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Prescribing Information

Information about treatment, getting started, access, support, and more.

Resources for HCPs

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See key details for VYKAT XR

Download Brochure
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Learn how to support your 
patients with proactive 
monitoring and dose adjustments

Download Monitoring Flashcard

Hyperphagia in PWS and VYKAT XR

Uncover the signs of hyperphagia in PWS, from subtle to more pronounced. Learn about the clinical data for VYKAT XR, hear from a caregiver of a loved one with hyperphagia in PWS, and see how to get started on treatment.

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Resources to get started

VYKAT XR Start 
Form

Download the VYKAT XR Start Form

Patient Services Brochure for HCPs

Download the Patient Services Brochure for HCPs

Sample Letter of Medical Necessity

Download the Medical Necessity Sample Letter

Resources for your patients

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VYKAT XR results, possible 
side effects, and more for 
caregivers and their loved ones

Download Brochure
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Understand how VYKAT XR 
should be taken

VYKAT XR Dosing Booklet
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Help caregivers and their 
loved ones stay on track with 
treatment every day

VYKAT XR Tracker
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Understand your patients  
and their caregivers’ unique 
experience with PWS

Discussion Guide
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Take a closer look at how to 
identify hyperphagia

hyperphagia in pws
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See once-daily dosing 
for VYKAT XR

Dosing & monitoring
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).