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ORTHO EVRA
®
PRESCRIBING INFORMATION UPDATED
RARITAN, N.J., January 18, 2008 - Ortho Women's Health & Urology
TM
, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., has updated
the prescribing information for ORTHO EVRAŽ (norelgestromin/ethinyl
estradiol transdermal system) to include further epidemiologic data.
The revised labeling includes two new additional estimates of relative
risk (odds ratios) for venous thromboembolic events (VTE) of 1.1
(indicating no increase in risk) and 2.0 (indicating an approximate
doubling of risk) in women using ORTHO EVRA compared to women using
birth control pills. The previous labeling reported two estimates of
relative risk for VTE of 0.9 (indicating no increase in risk) and 2.4
(indicating an approximate doubling of risk). This information is
presented in a table in the WARNINGS section and is available at
www.fda.gov and
www.orthoevra.com
. The results from all of these epidemiologic studies can be found on
www.clinicaltrials.gov
or by calling Ortho-McNeil Janssen Scientific
Affairs, LLC Customer Communications Center at 1-800-526-7736.
The detailed patient information for ORTHO EVRA also has been revised to
include this information in the OTHER CONSIDERATIONS BEFORE USING ORTHO
EVRA section.
ORTHO EVRA is a hormonal birth control option and is safe and effective
when used according to the product label. The Company consulted with the
U.S. Food and Drug Administration on this label change. ORTHO EVRA, like
all hormonal birth control, has risks and benefits. It is important that
women speak to their health care professional to determine the option
that is right for them.
ORTHO EVRA is indicated for the prevention of pregnancy in women who
elect to use a transdermal patch as a method of contraception.
For more information about ORTHO EVRA, please visit
www.orthoevra.com
, call Ortho-McNeil Janssen Scientific Affairs, LLC Customer
Communications Center at 1-800-526-7736 or contact your health care
professional.
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 2.4 (approximate doubling of risk).
The Patch does not protect against HIV or sexually
transmitted diseases.
Please see full U.S. Prescribing Information at
www.orthoevra.com
.
About Ortho Women's Health & Urology
TM
Ortho Women's Health & Urology
TM
, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is a leader in
the fields of women's health and urology, celebrating more than 75 years
of partnering with women. Ortho Women's Health & Urology is committed to
helping people live healthier lives and to meeting the needs of
providers and patients with products such as ORTHO TRI-CYCLEN
®
LO (norgestimate/ethinyl estradiol), ORTHO EVRA
®
(norelgestromin/ethinyl estradiol transdermal system), and ELMIRON
®
(pentosan polysulfate sodium). For more information on these products,
birth control, bladder health or general women's health issues, please
visit www.orthowomenshealth.com.
Ortho Women's Health & Urology Media Contact:
Gloria Vanderham, 908-927-3756, gvanderh@ompus.jnj.com
###
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