ORTHO EVRA (Transdermal)

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ORTHO EVRA (Transdermal Patch)

Introduction

ORTHO EVRA is a transdermal contraceptive patch that delivers a combination of two hormones: ethinyl estradiol (an estrogen) and norelgestromin (a progestin). It is designed as a weekly patch applied to the skin to provide continuous hormone delivery for contraception. Approved by the FDA in 2001, ORTHO EVRA offers a non-oral alternative to birth control pills, aiming to improve compliance and provide effective pregnancy prevention with a convenient dosing schedule.

Uses & Indications

ORTHO EVRA is prescribed for:

  • Contraception: Prevention of pregnancy in women who choose a weekly transdermal patch instead of daily oral contraceptive pills.
  • Regulation of menstrual cycles: For women experiencing irregular cycles, ORTHO EVRA can help establish regular menstruation.
  • Treatment of dysmenorrhea: It can reduce painful menstruation by suppressing ovulation and stabilizing hormone levels.
  • Management of acne vulgaris: Due to its hormonal effects, it may improve acne symptoms in some women.

ORTHO EVRA is a combined hormonal contraceptive that prevents ovulation and alters cervical mucus and endometrial lining, providing multiple mechanisms to avoid pregnancy.

Pharmacology and Mechanism of Action

ORTHO EVRA contains:

  • Ethinyl Estradiol (EE): A synthetic estrogen analog, structurally similar to natural estradiol but with increased oral bioavailability and potency.
  • Norelgestromin: A synthetic progestin, the active metabolite of norgestimate.

The patch releases steady levels of EE and norelgestromin through the skin into systemic circulation, avoiding first-pass hepatic metabolism.

Mechanisms of contraceptive action:

  1. Suppression of ovulation:
    The hormones inhibit the hypothalamic-pituitary-ovarian axis, reducing gonadotropin (LH and FSH) secretion, thus preventing follicular development and ovulation.
  2. Cervical mucus alteration:
    Progestin thickens cervical mucus, creating a barrier to sperm penetration.
  3. Endometrial changes:
    Hormonal exposure causes the endometrium to become less receptive to implantation.

Dosage and Administration

Patch Application:

  • Each ORTHO EVRA patch delivers 20 mcg ethinyl estradiol and 150 mcg norelgestromin daily.
  • Application schedule: One patch applied once weekly for three consecutive weeks, followed by a patch-free week during which withdrawal bleeding occurs.
  • Application sites: The patch should be placed on clean, dry, intact skin on the buttocks, abdomen, upper outer arm, or upper torso (excluding breasts).
  • Site rotation: Avoid reapplying on the same site consecutively to reduce skin irritation.

How to apply:

  1. Wash and dry hands before handling the patch.
  2. Remove the patch from the sealed pouch, avoiding touching the adhesive.
  3. Apply firmly and smooth to ensure full contact with skin.
  4. Avoid lotions, oils, powders, or makeup on the application site.

Missed patch guidance:

  • If the patch is off for less than 24 hours:
    Apply a new patch immediately, no backup contraception required.
  • If off for more than 24 hours or if the patch-free week is extended:
    Backup contraception (e.g., condoms) should be used for 7 days, and contraception effectiveness may be reduced.

Pharmacokinetics

  • Absorption: Rapid transdermal absorption with steady plasma levels within 48 hours.
  • Distribution: Both hormones are highly protein-bound in plasma.
  • Metabolism: EE is metabolized primarily in the liver via CYP3A4; norelgestromin is converted from norgestimate and undergoes hepatic metabolism.
  • Elimination: Excreted via urine and feces.
  • Half-life: Approximate half-life is 28 hours for EE and 15 hours for norelgestromin, supporting weekly dosing.

Effectiveness

  • Clinical trials demonstrate a typical-use failure rate of approximately 0.7% to 3%, comparable to combined oral contraceptive pills.
  • High patient satisfaction reported due to convenience and reduced need for daily adherence.
  • Effectiveness may be reduced in women over 90 kg (198 lbs), although data is limited.

Side Effects

Common Side Effects:

  • Skin irritation, rash, or itching at the application site (reported by up to 17% of users)
  • Breast tenderness or enlargement
  • Nausea, vomiting, or abdominal discomfort
  • Headaches or migraines
  • Mood changes such as depression or irritability
  • Breakthrough bleeding or spotting
  • Weight changes or fluid retention

Serious Side Effects:

  • Venous thromboembolism (VTE): Increased risk of deep vein thrombosis and pulmonary embolism; higher than with some oral contraceptives.
  • Arterial thromboembolism: Including stroke and myocardial infarction, particularly in smokers and women over 35.
  • Hypertension: May worsen pre-existing high blood pressure.
  • Gallbladder disease: Risk may be elevated.
  • Liver dysfunction: Rare cases of cholestasis or hepatic tumors.
  • Breast and cervical cancer: Long-term hormonal contraceptive use has been associated with a slight increase in risk; however, evidence is mixed.

