ORTHO EVRA TRANSDERMAL SYSTEM (The Patch)
Ortho Evra is a combination transdermal contraceptive patch containing 6.0 mg
norelgestromin (NGMN) and 0.75mg of ethinyl estradiol (EE). The patch has a
contact surface area of 20cm2. It releases 150 micrograms of norelgestromin and
20 micrograms of ethinyl estradiol into the bloodstream per 24 hours. In 2008 the
manufacturer changed the package insert to address the slight increase in the risk of
adverse events including venous thromboembolism.
Ortho Evra is a thin, matrix-type patch consisting of three layers:
The backing layer (polyethylene/polyester) protects the contents from the
The middle layer contains the hormones. Inactive components of this layer
include: polyisobutylene/polybutene adhesive, crospovidone, non-woven
polyester fabric and lauryl lactate.
The release liner protects the adhesive layer during storage and is removed just
prior to application. It is made of polyethylene terephthalate (PET) film with a
polydimethylsiloxane coating on the side in contact with the middle adhesive
Following application of the Ortho Evra, the hormones reach reference levels within
48 hours. The patch can maintain serum concentrations in the target range through
9 full days. Hormone absorption was also tested under various environmental
conditions such as a health club (sauna, whirlpool, treadmill) and in a cold water
bath. The hormone concentrations in the bloodstream remained within the reference
II. CLIENT SELECTION
Indications - Ortho Evra may be provided when contraindications do not exist.
o For contraception
Contraindications (WHO 3--Use of method not usually recommended unless
other more appropriate methods are not available or acceptable, WHO 4--
Method NOT to be used)
o History of or current deep vein thromobosis (DVT)/pulmonary embolism (PE)
o History of cerebrovascular accident (stroke) (WHO 4)
o Known thrombogenic mutations (e.g. Factor V Leiden, Prothrombin mutation,
Lupus Anticoagulant, Protein C, Protein S and Antithrombin deficiencies)
o History of or current ischemic heart disease (WHO 4)
o Multiple cardiovascular risk factors
Age > 35 years old and any tobacco use (WHO 3,4)
Diabetes mellitus with nephropathy, retinopathy, neuropathy, other
vascular disease or diabetes of >20 years duration (WHO 3,4)
Revised 1/2010 1
Uncontrolled chronic hypertension, or controlled hypertension and
tobacco use (WHO 4)
o Active liver disease (viral hepatitis and cirrhosis) (WHO 4)
o Liver tumor (adenoma or malignant) (WHO 4)
o Breast cancer (current or past) (WHO 4)
o Prolonged immobilization due to recent/anticipated surgery or illness (WHO 4)
o Valvular heart disease with complications (pulmonary hypertension, history of
sub-acute bacterial endocarditis, risk of atrial fibrillation) (WHO 4)
o Migraine with aura
o Known or suspected pregnancy (WHO 4)
o Gallbladder disease (currently symptomatic) (WHO 3)
o Cholestastic jaundice with pregnancy (PI)
o Jaundice with prior hormonal use (WHO 3)
o Undiagnosed vaginal bleeding (PI)
o Cancer of the endometrium or other known or suspected estrogen -
dependent neoplasia (PI)
o Systemic Lupus Erythematous – With positive (or unknown) antiphospholipid
antibodies (WHO 4)
o Severe hypertension
(systolic ≥160 or diastolic ≥ 100) (WHO 4);
(systolic >140-159 or diastolic of 90-99 (WHO3)
o Hypersensitivity to any component of this product
In 2005, the package labeling for Ortho Evra was changed to include recent findings
that 60% more estrogen is absorbed from the patch than from some low dose pills and
the ring. Increased levels of estrogen may raise the risk of side effects, including VTE.
There are conflicting findings regarding increased risk of DVT. Two recent studies (one
comparing the patch to a pill with levonorgestrel and the other to a pill with
norgestimate) found a two-fold increased risk of blood clots among women using the
patch, although in absolute numbers, the risk remains very low. Even a two-fold
increase risk is dwarfed by the risk of VTE associated with pregnancy. A third study,
recently updated with an additional 17 months of data, found no increase in risk for DVT
in patch users compared to a norgestimate-containing pill. Clients need to be aware of
this issue since there have been law suits related to it.
