XYREM Drug Company Behind Narcolepsy Medicine User Guide

September 3, 2024
XYREM

Drug Company Behind Narcolepsy Medicine

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Specifications

  • Product Name: XYREM

  • Usage: Prescription medicine for narcolepsy in patients 7 years
    and older

  • Effects: Reduces daytime sleepiness and cataplexy

Product Usage Instructions

Enrolling in the XYWAV and XYREM REMS

What am I required to do in the REMS?
As a patient, discuss safe use with your healthcare provider, read
the Quick Start Guide, inform about other medications or conditions
affecting breathing.

Do I have to enroll in the REMS?
Yes, sign an enrollment form with your healthcare provider, verify
counseling on risks and safe use of XYREM.

Filling Your XYREM Prescription

How is my prescription filled?
Certified Pharmacy fills your prescription.

What will I get with my XYREM
prescription?

Instructions on usage and storage.

How Do I Take My XYREM?

How do I prepare my doses?
Follow instructions provided by your healthcare provider.

How do I take my doses?
Take as prescribed. Do not drink alcohol or take other
sedatives.

What should I do if I miss a XYREM dose?
Take it as soon as you remember, unless it’s almost time for the
next dose. Do not double dose.

Storage and Safety Tips at Home

How do I store XYREM?
Store at room temperature away from light and moisture.

How do I properly dispose of XYREM?
Follow local regulations for medication disposal. Do not flush down
the toilet.

FAQ

Will insurance pay for my XYREM?

Contact your insurance provider for coverage details.

Where can I get more information about XYREM?

You can call the XYWAV and XYREM REMS at 1-866-997-3688 or refer
to the Medication Guide for detailed information.

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PATIENT QUICK START GUIDE
Important information about the safe use and handling of XYREM

Dear Patient, Welcome to the XYWAV and XYREM REMS. You are receiving these materials because your healthcare provider has prescribed XYREM® (sodium oxybate) oral solution, 0.5 g/mL, for you. XYREM is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. If you are the caregiver of a pediatric patient receiving XYREM, please refer to the XYREM Brochure for Pediatric Patients and Their Caregivers instead of this guide for important information about helping your child get started with XYREM. Because of the serious risks associated with XYREM, the Food and Drug Administration (FDA) has required a special program called a Risk Evaluation and Mitigation Strategy (REMS). The purpose of this REMS is to make sure the benefits of XYREM outweigh the risks. All patients must be enrolled in the REMS to receive XYREM. This Quick Start Guide contains information you need to know about XYREM and will help you to use XYREM correctly. Read this Quick Start Guide before you start taking XYREM. After your healthcare provider sends in your enrollment form and first prescription for XYREM, you will receive a call from the Certified Pharmacy of the REMS to tell you how the REMS helps you get started with taking XYREM and to answer any questions you may have about XYREM.
Any questions? Please call the XYWAV and XYREM REMS at 1-866-997-3688. Please see the Medication Guide for more detailed information about XYREM. 2

You will also speak with appropriate staff at the Certified Pharmacy, who will go over your insurance information with you. Before you can receive your first shipment of XYREM, a pharmacist at the Certified Pharmacy will ask if your healthcare provider reviewed the XYREM Patient Quick Start Guide with you and explain that you will receive this guide with your first shipment, and that all drug shipments will include the XYREM Medication Guide. The pharmacist will also ask you about your medical history and other medications you may be taking, and give you advice on how to prepare and take your XYREM and how to store it safely. You must take this call before you can get your XYREM. Please call your healthcare provider if you have questions about XYREM, or you can contact the REMS toll free at 1-866-997-3688. You can reach a pharmacist at this number 24 hours a day, 7 days a week with any questions. We hope you find this information and the REMS services helpful. Sincerely, Jazz Pharmaceuticals
3

