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ORTHO-EVRA TRANSDERMAL SYSTEM _The Patch_

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					ORTHO EVRA TRANSDERMAL SYSTEM (The Patch)

I. INTRODUCTION 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 environment.  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 layer. 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 range. II. CLIENT SELECTION  Indications - Ortho Evra may be provided when contraindications do not exist. o For contraception Contraindications o History of/current deep vein thrombosis (DVT) or pulmonary embolism (PE) (WHO 4) o History of cerebrovascular accident (stroke) (WHO 4) o Known thrombogenic mutations (ie Factor V Leiden, Prothrombin mutation, Protein C, Protein S and Antithrombin deficiencies) (WHO 4) o History of or current ischeamic heart disease (WHO 4) o Multiple cardiovascular risk factors ( age >35 or older, tobacco use, diabetes mellitus, hypertension, known hyperlipidemia) (WHO 3, 4) o Active liver disease (viral hepatitis or cirrhosis) (WHO 3,4) o Liver tumor (benign or malignant) (WHO 4) o Symptomatic gall-bladder disease (current or medically treated) (WHO 3) o Undiagnosed abnormal genital bleeding (PI) Developed: 2007 1 Reviewed: 2008
Revised: 02/09

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Cholestatic jaundice in pregnancy (PI) Jaundice with prior hormonal contraceptive use (WHO 3) Breast cancer (current or past) (WHO 3,4) Endometrial cancer or other known or suspected estrogen-dependent neoplasia (PI) Prolonged immobilization due to recent/anticipated surgery or illness (WHO 4) Migraine with aura (WHO 4) Migraine without aura but 35 y/o or older (WHO 3,4) Valvular heart disease with complication (pulmonary hypertension, history of subacute bacterial endocarditis, risk of atrial fibrillation) (WHO 4) 35 y/o or older and smoking (< 15 cigarettes/ day) or (>15 cigarettes) (WHO 3,4) Postpartum (breastfeeding) up to 6 weeks (WHO 4) Postpartum (breastfeeding) 6 weeks to 6 months (WHO 3) Postpartum (non-breastfeeding) < 3 weeks (WHO 3), < 4 weeks (PI) Known or suspected pregnancy (WHO 4) Renal insufficiency (WHO 4) Hepatic dysfunction (WHO 4) Adrenal insufficiency (WHO 4) Severe hypertension (systolic >160 or diastolic >100) (WHO 4) 140-159/90-99 (WHO 3) Hypersensitivity to any component of this product (PI)

INFORMATION BOX: Hormonal Contraceptive Use in Women with Migraine Syndrome with Aura
The WHO 2004 Guidelines explain their restrictions on Ortho Evra use for women with migraines with the following data: Women who have migraine with focal neurological symptoms have a higher risk of stroke than those without focal neurologic symptoms. Additionally, among women with migraines, those who use Ortho Evra have a 2 to 4 fold increased risk of stroke compared with women who do not use Ortho Evra The neurologic symptoms that comprise aura usually develop gradually aver 5-20 minutes and last less than 60 minutes. Headache usually follows immediately after the aura but it may begin during the aura, after an aura-free interval, or it may not occur at all. At least 2 attacks are required to meet the definition of migraine with aura. Scintillating scotoma: A localized area of blindness that may follow the appearance of brilliantly colored shimmering lights and is associated with the aura of migraine. Some visual loss may occur. This process usually takes about 10-20 minutes and lasts for about 20-30 minutes. Most are followed by a headache but a gap in time may occur between the aura and the headache. Flashing of lights, photophobias, or blurring of vision are not considered aura.

