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Ethinyl estradiol / norelgestromin

Xulane · Zafemy contraceptive patches

A combined hormonal contraceptive patch delivering 150 mcg/day norelgestromin and 35 mcg/day ethinyl estradiol. Product-specific BMI/weight limits, weekly application, missed/detached patch instructions and CDC 2024 guidance are separately identified.

Therapeutic class
Combined estrogen/progestin contraception
Representative product
Xulane · 150/35 mcg per day patch
Reference focus
Xulane and Zafemy · weekly transdermal use
Essential safety

Avoid with BMI ≥ 30 or smoking above age 35.

The patch carries boxed cardiovascular/BMI warnings. Assess clot, migraine-aura, blood-pressure and postpartum risks before use. Check adhesion daily and follow exact product instructions after detachment/delay; obtain prompt pregnancy/emergency-contraception advice after unprotected sex. It does not protect against STIs.

Warnings and precautions
01

Indications

Use for pregnancy prevention when combined hormonal contraception is appropriate.

Labeled indication and limitations

Pregnancy prevention in females with BMI < 30 kg/m² for whom a CHC is appropriate. At weight ≥ 90 kg (198 lb), effectiveness may be lower even if BMI is below 30; BMI ≥ 30 is a contraindication, not merely an efficacy warning. Not indicated before menarche or after menopause. No STI protection, emergency-contraceptive use or automatic equivalence to a levonorgestrel patch is inferred.

CDC clinical eligibility context

CDC 2024 treats CHC eligibility across pill/patch/ring; migraine with aura is category 4, and postpartum/thrombosis risks need individualized classification. General obesity category 2 does not override these products’ labeled BMI ≥ 30 contraindication. The selected profile preserves product limits rather than treating all CHC patches as equivalent.

02

Dosage and administration

Wear one patch at a time for three weekly applications.

Labeled 28-day cycle and application

Apply a new intact patch on the same weekday for weeks 1, 2 and 3; week 4 is patch-free. Begin the next cycle the day after week 4 ends. Place on clean dry intact upper outer arm, abdomen, buttock or back, avoiding breasts/irritation/tight-clothing rub and the previous site. Avoid lotions/oils/powders; press with the palm 10 seconds and inspect edges daily. Remove the old patch; never cut or use multiple patches.

Labeled starting and switching

First-day start within 24 hours of menstruation needs no backup; later first application requires nonhormonal backup 7 days. Sunday start needs backup 7 days unless menses began that Sunday. Label switching directions depend on prior pill, ring, patch, injection, IUS, implant or progestin-only pill; verify its exact transition and residual-pregnancy risk rather than allow an arbitrary gap. CDC 2024 clinician-led initiation uses a different first 5-days criterion when pregnancy is reasonably excluded.

Labeled detachment or late replacement

Detached < 1 day: reapply if still clean/sticky or replace immediately; keep change day, no backup. Detached > 1 day or duration unknown: new patch/new 4-week cycle and backup 7 days; label wording leaves exactly 24 hours less explicit, so seek prompt advice rather than invent safe coverage. Late cycle start: apply now, new change day and backup 7 days. Midcycle delay ≥ 48 hours: start a new cycle and backup 7 days; shorter delay replace now/keep change day. The PI’s “up to 48” and “48 or more” wording overlaps at the boundary; use the safer ≥ 48-hour action and confirm with the clinician. Late week 4 removal: remove now and start the next cycle on schedule. Never tape a poorly adhering patch.

CDC 2024 missed-patch guidance · distinct protocol

Figure 2 uses a 48-hour delay/detachment threshold. At ≥ 48 hours: replace now, retain change day and use backup until 7 consecutive patch days; if week 3, omit the hormone-free week. Consider emergency contraception if first-week error and unprotected sex in the prior 5 days. This differs from product-label detachment/new-cycle directions; obtain one clinician/pharmacist plan instead of mixing algorithms. Ulipristal needs specific hormonal-restart timing, so emergency-contraceptive selection requires advice.

