[msb-alumni] FYI About non-24 Fw: HETLIOZ Information from Vanda
- From: Steve <pipeguy920@xxxxxxxxx>
- To: <msb-alumni@xxxxxxxxxxxxx>
- Date: Wed, 30 Apr 2014 18:41:57 -0400
----- Original Message -----
From: Sara Johnston
To: Sara Johnston
Cc: April Voliva
Sent: Wednesday, April 30, 2014 5:12 PM
Subject: HETLIOZ Information from Vanda
Hello Ambassadors!
I hope this message finds you well! Vanda wanted to share the below
information on HETLIOZ. Please let me know if you have any questions or
feedback!
Thank you,
Sara
Not long ago, you asked to receive information about Non-24-Hour
Sleep-Wake Disorder, also known as Non-24.
So, we thought you'd want to know about the first and only
FDA-approved treatment for people with Non-24. It's called HETLIOZ™
(tasimelteon), and it's now available by prescription from your doctor.
With Non-24, you experience a constant shift in the times when
your body expects to sleep and be awake, creating periods when you may be
awake at night and want to sleep during the day. Non-24 is a serious,
chronic circadian rhythm disorder that affects up to 70% of people who are
totally blind.
It may be time to ask your doctor about HETLIOZ™.
In clinical studies, HETLIOZ™ helped many people living with
Non-24 sleep at night and stay awake during the day. So, now that there's an
FDA-approved treatment for Non-24, it's time to talk with your doctor about
your symptoms and determine if HETLIOZ™ is the right treatment for you.
The most common side effects associated with HETLIOZ™ include
headache, elevated liver enzymes (ALT), nightmares or abnormal dreams, and
upper respiratory or urinary tract infection. These side effects may occur
more frequently in patients 65 years of age or older.
HETLIOZSolutions™ was created to support people with Non-24 who
are totally blind.
For help with questions you may have about insurance or
financial support, as well as starting HETLIOZ™, we created
HETLIOZSolutions™. Care Coordinators are available to talk about Non-24 or
HETLIOZ™ Monday through Friday, 9AM to 8PM, Eastern Standard Time. Call
1-844-HETLIOZ. That's 1-844-438-5469.
For help with talking to your doctor about Non-24 and HETLIOZ™,
we've posted three accessible PDFs to the website, AboutHETLIOZ.com, for you
to download and bring with you to your next doctor's appointment.
The first PDF can help you get the conversation with your doctor
started.
At AboutHETLIOZ.com, you'll find a downloadable Doctor
Discussion Guide you can use to help describe your Non-24 symptoms to your
physician. It can also help you discuss treatment with HETLIOZ™. Review the
guide and send it to your smartphone or notetaker, or print it out, and
bring it to share with your doctor at your next appointment.
The second PDF can help you get your medication delivered.
Because HETLIOZ™ is not available at retail pharmacies, there is
a special process that you and your doctor will need to follow to have
HETLIOZ™ delivered to you. Once you have been diagnosed, and your doctor has
determined HETLIOZ™ is right for you, you and your healthcare professional
will need to fill out and sign the HETLIOZSolutions™ Prescription and
Service Request Form, also found at AboutHETLIOZ.com.
And because your doctor may need more information, there's a
third PDF for that, too.
The last PDF is the Doctor's Guide to HETLIOZ™. It's been
written specifically for doctors and covers the science behind a circadian
rhythm disorder and Non-24, as well as information about the saftey and
effectiveness of HETLIOZ™. This PDF can be helpful if your doctor isn't
familiar with Non-24 or HETLIOZ™. So, be sure to share the information with
your doctor.
If your doctor still has questions about Non-24 and HETLIOZ™, it
may be helpful to refer him or her to HETLIOZPRO.com, where we explain
Non-24 and how HETLIOZ™ can help.
If you have any questions, just give us a call.
Again, we're here to help. So, call HETLIOZSolutions™ at
1-844-HETLIOZ. That's 1-844-438-5469.
We hope you found this email to be helpful and informative. But
if you'd prefer not to receive any future email communications about Non-24
or HETLIOZ™, simply click here.
Here's some Important Safety Information about HETLIOZ™.
HETLIOZ™ (HeT-lee-ōz) is a prescription medication used to treat
Non-24-Hour Sleep-Wake Disorder (Non-24).
HETLIOZ™ may cause drowsiness. After taking HETLIOZ™, limit your
activity to preparing for bed. HETLIOZ™ can potentially impair your ability
to perform activities that require complete mental alertness.
The most common side effects associated with HETLIOZ™ include
headache, elevated liver enzymes (ALT), nightmares or abnormal dreams, and
upper respiratory or urinary tract infection. These side effects may occur
more frequently in patients 65 years of age or older.
Tell your healthcare provider about all of the medicines you're
taking. HETLIOZ™ should not be taken in combination with fluvoxamine or
rifampin.
Tell your healthcare provider about all of your health
conditions, including whether you are pregnant, planning to become pregnant,
or breastfeeding. HETLIOZ™ has not been studied in pregnant women. HETLIOZ™
should be used during pregnancy only if the potential benefit justifies the
potential risks.
HETLIOZ™ has not been studied in children and it is not
recommended for use in patients with severe liver problems.
You are encouraged to report side effects of prescription drugs
to the FDA. Visit www.fda.gov/medwatch, call 1-800-FDA-1088, or report by
fax at 1-800-FDA-0178.
For more information, ask your doctor or call 1-844-HETLIOZ.
That's 1-844-438-5469.
This information does not take the place of talking with your
doctor for medical advice about your condition or treatment.
To hear the full Prescribing Information, go to HETLIOZ.com.
VANDA, HETLIOZ and HETLIOZSolutions are trademarks or registered
trademarks of Vanda Pharmaceuticals Inc. in the United States and other
countries. ©2014 VANDA PHARMACEUTICALS INC. All rights reserved. HET0104
04/14
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