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Prescribing Information

Adverse reactions occurring in ≥5% of patients with VYKAT XR and ≥2% greater than placebo in Study 1*

Adverse
Reaction		VYKAT XR
(N=84)		Placebo
(N=42)
Hypertrichosis36%14%
Edema†27%12%
Hyperglycemia‡17%5%
Rash§12%2%
Pyrexia6%0%
Arthralgia5%2%
Influenza5%2%
Nasopharyngitis5%2%

The primary safety analyses were based on Study 1, a randomized, placebo-controlled trial designed to assess the efficacy and safety of VYKAT XR

For additional safety data from Study 2-RWP and Study 3, see the full Prescribing Information.

Learn about monitoring and dose adjustments for hyperglycemia and fluid overload

REVIEW GUIDANCE

Erythema multiforme was reported in one patient in Study 1. One patient in Study 3 experienced a serious adverse reaction of diabetic ketoacidosis.

Edema includes peripheral edema, periorbital edema, swelling face, pulmonary edema, and peripheral swelling.

Hyperglycemia includes type 2 diabetes mellitus.

Rash includes contact dermatitis, erythema multiforme, maculo-papular rash, papular rash, and urticaria.

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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. Miller JL, Gevers E, Bridges N, et al. Diazoxide choline extended-release tablet in people with Prader-Willi syndrome: results from long-term open-label study. Obesity (Silver Spring). 2024;32(2):252-261.
  2. Gevers EF, Miller JL, Bridges NA, et al. Withdrawal of diazoxide choline extended-release (DCCR) tablets worsens hyperphagia and increases weight and BMI in a 16-week, double-blind, placebo-controlled, randomized withdrawal period in patients with Prader-Willi syndrome. Presented at ENDO 2024; June 1-4, 2024; Boston, MA.