Twirla 2.3 mg/1
levonorgestrel/ethinyl estradiol · PATCH · Agile Therapeutics, Inc.
Twirla is a birth control patch that releases the hormones levonorgestrel and ethinyl estradiol through your skin to prevent pregnancy. You wear the patch on your body, and it provides continuous hormone delivery over the course of a week.
Key Facts
- Brand Name
- Twirla
- Generic Name
- levonorgestrel/ethinyl estradiol
- NDC Code (Product)
71671-100- Manufacturer
- Agile Therapeutics, Inc.
- Strength
- 2.3 mg/1
- Dosage Form
- PATCH
- Route
- TRANSDERMAL
- Marketing Status
- Application #
- NDA204017
- Drug Class
- Estrogen [EPC]; Progestin [EPC]
- Marketing Start
- 09/11/2020
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE TWIRLA is indicated as a method of contraception for use in women of reproductive potential with a BMI < 30 kg/m 2 for whom a combined hormonal contraceptive is appropriate. Limitation of Use Consider TWIRLA’s reduced effectiveness in women with a BMI ≥ 25 to < 30 kg/m 2 before prescribing TWIRLA [see Use in Specific Populations ( 8.9 ) and Clinical Studies ( 14 )] . TWIRLA is contraindicated in women with a BMI ≥ 30 kg/m 2 [see Contraindications ( 4 )] . TWIRLA is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated as a method of contraception for use in women of reproductive potential with a BMI < 30 kg/m 2 for whom a combined hormonal contraceptive is appropriate. ( 1 ) Limitation of Use Consider TWIRLA’s reduced effectiveness in women with a BMI ≥ 25 to < 30 kg/m 2 before prescribing. ( 4 , 8.9 , 14 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For transdermal use only ( 2.2 ) Apply one TWIRLA transdermal system (TDS) every week for three consecutive weeks ( 2.1 , 2.2 ) Apply TWIRLA to one of the following sites: abdomen, buttock or upper torso (excluding breasts) ( 2.2 ) Do not cut or alter the TDS in any way ( 2.2 ) 2.1 How to Start Using TWIRLA See the FDA-approved patient labeling ( Instructions for Use ) . The TWIRLA transdermal system (TDS) is used in a 28-day (four-week) cycle. A new TDS is applied and worn for seven days for three consecutive weeks (Weeks 1, 2, and 3). No TDS is worn during Week 4 (the TDS-Free Week), when withdrawal bleeding is expected. On the day after Week 4 ends, a new 28-day cycle is started by applying a new TDS. Under no circumstances should there be more than a 7-day TDS-free interval between dosing cycles. Breakthrough (Unscheduled) Bleeding or Spotting Occurrence If unscheduled (breakthrough) spotting or bleeding occurs, instruct the woman to continue the same regimen. If the bleeding is persistent or prolonged consider causes other than TWIRLA. If the bleeding is persistent or prolonged, instruct the woman to consult with her healthcare provider. In Case of …
Contraindications
4 CONTRAINDICATIONS 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 Warnings and Precautions ( 5.1 )] Have coronary artery disease [see Warnings and Precautions ( 5.1 )] Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions ( 5.1 )] Have inherited or acquired hypercoagulopathies [see Warnings and Precautions ( 5.1 )] Have uncontrolled hypertension or hypertension with vascular disease [see Warnings and Precautions ( 5.4 )] Have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or vascular disease or other end-organ damage, or diabetes mellitus of > 20 years duration [see Warnings and Precautions ( 5.7 )] Have headaches with focal neurological symptoms, migraine headaches w…
Drug Interactions
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 effectiveness or safety are suggested. Consult the approved product labeling of all concurrently used drugs to obtain further information about interactions with CHCs or the potential for metabolic enzyme or transporter system alterations. No drug-drug interaction studies were conducted with TWIRLA. Enzyme inducers (e.g., CYP3A4): May decrease the effectiveness of TWIRLA or increase breakthrough bleeding. Counsel women to use a back-up or alternative method of contraception when enzyme inducers are used with TWIRLA. ( 7.1 ) 7.1 Effects of Other Drugs on Combined Hormonal Contraceptives Substances Decreasing Plasma Concentration of CHCs and Potentially Diminishing the Efficacy of CHCs: Table 4 includes substances that demonstrated an important drug interaction with TWIRLA. Table 4: Significant Drug…
Adverse Reactions
6 ADVERSE REACTIONS 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, Inc. at 1-888-389-4752 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of one product cannot be directly compared to rates in the clinical trials of another product and may not reflect the rates observed in practice. The safety of TWIRLA was evaluated in a 12-month, multicenter, open-label, single-arm clinical trial (NCT02158572) conducted in the United States [see Clinical Studies ( 14 )] . Women applied TWIRLA (120 mcg LNG/30 mcg EE) for 13 28-day treatment cycles. One treatment cycle is defined as three consecuti…
Frequently Asked Questions
What is Twirla used for?
Twirla is a birth control patch that releases the hormones levonorgestrel and ethinyl estradiol through your skin to prevent pregnancy. You wear the patch on your body, and it provides continuous hormone delivery over the course of a week.
Is Twirla a controlled substance?
Twirla is not classified as a controlled substance by the DEA.
What is the generic name for Twirla?
The generic name for Twirla is levonorgestrel/ethinyl estradiol. There are 3 other brand versions of levonorgestrel/ethinyl estradiol.
What is the NDC code for Twirla 2.3 mg/1?
The NDC (National Drug Code) for Twirla 2.3 mg/1 is 71671-100, listed by Agile Therapeutics, Inc..