`
`<Front Cover>
`
`Xyrem Success ProgramSM
`
`Physician Success ProgramSM
`
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`<Page 1>
`
`Table of Contents
`
`Prescribing Xyrem - A Brief Guide ..............................................................................................X
`
`Prescription and Enrollment Form ...............................................................................................X
`
`Suggested Guidelines for Titrating Xyrem ..................................................................................... X
`
`Information You Need To Know About Xyrem ................................................................................X
`
`Contact Information ....................................................................................................................X
`
`Package Insert .......................................................................................................................... X
`
`Medication Guide ......................................................................................................................X
`
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`<Page 2 text>
`
`Prescribing Xyrem® — A Brief Guide
`
`The procedure for writing and dispensing Xyrem® (sodium oxybate) oral solution prescriptions is outlined
`below. The Central Pharmacy is always available at 1-877—67 XYREMSM (1-877—679—9736) to support you,
`your staff and your patients to answer any questions.
`
`Before Prescribing Xyrem®
`
`. Read Physician Success Program material. You must acknowledge that you have read these materials
`before an initial patient prescription can be filled. The enclosed “Prescription and Enrollment Form” has
`a designated area for you to do this.
`
`Prescribing Requirements
`
`o
`
`0 You must verify that each patient you prescribe Xyrem® for has been educated with respect to Xyrem®
`preparation, dosing and scheduling.
`Prescriptions for Xyrem® must be rewritten at least every 3 months. The required starting dose is 4.5
`grams, with titration up to 9 grams.
`Patients must be seen at least every 3 months
`0
`0 You must complete the enclosed "Xyrem Post-Marketing Patient Evaluation" form at the 3 month and 6
`month visits
`
`How Do I Prescribe Xyrem®?
`
`Complete Xyrem® Patient Prescription form (including statement of medical necessity).
`0
`. Obtain patient’s signature on the Assignment of Benefits (AOB) form. This is completed only for the
`initial prescription.
`Fax completed prescription and A08 form to Central Pharmacy at 1-XXX-XXX—XXXX.
`Fax subsequent prescriptions to the Central Pharmacy at 1-XXX-XXX-XXXX.
`
`0
`0
`
`Central Pharmacy Role
`
`Following receipt of your prescription the Central Pharmacy will:
`0 Contact you or your office to confirm prescription details and collect additional information (if needed).
`0 Contact the patients insurance provider to verify patient benefits and eligibility.
`-
`Send Xyrem Patient Success ProgramSM materials to the patient
`0 Contact the patient to:
`o
`confirm that Xyrem Patient Success ProgramSM materials have been read
`-
`confirm Xyrem® delivery details.
`.
`reinforce preparation, administration and storage instructions.
`0
`advise patient of the availability of the Xyrem® Helpline.
`o Dispense and ship Xyrem® to the patient or their designee.
`0 Maintain a patient and prescriber registry.
`
`If you have any questions please call the Xyrem Physician Success Program M at 1-877-67
`vaEMSM (1-877-679-9736)
`
`C:\WPFlLES\NDA\Xyrem\approval\zipdisk\NDA 21196 RTAL2 Ed DocBook.doc
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`

`Please see full prescribing information for Xyrem” (sodium oxybate) oral solution.
`
`C:\WPFILES\NDA\Xyrem\approval\zipdisk\NDA 21196 RTAL2 Ed DocBook.doc
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`<Page 3 {exp
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`
`
`success PROGRAM 3'“
`Prescription and Enrollment Form
`Prescriber Information
`
`Prescriber's Name:
`
`Office Contact:
`
`Zip: _,__________
`
`
`
`Quantity: _______ months supply
`
`Refills (circle one):
`
`0
`
`1
`
`2
`
`(maximum of 3 month supply)
`
`Physician Declaration — Please check each box
`
`
`Rx: Xyrem Oral Solution (500 mg/mL) 180 mL bottle
`
`
`Sig: Take _____ gms p.o. diluted in 60mL water at h.s. and then again 2 ‘Ao 4 hours later.
