin

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 primary active metabolite produced following oral administration of NGM, the progestin component of some oral contraceptive products.

• Norelgestromin and ethinyl estradiol transdermal system is indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m 2 for whom a combined hormonal contraceptive is appropriate. Limitations of Use: Norelgestromin and ethinyl estradiol transdermal system may be less effective in preventing pregnancy in women who weigh 198 lbs (90 kg) or more.ICD-10: Z30.9

• Norelgestromin and ethinyl estradiol transdermal system is contraindicated in females who are known to have or develop the following conditions: ● At high risk of arterial or venous thromboembolic events.contraindicated

To achieve maximum contraceptive effectiveness, norelgestromin and ethinyl estradiol transdermal system 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. Norelgestromin and ethinyl estradiol transdermal system uses a 28-day (4-week) cycle. Apply a new patch to the upper outer arm, abdomen, buttock or back each week for 3 weeks (21 total days). Week 4 is patch-free. ( 2.1 , 2.3 ) Apply each new patch on the same day of the week. Wear only one patch at a time. ( 2.1 ) Do not cut or alter the patch in any way. ( 2.1 ) 2.1 How to Use Norelgestromin and Ethinyl Estradiol Transdermal System The norelgestromin and ethinyl estradiol transdermal system uses a 28-day (4-week) cycle. A new patch is applied each week for 3 weeks (21 total days). Week 4 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 system patch in any way. If the norelgestromin and ethinyl estradiol transdermal system patch is cut, damaged or altered in size, contraceptive efficacy may be impaired. On the day after Week 4 ends, a new 4-week cycle is started by applying a new patch.

Vascular risks : Stop norelgestromin and ethinyl estradiol transdermal system if a thrombotic event occurs. Stop 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. Consider cardiovascular risk factors before initiating in all women, particularly those over 35 years. ( 5.1 ) Liver disease : Discontinue norelgestromin and ethinyl estradiol transdermal system if jaundice occurs. ( 5.3 ) High blood pressure : Do not prescribe norelgestromin and ethinyl estradiol transdermal system for women with uncontrolled hypertension or hypertension with vascular disease. ( 5.5 ) Carbohydrate and lipid metabolic effects : Monitor prediabetic and diabetic women taking norelgestromin and ethinyl estradiol transdermal system. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia. ( 5.7 ) Headache : Evaluate significant change in headaches and discontinue norelgestromin and ethinyl estradiol transdermal system if indicated. ( 5.8 ) Uterine bleeding : Evaluate irregular bleeding or amenorrhea. ( 5.9 ) 5.1 Thromboembolic Disorders and Other Vascular Conditions Stop norelgestromin and ethinyl estradiol transdermal system if an arterial or venous thromboembolic event (VTE) occurs. Stop norelgestromin and ethinyl estradiol transdermal system if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.

The following serious adverse reactions with the use of combination hormonal contraceptives, including norelgestromin and ethinyl estradiol transdermal system, are discussed elsewhere in the labeling: Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions ( 5.1 )] Vascular events, including venous and arterial thromboembolic events [see Warnings and Precautions ( 5.1 )] Liver disease [see Warnings and Precautions ( 5.3 )] Adverse reactions commonly reported by users of combination hormonal contraceptives are: Irregular uterine bleeding Nausea Breast tenderness Headache The most frequent adverse reactions reported during clinical trials (≥ 5%) were breast symptoms, nausea/vomiting, headache, application site disorder, abdominal pain, dysmenorrhea, vaginal bleeding and menstrual disorders, and mood, affect and anxiety disorders. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 drug and may not reflect the rates observed in clinical practice.

Nursing mothers : Not recommended; can decrease milk production. ( 8.3 ) 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 risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose hormonal contraceptives prior to conception or during early pregnancy. The administration of hormonal contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy. Hormonal contraceptives should not be used during pregnancy to treat threatened or habitual abortion. 8.3 Nursing Mothers The effects of norelgestromin and ethinyl estradiol transdermal system 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. Estrogen-containing CHCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. Small amounts of contraceptive steroids and/or metabolites are present in breast milk.

Metabolism

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 with intravenous (IV) data. Following a single application of norelgestromin and ethinyl estradiol transdermal system, both NGMN and EE reach a plateau by approximately 48 hours.

