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ORTHO EVRA^® (norelgestromin/ethinyl estradiol transdermal system) is indicated for the prevention of pregnancy in women who elect to use a transdermal patch as a method of contraception.

The pharmacokinetic profile for ORTHO EVRA^® transdermal patch is different from that of an oral contraceptive. Healthcare professionals should balance the higher estrogen exposure and possible increased risk of venous thromboembolism with ORTHO EVRA^® against the chance of pregnancy if a contraceptive pill is not taken daily.

Application site reaction has been reported.

IMPORTANT SAFETY INFORMATION
Serious as well as minor side effects have been reported with the use of hormonal contraceptives. Serious risks include blood clots, stroke and heart attacks. Cigarette smoking increases the risk of serious cardiovascular side effects, especially in women over 35. Women who use the contraceptive patch are strongly advised not to smoke.

The pharmacokinetic (PK) profile for the ORTHO EVRA^® patch is different from the PK profile for oral contraceptives in that it has higher steady state concentrations (60% higher) and lower peak concentrations (25% lower) of ethinyl estradiol (EE) compared with an oral contraceptive containing 35 mcg EE. It is not known whether there are changes in the risk of serious adverse events based on the differences in PK profiles of EE in women using ORTHO EVRA compared with women using oral contraceptives containing 35 mcg EE. Increased estrogen exposure may increase the risk of adverse events, including venous thromboembolism. (See CLINICAL PHARMACOLOGY, Transdermal versus Oral Contraceptives, BOLDED WARNING in the Package Insert).

The results of epidemiologic studies evaluating the risk of venous thromboembolism (VTE) among women using ORTHO EVRA^® compared to those using oral contraceptives containing 30-35 mcg EE and either levonorgestrel or norgestimate reported odds ratios ranging from 0.9 (no increase in risk) to 2.5 (approximate doubling of risk).

The Patch does not protect against HIV or sexually transmitted diseases.

Please click here for full Prescribing Information, including Boxed Warning.

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ORTHO TRI-CYCLEN^® LO (norgestimate/ethinyl estradiol) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as their method of contraception.

IMPORTANT SAFETY INFORMATION
Serious as well as minor side effects have been reported with the use of oral contraceptives. Serious risks include blood clots, stroke and heart attacks. Cigarette smoking increases the risk of serious cardiovascular side effects, especially in women over 35. Women who use oral contraceptives are strongly advised not to smoke. The Pill does not protect against HIV or sexually transmitted diseases.

Please click here for full Prescribing Information, including Boxed Warning.

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Important Safety Information

• Contraindications: ELMIRON® is contraindicated in patients with known hypersensitivity to the drug, structurally related compounds, or excipients
• Anticoagulant Activity: ELMIRON® is a weak anticoagulant (blood thinner) which may increase bleeding. Patients undergoing invasive surgery or having signs/symptoms of underlying coagulopathy or other increased risk of bleeding (due to anticoagulant therapy or high doses of anti-inflammatory drugs) should be evaluated for the risk of hemorrhage
• Alopecia: In clinical trials of ELMIRON®, alopecia began within the first 4 weeks of treatment. Ninety-seven percent (97%) of the cases of alopecia reported were alopecia areata, limited to a single area on the scalp
• Use in Pregnancy: ELMIRON® is a Pregnancy Category B drug
• Most Common Adverse Reactions (frequency 1% to 4%): Alopecia (4%), diarrhea (4%), nausea (4%), headache (3%), rash (3%), dyspepsia (2%), abdominal pain (2%), liver function abnormalities (1%), dizziness (1%)

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Last modified Dec 22 2009 at 10:05:14 EST