`
`
`
`
`
`El l have read the materials in the Xyrem Physician Success Program
`
`
`D l verify that the patient has been educated with respect to Xyrem preparation, dosing and scheduling
`
`
` D I understand that Xyrem is approved for the treatment of cataplexy in patients with narcolepsy, and that
`safety or efficacy has not been established for any other indication
`I] l understand that the safety of doses greater than 9 gm/day has not been established
`'
`Evaluation Pro oram at month
`and 6 of th re a
`
`
`
`
`
`Relationship to Patient:
`
`Identification Number:
`
`Policy/Group Number:
`
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`Prescription Card: D No D Yes
`
`If Yes, Carrier: __
`
`Policy #:
`
`Please attach copies ofpatient's insurance cards
`
`Fax completed form to Xyrem Success Program (toll-free) XXX-XXX-XXXX
`For information, call the Xyrem Team (toll-free) at 1-877-67 XYREM (XXX-XXX-XXXX)
`
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`<Page 4 text>
`Suggested Guidelines for Titrating Xyrem®
`
`Xyrem® can be effective treatment to reduce the incidence of cataplexy associated with narcolepsy.
`
`Xyrem® is different from other medications in that:
`> it is taken nightly in two equal doses.
`> It is a liquid that must be diluted with water (approximately 60 mL, 2 02., 1Azup or 4 tablespoons).
`> Both doses are prepared before bed and kept in dosing cups with child-resistant caps.
`> First Xyrem® dose is taken while sitting in bed, immediately before lying down to go to sleep.
`> On awakening, 2‘/2-— 4 hours later, the second dose of Xyrem® is taken before continuing sleep.
`
`Recommended X rem Titration
`
`1. The recommended starting dose is 4.5 grams per night (4.5 g = 9 mL total dose = two nightly doses of
`4.5 mL each).
`If adequate symptom control is not achieved, increase total dose by 1.5 grams per night.
`Dose titration may be required up to 9 grams per night.
`it is recommended that each dose titration not exceed 1.5 grams per night.
`it is recommended that review of dose response take place at 2-week intervals until a stable dose is
`achieved.
`
`WP?!”
`
`9°.“9’
`
`lf unpleasant side effects occur, decrease total dose by 1.5 grams per night.
`The maximum approved dose is 9 grams per night.
`Improvement may be expected during the first weeks of therapy. Titration to optimal dose may take up
`to 8 weeks.
`
`
` Recommended Starting Dose
`
`4.5 g per night
`2.25 g | 2.25 g
` Increase dosage by
`
`1.5 g per night
`
`
`NOTE: Total daily dose
`
`greater than 99 should
`
`ordinarily not be used.
`
`
`
`
`
`Reassess at 2-week intervals
`
`Symptoms adequately
`controlled
`
`Decrease dosage
`by 1.5 g per night
`
`
`
`
`
`Maintain therapy
`Monitor progress
`
`
`
`Dose well tolerated
`
`Yes
`
`C:\WPFlLES\NDA\Xyrem\approval\zipdisk\NDA 21196 RTAL2 Ed DocBookdoc
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`Please see full prescribing information for Xyremon (sodium oxybate) oral solution.
`
`C:\WPF|LES\NDA\Xyrem\approvai\zipdisk\NDA 21196 RTAL2 Ed DocBook.doc
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`<Page 5 text>
`
`Information You Need To Know About Xyrem®
`
`0
`
`.
`
`0
`
`0
`
`Be diagnostically accurate. Confirm patient's diagnosis of narcolepsy with cataplexy, particularly those
`patients new to you and/or your practice.
`
`Be judicious when deciding to increase a dose. Make sure the indicators are there for increasing or
`altering a dose.
`
`Be suspicious of a pattern of excuses for refills or repeated requests for refills on an emergency basis.
`
`Be vigilant. Recognize that there is potential for patients to abuse Xyrem®.