Developed: 2007 Reviewed: 2008 Revised: 02/09

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III. MANAGEMENT OF WOMEN WITH SPECIAL CONDITIONS REQUIRING FURTHER EVALUATION 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. These medical conditions include:  Adverse Cardiovascular Risk Profile (WHO 3,4) o Risk is multi-factoral. If a woman has two or more risk factors:  Age 35 or over  Tobacco use  Reported hyperlipdemia  High cholesterol levels: 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).  Diabetes  Chronic hypertension (> 140 systolic or > 90 diastolic)  Family history of premature coronary heart disease (CHD); in male first degree relative < 55 years of age.  Family history of premature coronary heart disease (CHD) in a first degree female relative <65 years of age. Diabetes Mellitus (WHO 2, 3) 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. o The health care provider managing the clients diabetes should be consulted before a client with diabetes is initiated on Ortho Evra. If the client is prehypertensive or hypertensive, it is mandatory to consult the woman’s health care provider. o A Request for Hormonal Contraceptives by Women with Risk Factors Consent Form must be signed and this must be documented in the medical record. High Blood Pressure (WHO 3, 4) 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 BP elevation results from Ortho Evra use. If so, Ortho Evra should be discontinued or a different contraceptive used.  A Request for Hormonal Contraceptives by Women with Risk Factors Consent Form must be signed and this must be documented in the medical record. See blood pressure flow chart in Appendix A for management. Medication Issues with Ortho Evra o Certain drugs may interact with Ortho Evra and may decrease the effectiveness in preventing pregnancy. 3

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Developed: 2007 Reviewed: 2008 Revised: 02/09

Drugs known to increase liver enzyme metabolism/decrease contraceptive effectiveness
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) Note - Data is limited and rapidly changing. For up-to-date information check: http://hivinsite.ucsf.edu ( Anti-Mycobacterials (Drugs used to treat tuberculosis) (WHO 3) Rifampin, Rifampicin, Rifamate

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Management 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 protection. 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.

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Natural medications may decrease efficacy (St. John’s Wort) May be less effective if client weighs 198# or more

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). The reason for the deferral must be documented in the client’s medical record. However, a complete history and BP are required in the medical record.

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Written results of exam done elsewhere within the last 12 months are 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 Ortho Evra is desired.

V. CLIENT INFORMATION/INFORMED CONSENT  Must Include: o Information/counseling regarding all contraceptive options available o Information 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 Insert (PPI) o Information regarding sexually transmitted infections (STIs, including HIV infections) and counseling that Ortho Evra provides no protection. o Client Information/Consent Form (Method Specific Consent) o A Request for Hormonal Contraceptives by Women with Risk Factors Consent Form (such as diabetes, chronic hypertension, or multiple cardiovascular risk factors), as indicated.  The client must be given: o Written and verbal instruction on method use. o A copy of the FDA approved product packaging insert (PPI). The importance of reading the pamphlet should be explained to the client. 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 Client 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 she is not pregnant (i.e. client states used condom) and the client is not in need of emergency contraception. Instruct the client to apply the first patch on the day of the 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.

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Timing of initiation: The table below should be followed when initiating Ortho Evra. Alternative timings must be individualized to ensure contraceptive protection. Apply Patch
Anytime in cycle if it is certain client is not pregnant Anytime within 5 days of the last COC tablet taken or ring removed. Any day of the month. There should be no skipped days between last pill and first day of Ortho Evra® use On the same day the implant is removed On the day when the next injection is due On the same day the IUD is removed Within 5 days of a completed procedure OK to initiate prior to ultrasound confirmation of termination of pregnancy Day of Misoprostol up to 7 days after Mifepristone Beyond 7 days after Mifepristone if intercourse not already resumed None

Current Method
No effective contraception in preceding cycle COCs or NuvaRing® in preceding cycle Progestin-only pills in preceding cycle

Back Up
Back up method recommended for 7 days None

Back up method recommended for 7 days Back up method recommended for 7 days Back up method recommended for 7 days Back up method recommended for 7 days None

IMPLANON

DMPA in preceding cycle

Paragard® in place Mirena@ in place Post surgical abortion

Post medical abortion

Back up method for 7 days If menses has not restarted, back up method recommended for 7 days

Post delivery after 24 weeks gestation

At least 3 weeks (WHO), 4 weeks post delivery in women not breast feeding (PI), 6 months post-partum nursing women (WHO )

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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.