Contraindications

  • History of or current thrombosis or thromboembolic disorders
  • Cerebrovascular or coronary artery disease
  • Known or suspected estrogen-dependent neoplasia
  • Undiagnosed abnormal vaginal bleeding
  • Pregnancy or breastfeeding
  • Liver disease or dysfunction
  • Smoking in women over 35 years
  • Hypersensitivity to patch components

Warnings and Precautions

  • Thromboembolic Risk: Monitor and assess risk factors before initiation; discontinue in cases of immobilization or surgery with high thrombosis risk.
  • Cardiovascular Disease: Careful evaluation in women with risk factors.
  • Blood Pressure Monitoring: Regular checks recommended.
  • Liver Disease: Use cautiously and discontinue if liver function deteriorates.
  • Headache: Particularly migraine with aura warrants caution.
  • Breast Cancer Screening: Follow guidelines for mammography and clinical exams.
  • Depression: Monitor mood changes and discontinue if severe.

Drug Interactions

  • Enzyme-inducing drugs (e.g., rifampin, carbamazepine, phenytoin) reduce contraceptive efficacy by accelerating metabolism.
  • Some antibiotics and herbal supplements (e.g., St. John’s Wort) may also reduce effectiveness.
  • Anticoagulants, anticonvulsants, and other hormonal therapies require monitoring.
  • Inform healthcare providers of all medications.

Clinical Considerations

  • Not recommended for women with BMI >30 kg/m² due to possible reduced efficacy.
  • Counseling on smoking cessation critical before prescribing.
  • Monitor for signs of thromboembolism especially during first year of use.
  • Alternative contraception advised during immobilization or surgery.
  • Emergency contraception should be available as backup if patch failure suspected.

Patient Counseling Points

  • Apply patch on schedule and rotate application sites.
  • Watch for and report any signs of blood clots (leg pain, chest pain, sudden shortness of breath).
  • Understand side effects and when to seek medical attention.
  • Do not smoke while using ORTHO EVRA.
  • Maintain regular follow-ups for blood pressure and breast exams.
  • Use backup contraception if patch falls off for more than 24 hours.

FAQs

Q1: How effective is ORTHO EVRA compared to pills?
A: Effectiveness is comparable, with about 99% perfect-use efficacy. Real-world use shows typical failure rates of 0.7–3%.

Q2: Can the patch fall off during swimming or exercise?
A: It is water-resistant and designed to stay adhered during bathing or physical activity.

Q3: What if I forget to change the patch on time?
A: If less than 24 hours late, apply a new patch immediately. If more than 24 hours, use backup contraception and consult a healthcare provider.

Q4: Can ORTHO EVRA be used immediately after childbirth?
A: Generally, initiation is recommended after 4 weeks postpartum due to increased thrombosis risk.

Q5: Are there weight restrictions?
A: Effectiveness may be reduced in women over 90 kg (198 lbs), so consult your doctor for personalized advice.

Monitoring Parameters

  • Blood pressure before and during therapy
  • Signs and symptoms of thromboembolism
  • Liver function tests if indicated
  • Breast and pelvic exams
  • Patient adherence and side effect profile

Conclusion

ORTHO EVRA offers an effective, convenient, and discreet weekly contraceptive option for women seeking alternatives to daily oral pills. Its transdermal delivery ensures steady hormone levels and may reduce some risks associated with oral estrogens. However, the increased risk of venous thromboembolism compared to some contraceptive methods necessitates careful patient selection and education. Proper application, adherence, and monitoring are essential for safety and efficacy.

References

  1. Ortho-McNeil-Janssen Pharmaceuticals, Inc. ORTHO EVRA (ethinyl estradiol and norelgestromin) transdermal system prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021180s020lbl.pdf
  2. Kuehl TJ, Mellinger U, Chwalisz K. The transdermal contraceptive patch. Int J Fertil Womens Med. 2002;47(3):117-23.
  3. Westhoff C et al. Adherence and satisfaction with ORTHO EVRA and oral contraceptives: a randomized controlled trial. Contraception. 2005;71(5):367-73.
  4. Food and Drug Administration. FDA Drug Safety Communication: Updated safety information about contraceptive patch. 2005.
  5. MedlinePlus. Birth Control Patch. https://medlineplus.gov/druginfo/meds/a606020.html

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