`
`Xyrem® has been placed in a bifurcated Federal schedule. To meet legitimate medical need, when used as
`prescribed, Xyrem® is a Schedule lll controlled substance.
`if used other than as is prescribed, or by
`individuals other than for whom it is prescribed, however, Xyrem®, like all GHB is a Schedule I controlled
`substance. You need to educate your patients about the bifurcated scheduling of Xyrem®; in particular, you
`should inform the patient about the legal penalties associated with diversion of the drug.
`If you have
`questions about this, please call 1-877-67 XYREMSM (1-877-679—9736).
`
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`<Page 6>
`
`Contact information
`
`Keep the phone number for the Xyrem Physician Success ProgramSM near at hand or in your phone record
`to get answers to all your questions.
`
`Xyrem
`Success
`ProgramSM
`For medical
`
`information,
`insurance
`
`reimbursement,
`
`prescription
`information, and
`
`any other questions,
`call the Xyrem Physician Success Programs”.
`1-877-67 XYREMSM
`
`(1-877—679—9736)
`
`The above card can be found on the packaging this booklet was contained in.
`
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`<Page 7>
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`Package Insert
`
`<Full prescribing information for Xyrem® (sodium oxybate) oral solution will be inserted here. >
`
`Please see full prescribing information for Xyrem” (sodium oxybate) oral solution.
`
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`<Page 8>
`
`Package Insert
`
`<Full prescribing information for Xyrem® (sodium oxybate) oral solution will continue on this page.>
`
`Please see full prescribing information for Xyrem” (sodium oxybate) oral solution.
`
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`<Page 9>
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`Medication Guide
`
`<Medication Guide for Xyrem® (sodium oxybate) oral solution will be inserted here.>
`
`Please see full prescribing information for Xyrem“ (sodium oxybate) oral solution.
`
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`<Page 10>
`
`Medication Guide
`
`<Medication Guide for Xyrem® (sodium oxybate) oral solution will continue on this page.>
`
`Please see full prescribing information for Xyremo (sodium oxybate) oral solution.
`
`C:\WPF|LESWDA\Xyrem\appr0vai\zipdisk\NDA 21196 RTALZ Ed DocBook.doc
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`

`<Back Cover>
`
`<Orphan Medical Logo>
`
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`

`Dear Patient,
`
`Your doctor has recently prescribed Xyrem® (sodium oxybate) oral solution for you. Xyrem® is a
`medication that has been approved for the treatment of cataplexyIn patients with narcolepsy.
`Xyrem® has several unusual features including.
`
`0 Daytime cataplexy is treated by taking Xyrem® at night
`
`0 Twice nightly dosing: the first dose is taken at bedtime and the second dose
`2% -4 hours later
`
`0 The first dose must be taken before going to sleep, when you are in bed
`
`- Xyrem® should not be taken with alcohol or other medications that cause drowsiness
`
`o Xyrem® is dispensed from one central pharmacy only
`
`. The active ingredient of Xyrem® (also known as gamma hydroxybutyrate or GHB) has
`been used as a substance of abuse. Therefore your Xyrem® must be used only by you,
`only as directed by your physician, and storedIn a safe, secure place.
`
`To supportyou in obtaining and using Xyrem® we have developed the Xyrem Patient Success
`ProgramSM which includes educational materials (enclosed) and a toll-free phone number:
`1-877-67 XYREMSM (1-877-679—9736)®The educational material contains important information
`on obtaining, taking and storing Xyrem® and an accompanying short video.
`
`The 1-877—67 XYREMSM (1 8-77-679-9736) numberIs staffed by pharmacists who®will dispense
`your medication and be available to answer questions you may have about Xyrem® and your
`prescription.
`
`We hope that you will find these materials helpful in using Xyrem® to manage your narcolepsy.
`
`Yours sincerely,
`
`David Fuller, M.D.