The FDA considers Ortho Evra safe and effective when it is used according to the
labeling. (Sources: FDA, Ortho, January 18,2008)
Revised 1/2010 2
III. MANAGEMENT OF WOMEN WITH SPECIAL CONDITIONS REQUIRING
Decisions regarding individualized management, follow-up intervals, the need for
additional testing or referral must be made based on protocols approved by the
Medical Director. In addition, there should be consultation with the Medical
Director if needed. A Request for Hormonal Contraceptives by Women with Risk
Factors Consent Form must be signed and this must be documented in the
medical record for any of the following medical conditions:
Adverse Cardiovascular Risk Profile (WHO 3,4)
o Tobacco use
o Reported hyperlipidemia
CHO>240mg/dl, LDL>160 mg/dl, HDL<40 mg/dl, triglycerides 200-
499 mg/dl. (There is no mandatory cholesterol/lipid screening
requirements in Title X).
o Chronic hypertension (> 140 systolic or > 90 diastolic)
o Family history of premature coronary heart disease (CHD) in male first
degree relative <55 years of age
o Family history of premature coronary heart disease (CHD) in female first
degree relative <65 years of age.
Diabetes Mellitus (WHO 2, 3)
o Ortho Evra use in women with diabetes must be individualized. As risk
factors increase in number or severity, the less appropriate it is to
prescribe Ortho Evra.
If the client is prehypertensive or hypertensive, it is mandatory to
consult the woman’s health care provider.
High Blood Pressure (WHO 3)
o If hypertension is controlled with diet or medication, the complete
cardiovascular risk profile must be considered.
Close follow-up is necessary to determine whether blood pressure
elevation results from Ortho Evra use. If so, Ortho Evra should be
discontinued or a different method used (as described in the blood
pressure flow chart – see appendix A).
Ortho Evra may induce hypertension in a very small percentage of
previously normotensive women. If an Ortho Evra user is found to have a
blood pressure of 140 systolic or above or 90 diastolic or above, the rise
should be interpreted as being due to the Ortho Evra. Ortho Evra must be
discontinued if such rise persists.
Migraine without aura >35 years old (WHO 3,4)
Revised 1/2010 3
o Breastfeeding up to 6 weeks (WHO 4)
o Breastfeeding 6 weeks to 6 months (WHO 3)
o Non-breastfeeding < 3 weeks (WHO 3), < 4 weeks (PI)
Medication Issues with Ortho Evra
o Certain drugs may interact with Ortho Evra and may decrease the
effectiveness in preventing pregnancy.
Drugs known to increase liver enzyme metabolism/decrease
Anti Epilepsy Drugs (AEDs) - may also be used to treat certain psychiatric illnesses,
headaches, chronic pain and other conditions (WHO 3)
Carbamazepine (Tegretol) Oxcarbazepine (Trileptal) Phenobarbital, Phenytoin (Dilantin),
Primidone (Mysoline), Topirimate (Topamax)- mild
Anti-HIVs (HAARTS)- See management section below. (WHO 2)
Antiretroviral – Ritonavir-boosted protease inhibitors (WHO 3)
Note - Data is limited and rapidly changing. For up-to-date information check:
Anti-Mycobacterials (Drugs used to treat tuberculosis) (WHO 3)
Rifampin, Rifampicin, Rifamate
Natural medications may decrease efficacy (St. John’s Wort) (PI)
Antifungals – Griseofulvin (PI)
o HAARTs - HIV positive women who choose to use hormonal contraception
should be encouraged to use condoms with each act of intercourse. Choice
of hormonal contraceptive should be based on the woman’s HAART regimen
and in consultation with provider delivering HIV care.
o Anti-Epileptic Drugs (AEDS) and others listed above - Use of back-up barrier
methods and the benefits and risks of using DMPA, IUD, or sterilization as
alternatives should be discussed with women who need a high degree of
o There is no pharmacologic evidence that the acute or chronic use of systemic
antibiotics (ie tetracycline, ampicillin) decreased the efficacy of Ortho Evra in
women who use it correctly. The Ortho Evra package insert states that
possibly certain antibiotics may decrease the effectiveness of use. Clients
should be advised of this when deciding whether or not to use a back-up
method of contraception.
OrthoEvra may be less effective if client weighs 198# or more
Revised 1/2010 4
IV. MEDICAL SCREENING AND EVALUATION
Comprehensive medical data base (history, physical examination and laboratory
testing) should be completed prior to provision of Ortho Evra.
