FDA Approves Femlyv, First Orally Disintegrating Tablet for Birth Control

Femlyv (norethindrone acetate and ethinyl estradiol) has received approval from the FDA for preventing pregnancy.¹

Femlyv is the first orally disintegrating tablet to receive FDA approval for pregnancy prevention, though norethindrone acetate and ethinyl estradiol have been approved in a swallowable tablet form for preventing pregnancy since 1968.

“There are many variables that might cause someone to have difficulty swallowing,” Janet Maynard, MD, MHS, director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research said in an FDA statement. “This drug provides another treatment option and expands access to this form of contraception for individuals who may have experienced those challenges.”

The prescribing packet for Femlyv has also been released, highlighting multiple points clinicians should discuss with their patients before administering Femlyv.² These include instructions on taking the tablet. Femlyv should be dissolved on the tongue and followed with 240 ml of water. It should also be taken at the same time each day regardless of mealtimes.²

Side effects include vaginal candidiasis, nausea, headache, breast tenderness, menstrual cramps, acne, abnormal cervical smear, bacterial vaginitis, weight gain, and mood swings.

Contraindications for Femlyv include a high risk of venous thrombotic diseases, breast cancer, liver tumors, undiagnosed abnormal uterine bleeding, and co-administration with certain Hepatitis C drug combinations. Femlyv should not be used by women older than age 35 years who smoke.

Patients should discontinue Femlyv use following a thrombotic event and if blood pressure significantly increases. Other events that may lead to discontinuation include diagnosis of a hormonally sensitive malignancy, chronic disturbance of liver function, and symptomatic gallbladder.

The recommended dosage of Femlyv is 1 tablet per day for 28 days, with no doses skipped or taken after 24 hours. However, the efficacy of this regime has not been evaluated in patients with a body mass index over 35 kg/m². Initiation of the regimen is recommended on the first day of a patient’s menstrual period or the first Sunday after menstruation onset.

Femlyv’s safety and efficacy data is supported by studies comparing safety outcomes among women using combined oral contraceptives (COC) vs non-COC users. In 5 studies, breast cancer risk did not significantly vary between ever-user and never-users with effect estimates ranging from 0.90 to 1.12.

Despite this data, 2 studies have indicated increased breast cancer risk from recent COC use under 6 months. The relative risk increased by 1.19 to 1.33 among patients with current or recent COC use, with the risk increasing from longer use.

The prescription packet also detailed other drugs that may impact the efficacy of COCs. These include drugs containing enzymes such as cytochrome. Additionally, the plasma concentration of COCs may be increased form co-administration with atorvastatin.²

Patients should not continue Femlyv use if they become pregnant. Additionally, milk production may be impacted in lactating individuals, but this reduction is less likely if breast feeding is well-established.

Patient adherence is crucial for treatment efficacy. Health care providers can support their patients in establishing a treatment regimen or discontinuing Femlyv use if necessary.

References
1. FDA roundup: July 23, 2024. US Food and Drug Administration. July 23, 2024. Accessed July 24, 2024. https://www.fda.gov/news-events/press-announcements/fda-roundup-july-23-2024
2. FEMLYV (norethindrone acetate and ethinyl estradiol orally disintegrating tablets) initial US Approval: 1968. US Food and Drug Administration. Accessed July 24, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218718s000lbl.pdf