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Ortho Evra
Generic Name: Norelgestromin/Ethinyl Estradiol Transdermal System
Drug Category: Estrogen/Progestin (CHC)
Litigation Alert Level: High
This drug has been approved for use by females over the age of 15 years old and under the age of 45 years old for a maximum duration of 0 year.
| Approved Uses |
|
Indicated for the prevention of pregnancy in women who elect to use a transdermal patch as a method of contraception. ORTHO EVRA may be less effective in preventing pregnancy in women who weigh 198 lbs (90 kg) or more. Cigarette smoking increases the risk of serious cardiovascular events from hormonal contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason,hormonal contraceptives, including ORTHO EVRA, should not be used by women who are over 35 years of age and smoke. The risk of venous thromboembolism (VTE) among women aged 15-44 who used the ORTHO EVRA patch compared to women who used several different oral contraceptives was assessed in five U.S. epidemiologic studies using electronic healthcare claims data. The relative risk estimates ranged from 1.2 to 2.2; one of the studies found a statistically significant increased relative risk of VTE for current users of ORTHO EVRA. The pharmacokinetic (PK) profile of ethinyl estradiol (EE) for the ORTHO EVRA patch is different from the PK profile for oral contraceptives in that it has a higher steady state concentrations and a lower peak concentration. If feasible, stop ORTHO EVRA at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE. The risk of VTE is highest during the first year of use of CHCs and when restarting hormonal contraception after a break of 4 weeks or longer. Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) CHC users. Studies suggest a small increased relative risk of developing gallbladder disease among CHC users. Use of CHCs may also worsen existing gallbladder disease. Carefully observe women with a history of depression and discontinue ORTHO EVRA if depression recurs to a serious degree. In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema. Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while using ORTHO EVRA. Do not prescribe ORTHO EVRA to women who are known to have the following conditions:
Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of CHCs and potentially diminish the effectiveness of CHCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations. Significant changes (increase or decrease) in the plasma concentrations of estrogen and/or progestin have been noted in some cases of co-administration with HIV protease inhibitors (decrease [e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos) amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir] or increase [e.g., indinavir and atazanavir/ritonavir])/HCV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors (decrease [e.g., nevirapine] or increase [e.g., etravirine]). CHCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, and temazepam. Significant decrease in plasma concentration of lamotrigine has been shown, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary. The administration of hormonal contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy. Hormonal contraceptives should not be used during pregnancy to treat threatened or habitual abortion. The effects of ORTHO EVRA in nursing mothers have not been evaluated and are unknown. When possible, advise the nursing mother to use other forms of contraception until she has completely weaned her child. Estrogen-containing CHCs can reduce milk production in breastfeeding mothers. |
| Off-label Uses |
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• Acne. GoToSource • Hirsutism. GoToSource • Endometriosis. GoToSource • Premenstrual syndrome. GoToSource |
| Adverse Events |
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Breakthrough bleeding and breast tenderness. GoToSource Increased risk of gallbladder disease. GoToSource Increased risk of breast cancer, cervical cancer, hepatocellular carcinoma (liver cancer), cancer of the central nervous system or pituitary gland, stomach cancer and gestational trophoblastic disease. GoToSource Application site reaction, nasopharyngitis, emotional lability and cervical dysplasia (abnormal cells on surface of cervix), including atypical squamous cells of undetermined significance. GoToSource Skin irritation and hypersensitivity reactions. GoToSource Venous thromboembolism (blood clot starting in a vein), myocardial infarction and stroke. GoToSource |
| Litigation |
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Lawsuits filed for blood clots, pulmonary emboli, deep vein thrombosis, death, strokes and heart attacks. |
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