Written by Angeline Ti

Two contraceptive patches are currently available in the United States: one containing norelgestromin (NGMN) 150 mcg/day with ethinyl estradiol (EE) 35 mcg/day (Xulane¹ or the generic Zafemy²) and a newer one containing levonorgestrel (LNG) 120 mcg/day and EE 30 mcg/day (Twirla³). When prescribing the patch for patients with larger bodies, there are some nuances that clinicians should be aware of.

Both patches have a body-mass index (BMI) ≥ 30 kg/m² as a contraindication listed on their Food and Drug Administration (FDA) label because of slightly increased risks of venous thromboembolism. However, the risks seen in clinical trials appear to be similar to those with other combined hormonal contraceptives (e.g. the pill and ring). The FDA labels for one of the NGMN/EE patches (Xulane) and the LNG/EE (Twirla) patch also report decreased effectiveness for people with larger bodies. Limited data from clinical trials of the NGMN/EE patch found 5 of the 15 pregnancies occurred among people weighing more than 198 lbs (90 kg). However, people over 198 lbs made up less than 3% of the study population,¹ so these data should be interpreted with caution. In phase 3 clinical trials of the lower dose LNG/EE patch (which had greater body size diversity compared to the NGMN/EE studies), there was decreasing patch effectiveness with increasing BMI.³ Despite these concerns, the contraceptive patch is category 2 in the US Medical Eligibility Criteria for Contraceptive Use, indicating the advantages of using the patch for someone with a BMI over 30 kg/m² generally outweigh the risks.⁴

When considering recommendations based on BMI, clinicians should recognize BMI’s racist and sexist origins that limit its usefulness as a marker of an individual patient’s health.⁵ Additionally, as seen in some of the data mentioned above, people with larger bodies may be poorly represented in the research, which limits what we know about how these medications affect people in these bodies. Patients with larger bodies should be counseled about the small safety and effectiveness concerns with the contraceptive patch, and be allowed to balance those concerns against their own preferences, experiences, and contexts.^⁶ When counseling patients on the limitations/risks of the patch related to BMI, providers should remind patients that it is not their fault that these medications do not work as well in all bodies and avoid using this time to counsel on intentional weight loss. In the absence of other medical comorbidities, elevated BMI alone should not be used to deny a patient the contraceptive patch.

RHAP resources:

Your Birth Control Choices Fact Sheet

Your Birth Control Choices Poster

Medical Eligibility Criteria for Initiating Contraception

Patch User Guide

Sources:

1. XULANE- norelgestromin and ethinyl estradiol patch  Mylan Pharmaceuticals Inc. Dailymed. March 2022. Accessed August 9, 2023. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?type=display&setid=f7848550-086a-43d8-8ae5-047f4b9e4382.

2. Zafemy- Norelgestromin and ethinyl estradiol patch. DailyMed. April 30, 2022. Accessed August 9, 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5ee34c07-65af-42b8-a98f-e299ff90a8a1.

3. Twirla – Prescribing Information. Twirla. April 2022. Accessed August 9, 2023. https://www.twirla.com/pdf/Twirla%20FINAL%20USPI%20PPI%20IFU.pdf.

4. Curtis KM, Tepper NL, Jatlaoui TC, et al. U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. MMWR Recomm Rep. 2016;65(RR-3):1-104. doi:10.15585/mmwr.rr6503a1

5. AMA J Ethics. 2023;25(7):E535-539. doi: 10.1001/amajethics.2023.535.

6. Folse, C., et al (2023 June 7). Contraceptive Care for Patients with Bigger Bodies [Webinar]. NAF and UCSF Beyond the Pill.

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The Reproductive Health Access Project does not accept funding from pharmaceutical companies. We do not promote specific brands of medication or contraception. The information in the Contraceptive Pearls is unbiased, based on science alone.

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