WARNING: XYREM can cause serious side effects. Do not drink alcohol or take other medicines that make you sleepy
XYREM is a prescription medicine used to treat patients 7 years of age and older with narcolepsy to reduce too much daytime sleepiness and to reduce cataplexy (suddenly weak or paralyzed muscles).
IMPORTANT INFORMATION ABOUT XYREM INCLUDES THE FOLLOWING:
· When taking XYREM, do not drink alcohol or take other medicines that slow your breathing or mental activity or make you sleepy. You could have serious side effects
· XYREM can cause serious side effects, including trouble breathing while asleep, confusion, unusual or disturbing thoughts, depression, and passing out, even at recommended doses. Tell your healthcare provider if you have any of these problems while taking XYREM
· Abuse of XYREM can lead to dependence (a physical need to take the drug), craving for the medicine, and severe withdrawal symptoms (symptoms that start when the drug is stopped, especially when it is stopped suddenly)
· Patients usually fall asleep in about 5 to 15 minutes, although some patients have reported falling asleep more quickly (without first feeling drowsy) and others take more time. The time that it takes to fall asleep might be different from night to night. You should take each dose of XYREM while in bed. Take the first dose at bedtime and the second 2½ to 4 hours later. You may need to set an alarm to awaken for the second dose
Any questions? Please call the XYWAV and XYREM REMS at 1-866-997-3688. Please see the Medication Guide for more detailed information about XYREM. 4

· Do not drive a car, use heavy machinery, fly an airplane, or do anything that is dangerous or that requires you to be alert for the first 6 hours after taking XYREM. When you first start taking XYREM, be careful until you know how XYREM affects you
· Keep XYREM out of the reach of children and pets. Get emergency medical help right away if a child drinks your XYREM
· Report all side effects to your healthcare provider
WHAT WILL YOU FIND IN THIS BOOKLET?
This booklet answers important questions about how to get your XYREM, how to use XYREM properly, and how to store it safely. It also gives you important information about XYREM.
WHAT IS THE XYWAV AND XYREM REMS?
Because of the serious risks associated with XYREM, the FDA has required a special program called the XYWAV and XYREM REMS. Enrollment in the REMS by prescribers and patients is required by the FDA to ensure the benefits of XYREM outweigh the risks associated with XYREM. You are enrolled in the REMS when your healthcare provider sends in the enrollment form you signed. At that time, your healthcare provider also sent your prescription for XYREM to the Certified Pharmacy. The Certified Pharmacy staff will review important information about XYREM with you. They will also answer any questions you may have about XYREM.
5

TABLE OF CONTENTS

ENROLLING IN THE XYWAV AND XYREM REMS

8

What am I required to do in the REMS?

8

Do I have to enroll in the REMS?

8

FILLING YOUR XYREM PRESCRIPTION

9

How is my prescription filled?

9

What does the Certified Pharmacy do?

9

What will I get with my XYREM prescription?

10

How do I get my XYREM refills?

11

Can my local pharmacy provide XYREM?

11

HOW DO I TAKE MY XYREM?

12

How do I prepare my doses?

12

How do I take my doses?

19

What should I do if I miss a XYREM dose?

19

How soon will I see a change in my symptoms?

20

What are the side effects of XYREM?

20

Are there any precautions I should take while on XYREM?

21

Any questions? Please call the XYWAV and XYREM REMS at 1-866-997-3688. Please see the Medication Guide for more detailed information about XYREM.
6

How often should my healthcare provider

check my progress with XYREM?

22

What do I need to do if I am taking XYWAV

and my doctor prescribes XYREM for me?

22

STORAGE AND SAFETY TIPS AT HOME

23

How do I store XYREM?

23

How do I properly dispose of XYREM?

23

XYWAV and XYREM Takeback Program

24

What if I have concerns about having XYREM in my home?

24

INSURANCE COVERAGE

25

Will insurance pay for my XYREM?

25

What is the pharmacy’s role with my insurance?

25

GETTING MORE INFORMATION

26

Where can I get more information about XYREM?

