FDA Approves Weekly Contraceptive Patch Twirla

Posted on February 18, 2020

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SOURCE: Agile Therapeutics, Inc.

Agile Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Twirla® (levonorgestrel and ethinyl estradiol) transdermal system. A new weekly contraceptive patch delivering a 30 mcg daily dose of estrogen and 120 mcg daily dose of progestin.

INDICATION AND USAGE

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.

Limitations of Use

Consider TWIRLA’s reduced effectiveness in women with a BMI > 25 to < 30 kg/m2 before prescribing. TWIRLA is contraindicated in women with a BMI > 30 kg/m2.

Please see Important Safety Information for TWIRLA, including BOXED WARNING on Cigarette Smoking and Serious Cardiovascular Events and Contraindication in Women with a BMI > 30 kg/m2, below in “About Twirla.”

“Twirla is an important addition to available hormonal contraceptive methods, allowing prescribers to now offer appropriate U.S. women a weekly transdermal option that delivers estrogen levels in line with labeled doses of many commonly prescribed oral contraceptives,” said Dr. David Portman, a primary investigator on the SECURE clinical trial. “I’m pleased that Agile conducted a comprehensive study in a diverse population providing important data to prescribers and to women seeking contraception. It is vital to expand the full range of contraceptive methods and inform the choices that fit an individual’s family planning needs and lifestyle. I am excited healthcare providers can now include Twirla among available contraception options.”

Twirla is designed for weekly application to deliver a 30 mcg daily dose of ethinyl estradiol, a type of estrogen, along with a 120 mcg daily dose of levonorgestrel, a well-known progestin with a long history in the category. The newly approved patch can be worn on the abdomen, buttock, or upper torso (excluding the breasts).

CONTRAINDICATIONS

TWIRLA is contraindicated and should not be used in women with a high risk of arterial or venous thrombotic disease, including women with a BMI ≥ 30 kg/m2; have 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 or other estrogen- or progestin-sensitive cancer; hypersensitivity to any components of TWIRLA; and use of Hepatitis C drug combinations containing ombitasvir/paraparesis/ritonavir with or without dasabuvir.

WARNINGS AND PRECAUTIONS

  • Thromboembolic Disorders and Other Vascular Conditions-
    Women are at increased risk for a venous thromboembolic event (VTE) when using TWIRLA
    • Stop TWIRLA if an arterial or venous thrombotic/thromboembolic event occurs
    • Stop TWIRLA if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately
    • Discontinue TWIRLA during prolonged immobilization and, if feasible, stop TWIRLA at least 4 weeks before and through 2 weeks after major surgery
    • Start TWIRLA no earlier than four weeks after delivery in women who are not breast-feeding
    • Before starting TWIRLA, evaluate any past medical history or family history of thromboembolism or thromboembolic disorders and consider whether history suggests inherited or acquired hypercoagulopathy

Arterial Events- CHCs increase the risk of cardiovascular events and cerebrovascular events, such as myocardial infarction and stroke, particularly among older women (> 35 years of age), smokers, and women with hypertension, dyslipidemia, diabetes, or obesity.

  • Liver Disease- Discontinue TWIRLA if jaundice develops
  • Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment- Discontinue TWIRLA prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. TWIRLA can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen.
  • Hypertension- Monitor blood pressure at routine visits and stop TWIRLA if blood pressure rises significantly. An increase in blood pressure has been reported in women using CHCs, and this increase is more likely in older women with extended duration of use.
  • Gallbladder Disease- Studies suggest CHCs increase risk of developing gallbladder disease and may also worsen existing gallbladder disease.
  • Adverse Carbohydrate and Lipid Metabolic Effects-
    • TWIRLA may decrease glucose tolerance. Carefully monitor prediabetic and diabetic women who are using TWIRLA.
    • Consider alternative contraception for women with uncontrolled dyslipidemia. TWIRLA may cause adverse lipid changes. Women with hypertriglyceridemia, or a family history thereof, may have an increase in serum triglyceride concentrations when using TWIRLA, which may increase the risk of pancreatitis.
  • Headache- If a woman using TWIRLA develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue TWIRLA if indicated. Consider discontinuation of TWIRLA if there is any increased frequency or severity of migraines during CHC use (which may be prodromal of a cerebrovascular event).
  • Bleeding Irregularities and Amenorrhea- Women using TWIRLA may experience unscheduled bleeding, especially during the first three months of use, or experience absence of scheduled bleeding. If bleeding persists or occurs after previously regular cycles on TWIRLA, or if scheduled bleeding does not occur, evaluate for causes such as pregnancy or, in the case of unscheduled bleeding, malignancy.
  • Other Warnings and Precautions- Other warnings and precautions include, depression, cervical cancer, increased serum concentrations of binding globulins, hereditary angioedema, and chloasma.

ADVERSE REACTIONS

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 four 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).

DRUG INTERACTIONS

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.

INDICATIONS AND USAGE

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.

Limitations of Use:

Consider TWIRLA’s reduced effectiveness in women with a BMI ≥ 25 to < 30 kg/m2 before prescribing TWIRLA. TWIRLA is contraindicated in women with a BMI ≥ 30 kg/m2.