Labeled postpartum and postabortion initiation

In nonbreastfeeding users, label start no sooner than 4 weeks postpartum; if no period yet, assess pregnancy and use backup 7 days. First-trimester abortion/miscarriage permits immediate start; if not started within 5 days use first-start instructions/backup. Label waits at least 4 weeks after second-trimester abortion/miscarriage. General CDC postpartum/abortion recommendations differ and require eligibility assessment; they do not establish product safety for everyone at 4 weeks.

03

Safety

Thrombosis and cardiovascular suitability are central.

Warnings and precautions

Stop and assess suspected clot, unexplained vision loss, stroke symptoms or severe new/migraine headache. If feasible stop ≥ 4 weeks before and through 2 weeks after high-VTE-risk surgery; interrupt prolonged immobilization with clinician-directed restart. Patch estrogen exposure is higher than a 35 mcg oral EE comparator, so route does not remove clot risk. Assess BP, liver/gallbladder disease, glucose/lipids, depression, persistent abnormal bleeding and hereditary angioedema. Stop for jaundice, significant BP rise or serious recurrent depression. Persistent bleeding or missed periods may need pregnancy/pathology evaluation; the patch is not a pregnancy test.

Contraindications

BMI ≥ 30 kg/m²; high arterial/venous thrombotic risk including smoking over 35, current/past DVT/PE, thrombophilia, cerebrovascular/coronary disease, thrombogenic heart disease, uncontrolled hypertension or vascular diabetes. Migraine aura/focal neurological headache, and any migraine above 35. Liver disease or benign/malignant liver tumors; unexplained abnormal uterine bleeding; pregnancy; current/past breast cancer; ombitasvir/paritaprevir/ritonavir with or without dasabuvir. Check the complete product list and clinical eligibility before prescribing.

Boxed warning status

Both selected patches have boxed warnings for cigarette smoking/serious cardiovascular events and contraindication at BMI ≥ 30 kg/m². Smoking-related cardiovascular risk rises with age and cigarette use; smoking above 35 contraindicates these CHCs. This is not a boxed warning shared identically by every contraceptive formulation.

Adverse reactions

Common trial reports: breast discomfort, nausea/vomiting, headache, application-site reaction, abdominal pain, dysmenorrhea, bleeding changes and mood/anxiety symptoms. Serious postmarketing vascular, hepatic, allergic and other reports cannot establish incidence or a direct causal cancer risk. Overdose may cause nausea/vomiting and withdrawal bleeding: remove all patches and obtain medical/Poison Help guidance.

04

Drug interactions

Enzyme induction can reduce contraceptive effectiveness.

Interaction actions

CYP3A4 inducers such as rifampin/rifabutin, carbamazepine, phenytoin, selected other antiseizure drugs, bosentan and St John’s wort can cause breakthrough bleeding/contraceptive failure: use an alternative or backup throughout and 28 days after stopping the inducer. Inhibitors and selected antiviral regimens can raise/lower hormone exposure; review the exact combination. The contraindicated HCV regimen needs stopping beforehand, with label restart about 2 weeks after completion. CHCs lower lamotrigine concentrations and can impair seizure control; also review tizanidine/cyclosporine/theophylline exposure and thyroid replacement. Contraceptive steroids can alter coagulation/lipid/glucose/binding-protein tests.

05

Use in specific populations

Postpartum, lactation and organ disease require individual assessment.

Pregnancy, postpartum and lactation

Stop if pregnant; the label’s reassuring inadvertent early-CHC exposure data do not justify continued use or treatment of threatened abortion. Estrogen can reduce milk production; small hormone/metabolite amounts enter milk, and labels advise another method when possible until weaning. CDC 2024: CHCs are unacceptable before 21 days postpartum; breastfeeding users at 21–< 30 days generally should not use them, with later eligibility depending on VTE risks. Product labels retain their nonbreastfeeding ≥ 4-week start. Discuss the exact method and timing rather than a universal postpartum prescription.

Adolescents, older patients and weight

Efficacy is expected in postpubertal adolescents under 18; not indicated before menarche. Not studied/indicated after menopause. Evaluate age-related clot/smoking/migraine risk. Weight ≥ 90 kg can reduce efficacy; BMI ≥ 30 contraindicates use regardless of weight, and these are different measurements.