`Vice President of Medical Affairs
`
`Orphan Medical
`
`C:\WPFILES\NDA\Xyrem\approval\zipdisk\NDA 21196 RTAL2 Ed PatLett.doc
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`

`

`
`
`<Cover text>
`
`Patient Success ProgramSM
`
`Your Doctor has prescribed Xyrem® (sodium oxybate) oral
`solution.
`
`Now what?
`
`Frequently asked questions about the use and safe
`handling of Xyrem®.
`
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`<Page 1 text>
`Your Xyrem® Prescription
`
`Your doctor has prescribed Xyrem”. XyremCD contains sodium oxybate, which has been shown to
`reduce the number of cataplexy attacks in patients with narcolepsy. This booklet answers important
`questions about obtaining and taking Xyrem” and precautions to be considered when using Xyrem®.
`
`HOW DO I OBTAIN XYREMO? ...................................................................................................x
`
`Who will fill Xyrem® prescriptions?......................................................................................... x
`What does the Central Pharmacy do? ................................................................................... X
`How does the Central Pharmacy dispense Xyrem®?................................................................ X
`What will I receive? .............................................................................................................. X
`
`When will I receive Xyrem®?.................................................................................................. x
`Could my local pharmacy provide Xyrem®?.............................................................................X
`Will insurance pay for Xyrem®? ............................................................................................. X
`
`HOW DO I TAKE XYREM”?.......................................................................................................X
`
`When do I take Xyrem®? ...................................................................................................... X
`What do I need to do before taking Xyrem” each night?........................................................... X
`Can I take Xyrem with food? ................................................................................................. X
`Can I take Xyrem any time before I go to bed?........................................................................X
`What do I do if I miss a Xyrem® dose? ................................................................................... X
`Will my dose change? ......................................................................................................... X
`How soon might I see a change in my symptoms? ................................................................. X
`What side effects have been reported with Xyrem®? ................................................................X
`
`PRECAUTIONS NEEDED FOR XYREM” USE. .............................................................................X
`
`How do I store Xyrem®?........................................................................................................ X
`Are there any interactions with other medications? .................................................................X
`What should I avoid while taking Xyrem®? ..............................................................................X
`How will the use of my Xyrem® be monitored? ....................................................................... X
`
`OTHER INFORMATION .............................................................................................................X
`
`Where can I get more information on Xyrem? ......................................................................... X
`Where can I get more information on sleep disorders? ............................................................X
`
`MY PRESCRIPTION RECORD ...................................................................................................X
`
`AT HOME STORAGE AND SAFETY TIPS ..................................................................................X
`
`TRAVELING TIPS .....................................................................................................................X
`
`REIMBURSEMENT INFORMATION FOR PATIENTS ...................................................................X
`
`MEDICATION GUIDE ................................................................................................................X
`
`WALLET CARD ........................................................................................................................X
`
`Any questions? Please call 1-877-67 XYREMSM (1-877-679-9736)
`
`Xyrem Patient Success ProgramSM
`
`Please see FDA-approved medication guide for more detailed information.
`
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`<Page 2 text>
`1. How do I obtain Xyrem®?
`
`Who will fill Xyrem® prescriptions?
`
`All Xyrem® prescriptions will be processed by one Central Pharmacy.
`
`What does the Central Pharmacy do?
`
`The Central Pharmacy will provide three main services to you.
`
`They will:
`
`Provide patient counseling, dispense and ship your Xyrem®.
`.
`. Work with your insurance plan to facilitate coverage.
`.
`Collect information about the safety of Xyrem®. Your name and any problems with Xyrem you
`report will be recorded.
`Provide information about Xyrem at 1-877-67 XYREMSM (1 -877-679-9736).
`
`-
`
`How does the Central Pharmacy dispense Xyrem®?
`
`0 Your doctor sends the Xyrem® prescription directly to the Central Pharmacy.
`o
`The Central Pharmacy contacts you to confirm the location of, and who will sign for, delivery of
`your Xyrem” as well as any insurance details.
