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Prescribing Information

Privacy Policy

Last updated: [20th September 2024]
Soleno Therapeutics (“us”, “we”, or “our”) operates websites and online services (the “Sites”). This page informs you of our policies regarding the collection, use and disclosure of Personal Information we receive from users of the Sites.
We use your Personal Information only for providing and improving the Sites. By using the Sites, you agree to the collection and use of information in accordance with this policy.

Information Collection and Use

While using our Sites, we may ask you to provide us with certain personally identifiable information that can be used to contact or identify you. Personally identifiable information may include, but is not limited to your name, location, contact information, and demographic information (“Personal Information”).

Access to your information and correction

You have the right to review and amend any information submitted to Soleno if you believe it to be incorrect or out of date. Please contact Soleno using the information given below.

Log Data

Like many site operators, we collect information that your browser sends whenever you visit our Sites (“Log Data”). This Log Data may include information such as your computer’s Internet Protocol (“IP”) address, browser type, browser version, the pages of our Sites that you visit, the time and date of your visit, the time spent on those pages and other statistics.

Cookies

Cookies are files with small amount of data, which may include an anonymous unique identifier. Cookies are sent to your browser from a web site and stored on your computer’s hard drive.
Like many sites, we use “cookies” to collect information and administer the website. You can instruct your browser to block cookies. However, if you do not accept cookies, you may not be able to use some portions of our Sites.

Security

The security of your Personal Information is important to us, but remember that no method of transmission over the Internet, or method of electronic storage, is 100% secure. While we strive to use commercially acceptable means to protect your Personal Information, we cannot guarantee its absolute security.

Links to other Web Sites

Our website may contain links to third-party web sites or services that are not owned or controlled by Soleno Therapeutics.
Soleno Therapeutics has no control over, and assumes no responsibility for, the content, privacy policies, or practices of any third party web sites or services. You further acknowledge and agree that Soleno Therapeutics shall not be responsible or liable, directly or indirectly, for any damage or loss caused or alleged to be caused by or in connection with use of or reliance on any such content, goods or services available on or through any such web sites or services.

Changes to this Privacy Policy

This Privacy Policy is effective as of 20th September 2024 and will remain in effect except with respect to any changes in its provisions in the future, which will be in effect immediately after being posted on this page. We reserve the right to update or change our Privacy Policy at any time and you should check this Privacy Policy periodically. Your continued use of the website after we post any modifications to the Privacy Policy on this page will constitute your acknowledgment of the modifications and your consent to abide and be bound by the modified Privacy Policy.

Contact Us

If you have any questions about this Privacy Policy, please contact us:
By email: [email protected]
Or write to us at:
Soleno Therapeutics, Inc.
100 Marine Parkway
Suite 400
Redwood City, CA 94065

IMPORTANT SAFETY INFORMATION

Contraindications

Use of VYKAT XR is contraindicated in patients who have a known hypersensitivity to diazoxide, other components of VYKAT XR, or to thiazides.

Warnings and Precautions

Hyperglycemia

Hyperglycemia, including diabetic ketoacidosis, has been reported. Before initiating VYKAT XR, test fasting plasma glucose (FPG) and HbA1c; optimize blood glucose in patients who have hyperglycemia. During treatment, regularly monitor fasting glucose (FPG or fasting blood glucose) and HbA1c. Monitor fasting glucose more frequently during the first few weeks of treatment in patients with risk factors for hyperglycemia.

Risk of Fluid Overload

Edema, including severe reactions associated with fluid overload, has been reported. Monitor for signs or symptoms of edema or fluid overload. VYKAT XR has not been studied in patients with compromised cardiac reserve and should be used with caution in these patients.

Adverse Reactions

The most common adverse reactions (incidence ≥10% and at least 2% greater than placebo) included hypertrichosis, edema, hyperglycemia, and rash.

Drug Interactions

Concomitant use of VYKAT XR with strong CYP1A2 inhibitors increases exposure of diazoxide. Reduce VYKAT XR dosage with strong CYP1A2 inhibitors. Concomitant use of VYKAT XR is not recommended with CYP1A2 substrates due to increased exposure of these substrates. Concomitant use of VYKAT XR is not recommended with dual strong CYP3A4/moderate CYP1A2 inducers due to decreased exposure of VYKAT XR. Diazoxide is highly bound to serum proteins and may displace other drugs that are also highly bound to protein of which impact is expected to be clinically important for narrow therapeutic index drugs; monitor INR with coumarin or its derivatives and monitor diphenylhydantoin serum levels and adjust dose if needed when used concomitantly with VYKAT XR. Concomitant use of VYKAT XR with thiazides or other diuretics may potentiate hyperglycemic and hyperuricemic effects; dose adjustment of VYKAT XR or diuretics may be needed.

To report SUSPECTED ADVERSE REACTIONS, contact Soleno Therapeutics, Inc. at 1-833-765-3661 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the full Prescribing Information, including Medication Guide.

INDICATION

VYKAT XR is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS).