VYKAT XR is administered using a weight-based titration schedule
to help mitigate the occurrence and severity of adverse events
VYKAT XR recommended once-daily dosage
| Weight | Starting Dosage Weeks 1 and 2 | Titration Dosage Weeks 3 and 4 | Titration Dosage Weeks 5 and 6 | Target Maintenance Dose |
|---|---|---|---|---|
| 20-<30 kg | 25 mg | 50 mg | 75 mg | 100 mg |
| 30-<40 kg | 75 mg | 150 mg | 150 mg | 150 mg |
| 40-<65 kg | 75 mg | 150 mg | 225 mg | 225 mg |
| 65-<100 kg | 150 mg | 225 mg | 300 mg | 375 mg |
| 100-<135 kg | 150 mg | 300 mg | 375 mg | 450 mg |
| ≥135 kg | 150 mg | 300 mg | 450 mg | 525 mg |
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See guidance on required dose adjustments for concomitant use with strong CYP1A2 inhibitors
VYKAT XR tablets are available in the following strengths
VYKAT XR 25 mg
12.9 mm
VYKAT XR 75 mg
8.6 mm
VYKAT XR 150 mg
15.3 mm
Green Pea
For size comparison only
9 mm
VYKAT XR can be taken with or without food
- The maximum recommended dose of VYKAT XR is 5.8 mg/kg/day or 525 mg per day
- Advise patients to swallow tablets whole. Do not split, crush, or chew tablets
Proactive monitoring and dose adjustments can support patients during treatment
Monitor and optimize blood glucose before starting and throughout treatment
Hyperglycemia
Monitor fasting glucose more frequently during the first few weeks of treatment in patients with risk factors for hyperglycemia.
Fasting blood glucose may be measured at home with a blood glucose meter at the discretion of the treating physician and the patient.
Before initiating VYKAT XR
- Test fasting plasma glucose (FPG) and HbA1c
- Optimize blood glucose in patients who have hyperglycemia
After initiating VYKAT XR
Fasting glucose
Weeks 1-2: Monitor fasting glucose (FPG or fasting blood glucose) at least once a week and as clinically indicated
Weeks 3 and ongoing: Monitor fasting glucose (FPG or fasting blood glucose) at least once every 4 weeks and as clinically indicated
HbA1c
Monitor HbA1c every 3 months and as clinically indicated
Monitor for clinically significant elevations in fasting glucose or HbA1c before starting and throughout treatment
- Titrate the dose in small increments, no greater than 25 mg for patients weighing <30 kg, and 75 mg for patients weighing ≥30 kg every 2 weeks or titrate over a longer duration to a maximum of 5.8 mg/kg/day
- Daily doses ≥525 mg, or above 5.8 mg/kg/day, have not been evaluated in patients with PWS
Monitor for fluid overload before starting and throughout treatment, and consider appropriate management of patients
- Titrate the dose in small increments, no greater than 25 mg for patients weighing <30 kg, and 75 mg for patients weighing ≥30 kg every 2 weeks or titrate over a longer duration to a maximum of 5.8 mg/kg/day
- Daily doses ≥525 mg, or above 5.8 mg/kg/day, have not been evaluated in patients with PWS
Clinically significant drug interactions with VYKAT XR
Select a drug interaction to see the potential effect and what actions to take. Examples of strong CYP1A2 and CYP3A4 inhibitors, sensitive CYP1A2 substrates, and dual strong CYP3A4/moderate CYP1A2 inducers can be found at FDA.gov.
- Potential effect
- May increase the frequency and/or severity of adverse reactions from VYKAT XR.
- Action
- Reduce dosage of VYKAT XR.
- Potential effect
- May increase the frequency and/or severity of adverse reactions from CYP1A2 substrates.
- Action
- Concomitant use of VYKAT XR and CYP1A2 substrates is not recommended.
- Clinical judgment should be used based on individual needs and responses.
- Potential effect
- May increase the frequency and/or severity of adverse reactions from VYKAT XR.
- Action
- Monitor the frequency and severity of adverse reactions from VYKAT XR.
- A dosage reduction of VYKAT XR may be needed.
- Potential effect
- May decrease the exposure and efficacy of VYKAT XR.
- Action
- Concomitant use of VYKAT XR and dual strong CYP3A4/moderate CYP1A2 inducers are not recommended.
- Clinical judgment should be used based on individual needs and responses.
- Potential effect
- Diazoxide may displace other drugs which are also highly bound to protein and with narrow therapeutic range, resulting in higher or lower blood levels of the concomitantly used drugs.
- Action
- Monitor international normalized ratio (INR) in patients who use coumarin or its derivatives concomitantly with VYKAT XR. Dosage modification of coumarin or its derivatives may be needed when used concomitantly with VYKAT XR.
- Monitor diphenylhydantoin serum levels when VYKAT XR is used concomitantly with diphenylhydantoin. Dosage modification of diphenylhydantoin may be needed when used concomitantly with VYKAT XR.
- Potential effect
- The concomitant use of VYKAT XR with thiazides or other diuretics may potentiate the hyperglycemic and hyperuricemic effects of diazoxide.
- Action
- Monitor for signs and symptoms of hyperglycemia and hyperuricemia when VYKAT XR is used concomitantly with thiazides or other diuretics.
- Dosage adjustment of VYKAT XR or diuretics may be needed when VYKAT XR is concomitantly used with diuretics.
Dose modifications for concomitant use with strong CYP1A2 inhibitors
| Weight | Starting Dosage Weeks 1 and 2 | Titration Dosage Weeks 3 and 4 | Titration Dosage Weeks 5 and 6 | Target Maintenance Dose |
|---|---|---|---|---|
| 20-<30 kg | 25 mg | 25 mg | 50 mg | 75 mg |
| 30-<40 kg | 50 mg | 100 mg | 100 mg | 100 mg |
| 40-<65 kg | 50 mg | 100 mg | 150 mg | 150 mg |
| 65-<100 kg | 100 mg | 150 mg | 200 mg | 250 mg |
| 100-<135 kg | 100 mg | 200 mg | 250 mg | 300 mg |
| ≥135 kg | 100 mg | 200 mg | 300 mg | 325 mg |
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- Discontinuation or interruption of treatment
- Treatment with VYKAT XR can be discontinued without tapering.
- Following a dose interruption or missed dose of:
Less than 7 days
Resume VYKAT XR at the previous dose
7 days or more
Re-titrate VYKAT XR when resumed according to the dosing table
Prescribe with confidence.
Learn about access and support for patients taking VYKAT XR
Take a closer look at how to identify hyperphagia
hyperphagia in pws
