Last Reviewed: December 2020
Sarepta Therapeutics, Inc. ("Sarepta", "Company" or "We") respects your privacy and is committed to protecting it through our compliance with this policy. This policy describes the types of information we may collect from you or that you may provide when you visit www.sarepta.com, http://www.duchenne.com/ or any social media site, mobile sites, or online application owned and/or operated by the Company, including any content, functionality and services offered on or through these sites or channels (our "Websites") and our practices for collecting, using, maintaining, protecting and disclosing that information.
This policy applies to personal (i.e., individually identifiable) and other information we may collect:
This policy does not apply to information collected by:
No one under age 13 may provide information on our Websites. Our Websites are not directed at children under 13. If you are under 13, and would like to access our Websites and the information and services we provide, please consult your parent or guardian and ask him or her to register or use our Website features on your behalf. If you believe we have any information from or about a child under 13 without parental or guardian consent, please contact us at email@example.com so that we may identify and delete that information.
We collect several types of information from and about users of our Websites, including:
We collect information about you:
Information Collected Automatically
The information about you that we collect automatically does not identify you personally, but rather only by reference to the device you use to access our Websites. This information tells us about your usage of our Websites, which helps us to improve our Websites and to deliver a better and more personalized service to you. By enabling us to take into account your Website usage patterns and preferences, this information helps us to customize our Websites according to your individual interests, to speed up your searches, and to recognize you when you return to our Websites.
The technologies we use for this automatic data collection may include:
Although the information we collect automatically does not personally identify you, we may link that information to information that does personally identify you that we otherwise collect as described in this policy.
We do not control these third parties' tracking technologies or how they may be used. If you have any questions about an advertisement or other targeted content, you should contact the responsible advertiser or content provider directly.
We use information that we collect about you or that you provide to us, including any personal information:
Some of our Websites or forms in which we collect information from you, will have an “Opt-In” option for you to allow Sarepta and companies working on its behalf to communicate with you regarding information and services that may be available to you. If you register for one of our Websites, we may provide you with information or services consistent with the information you provide. For example, if you identify yourself as a parent of a child with Duchenne muscular dystrophy (DMD), we may ask you to provide medical information such as the genetic mutation responsible for your child’s disorder. We will use this and other information you may provide to offer you relevant information about DMD, opportunities to participate in clinical trials, products and services, or other information.
Sarepta does not share personally identifiable information with any unaffiliated third party for such third party’s own marketing purposes. We may disclose aggregated information about our users, and other information that does not identify any individual user, without restriction.
We may also disclose your personal information:
We strive to provide you with reasonable choices regarding the our collection and use of information about you. For example, you may: (1) choose not to provide personal information on our Websites, (2) set your browser preferences and use web tools available to block the cookies sent in connection with your use of our Websites, (3) follow the instructions to unsubscribe from our services included on our Websites and the communications sent to you, and/or (4) email a request to unsubscribe from our services to firstname.lastname@example.org.
We have implemented measures designed to secure your personal information from unauthorized access, use, alteration and disclosure. All information you provide to us is stored on our secure servers behind firewalls.
Unfortunately, the transmission of information via the internet is not completely secure. Although we do our best to protect your personal information, we cannot guarantee the security of your personal information transmitted to our Websites. Any transmission of personal information is at your own risk. We are not responsible for circumvention of any privacy settings or security measures contained on our Websites.
Attn: Corporate Communications
215 First Street
Cambridge, MA 02142
VYONDYS 53 is used to treat patients with Duchenne muscular dystrophy (DMD) who have a confirmed mutation in the dystrophin gene that can be treated by skipping exon 53.
This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with VYONDYS 53. Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials.
Allergic reactions, including rash, fever, itching, hives, and inflammation and/or peeling of the skin have occurred in patients who were treated with VYONDYS 53. Seek immediate medical care if signs and symptoms of allergic reactions occur.
Damage to the kidneys was seen in animals who received golodirsen. Although damage to the kidneys was not seen in clinical studies with VYONDYS 53, potentially fatal kidney damage has occurred with other drugs that work in a similar way. Your doctor may recommend urine and blood testing before starting treatment followed by urine testing every month and a blood test every 3 months to monitor your kidneys.
Adverse reactions that have occurred in at least 20% of patients treated with VYONDYS 53 and more often than in patients who received an inactive intravenous (IV) infusion were headache (41%, 10%), fever (41%, 14%), fall (29%, 19%), pain in the abdomen (27%, 10%), infection of the nose and throat (27%, 14%), cough (27%, 19%), vomiting (27%, 19%), and nausea (20%, 10%).
Other adverse reactions that occurred in greater than 5% of patients treated with VYONDYS 53 and more often than in patients who received an inactive IV infusion were pain at the IV site, back pain, pain, diarrhea, dizziness, stretch or tear in a ligament, bruising, flu, pain in the mouth and throat, stuffy or runny nose, scrapes or scratches of the skin, ear infection, seasonal allergy, fast heartbeat, reactions related to the IV catheter site, constipation, and broken bones.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Sarepta Therapeutics at 1-888-SAREPTA (1-888-727-3782).
Please see the full Prescribing Information for VYONDYS 53 (golodirsen).