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Twirla

Last reviewed on RxList: 2/27/2020
Twirla Side Effects Center

What Is Twirla?

Twirla (levonorgestrel and ethinyl estradiol) is a combination of the female hormones progestin and estrogen used as a method of contraception for use in women of reproductive potential with a BMI less than 30 kg/m2 for whom a combined hormonal contraceptive is appropriate.

What Are Side Effects of Twirla?

Side effects of Twirla include:

  • application site reactions (acne, bleeding, dermatitis, hypersensitivity, rash, discoloration, hard lump, reaction, dryness, irritation, ulcer, pain, hives, redness, vesicles, exfoliation, itching),
  • nausea,
  • headache,
  • menstrual cramps, and
  • weight gain
  • Dosage for Twirla

    Apply one Twirla transdermal system (TDS) every week for three consecutive weeks. Apply Twirla to one of the following sites: abdomen, buttock or upper torso (excluding breasts).

    Twirla In Children

    The safety and effectiveness of Twirla as a method of contraception have been established in females of reproductive potential with a BMI less than 30 kg/m2. Efficacy is expected to be the same in postmenarcheal females regardless of age. Twirla is not indicated in females before menarche.

    What Drugs, Substances, or Supplements Interact with Twirla?

    Twirla may interact with other medicines such as:

  • aprepitant,
  • barbiturates,
  • bosentan,
  • carbamazepine,
  • efavirenz,
  • felbamate,
  • griseofulvin,
  • oxcarbazepine,
  • phenytoin,
  • rifampin,
  • rifabutin,
  • rufinamide,
  • topiramate,
  • St. John's wort,
  • protease inhibitors,
  • colesevelam
  • atorvastatin or rosuvastatin,
  • ascorbic acid,
  • acetaminophen,
  • itraconazole,
  • voriconazole,
  • fluconazole,
  • ketoconazole,
  • grapefruit juice,
  • thyroid hormone,
  • cortisol therapy,
  • morphine,
  • salicylic acid,
  • temazepam,
  • cyclosporine,
  • prednisolone,
  • theophylline, and
  • tizanidine
Tell your doctor all medications and supplements you use.

Twirla During Pregnancy and Breastfeeding

Twirla is contraindicated in pregnancy because there is no reason to use combined oral contraceptives (CHCs) in pregnancy. Discontinue Twirla if pregnancy occurs. Contraceptive hormones and/or metabolites are present in breast milk. CHCs such as Twirla can reduce milk production in breastfeeding women. Nursing women are advised to use another method of contraception while breastfeeding.

Additional Information

Our Twirla (levonorgestrel and ethinyl estradiol) Transdermal System Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Choosing Your Birth Control Method See Slideshow
Twirla Professional Information

SIDE EFFECTS

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]
  • Liver disease [see WARNINGS AND PRECAUTIONS]

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 (NCT # 02158572) conducted in the United States [see Clinical Studies]. Women applied TWIRLA (120 mcg LNG/30 mcg EE) for 13 28-day treatment cycles. One treatment cycle is defined as three consecutive weeks that one TWIRLA TDS is applied for seven-day wear followed by one week that TWIRLA is not applied.

The safety population for this clinical trial was composed of 2,031 women that contributed 18,841 treatment cycles of exposure. Of these 2,031 women, 989 women completed 13 treatment cycles. The mean age was 27.5 years. The mean BMI for the safety population was 28.3 kg/m². The BMI of the safety population was widely distributed: 39.4% had a BMI < 25 kg/m², 25.3% had a BMI ≥ 25 kg/m² and < 30 kg/m², and 35.3% had a BMI ≥ 30 kg/m².

For women who received TWIRLA, the most common reasons for discontinuation from the study were a woman's decision (15.3%) and lost to follow-up (11.3%).

Discontinuation due to an adverse reaction occurred in 10.9% of women. The most common (≥ 2%) adverse reactions leading to discontinuation were application site disorder (3.1%) and any bleeding irregularities (2.2%).

The most common adverse reactions that occurred in ≥ 2% of the 2,031 women that used TWIRLA are shown in Table 3.

Table 3: Adverse Reactions Reported by ≥ 2% of TWIRLA-Treated Women in One Phase 3 Clinical Trial

Adverse reactionTWIRLA
(n=2,031)
General disorders and administration site conditions
Application site disorder*6.2%
Gastrointestinal disorders
Nausea4.1%
Nervous system disorders
Headache3.6%
Reproductive system and breast disorder
Dysmenorrhea2.3%
Investigations
Weight increased2.0%
* 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, pruritis.

Venous Thromboembolic Events (VTEs)

A total of four VTEs (including pulmonary embolism and deep vein thrombosis) in TWIRLA-treated patients were identified in the clinical trial. Of these, all were in women with a BMI > 30 kg/m² [see CONTRAINDICATIONS].

Other Serious 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.

Read the entire FDA prescribing information for Twirla (Levonorgestrel and Ethinyl Estradiol Transdermal System)

QUESTION

Which of the following are methods for contraception? See Answer
Related Resources for Twirla

© Twirla Patient Information is supplied by Cerner Multum, Inc. and Twirla Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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