`Xyrem® will be shipped via an overnight courier.
`0
`. When the courier arrives you, or someone you designate, must sign for the Xyrem”.
`
`What will I receive?
`
`In each Xyrem® carton you receive, there will be one bottle of Xyrem, a liquid measuring device, 2
`dosing cups with child resistant caps and a printed medication guide. Your shipment may include
`more than one carton of Xyrem.
`
`When will i receive Xyrem®?
`
`The Central Pharmacy will call you to arrange a convenient time and location for delivery.
`
`Could my local pharmacy provide Xyrem®?
`
`No. The use of a Central Pharmacy is designed to reduce any diversion or illicit use of Xyrem®.
`However, in some cases, you may be able to have the courier deliver Xyrem® to your local
`pharmacy for later collection.
`
`Will insurance pay for my Xyrem®?
`
`In most cases, YES. A reimbursement specialist from the Central Pharmacy will contact you and
`your insurance plan to facilitate benefits.
`
`Any questions? Please call 1-877-67 XYREMSM (1-877-679-9736) Xyrem Patient Success ProgramSM
`
`C:\WPF|LES\NDA\Xyrem\approval\zipdisk\NDA 21196 RTAL2 Ed PatBookrev.doc
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`

`

`Please see FDA-approved medication guide for more detailed information.
`
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`<Page 3 text>
`2. How do I take Xyrem®?
`
`Xyrem® is to be taken only as directed by your physician.
`
`When do l take Xyrem®?
`
`Xyrem® should be taken twice nightly: the first dose is taken at bedtime while you are in bed and
`the second dose is taken in bed 2/10 4 hours later.
`
`What do I need to do before taking Xyrem® each night?
`
`Please see the Xyrem® Medication Guide for complete details.
`
`0
`
`a
`
`Prepare your doses: Your doctor will have determined what dose you should take. Prior to
`going to bed, you will need to measure out each of your Xyrem® doses into the provided dosing
`cups and then dilute each dose with 2 oz of water. 2 oz is about 60mL, ‘/4 cup, or 4
`tablespoons. Once you have done this you should place the child-resistant caps onto the
`dosing cups and put them in a safe place by your bed.
`Set an alarm clock: set an alarm to go off 2/10 4 hours after your first dose to wake you up for
`your second dose
`
`Can I take Xyrem® with food?
`
`Food will decrease the amount of Xyrem® that is absorbed. Therefore you should take Xyrem well
`after a meal (several hours).
`
`Can I take Xyrem® any time before I go bed?
`
`No. Xyrem® works quickly and therefore you need to lie down after you have taken it.
`
`What do I do if I miss a Xyrem® dose?
`
`Follow these rules if you miss a dose:
`
`0 Never take two doses of Xyrem® at once.
`0 You must leave a minimum of 2'A1ours between each dose of Xyrem®.
`
`Will my close change?
`
`You and your physician will discuss your response to treatment and your physician may adjust
`your dose as a result. NEVER CHANGE THE DOSE OF XYREMO YOURSELF.
`
`How soon might I see a change in my symptoms?
`
`You can expect to see some improvement within the first weeks of Xyrem“> therapy. However. it may
`take up to 8 weeks after you begin using Xyrem® to find the dose that is best for you.
`
`Any questions? Please call 1-877-67 XYREMSM (1-877-679-9736)
`
`Xyrem Patient Success ProgramSM
`
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`

`Please see FDA-approved medication guide for more detailed information.
`
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`<Page 4 text>
`What side effects have been reported with Xyrem®?
`
`The most common side effects of Xyrem® are headache, nausea, sleep problems (including sleep
`walking), vomiting, bed-wetting, confusion, and dizziness.
`
`if you experience confusion, vomiting, bedwetting, sleep walking, breathing problems (at night),
`depression, or abnormal thinking while using Xyrem”, you should notify your doctor. These are not
`all the side effects you may experience with Xyrem“. if you are concerned about any possible side
`effects please consult your doctor.