Renal and hepatic impairment

No renal-impairment studies or numeric patch adjustment are supplied. Liver disease/tumors contraindicate use; impaired steroid metabolism or new jaundice/LFT abnormalities requires stopping/review. Kidney disease can independently alter CHC clot/eligibility risk; assess the current MEC category rather than infer that missing renal PK data means unrestricted safety.

06

Clinical pharmacology

Continuous transdermal delivery suppresses ovulation.

Mechanism and disposition

Combined hormones suppress gonadotropins/ovulation and alter cervical mucus/endometrium. Transdermal delivery avoids initial GI/hepatic first-pass absorption but not later hepatic metabolism or interactions. Norelgestromin is highly protein-bound > 97%; EE is extensively albumin-bound. Post-removal half-lives are approximately 28 and 17 hours respectively, with renal/fecal metabolite elimination. Labeled EE AUC is about 60% higher than an oral 35 mcg comparator; these PK differences are not interchangeable oral doses.

07

Monitoring and counseling

Check BP, BMI, adhesion and evolving contraindications.

Monitoring priorities

Measure BP before starting and during routine care; assess BMI/weight for these specific products, pregnancy likelihood, clot/smoking/migraine history, interacting drugs and adherence. Review persistent bleeding, missed periods, mood, liver symptoms and metabolic disease. CDC does not require routine pelvic examination or universal glucose/lipid/LFT/thrombophilia panels for otherwise healthy CHC initiation; clinically indicated evaluation still applies. Product BMI restrictions remain despite general CDC obesity guidance.

Patient counseling

Wear only one intact patch and inspect it daily; know change day, backup and detachment plan. Seek urgent care for unilateral leg pain/swelling, sudden chest pain/dyspnea, weakness/speech difficulty, severe headache or vision loss. Report pregnancy, persistent bleeding, major surgery/immobility and new medicines. Use condoms for STI protection; the patch has no emergency-contraceptive role. Store used patches safely because hormone remains.

08

Product identification

Identify delivery strength and product-specific patch design.

Representative product

Xulane 14 cm² peach patch printed Xulane 150/35 mcg per day, brown ink; NDC 0378-3340-53, 3-patch cycle carton. Verify the original pouch and exact identity; not local-stock evidence.

Dosage forms and strengths

Both deliver 150 mcg/day norelgestromin and 35 mcg/day EE. Xulane 14 cm² contains 4.86 mg norelgestromin/0.53 mg EE; Zafemy 12.5 cm² tan rounded-corner patch contains 3.15 mg/0.289 mg and has a different liner. These contents are not the daily delivered dose. Current selected ANDA 200910/ANDA 213950 are Prescription records; other hormone patches are excluded.

Storage and handling

Store 20–25°C in protective pouches; selected Zafemy permits 15–30°C excursions. Apply immediately after opening; never refrigerate/freeze. Fold used adhesive sides together, place in a sturdy preferably child-resistant container and dispose in trash; do not flush. Do not tape, cut or reuse a dirty/nonsticky patch.

09

References

Original sources for the clinical and product information.

  1. DailyMed / National Library of MedicineMylan · Xulane full PI and patient instructions

    Full public manufacturer label and patient instructions; SPL version 17, effective 20220304. Product-specific directions reviewed October 1, 2026.

  2. DailyMed / National Library of MedicineAvKARE / Amneal · current Zafemy full PI and instructions

    Full public manufacturer label and patient instructions; SPL version 2, effective 20260119. Product-specific directions reviewed October 1, 2026.

  3. Centers for Disease Control and PreventionCDC · U.S. SPR2024 combined hormonal contraception

    Full public page and figure2 text, initiation/postpartum/monitoring sections retrieved/read. General guideline differs from product-specific detachment/start directions; separate provenance.

  4. Centers for Disease Control and PreventionCDC · U.S. MEC2024 combined hormonal contraception

    Full public CHC appendix, relevant migraine/obesity/postpartum/thrombosis/renal classifications retrieved/read; not a waiver of product-specific BMI contraindication.

  5. U.S. Food and Drug AdministrationFDA · ANDA200910 product-status record

    Current official FDA product record checked October1,2026; status is not stock.

  6. U.S. Food and Drug AdministrationFDA · ANDA213950 product-status record

    Current official FDA product record checked October1,2026; status is not stock.

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