TWIRLA (ethinyl estradiol)

TWIRLA is a TDS designed with an active matrix core containing LNG and EE. TWIRLA delivers medication to the systemic circulation by absorption of LNG and EE through the skin.

AbsorptionFollowing application of TWIRLA, both LNG and EE reach a plateau by 24 to 48 hours (Figures 5 and 6). Delivery of hormones is continuous over the 7 days of TWIRLA wear. The mean pharmacokinetic parameters (C ss and AUC 0‑168 ) for LNG and EE following two consecutive cycles of TWIRLA are summarized in Table 6. T...

The efficacy of TWIRLA was evaluated in one open label, single arm, multicenter trial in the United States (Study 1) (NCT02158572) of one-year duration that enrolled 2,031 women, ranging in age between 18 and 60 years, who were healthy and sexually active with regular menstrual cycles. For the primary efficacy analysis, 1,736 women between the ages 18 and 35 years completed 15,165 evaluable 28-day cycles with TWIRLA, where no back-up contraception was used, and sexual intercourse occurred. The racial/ethnic distribution for the primary analysis was White (67%), Black/African American (24%), As...

The following serious adverse reactions with the use of CHCs, including TWIRLA, are discussed elsewhere in the labeling: Thromboembolic Disorders and Other Vascular Conditions [see Warnings and Precautions ( 5.1 )] Liver disease [see Warnings and Precautions ( 5.3 )] The most common adverse reactions (≥ 2%) in clinical trials for TWIRLA are application site disorders, nausea, headache, dysmenorrhea, and increased weight. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Agile Therapeutics, ...

Twirla is contraindicated in females who are known to have or develop the following conditions: At high risk of arterial or venous thrombotic diseases. Examples include women who Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions ( 5.1 )] Have current or history of deep vein thrombosis or pulmonary embolism [see Warnings and Precautions ( 5.1 )] Have cerebrovascular disease [see...

Vascular Risks : Stop TWIRLA if a thromboembolic event occurs. Stop TWIRLA at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breast-feeding. Consider cardiovascular risk factors before initiating in all women, particularly those over 35 years. ( 5.1 , 5.5 ) Liver Disease : Discontinue TWIRLA if jaundice occurs. ( 5.2 ) Risk of Liver Enzyme Elevations with Concomitant Hepatitis C . ( 5.3 ) Hypertension : If used in ...

7 DRUG INTERACTIONS The sections below provide information on substances for which data on drug interactions with CHCs are available. There is little information available about the clinical effect of most drug interactions that may affect CHCs. However, based on the known pharmacokinetic effects of these drugs, clinical strategies to minimize any potential adverse effect on contraceptive effectiv...