Vykat XR Dosage

Important Recommendations Prior to VYKAT XR Initiation

Laboratory Testing Prior to VYKAT XR Initiation

Prior to initiating treatment with VYKAT XR, test fasting plasma glucose (FPG) and HbA1c and optimize blood glucose in patients who have hyperglycemia.

For fasting glucose and HbA1c monitoring recommendations during VYKAT XR treatment and for dosage modifications based on results, see Dosage and Administration (2.3).

Important Information Regarding Substitution

Do not substitute VYKAT XR with diazoxide oral suspension because the pharmacokinetic profiles are different.

Dosage and Administration Recommendations

Administer VYKAT XR orally with or without food once daily.

Swallow tablets whole. Do not split, crush, or chew the extended-release tablets because doing so may compromise the extended-release characteristics, efficacy, or safety of VYKAT XR.

The recommended oral dosage of VYKAT XR is based on body weight. The recommended starting dosage and titration schedule of VYKAT XR are shown in Table 1.

The maximum recommended dosage of VYKAT XR is 5.8 mg/kg/day or 525 mg per day. Dosages above 5.8 mg/kg/day or 525 mg per day have not been evaluated in patients with PWS.

Monitoring and Dosage Modifications Due to Adverse Reactions

Elevations in Fasting Glucose or HbA1c

After initiating treatment with VYKAT XR, monitor:

• Fasting glucose (FPG or fasting blood glucose) at least once every week for the first 2 weeks, then at least once every 4 weeks, and as clinically indicated.
• HbA1c every 3 months and as clinically indicated.

Monitor fasting glucose more frequently during the first few weeks of VYKAT XR treatment in patients with risk factors for hyperglycemia.

If clinically significant elevations in fasting glucose of HbA1c occur during treatment, temporarily interrupt VYKAT XR or reduce the dosage until glycemic parameters are appropriately managed. Consider initiation or adjustment of standard antidiabetic therapy(ies). If clinically significant glucose elevations are noted during titration, titrate over a longer duration and/or to a lower dosage.

Fluid Overload

Monitor for signs or symptoms of edema or fluid overload. Consider dosage reduction or temporary dosage interruption in the event of clinically significant fluid overload. If clinically significat fluid overload is noted during titration, titrate over a longer duration and/or to a lower dosage.

Titration After Resolution of Fluid Overload or Elevation in Fasting Glucose or HbA1c

If fluid overload or elevations in fasting glucose or HbA1c resolve after a dosage reduction:

• For patients weighing less than 30 kg, titrate the dosage in increments of no more than 25 mg every 2 weeks or titrate over longer duration to a maximum dosage of 5.8 mg/kg/day.
• For patients weighing greater than or equal to 30 kg, titrate the dosage in increments of no more than 75 mg every 2 weeks or titrate over longer duration to a maximum dosage of 5.8 mg/kg/day.

For recommendations on resuming VYKAT XR after dosage interruption, see Dosage and Administration (2.5).

Dosage Modifications for Concomitant Use with Strong CYP1A2 Inhibitors

VYKAT XR dosage modifications for concomitant use with strong CYP1A2 inhibitors are shown in Table 2.

Based on clinical response, VYKAT XR may be titrated to a maximum recommended dosage of 3.6 mg/kg/day. The VYKAT XR daily dosage should not exceed 325 mg per day.

No dosage modification is recommended when VYKAT XR is concomitantly used with moderate CYP1A2 inhibitors.

Recommendations Regarding Dosage Interruption, Missed Dose, or Discontinuation of Treatment

Following a dosage interruption or missed dose of:

• Less than 7 days, resume VYKAT XR at the previous dosage
• 7 days or more, re-titrate VYKAT XR according to Table 1 or 2, as appropriate

Treatment with VYKAT XR can be discontinued without tapering.