XYREM Drug Company Behind Narcolepsy Medicine User Guide
- September 3, 2024
- XYREM
Table of Contents
Drug Company Behind Narcolepsy Medicine
“`html
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.
“`
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