FDA approves first orally disintegrating contraceptive, Femlyv

Femlyv, containing norethindrone acetate and ethinyl estradiol, has received FDA approval as the first orally disintegrating tablet for pregnancy prevention. This approval marks a significant advancement in contraceptive options, particularly for individuals who encounter challenges with swallowing traditional tablets.

Femlyv is unique as it is the first contraceptive to be approved in an orally disintegrating tablet form. The tablet contains norethindrone acetate and ethinyl estradiol, hormones that have been used in swallowable contraceptive forms since 1968. To use Femlyv effectively, the tablet should be dissolved on the tongue, followed by 240 mL of water, and taken simultaneously every day, regardless of meals. Consistent daily use is crucial for its efficacy, and healthcare providers play a key role in supporting patient adherence to the regimen.

“There are many variables that might cause someone to have difficulty swallowing,” said 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. “This drug provides another treatment option and expands access to this form of contraception for individuals who may have experienced those challenges.”

The release of Femlyv’s prescribing packet highlights several important points for clinicians to discuss with their patients. These include the proper administration method and the necessity of taking the tablet simultaneously daily. Femlyv should not be used by individuals with a high risk of venous thrombotic diseases, breast cancer, liver tumors, unexplained abnormal uterine bleeding, or women aged over 35 who smoke.

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

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

Femlyv’s approval is supported by studies comparing safety outcomes between combined oral contraceptive (COC) users and non-users. In five studies, breast cancer risk did not significantly differ between ever-users and never-users, with effect estimates ranging from 0.90 to 1.12. However, two studies indicated a slight increase in breast cancer risk from recent COC use, with relative risk increasing by 1.19–1.33 among current or recent users.

The prescribing packet also details potential drug interactions that may impact the efficacy of COCs. These include drugs that contain certain enzymes like cytochrome and medications such as atorvastatin, which may increase the plasma concentration of COCs. Patients should not continue Femlyv use if they become pregnant, and it may affect milk production in lactating individuals, although this reduction is less likely if breastfeeding is well-established.

Femlyv's approval expands contraceptive options, particularly for individuals with difficulty swallowing traditional tablets. Healthcare providers are instrumental in supporting patient adherence to ensure the efficacy of this new contraceptive method. Patient education on proper use and potential risks is crucial for maximizing benefits and minimizing adverse effects.