`
`3. Precautions needed for Xyrem® use
`
`Xyrem” is classified as a Schedule III medication which means that it is legal to use Xyrem” as
`prescribed. However, Xyrem’s active ingredient, sodium oxybate (also known as gamma
`hydroxybutyrate or GHB), has been used as a substance of abuse. Therefore your Xyrem” must be:
`0
`used only by you.
`.
`used only as directed by your physician.
`0
`stored in a safe and secure place.
`
`Because Xyrem” is classified under Schedule "i it is illegal for you to sell, distribute or give your
`Xyrem” to anyone else, or to use your Xyrem” for purposes other than it was prescribed. Failure to
`adhere to these rules may result in prosecution and fines as defined in Schedule I of the Controlled
`Substances Act.
`
`How do I store Xyrem®?
`
`It is critical that XyremED should be kept in a secure location, out of reach of children or pets. Xyrem
`does not require refrigeration.
`
`Are there any interactions with other medications?
`
`It is very important to inform your doctors and pharmacists that you are taking Xyrem® before
`starting or changing any medications. Xyrem” should not be used in combination with alcohol or
`other medications that cause drowsiness. You should tell your doctor about any other medicines
`you are taking, including non-prescription medicines and any vitamins or herbal, nutritional, or
`dietary supplements.
`
`What should I avoid while taking Xyrem®?
`
`Do not drive a car, operate heavy machinery, or perform any activity that is dangerous or that
`requires mental alertness, for at least 6 hours after taking Xyrem®. When you first start taking
`Xyrem or any other sleep medicine, until you know whether the medicine will still have some
`
`carryover effect in you the next day, use extreme care while driving a car, operating heavy
`machinery or doing anything else that could be dangerous or needs you to be fully mentally alert
`
`Before starting Xyrem”, tell your health care provider if you are pregnant, breastfeeding or planning
`on becoming pregnant.
`
`While taking Xyrem”, you should avoid drinking alcoholic beverages or taking medications that
`cause drowsiness.
`
`How will my use of Xyrem® be monitored?
`
`It is critical
`Your doctor will need to see you at least every 3 months while you are taking Xyrem”.
`that you keep these appointments so that your treatment can be continued safely and your
`prescription can be renewed.
`
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`

`

`Any questions? Please call 1-877-67 XYREMSM (1-877-679-9736)
`Xyrem Patient Success Programs"
`
`Please see FDA-approved medication guide for more detailed information.
`
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`<Page 5 text>
`
`4. OTHER INFORMATION
`
`Where can I get more information on Xyrem®?
`
`Please call your helpline at 1-877-67 XYREMSM (1-877-679—9736)
`
`Where can I get more information on narcolepsy or sleep disorders?
`
`www.0rphan.com
`
`Orphan Medical, Inc.
`
`www.sleepfoundationotg
`
`National Sleep Foundation
`
`13911 Ridgedale Drive, Suite 250
`
`1522 K Street NW, Suite 500
`
`Minnetonka, MN 55305
`
`Phone: 1-877-679-9736
`
`Washington, DC 20005
`
`Phone: 202-347-3471
`
`www.aasmnet.org
`
`www.narcolepsvnetworkprg
`
`American Academy of Sleep Medicine
`
`Narcolepsy Network
`
`6301 Bandel Road NW, Suite 101
`
`10921 Reed Hartman Highway
`
`Rochester, MN 55901
`
`Phone: 507-287-6006
`
`www.mrediseases.org
`
`Cincinnati, OH 45242
`
`Phone: 513—891-35212
`
`Email: nametfaiaol.c0m
`
`National Organization for Rare Disorders, Inc.