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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. 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. 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 needed. 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.

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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.

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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 nausea, vomiting, breast tenderness, and headache should be further assessed.

VIII. FOLLOW-UP  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 hormonal contraceptive use, as indicated o If pre-hypertensive, (systolic BP is 120-139 or diastolic BP is 80-89 on 2 consecutive visits) she may continue Ortho Evra but should be counseled regarding lifestyle modifications. Referral to Primary Care Provider is also recommended. 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. IX. DOCUMENTATION  Order must be written in medical record initially, annually and upon method change.  All Ortho Evra (patches) distributed must be documented in the medical record and/or computer system.

References: World Health Organization (WHO). Medical Eligibility Criteria for Contraceptive Use. Third Edition, 2004 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. Manufacturers FDA approved product package insert

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ALGORITHM FOR THE MANAGEMENT OF CLIENTS WHO DEVELOP HIGH BLOOD PRESSURE

SYSTOLIC (SBP) ≥140 OR DIASTOLIC (DBP) ≥ 90

Instruct client to return two or more times within a 4 week period for BP checks. At each visit, take two readings, five minutes apart, sitting in a chair. Confirm elevated readings in contralateral arm.

If <120/80 on all readings may continue CHC.

If any three or more readings on at least two different visits are SBP ≥140-159 or DBP ≥90-99, discontinue CHC. If any reading is SBP >159 or DBP >99, discontinue CHC.

If the predominant readings are SBP 120-139 or DBP 80-89 with no more than two readings on at least two different visits at SBP 140-159 or DBP 90-99, may continue CHC as long as client is being evaluated and followed for prehypertension.

Educate client on alternative methods of birth control. With client’s consent, initiate a non-estrogen containing method. Please note if prescribing DMPA, BP ≥ 160/100 is a special condition requiring further evaluation.

Recommend or refer for evaluation and lifestyle modifications and/or treatment – within or outside affiliate.

Re-check BP within three months.

If BP returns to normal (<120/80) or prehypertensive range (SBP 120-139 or DBP 80-89), may consider initiating lower dose CHC, if available.

Key: Combined Hormonal Contraception (CHC) 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: April 2005. Appendix A

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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  less acne  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  heart attack  stroke  liver tumors 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, kidney or adrenal disease  a heart attack or stroke  cancer of the breast, uterus, or liver  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
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multiple cardiovascular risk factors (age >35 or older, tobacco use, diabetes, high blood pressure, high cholesterol) valvular heart disease with complications known clotting conditions symptomatic gallbladder undiagnosed vaginal bleeding jaundice with prior hormonal contraceptive use or with pregnancy prolonged immobilization due to recent/anticipated surgery or illness postpartum (if breastfeeding—wait 6 months; and if not breastfeeding--wait 3 weeks) known or suspected pregnancy allergy to any component of the patch

Minor reactions to Evra may include:  nausea, vomiting  weight gain or loss  breast tenderness  spotting between periods  skin irritation at the patch site You should watch for the following danger signs and to report any to a clinician immediately:  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  severe depression  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 bad infection could cause sterility. If you or your partner has other sex 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).

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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 question.

Signature of Client Date

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I witness the fact that the client received the above mentioned information and said she read and understood same. Signature of Witness____________________________________________ Date

Copy of consent given to client _____ Declined____

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REQUEST FOR HORMONAL CONTRACEPTIVES BY WOMEN WITH RISK FACTORS CONSENT FORM Date:

Name of Client: ______________________________________D.O.B.

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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 for you: Diabetes High Blood Pressure Multiple heart disease risk factors (more than one of: age >35, high cholesterol levels, diabetes, cigarette smoking, first degree relative with early heart disease). Other

I have been counseled, have read the fact sheet and above statement, and I clearly understand their meaning. Nevertheless, I request that hormonal contraceptives be prescribed for me.

Signature of Client

Date

Signature of Witness

Date

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