Norelgestromin
in XULANE patch
What it isProgestin delivered by transdermal contraceptive patch.
Why it mattersWeekly application rather than daily dosing improves adherence.
What it changesHigher estrogen exposure than an equivalent pill, so VTE risk is greater. Efficacy falls above about 90 kg.
FDA-approved for
- contraception via transdermal patch with ethinyl estradiol (2001)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Contraception | Females of reproductive potential, BMI <30 | 1 patch/week x3 wk (norelgestromin 220 mcg/day + EE 20 mcg/day) | 1 patch weekly wk 1-3, patch-free wk 4 | 1 patch at a time |
Renal Undefined
Hepatic Contraindicated in liver tumors, acute viral hepatitis, decompensated cirrhosis; not studied in hepatic impairment
Never exceed a 7-day patch-free interval between cycles
Instructions
- Transdermal use only; apply to clean, dry skin on upper outer arm, abdomen, buttock, or back
- Do not apply to breasts or cut/irritated skin; do not cut or alter the patch
- Press firmly 10 seconds; apply new patch same day each week; rotate application site
- Start no sooner than 4 weeks postpartum (non-breastfeeding)
Contraindications
- High risk of arterial/venous thromboembolism (smokers >35, DVT/PE, thrombophilia, cerebrovascular or coronary disease, thrombogenic valvular/rhythm disease, uncontrolled HTN, diabetes with vascular disease, migraine with aura or any migraine if >35)
- BMI ≥30 kg/m2
- Liver tumors (benign or malignant) or liver disease (acute viral hepatitis, decompensated cirrhosis)
- Undiagnosed abnormal uterine bleeding
- Current or past breast cancer or other estrogen/progestin-sensitive cancer
- Co-administration with HCV regimens containing ombitasvir/paritaprevir/ritonavir + dasabuvir ± ribavirin (ALT elevations)
Cautions
- Thromboembolic/vascular events — stop before major surgery and prolonged immobilization
- Liver disease — discontinue if jaundice occurs
- Hypertension — monitor BP, stop if it rises significantly
- Gallbladder disease
- Adverse carbohydrate/lipid effects — monitor glucose in diabetics
- New/worsening headache or migraine
- Bleeding irregularities and amenorrhea
- Depression — discontinue if it recurs
Adverse reactions
- Application site irritation/erythema/pruritus
- Intercycle bleeding
- Heavy withdrawal bleeding
- Nausea
Pregnancy Discontinue if pregnancy occurs; no increased birth-defect risk from inadvertent early-pregnancy CHC exposure
Lactation Contraceptive hormones present in milk; CHCs can reduce milk production; advise alternate method until weaning
⚠ BOXED WARNING
- Cigarette smoking and serious cardiovascular events over age 35
Classes and tags
Clinical profile
Mechanism of action: Norelgestromin ballicule
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