26

7

ENROLLING IN THE XYWAV AND XYREM REMS
WHAT AM I REQUIRED TO DO INTHE REMS?
As a patient, your responsibility is to discuss the safe use of XYREM with your healthcare provider and to read this XYREM Patient Quick Start Guide before you begin taking XYREM. Be sure to let your healthcare provider know if you are taking other medications or if you have any conditions that might affect your breathing.
DO I HAVE TO ENROLL IN THE REMS?
Yes. In order for you to receive XYREM, your healthcare provider will have you sign an enrollment form and will send the form to the REMS. You must verify that you have been counseled by your healthcare provider on the serious risks and safe use of XYREM and that you were able to ask your healthcare provider any questions you have about XYREM.
Any questions? Please call the XYWAV and XYREM REMS at 1-866-997-3688. Please see the Medication Guide for more detailed information about XYREM. 8

FILLING YOUR XYREM PRESCRIPTION
HOW IS MY PRESCRIPTION FILLED?
All XYREM prescriptions are filled only by the REMS Certified Pharmacy.
WHAT DOES THE CERTIFIED PHARMACY DO?
Your healthcare provider sends your XYREM prescription directly to the Certified Pharmacy. After your healthcare provider sends in your first prescription of XYREM, you will receive a call from the Certified Pharmacy to tell you how the REMS helps you get started with taking XYREM and to answer any questions you may have about XYREM. A staff member from the Certified Pharmacy will call you to complete a Patient Counseling Checklist. The Patient Counseling Checklist will include information about other medications that you are taking and other medical conditions which might increase your risk of serious side effects. The Certified Pharmacy will go over the information about how to use XYREM safely and provide a copy of the Medication Guide with each XYREM shipment. The Certified Pharmacy will always ask you where and when you would like your XYREM delivered and who will sign for the shipment. XYREM will be shipped by an overnight service. When the courier arrives, you or an adult you name must sign for your XYREM.
9

WHAT WILL I GET WITH MY XYREM PRESCRIPTION?
With each prescription, you will get 1 or more bottles of XYREM (each bottle, whether full or partial, has the concentrated medicine), a dosing syringe for drawing up your XYREM dose, 2 empty pharmacy containers with child-resistant caps, and a printed Medication Guide.

  • Please note that the measuring cup and water for dilution are not provided with your XYREM prescription

MEDICATION GUIDE
Medication Guide

Pharmacy Containers Figure A

Dosing Syringe

Any questions? Please call the XYWAV and XYREM REMS at 1-866-997-3688. Please see the Medication Guide for more detailed information about XYREM.
10

HOW DO I GET MY XYREM REFILLS?
The Certified Pharmacy will contact you when it is close to your refill time. You may opt-in to receive text, e-mail, or automated voice reminders. You may also call the Certified Pharmacy at 1-866-997-3688 to schedule your refills.
CAN MY LOCAL PHARMACY PROVIDE XYREM?
No. You can get your XYREM only from the REMS central Certified Pharmacy. You may be able to have your XYREM shipped to your place of work or to a local overnight carrier hub for pickup. Saturday deliveries may also be an option for you. The Certified Pharmacy will work with you on the best options available.
11

HOW DO I TAKE MY XYREM?
Take XYREM only as your healthcare provider tells you to take it.
HOW DO I PREPARE MY DOSES?
Step 1: Setup Take the XYREM bottle, syringe, and pharmacy containers out of the shipping box. Then, take the syringe out of the plastic wrapper (use only the syringe provided with the XYREM prescription). Fill a measuring cup (not provided) with about ¼ cup of water available for mixing your dose. Make sure the pharmacy containers are empty.
1 2
Figure B Then, open both pharmacy containers by holding the tab under the cap and turning counterclockwise (to the left).
Any questions? Please call the XYWAV and XYREM REMS at 1-866-997-3688. Please see the Medication Guide for more detailed information about XYREM. 12

Remove the tamper evident band by pulling at the perforations and then remove the child-resistant bottle cap from the XYREM bottle by pushing down while turning the cap counterclockwise.
1
Tamper Evident Band
2
Tamper Evident Band
Figure C
13