Delayed Exam: Physical exam and related preventative services should not be
deferred beyond 3 months after the initial visit and may not be deferred beyond 6
months (unless there is a compelling reason for extending the deferral in the
clinician’s judgment). Pelvic exams are not required on 13-18 y/o unless
indicated. The reason for the deferral must be documented in the client’s medical
record. A complete history and BP is required in the medical record.
Written results of the physical exam done elsewhere within the last 12 months is
acceptable. MDCH pap smear protocol guidelines must be followed for pap
smear screening. Clients transferring from another provider must have a blood
pressure measurement prior to providing Ortho Evra. A breast exam for women
over 20 years of age must be offered if a hormonal method is prescribed.
V. CLIENT INFORMATION/INFORMED CONSENT
o Information/counseling regarding all contraceptive options available
o Information (written or verbal) specific to Ortho Evra including effectiveness,
benefits, risks, use, danger signs, potential side effects, complications and
discontinuing issues, as documented in the FDA-approved Product Package
o Information regarding sexually transmitted infections (STIs, including HIV
infections) and counseling that Ortho Evra provides no protection against
o Client Information/Consent Form (Method Specific Consent)
o A Request for Hormonal Contraceptives by Women with Special
Conditions/Risk Factors (such as tobacco use, reported hyperlipidemia,
diabetes, chronic hypertension, or multiple cardiovascular risk factors, as
The Client Must be Given:
o Written and verbal instruction on method use (package insert may be used)
o A copy of the FDA approved product package insert (PPI). The importance of
reading the FDA pamphlet must be encouraged.
o A copy of the Method Specific Consent Form, if the client requests.
o Emergency 24 hour telephone number and location where emergency
services can be obtained
o Clinic access information
VI. PRESCRIBING ORTHO EVRA
Up to 14 cycles of Ortho Evra may be prescribed for initial and annual clients.
Quick Start: Use is an off-label practice supported by clinical research and
endorsed by the WHO.
o Quick Start (same day start method) can be initiated if it is reasonably certain
client is not pregnant and the client is not in need of emergency
contraception. Instruct the client to apply the first patch on the day of the
Revised 1/2010 5
clinic visit and use a backup method (condoms, etc.) for 7 days. If there is
concern about undetectable early pregnancy, the client should return for a
repeat pregnancy test 2 weeks. If the repeat pregnancy test is negative and
the client has no signs of pregnancy (i.e. nausea, breast tenderness),
continue the method.
Timing of initiation: The table below should be followed when initiating Ortho
Evra. Alternative timings must be individualized to ensure contraceptive
Current Method Apply Patch Back Up
No effective contraception Anytime in cycle if it is certain client is If more than 5 days since
not pregnant menstrual bleeding
If possibility of pregnancy is started, back-up for 7
suspected, a highly sensitive days
urine test must be completed.
If pregnancy test is negative,
initiate patch and advise client
to repeat urine test in 2 weeks
COCs or NuvaRing® Anytime within 5 days of the last COC None
Within 24 hours of ring removal None
Progestin-only pills Any day of the month. There should be None
no skipped days between last pill and
first day of Ortho Evra® use
IMPLANON On same day implant is removed Back up method for
DMPA On day when next injection is due None
Paragard® or Mirena® in place On same day IUD is removed Back up method for 7
Post surgical abortion
Within 5 days of completed procedure None
Post medical abortion OK to initiate prior to ultrasound
confirmation of termination of
Day of Misoprostol up to 7 days after None
Beyond 7 days after Mifepristone if
Back up method for 7
intercourse not already resumed
Revised 1/2010 6
Guidelines for Management of Deviations from the Recommended Regimen
If the patch becomes loose or has fallen off:
o For less than 1 day (24 hours) - advise the client to reapply the patch or to apply new
patch immediately. No back up contraception is needed. The patch change day
stays the same.
o For more than 1 day or if the client is unsure how long the patch has been loose or off
- advise the client that she may become pregnant. She should start a new 4 week
cycle immediately by putting on a new patch. This becomes day 1 of the new cycle
and is the new patch change day. The client must be advised to use back up
contraception for the first week of this new cycle.
The client should be advised not to attempt to re-apply a patch that is no longer
sticky, if it has become stuck to itself or another surface, if it has other material
stuck to it, or if it has previously become loose or fallen off. Advise the client
never to use tape or wraps to keep the patch in place. If the patch cannot be
reapplied, a new patch should be applied immediately.
