SAFETY AND TOLERABILITY

Demonstrated safety profile, studied in a large and diverse group of women

The safety population for the SECURE Trial included 2031 women
with more than 18,000 cycles combined.1

In the SECURE Trial,

10.9% of women using Twirla discontinued due to an adverse event, 3.1% discontinued due to an application-site disorder, and 2.2% discontinued due to a bleeding-related adverse event.

Well-tolerated in a clinical trial

Adverse reactions reported by ≥2% of women
enrolled in the SECURE Trial (N=2031)

*Represents a bundle of similar terms that include the following adverse reactions: application site acne, hemorrhage, pustules, dermatitis, hypersensitivity, rash, discoloration, induration, reaction, dryness, irritation, ulcer, erosion, pain, urticaria, erythema, papules, vesicles, exfoliation, and pruritus.

Most common site adverse reactions (≥1%) (N=2031)1

Additional application-site adverse reactions that occurred at <1% included: pruritus (0.94%), rash (0.84%), erythema (0.69%), dermatitis (0.59%), dryness (0.49%), pain (0.20%), acne (0.15%), reaction (0.15%), hypersensitivity (0.10%), papules (0.10%), urticaria (0.10%), and 0.05% incidence of erosion, exfoliation, hemorrhage, induration, pustules, ulcer, and vesicles.
The following serious adverse reactions occurred in <1% of women who received Twirla: cholelithiasis, deep vein thrombosis, major depression, pulmonary embolism, cholecystitis, suicidal ideation appendicitis, ectopic pregnancy, pneumonia, and gastroenteritis.1

Bleeding Profile


Withdrawal (scheduled) bleeding
In the SECURE Trial, the mean number of scheduled bleeding days went from 2.7 days during Cycle 2 to 2.3 days during Cycle 13.

Breakthrough (unscheduled) bleeding
When using Twirla, women may have unscheduled bleeding and/or spotting between periods, especially during the first 3 months of use. At cycles 1 and 2, 60.4% and 52.6%, respectively, reported at least 1 day of unscheduled bleeding and/or spotting. At cycle 13, 42.3% of women reported unscheduled bleeding and/or spotting. If unscheduled (breakthrough) spotting or bleeding occur, instruct the woman to continue the same regimen. If the bleeding is persistent or prolonged, consider causes other than Twirla.

Amenorrhea
Women who use Twirla may experience an absence of withdrawal bleeding, even if they are not pregnant. In the SECURE trial, the percentages of women with no bleeding and/or spotting days (amenorrhea) in 13 cycles ranged from 6.3% to 11.9%. Advise the woman to contact a healthcare provider in the event of amenorrhea in 2 or more consecutive cycles or in case of symptoms of pregnancy such as morning sickness or unusual breast tenderness.

Understanding VTE data

Of the 4 drug-related VTEs that occurred in the SECURE Trial, all were in women with a BMI ≥30 kg/m2.

Number of participants with a drug-related VTE
in the SECURE Trial (N=2031)1

. Consider the reduced effectiveness of Twirla in women with a BMI ≥25 to <30 kg/m2 before prescribing. Twirla is contraindicated in women with a BMI ≥30 kg/m2. Compared to women with a lower BMI, women with a BMI ≥30 kg/m2 had reduced effectiveness and may have a higher risk for VTEs.

The Secure Trial

had no BMI/weight limitations throughout enrollment.1

Learn more about the inclusive trial design.
Reference: 1. Data on file, Clinical Study Report 023; Agile Therapeutics.

IMPORTANT SAFETY INFORMATION

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WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI ≥30 kg/m2

Cigarette Smoking and Serious Cardiovascular Events

Cigarette smoking increases the risk of serious cardiovascular events from combined hormonal contraceptive (CHC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including TWIRLA, are contraindicated in women who are over 35 years of age and smoke.

Contraindicated in Women with a BMI ≥30 kg/m2

TWIRLA is contraindicated in women with a BMI ≥30 kg/m2. Compared to women with a lower BMI, women with a BMI ≥30 kg/m2 had reduced effectiveness and may have a higher risk for venous thromboembolic events (VTEs).