Step 2: Prepare the first XYREM dose (prepare before bedtime) Place the XYREM bottle on a hard, flat surface and grip the bottle with one hand and firmly press the syringe into the center opening of the bottle with the other. Pull back on the plunger until the medicine flows into the syringe and the liquid level is lined up with the marking on the syringe that matches your dose. Note: The XYREM medicine will not flow into the syringe unless you keep the bottle upright.
NO Plunger
Syringe is not pushed in far enough
YES
Syringe is pushed in correctly
Figure D
Any questions? Please call the XYWAV and XYREM REMS at 1-866-997-3688. Please see the Medication Guide for more detailed information about XYREM. 14

Figure E shows an example of drawing up a XYREM dose of 2.25 g. Figure F shows an example if an air space forms when drawing up the dose. Note: If an air space forms between the plunger and the liquid when drawing up the medicine, line up the liquid level with the marking on the syringe that matches your dose.

3.25 g 2.75 g 2.25 g 1.75 g

3.25 g Air Space 2.75 g
2.25 g
Liquid Level
1.75 g

Figure E

Figure F

15

After you draw up the first XYREM dose, remove the syringe from the opening of the XYREM bottle. Empty all of the medicine from the syringe into 1 of the provided empty pharmacy containers by pushing down on the plunger until it stops.
Figure G Using a measuring cup, pour about ¼ cup of water into the pharmacy container. Be careful to add only water to the pharmacy container and not more XYREM. All shipped bottles of XYREM contain the concentrated medicine. Water for mixing the medicine is not provided in the shipment.
Any questions? Please call the XYWAV and XYREM REMS at 1-866-997-3688. Please see the Medication Guide for more detailed information about XYREM. 16

After mixing the medicine and water in the provided pharmacy container, place the child-resistant cap provided on the filled pharmacy container and turn the cap clockwise (to the right) until it clicks and locks in its child-resistant position. Caution: the pharmacy container cap is reversible with a non-child resistant side. See Figure H. Make sure the child-resistant side of the cap is used to prevent access to the medicine by children.

Cap shown in child-resistant position.

Note: Do not place the cap back on the container in a non-child resistant position as shown.

Figure H

Step 3: Prepare the second XYREM dose (prepare before bedtime)

Repeat Step 2 drawing up the amount of medicine prescribed for your second dose; emptying the syringe into the second pharmacy container, adding about ¼ cup of water, and closing the pharmacy container.

17

Step 4: Store the prepared XYREM doses
Put the cap back on the XYREM bottle and store the XYREM bottle and both prepared doses in a safe and secure place. Store in a locked place if needed. Keep the XYREM bottle and both prepared XYREM doses out of the reach of children and pets.
Rinse the syringe out with water and squirt the liquid into the sink drain by pushing down on the plunger until it stops. Please refer to the Instructions for Use within the Medication Guide for additional details.
Step 5: Take the first XYREM dose
At bedtime, and before you take the first XYREM dose, put the second XYREM dose in a safe place. You may want to set an alarm clock for 2½ to 4 hours later to make sure you wake up to take the second dose.
When it is time to take the first XYREM dose, remove the cap from the pharmacy container by pressing down on the child-resistant locking tab and turning the cap counterclockwise. Drink all of the first XYREM dose while sitting in bed. Put the cap back on the first pharmacy container and immediately lie down to sleep.
You should fall asleep soon. Some people fall asleep within 5 minutes and most fall asleep within 15 minutes. Some patients take less time to fall asleep, and some take more time. The time it takes you to fall asleep might be different from night to night.
Step 6: Take the second XYREM dose
When you wake up 2½ to 4 hours later for your second dose of XYREM, take the cap off the second pharmacy container. If you wake up before
Any questions? Please call the XYWAV and XYREM REMS at 1-866-997-3688. Please see the Medication Guide for more detailed information about XYREM. 18