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

• Apr 16, 2014ANDAANDA200910Mylan Technologies
• Feb 25, 2021ANDAANDA213950Amneal
• Sep 14, 2023ANDAANDA214594Zydus Pharms

1. 1Product Adhesion Issue68538%
2. 2Wrong Technique In Product Usage Process33819%
3. 3Off Label Use22512%
4. 4Application Site Pruritus1649.0%
5. 5Application Site Erythema1196.5%
6. 6Application Site Rash1176.4%
7. 7Metrorrhagia1116.1%
8. 8Application Site Irritation1035.7%
9. 9Product Quality Issue985.4%
10. 10Application Site Pain744.1%
11. 11Drug Ineffective663.6%
12. 12Nausea653.6%
13. 13Headache573.1%
14. 14No Adverse Event452.5%
15. 15Rash452.5%

The 10 most recently updated of 29 ClinicalTrials.gov registrations naming Norelgestromin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Investigating Ovulation Inhibition for Use as a Contraceptive
  Recruiting · Phase 2 · Interventional · 60 enrolled · Mylan Pharmaceuticals Inc
  NCT07365904updated 2026-01-26
• Transdermal Ethinyl Estradiol and Norelgestromin for Irregular Bleeding in Contraceptive Implant Users
  Recruiting · Phase 2 · Interventional · 40 enrolled · Chulalongkorn University
  NCT07083635updated 2025-12-10
• Study of the Safety and Efficacy of MR-100A-01 in Approximately 1200 Healthy Women for up to 13 Cycles
  Completed · Phase 3 · Interventional · 1,319 enrolled · Mylan Technologies Inc.
  NCT05139121updated 2025-01-28
• Dose-finding Study of MR-130A-01 Contraceptive Transdermal Patch
  Completed · Phase 2 · Interventional · 168 enrolled · Mylan Pharmaceuticals Inc
  NCT06048536updated 2024-11-29
• Inpatient Adolescent Contraception
  Completed · Early phase 1 · Interventional · 25 enrolled · Children's Mercy Hospital Kansas City
  NCT04423068updated 2023-04-05
• A Trial in Healthy Female Subjects to Compare the Pharmacokinetics of Ethinyl Estradiol of NuvaRing®, a Contraceptive Patch (EVRA(TM)) and an Oral Contraceptive (Microgynon® 30) (Study 34237 (P06650)) (COMPLETED)
  Completed · Phase 4 · Interventional · 24 enrolled · Organon and Co
  NCT01044056updated 2022-02-04
• Effects of Oral vs. Non-oral Contraceptives on the GH/IGF-1 Axis
  Completed · Phase 4 · Interventional · 60 enrolled · Penn State University
  NCT02367833updated 2020-03-09
• Postmarketing Study of ORTHO EVRA (Norelgestromin and Ethinyl Estradiol Contraceptive Patch) in Relation to Venous Thromboembolism (Blood Clots), Stroke and Heart Attacks
  Completed · Observational · 334 enrolled · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  NCT00331071updated 2016-07-19
• Relative Risks for Non-fatal Venous Thromboembolism, Ischemic Stroke and Myocardial Infarction in Users of ORTHO EVRA(Norelgestromin and Ethinyl Estradiol Contraceptive Patch) Compared to Levonorgestrel-containing Oral Contraceptives.
  Completed · Observational · 440 enrolled · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  NCT00511784updated 2016-07-19
• A Postmarketing Study of the Risk of Venous Thromboembolism (Blood Clots), Myocardial Infarction (Heart Attacks), and Stroke Among Women Using ORTHO EVRA (Norelgestromin and Ethinyl Estradiol Contraceptive Patch) Compared With Women Who Take Oral Contraceptives for Birth Control
  Completed · Observational · 423 enrolled · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  NCT00377988updated 2016-07-19

Frequently asked questions

How does Norelgestromin work?

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 primary active metabolite produced following oral administration of NGM, the progestin component of some oral contraceptive products.

What is Norelgestromin used for?

According to FDA labeling, Norelgestromin carries indications including: Norelgestromin and ethinyl estradiol transdermal system is indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m 2 for whom a combined hormonal contraceptive is appropriate. Limitations of Use: Norelgestromin and ethinyl estradiol transdermal system may be less effective in preventing pregnancy in women who weigh 198 lbs (90 kg) or more.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Norelgestromin?

Norelgestromin is classified as Progestin, Progestational Hormone Receptor Agonists, Decreased Embryonic Implantation, Decreased Uterine Smooth Muscle Contraction or Tone, Gonadotropin Releasing Hormone Alteration, Increased Blood Pressure, Increased Coagulation Activity, Inhibit Ovarian Follicular Phase, Inhibit Ovulation.

What are the brand names for Norelgestromin?

Norelgestromin is marketed under brand names including Xulane, Zafemy.

What are the contraindications for Norelgestromin?

Norelgestromin labeling lists contraindications including: Norelgestromin and ethinyl estradiol transdermal system is contraindicated in females who are known to have or develop the following conditions: ● At high risk of arterial or venous thromboembolic events.. Always consult the full prescribing information and a clinician.