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Prescribing Information

Food preoccupation5,8

  • Spending time thinking, talking about, or asking for food
  • Feeling distressed if told to stop asking about food
  • Food-related interruptions in daily activities

Drive to consume food5

  • Bargaining to get more food
  • Trying to steal food
  • Foraging through trash for food
  • Getting up at night to food seek

Food-related behavior problems5

  • Getting upset when denied food
  • Persistently asking for food after being told no

Lack of satiety5

  • Consuming a significantly excessive amount of calories
  • Overeating to the point of gastric rupture or necrosis

Regardless of where they are in their journey with PWS, hyperphagia impacts every aspect of life for patients and caregivers5,9

  • Hyperphagia in PWS often prevents full participation in school, employment, social life, and independent living9-12

Siobhan

Daughter, friend, and dreamer taking VYKAT XR

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Even when weight appears to be managed and environmental controls are in place, patients may still be burdened by hyperphagia1

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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).

References:

  1. Heymsfield SB, Avena NM, Baier L, et al. Hyperphagia: current concepts and future directions proceedings of the 2nd international conference on hyperphagia. Obesity (Silver Spring). 2014;22 Suppl 1(0 1):S1-S17
  2. Miller JL, Tan M. Dietary management for adolescents with Prader-Willi syndrome. Adolesc Health Med Ther. 2020;11:113-118.
  3. Ho AY, Dimitropoulos A. Clinical management of behavioral characteristics of Prader-Willi syndrome. Neuropsychiatr Dis Treat. 2010;6:107-118.
  4. Tauber M, Hoybye C. Endocrine disorders in Prader-Willi syndrome: a model to understand and treat hypothalamic dysfunction. Lancet Diabetes Endocrinol. 2021;9(4):235-246.
  5. Schwartz L, Caixàs A, Dimitropoulos A, et al. Behavioral features in Prader-Willi syndrome (PWS): consensus paper from the International PWS Clinical Trial Consortium. J Neurodev Disord. 2021;13(1):25.
  6. Miller JL, Lynn CH, Driscoll DC, et al. Nutritional phases in Prader-Willi syndrome. Am J Med Genet A. 2011;155A(5):1040-1049.
  7. Kotler J, Balko K, Berall G, et al. Nutritional phases in Prader-Willi syndrome: evolutionary and clinical interpretations. J Evolutionary Med. 2016;(4):1-7. doi:10.4303/jem/235968
  8. Dykens EM, Maxwell MA, Pantino E, et al. Assessment of hyperphagia in Prader-Willi syndrome. Obesity (Silver Spring). 2007;15(7):1816-1826.
  9. Matesevac L, Vrana-Diaz CJ, Bohonowych JE, et al. Analysis of hyperphagia questionnaire for clinical trials (HQ-CT) scores in typically developing individuals and those with Prader-Willi syndrome. Sci Rep. 2023;13:20573.
  10. Cassidy SB, Schwartz S, Miller JL, et al. Prader-Willi syndrome. Genet Med. 2012;14(1):10-26.
  11. Driscoll DJ, Miller JL, Cassidy SB. Prader-Willi Syndrome. In: Adam MP, Feldman J, Mirzaa GM, Pagon RA, Wallace SE, Amemiya A, eds. GeneReviews®. Seattle (WA): University of Washington, Seattle; October 6, 1998.
  12. Bedard KE, Pacha D, Griffith AK, et al. Prader-Willi syndrome: a primer for school psychologists. Child Youth Services Rev. 2024;163:1-7.