If the client has forgotten to change her patch:
o At the start of any patch cycle (week one/day 1) - the client must be advised that she
could become pregnant. She should be advised to use back up contraception for one
week. She can apply the first patch of her new cycle as soon as she remembers.
This will give her a new day 1 and a new patch change day.
o In the middle of a patch cycle (week 2 or 3):
o If the client has forgotten to change her patch for 1 or 2 days, she can apply a new
patch as soon as she remembers. She should be advised to apply her next patch on
her normal patch change day. No back up contraception is needed.
o If the client has forgotten to change her patch for more than 2 days, she should be
advised that she could become pregnant. She should start a new 4 week cycle as
soon as she remembers by putting on a new patch. She will have a new day 1 and a
new patch change day. She should be advised to use back up contraception for the
first week of her new cycle.
o At the end of a patch change cycle (week 4) - if the client has forgotten to remove her
patch, she can take it off as soon as she remembers. She should be advised to start
her next cycle on her normal patch change day. No back up contraception is
o At the start of the next patch cycle (week one/day1) - If the client forgets to apply her
patch, she should be advised that she could become pregnant. She should apply the
first patch of the new cycle as soon as she remembers. She will have a new day 1
and a new patch change day. She should be advised to use back up contraception
for the first week of her new cycle.
If a client has adhered to the prescribed regimen and misses 2 consecutive periods,
pregnancy should be ruled out.
Ortho Evra must be discontinued if pregnancy is confirmed during use.
Revised 1/2010 7
VII. MANAGEMENT OF SIDE EFFECTS AND COMPLICATIONS
Warning Signs of ACHES – May or may not be related to Ortho Evra use and
further clinical evaluation is necessary to determine continuation.
o A - Abdominal pain
o C - Chest pain
o H - Headaches
o E - Eye Problems
o S - Severe Leg Pain
Vaginal Bleeding - Irregular menstrual patterns (spotting to menstrual flow) are
common in the first 2-3 cycles of use, if these patterns continue past the first
three cycles or if heavy bleeding continues, the client needs to be assessed.
o Irregular bleeding - After determining consistent usage; no underlying
pathology; R/O pregnancy; and if not at risk of STIs; reassure client. Use of a
3 day course of NSAIDS may help.
o Amenorrhea - R/O pregnancy
Other side effects such as skin irritation, nausea, vomiting, breast tenderness,
and headache should be further assessed.
Ortho Evra users must be advised to return to the clinic:
o If a significant hormonal related problem is suspected
o If at increased risk for complications resulting from OrthoEvra use
o If pre-hypertensive (systolic BP is 120-139 or diastolic BP is 80-89 on 2
consecutive visits) client may continue Ortho Evra but should be counseled
regarding lifestyle modifications. Referral to Primary Care Provider is also
o At each Ortho Evra related medical visit, the client should be queried about
changes in personal history, headaches, blurred or double vision, pain or
swelling in arms or legs, chest pain or shortness of breath, abdominal pain,
jaundice or severe depression.
Order must be written in medical record initially, annually and upon method
All Ortho Evra (patches) distributed must be documented in the medical
record and/or computer system.
All education/counseling sessions must be documented.
World Health Organization (WHO). Medical Eligibility Criteria for Contraceptive Use. Third Edition, 2004
Manufacturers FDA approved Product Package Insert (PPI)
Revised 1/2010 8
Algorithm For The Management Of Clients Using CHC
Who Develop High Blood Pressure
Reference: National Heart, Lung, and Blood Institute. Reference card from the seventh report of
the joint national committee on prevention, detection, evaluation, and treatment of high blood
pressure (JNC 7). May, 2003, Publication No. 03-5231.
http://www.nhlbi.nih.gov/guidelines/hypertension/phycard.pdf Retrieved: February 2006
Revised 1/2010 9
Client Information/Consent Form for Ortho Evra (The Patch)
Before you start using Ortho Evra, be sure you understand both the benefits and the
possible problems of using Ortho Evra (The Patch). This information sheet lists the
danger signs you should watch for. If you have any questions we will be happy to
discuss them with you.
You will get written information on the use, effectiveness, and medically recognized
benefits and risks of the available birth control methods and devices. You will get FDA
approved information provided by the manufacturer. You should read the information
and ask questions about anything you do not understand.
