Helping your patient with her Twirla® prescription
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Important Safety Information
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If your patient requires a replacement patch prior to the prescription refill date, she may be eligible for the patch replacement program* offered by Agile Therapeutics, which allows for direct shipment of a new patch at no additional out-of-pocket cost.
Once we determine your patient's eligibility, our affiliated specialty pharmacy will get authorization from you and a replacement patch will be shipped directly to your patient’s preferred address.
To request a replacement patch, your patient can:
TWIRLA is indicated as a method of contraception for use in women of reproductive potential with a BMI <30 kg/m2 for whom a combined hormonal contraceptive is appropriate.
Consider the reduced effectiveness of TWIRLA in women with a BMI ≥25 to <30 kg/m2 before prescribing TWIRLA. TWIRLA is 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).
TWIRLA is contraindicated and should not be used in women who have or develop a high risk of arterial or venous thrombotic disease, including women with a BMI ≥30 kg/m2; headaches with focal neurological symptoms, migraine with aura, women over 35 years of age with any migraine headache; liver tumors, acute viral hepatitis, or severe (decompensated) cirrhosis, or liver disease; undiagnosed abnormal uterine bleeding; pregnancy; current or history of breast cancer; hypersensitivity to any components of TWIRLA; and use of hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir with or without dasabuvir.
The following serious adverse reactions occurred in <1% of women who received TWIRLA: cholelithiasis, cholecystitis, major depression, suicidal ideation, appendicitis, ectopic pregnancy, pneumonia, and gastroenteritis. A total of 4 VTEs in TWIRLA-treated patients were identified in the phase 3 clinical trial. The most common adverse reactions (≥2%) in clinical trials for TWIRLA are application site disorders, nausea, headache, dysmenorrhea, and increased weight.
Patients should be counseled that TWIRLA does not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs).
Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of TWIRLA or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with TWIRLA.
This is not a comprehensive list of safety information related to TWIRLA.
Please see full Prescribing Information, including BOXED WARNING.
To report SUSPECTED ADVERSE REACTIONS, call 1‑855‑389‑4752 or report via the FDA MedWatch Program at www.fda.gov/medwatch or 1‑800‑FDA‑1088.