`
`www.talkaboutsleep.com
`
`PO. Box 8923
`
`New Fairfield, CT 06812-8923
`
`1-800-999—6673
`
`Talk About Sleep
`
`PO. Box 382276
`
`Germantown, TN 38183
`
`Phone: 901-482-2025
`
`Fax: 901-757-0651
`
`Any questions? Please call 1-877-67 XYREMSM (1-877-679-9736) Xyrem Patient Success Programs"
`
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`

`

`Please see FDA-approved medication guide for more detailed information.
`
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`<Page 6 text>
`
`My Prescription Record
`
`Using Xyrem® With Other Medications
`
`As with all prescriptions, it is important to follow
`your doctor's instructions. It is particularly
`important with Xyremo, because it may take
`several weeks to achieve the optimal dose.
`
`or dietary supplements you are taking, how often
`you take them, and the dose prescribed. This is
`important for ensuring safe use of your
`medications.
`
`In addition to following your doctor's advice, it is
`important to let all your doctor(s) and your
`pharmacist(s) know what other prescriptions,
`non-prescription medicines, vitamins, herbal,
`nutritional
`
`Use this form to keep a detailed record of this
`information and provide it to all your doctor(s)
`and your pharmacist(s).
`
`Xyrem is a medication that may need to be monitored by your physician for up to 3 months to
`achieve your optimal close. Your physician will likely start you at one dosage level and then adjust
`the dose (up or down) to find the best dosage for you. Please record your dose changes below.
`
`Dose _ (mL)
`
`Initial total Xyrem dose:
`
`Date __
`
`Changes in Xyrem dosing:
`
`Date
`
`Current Dose (mL) New Dose (mL)
`
`Reason for change
`
`Visit #1
`
`Visit #2
`
`Visit #3
`
`When your physician has achieved the best dose, record your maintenance dose here:
`
`Date
`
`Dose
`
`(mL)
`
`Other prescriptions, in addition to Xyrem:
`
`lt is important for your health care providers to know what other prescriptions, non-prescription
`medications, vitamins or herbal, nutritional or dietary supplements you take. They can help you
`predict any possible interactions among the medications you currently take.
`
`Drug name
`
`Rx number
`
`Date of Rx
`
`Prescribing physician
`
`Dosage & instructions
`
`More information:
`
`Make a copy of this information and give it to all your doctor(s) and your pharmacist(s) as it is
`updated with new information. If you have questions, don‘t hesitate to call the Xyrem Patient
`Success Program at 1-877-67 XYREM (1-877-679-9736)
`
` Any questions? Please call 1-877-67 XYREMSM (1-877-679-9736)
`
`
`Xyrem Patient Success ProgramSM
`
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`Please see FDA-approved medication guide for more detailed information.
`
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`<Page 7 text>
`
`At Home Storage and Safety Tips
`
`Keep this information folder on your desk, nightstand, or near your medicine storage area as a
`constant reminder to assist your safety and success with Xyrem” at home.
`
`Ordering
`
`Disposal
`
`o Xyrem” will be shipped via overnight courier
`directly to you from a central pharmacy.
`- You need to confirm receipt of your Xyremt3
`shipment by signing for your Xyrem”. Check
`the shipment to be sure it is complete
`before signing for it.
`
`Storage
`
`When you can no longer draw medication
`out of the bottle with the measuring device,
`it is time to throw the bottle away. Use a
`marker or pen to deface the bottle label
`so someone else cannot use it for illicit
`
`purposes. Pour any unused Xyremo
`down the drain. Place the empty bottle
`in the trash so it is not used for illegal
`purposes.
`
`0 Always keep Xyrem® in its original
`container.
`
`Refills
`
`0 Xyrem can be stored at room temperature. It
`is important that it is kept in a secure
`location at all times.
`
`.
`
`It is particularly important that Xyrem“ (like
`all medications) be kept out of the reach of
`children and pets. In case of accidental
`ingestion, call 911.
`
`Preparing Xyrem®
`
`c When mixing your nightly doses of Xyrem®,
`use your dosing cups with child-resistant
`caps and return the remaining medication to
`a secure location.