Ortho Evra works in the same way that birth control pills work, most of the benefits, risks
and side effects are considered to be the same for both methods but we know less
about its effects than we know about the effects of the Pill. Research studies with Ortho
Evra users are continuing.
Ortho Evra contains two hormones that are similar to hormones produced by a woman’s
body. They primarily work to prevent pregnancy by keeping eggs from being released
by the ovaries. You should not use the Patch if you have reason to believe that you
might be pregnant. In early studies of this new contraceptive, the pregnancy rate of
users was less than 1 per 100 women. Evra prevents pregnancy if you remember to
apply a patch once a week for three out of four weeks.
Benefits from using Ortho Evra include:
predictable, regular menstrual cycles
decreased menstrual cramps and blood loss
less iron deficiency anemia
some protection from non-cancerous breast tumors and ovarian cysts
some protection from ovarian and uterine lining cancer
decreased risk of infections of the pelvis(PID)
fewer ectopic pregnancies
There may be less protection from pregnancy when Evra is used with certain drugs,
especially those used to control seizures. You should talk to your clinician about what
to do if you take any other medicine with the Patch. If you see a healthcare provider for
any reason, you should tell them that you are using the Patch.
Patch users have a slightly greater chance than non-users of developing certain serious
problems that may become fatal in rare cases, including:
blood clots in the legs that can travel to the lungs
You should not use the Patch if you have had, now have, or develop in the future:
blood clots in the veins or arteries
serious liver disease
a heart attack or stroke
cancer of the breast, or uterus
headaches with numbness or weakness in the arms or legs
headaches with vision problems or feeling as if the room is spinning
migraine headaches and you are 35 years of age or older
Revised 1/2010 10
multiple cardiovascular risk factors (tobacco use, diabetes, high blood pressure, high
valvular heart disease with complications
known clotting conditions
gallbladder disease (currently symptomatic)
undiagnosed vaginal bleeding
jaundice with prior hormonal contraceptive use or with pregnancy
prolonged immobilization due to recent/anticipated surgery or illness
known or suspected pregnancy
allergy to any component of the patch
Minor reactions to Evra may include:
weight gain or loss
spotting between periods
skin irritation at the patch site
You should watch for the following danger signs and to report any to a clinician
sharp or crushing chest pain or coughing blood
shortness of breath
unusual swelling or pain in the legs or arms
sudden severe headaches
changes in the frequency, severity, or associated symptoms of your headache
eye problems such as loss of vision
severe pain in the stomach or abdomen
yellowing of the skin or eyes
new lump in your breast
unusually heavy bleeding from the vagina
no period after having a period every month
Using the Patch does not protect against sexually transmitted infections and a serious
infection could cause sterility. If you or your partner has other sexual partners, you
should use latex condoms to prevent infections, even though you are using the Patch.
The Patch may be less effective for women weighing more than 198 pounds (90kg).
Revised 1/2010 11
I have read the above and understand the Client Information/Consent Form. I hereby
request that a person authorized by _______________________________________
(agency name) examine and treat me and that the Ortho Evra ® be provided to me.
I have been given the package insert and have been advised to read the entire
insert. I have had the opportunity to ask any questions.
Signature of Client Date:
Signature of Witness Date:
Copy of consent given to client Declined
Revised 1/2010 12
REQUEST FOR HORMONAL CONTRACEPTIVES
BY WOMEN WITH SPECIAL CONDITIONS/RISK FACTORS
Name of Client: ______________________________________
Before you give your consent, be sure you understand the information we have given
you. If you have any questions as you read, we will be happy to discuss them with you.
You can change your mind at any time about using this method. Remember that your
consent is entirely voluntary. You may ask for a copy of this form.
There are special risk factors that increase the chance of developing a serious problem
while using Combined Hormonal Contraceptives (CHC). The more risk factors you
have the greater your risk. The following risk factors have been identified:
_______ Reported Hyperlipidemia
_______ Chronic Hypertension
_______ Familial premature coronary heart disease
I have been counseled, have read the fact sheet and above statement, and I clearly
understand the risk factors. After thorough discussion with the clinician regarding my
risk factors we have agreed that combined hormonal contraceptives will be prescribed
Signature of Client Date Signature of Witness Date
Revised 1/2010 13