the alarm and it has been at least 2½ hours since the first XYREM dose, turn off the alarm and take the second XYREM dose. Drink all of the second XYREM dose while sitting in bed. Put the cap back on the second pharmacy container and immediately lie down to continue sleeping.
HOW DO I TAKE MY DOSES?
Wait at least 2 hours after eating before taking XYREM. XYREM is a medicine that can make you sleepy quickly; therefore, take your doses while you are in bed. Take the first dose at bedtime and the second dose 2½ to 4 hours later. If you continue evening activities after taking your dose, such as watching television or walking around, you may experience light-headedness, dizziness, nausea, confusion, or other unpleasant feelings.
WHAT SHOULD I DO IF I MISS A XYREM DOSE?
· It is very important to take both doses of XYREM each night, as prescribed. If you miss the second dose, skip that dose ­ Do not take XYREM again until the next night ­ Never take both XYREM doses at once
· Any unused XYREM doses that you prepared but didn’t take must be thrown away within 24 hours from the time you first prepared your doses
19

HOW SOON WILL I SEE A CHANGE IN MY SYMPTOMS?
After starting XYREM, it may take a few weeks or longer to see your symptoms improve. It may also take time to find the right dose that works for you. It is important that you talk with your healthcare provider often when you first start taking XYREM. Tell your healthcare provider if you don’t feel any improvements while taking XYREM. XYREM may not be right for you.
WHAT ARE THE SIDE EFFECTS OF XYREM?
XYREM can cause serious side effects, including breathing problems (slower breathing, trouble breathing, and short periods of no breathing while asleep), mental health problems (confusion, seeing or hearing things that are not real, unusual or disturbing thoughts, feeling anxious or upset, depression, thoughts of suicide), and sleepwalking. If you have any of these side effects, call your healthcare provider right away. The most common side effects with XYREM are nausea, dizziness, throwing up, bedwetting, and diarrhea. Side effects may increase with higher doses. These are not the only possible side effects with XYREM. If you are worried about any possible side effects with XYREM, talk with your healthcare provider or the pharmacist at the REMS. You should report all side effects by contacting your healthcare provider, Jazz Pharmaceuticals at 1-800-520-5568, or the FDA at 1-800-FDA-1088.
Any questions? Please call the XYWAV and XYREM REMS at 1-866-997-3688. Please see the Medication Guide for more detailed information about XYREM. 20

ARE THERE ANY PRECAUTIONS I SHOULD TAKE WHILE ON XYREM?
· While taking XYREM, do not drink alcohol or take medicines that cause sleepiness
· Do not drive a car, use heavy machinery, or do anything that is dangerous or requires you to be alert, for the first 6 hours after taking XYREM. When you first start taking XYREM, be careful until you know how it will affect you
· Before starting XYREM, tell your healthcare provider if you are pregnant, or plan to become pregnant, or if you are breastfeeding. XYREM passes into breast milk. You and your doctor should decide if you will take XYREM or breastfeed.
· Keep your XYREM in a safe place, out of the reach of children · Take XYREM while in bed Tell your healthcare provider and pharmacist about any other medicines you are taking, including prescription and non-prescription medicines, vitamins, and supplements. It is also important to tell other healthcare providers, including pharmacists, that you are taking XYREM before you start or change any medications.
21

HOW OFTEN SHOULD MY HEALTHCARE PROVIDER CHECK MY PROGRESS WITH XYREM?
When you first start taking XYREM, you may need to talk to your healthcare provider often until he or she has determined the best dose for you. You can expect that your dose may need to be adjusted. After your dose has been established, your healthcare provider should check on you every 3 months while you are taking XYREM.
WHAT DO I NEED TO DO IF I AM TAKING XYWAV® AND MY DOCTOR PRESCRIBES XYREM FOR ME?
· Never take both XYREM and XYWAV at the same time, it can lead to serious side effects
· XYREM contains the same medicine as XYWAV, which is called oxybate, but with more sodium
· Take your XYREM exactly as instructed by your doctor
· Prepare your XYREM the same way you prepared XYWAV
· Do not mix XYREM and XYWAV together. If you have unused XYWAV, dispose of it before starting XYREM. Refer to “HOW DO I PROPERLY DISPOSE OF XYREM?” for further instructions
· The Certified Pharmacy will contact you to talk to you about how to make this change
· XYREM contains a high amount of sodium (salt) and may not be right for you, especially if you are on a salt-restricted diet or have had heart failure, high blood pressure (hypertension), or kidney problems. Make sure to tell your doctor if you have any of these conditions before you start XYREM.
Any questions? Please call the XYWAV and XYREM REMS at 1-866-997-3688. Please see the Medication Guide for more detailed information about XYREM. 22