`It is especially important
`that your second nightly dose of Xyrem” is
`left in a secure place, not within the reach of
`children or pets.
`
`Remember to reorder your Xyrem” when you
`have only a 7-day supply remaining. Call
`the Patient Success Program to initiate a
`refill.
`
`Problems
`
`If your supply of Xyrem” is lost or stolen,
`please report the incident immediately to the
`local police and the Xyrem Patient Success
`Programs”.
`Use only as directed. Be aware that use of
`your Xyrem by others is illegal.
`If you have questions, concerns, or need
`advice regarding Xyrem”, call your physician
`or call the Patient Success Program
`Pharmacy.
`
`Any questions? Please call 1-877-67 XYREM (1-877-679-9736) Xyrem Patient Success Program
`
`Please see FDA-approved medication guide for more detailed information.
`
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`<Page 8 Layout>
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`Traveling Tips
`
`Before your trip
`
`0 When packing for your trip, be sure to take
`a sufficient amount of Xyrem” for the length
`of time you will be away.
`0 Always travel with XyremQ in its original
`container.
`
`o
`
`.
`
`0
`
`Take only the number of bottles of Xyrem”
`needed for your stay away from home.
`Ensure that any remaining Xyrem” is in a
`secure place before you leave home.
`XyremD should be kept in a secure location
`at all times.
`
`During your trip
`
`0
`
`Do not pack your Xyrem” in a suitcase that
`will be checked baggage. Always keep it in
`your possession.
`- Remember to take your dispensing device
`and the dosing cups with child-resistant
`caps when traveling. In an unfamiliar
`environment, it is especially important that
`your second nightly dose of Xyrem” is not
`left in an unsecured place or within the
`reach of children or pets.
`Do not leave your Xyrem“D behind when you
`return home.
`
`0
`
`If traveling internationally, be aware that
`Xyrem” may be subject to different
`regulations in other countries. Call the
`appropriate consulate for guidance on safe
`handling of your Xyrem° when you travel in
`their country.
`
`Problems
`
`o
`
`If your supply of Xyrem” is lost or stolen
`while traveling, please report the incident
`immediately to the local police and the
`Xyrem Patient Success Program”.
`
`If you have questions, concerns, or need advice
`regarding Xyrem” while traveling. call the Xyrem
`Patient Success Programs“.
`
`Xyrem Patient Success Programs"
`1-877-67 XYREMSM (1 -877-679-9736)
`FAX 1-XXX-XXX-XXXX
`
`For international access call the Xyrem Patient
`Success ProgramSM at
`
`XX- XXX-XXX-XXXX
`
`o
`
`It you should forget your Xyrem“ while
`traveling within the United States or need
`more due to an extended stay, call the the
`Xyrem Patient Success Program.SM
`
`Any questions? Please call 1-877-67 XYREM (1-877-679-9736)
`
`Xyrem Patient Success Program
`
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`Please see FDA-approved medication guide for more detailed information.
`
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`<Page 9 text>
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`Reimbursement information for patients...
`
`The Xyrem Patient Success ProgramSM provides reimbursement assistance for patients receiving
`Xyrem®.
`
`An experienced Reimbursement Specialist will:
`
`. Verify your benefits and eligibility
`. Obtain prior authorization from your insurance company (if needed)
`.
`File appropriate appeals on your behalf”
`.
`Support you with all aspects of insurance
`
`**
`
`The Xyrem Patient Success Program’s attempt to obtain coverage from a patient’s
`third-party payer does not constitute or guarantee success in resolving denials.
`
`If you have questions or need information,
`don’t hesitate to contact The Patient Success Program
`and ask for a Reimbursement Specialist.
`
`1-877-67 XYREMSM (1-877-679-9736)
`
`FAX 1-XXX-XXX-XXXX
`
`Any questions? Please call 1-877-67 XYREM (1 -877-679-9736)
`
`Xyrem Patient Success Program
`
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`Please see FDA-approved medication guide for more detailed information.
`
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