[Ohio-talk] Fwd: FDA Approves First Treatment for Non-24-Hour Sleep-Wake Disorder

Sat Feb 8 04:38:27 UTC 2014

---------- Forwarded message ----------
From: "supportprogram at hetlioz.com" <supportprogram at hetlioz.com>
Date: Fri, 07 Feb 2014 22:57:41 +0000
Subject: FDA Approves First Treatment for Non-24-Hour Sleep-Wake Disorder
To: cherylelaine1957 at gmail.com

     New HETLIOZ™ (tasimelteon): The First Approved Treatment for Non-24
                Approved by the FDA on
Jan. 31, 2014   Product will be available
Spring 2014                          The first and only FDA-approved
treatment for Non-24-Hour Sleep-Wake Disorder (Non-24).

 We are pleased to inform you that the U.S. Food and Drug Administration
has approved HETLIOZ™ (tasimelteon) for the treatment of Non-24-Hour
Sleep-Wake Disorder (Non-24).

 Non-24 is a serious, chronic disorder that affects a person's circadian
rhythms in up to 70 percent of people who are totally blind.
<http://www.hetlioz.com/?EmailGUID=F86540A6-14C1-4935-89A5-28E8C1BABD5B&EMCID=Hetlioz-Launch-Email>
Or call
1-844-HETLIOZ
(1-844-438-5469)

 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. After taking HETLIOZ™, activity
should be limited to preparing for bed. HETLIOZ™ can potentially impair
the ability to perform activities that require complete mental alertness.

 If you or someone you love has or believes they have Non-24, please
discuss with a doctor or other healthcare provider.

                     Indication

 HETLIOZ™ is indicated for the treatment of Non-24-Hour Sleep-Wake
Disorder (Non-24).

 Important Safety Information

 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 take,
including prescription and nonprescription drugs, vitamins, and herbal or
dietary supplements, including those that contain or are known to affect
melatonin levels.

 Tell your healthcare provider about all of your health conditions,
including if 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™ should not be used in children or in people with severe liver
problems.

 See Full Prescribing Information for additional information
<http://www.hetlioz.com/Content/HetliozPI.pdf?EmailGUID=F86540A6-14C1-4935-89A5-28E8C1BABD5B&EMCID=Hetlioz-Launch-Email>.

 You are encouraged to report side effects of prescription drugs to the
FDA. Visit www.fda.gov/medwatch <http://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
(1-844-438-5469).

 This information does not take the place of talking with your doctor for
medical advice about your condition or treatment.

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