STORAGE AND SAFETY TIPS AT HOME
HOW DO I STORE XYREM?
· Always store XYREM in its original bottle · Store XYREM at room temperature. Do not refrigerate XYREM · Keep XYREM in a safe place, out of the reach of children and pets.
Get emergency medical help (call 911) right away if a child drinks your XYREM
HOW DO I PROPERLY DISPOSE OF XYREM?
To properly dispose of XYREM, pour any unused XYREM down the sink or toilet drain. Mark out all personal information on the prescription label, including the XYREM name, to make it unreadable before putting the empty bottle in the trash. XYREM patients have the option to return unused or expired drug. Please ask the Certified Pharmacy for more details. If you misplace, lose, or damage your XYREM dosing syringe, contact the Certified Pharmacy to have it replaced. Do not use a different syringe or try to guess the correct dose.
23

XYWAV AND XYREM TAKEBACK PROGRAM
XYWAV or XYREM patients have an option to return any unused, leftover or expired XYWAV or XYREM product through a drug takeback program, upon request. Patients can request a shipper from the Certified Pharmacy. Once you receive the shipper, remember to mark out or remove your personal information from the bottle(s) and place the bottle(s) in the shipper. For more information, please ask the Certified Pharmacy for more details.
WHAT IF I HAVE CONCERNS ABOUT HAVING XYREM IN MY HOME?
· If your XYREM is lost or stolen, report the incident right away to the local police and to the Certified Pharmacy
· Use XYREM only as your healthcare provider tells you. Remember that use of your XYREM by others is illegal
· If you have any questions or concerns, or if you need advice about XYREM, call your healthcare provider or the Certified Pharmacy
Any questions? Please call the XYWAV and XYREM REMS at 1-866-997-3688. Please see the Medication Guide for more detailed information about XYREM. 24

INSURANCE COVERAGE
WILL INSURANCE PAY FOR MY XYREM?
In most cases, YES. A staff member from the Certified Pharmacy will call and work with your insurance company to help you get coverage for XYREM. In the unlikely event your insurance does not cover XYREM or you can’t afford the out-of-pocket costs, ask the Certified Pharmacy about available financial assistance programs.
WHAT IS THE PHARMACY’S ROLE WITH MY INSURANCE?
An experienced staff member will: · Call you to go over your prescription benefits and coverage · Tell you what your co-pay is, if applicable · Tell you about any XYREM prescription savings plans for which
you may qualify · Work with your healthcare provider on prior authorizations,
if required by your insurance company · Provide information about any financial help that may be available
to you The Certified Pharmacy’s attempt to get coverage from a third-party payer does not guarantee that you will get coverage.
25

GETTING MORE INFORMATION
WHERE CAN I GET MORE INFORMATION ABOUT XYREM?
For more information about XYREM, contact the REMS: · Phone: 1-866-997-3688 · Fax: 1-866-470-1744 (toll free) · Outside the US: +314-475-6000, ext 361 587 · Website: www.XYWAVXYREMREMS.com
Any questions? Please call the XYWAV and XYREM REMS at 1-866-997-3688. Please see the Medication Guide for more detailed information about XYREM. 26

NOTES
27

KEEP THIS BOOKLET AS A HELPFUL REMINDER
If you have questions or need information, contact the XYWAV and XYREM REMS.

Please see the Medication Guide for more detailed information about XYREM.

Any questions? Please call the XYWAV and XYREM REMS at 1-866-997-3688.

Please see the Medication Guide for more detailed information about XYREM.

28Copyright 2024 Jazz Pharmaceuticals, All rights reserved

XYR-3001 v4 Rev0224

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