Vykat

(Diazoxide Choline)

Check Drug InteractionsCheck known drug interactions.

Dosage & Administration

* Prior to initiation, test fasting plasma glucose and HbA1c; optimize blood glucose in patients who have hyperglycemia. (

2.1 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

[see Warnings and Precautions (5.1)]

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

[see Clinical Pharmacology (12.3)]

)
* Do not substitute with diazoxide oral suspension. (

2.1 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

[see Warnings and Precautions (5.1)]

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

[see Clinical Pharmacology (12.3)]

)
* Administer orally once daily. (

2.2 Dosage and Administration Recommendations

Administer VYKAT XR orally with or without food once daily

[see Clinical Pharmacology (12.3)]

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.

Table 1: Recommended Starting Dosage and Titration Regimen in Adults and Pediatric Patients 4 Years of Age and Older
Weight	Recommended Once Daily Dosage
	Starting Dosage	Titration Dosage	Titration Dosage	Target Maintenance Dose
	Weeks 1 and 2	Weeks 3 and 4	Weeks 5 and 6	Target Maintenance Dose
20 kg to <30 kg	25 mg	50 mg	75 mg	100 mg
30 kg to <40 kg	75 mg	150 mg	150 mg	150 mg
40 kg to <65 kg	75 mg	150 mg	225 mg	225 mg
65 kg to <100 kg	150 mg	225 mg	300 mg	375 mg
100 kg to <135 kg	150 mg	300 mg	375 mg	450 mg
≥135 kg	150 mg	300 mg	450 mg	525 mg

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.

)
* Recommended starting dosage and titration schedule is based on patient’s body weight. (

2.2 Dosage and Administration Recommendations

Administer VYKAT XR orally with or without food once daily

[see Clinical Pharmacology (12.3)]

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.

Table 1: Recommended Starting Dosage and Titration Regimen in Adults and Pediatric Patients 4 Years of Age and Older
Weight	Recommended Once Daily Dosage
	Starting Dosage	Titration Dosage	Titration Dosage	Target Maintenance Dose
	Weeks 1 and 2	Weeks 3 and 4	Weeks 5 and 6	Target Maintenance Dose
20 kg to <30 kg	25 mg	50 mg	75 mg	100 mg
30 kg to <40 kg	75 mg	150 mg	150 mg	150 mg
40 kg to <65 kg	75 mg	150 mg	225 mg	225 mg
65 kg to <100 kg	150 mg	225 mg	300 mg	375 mg
100 kg to <135 kg	150 mg	300 mg	375 mg	450 mg
≥135 kg	150 mg	300 mg	450 mg	525 mg

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.

)

Weight	Starting Dosage	Titration Dosage	Titration Dosage	Target Maintenance Dose
Weight	Weeks 1 and 2	Weeks 3 and 4	Weeks 5 and 6	Target Maintenance Dose
20 to <30 kg	25 mg	50 mg	75 mg	100 mg
30 to <40 kg	75 mg	150 mg	150 mg	150 mg
40 to <65 kg	75 mg	150 mg	225 mg	225 mg
65 to <100 kg	150 mg	225 mg	300 mg	375 mg
100 to <135 kg	150 mg	300 mg	375 mg	450 mg
≥135 kg	150 mg	300 mg	450 mg	525 mg

* The maximum recommended dosage is 5.8 mg/kg/day or 525 mg per day. (

2.2 Dosage and Administration Recommendations

Administer VYKAT XR orally with or without food once daily

[see Clinical Pharmacology (12.3)]

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.

Table 1: Recommended Starting Dosage and Titration Regimen in Adults and Pediatric Patients 4 Years of Age and Older
Weight	Recommended Once Daily Dosage
	Starting Dosage	Titration Dosage	Titration Dosage	Target Maintenance Dose
	Weeks 1 and 2	Weeks 3 and 4	Weeks 5 and 6	Target Maintenance Dose
20 kg to <30 kg	25 mg	50 mg	75 mg	100 mg
30 kg to <40 kg	75 mg	150 mg	150 mg	150 mg
40 kg to <65 kg	75 mg	150 mg	225 mg	225 mg
65 kg to <100 kg	150 mg	225 mg	300 mg	375 mg
100 kg to <135 kg	150 mg	300 mg	375 mg	450 mg
≥135 kg	150 mg	300 mg	450 mg	525 mg

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.

)
* Interrupt VYKAT XR or reduce dosage for clinically significant elevations in fasting glucose or HbA1c; consider dosage reduction or interruption for clinically significant fluid overload. (

2.3 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

[see Warnings and Precautions (5.1)]

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

[see Warnings and Precautions (5.2)]

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)

)
* See full prescribing information for VYKAT XR dosage modifications due to drug interactions (

2.4 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

[see Drug Interactions (7)]

Table 2: VYKAT XR Dosage Modifications for Concomitant Use with Strong CYP1A2 Inhibitors
Weight	VYKAT XR Recommended Once Daily Dosage
	Starting Dosage	Titration Dosage	Titration Dosage	Target Maintenance Dose
	Weeks 1 and 2	Weeks 3 and 4	Weeks 5 and 6	Target Maintenance Dose
20 to <30 kg	25 mg	25 mg	50 mg	75 mg
30 to <40 kg	50 mg	100 mg	100 mg	100 mg
40 to <65 kg	50 mg	100 mg	150 mg	150 mg
65 to <100 kg	100 mg	150 mg	200 mg	250 mg
100 to <135 kg	100 mg	200 mg	250 mg	300 mg
≥135 kg	100 mg	200 mg	300 mg	325 mg

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.

)
* Following dosage interruption or a missed dose of 7 days or more, re-titrate according to

Table 1: Recommended Starting Dosage and Titration Regimen in Adults and Pediatric Patients 4 Years of Age and Older
Weight	Recommended Once Daily Dosage
	Starting Dosage	Titration Dosage	Titration Dosage	Target Maintenance Dose
	Weeks 1 and 2	Weeks 3 and 4	Weeks 5 and 6	Target Maintenance Dose
20 kg to <30 kg	25 mg	50 mg	75 mg	100 mg
30 kg to <40 kg	75 mg	150 mg	150 mg	150 mg
40 kg to <65 kg	75 mg	150 mg	225 mg	225 mg
65 kg to <100 kg	150 mg	225 mg	300 mg	375 mg
100 kg to <135 kg	150 mg	300 mg	375 mg	450 mg
≥135 kg	150 mg	300 mg	450 mg	525 mg

Table 2: VYKAT XR Dosage Modifications for Concomitant Use with Strong CYP1A2 Inhibitors
Weight	VYKAT XR Recommended Once Daily Dosage
	Starting Dosage	Titration Dosage	Titration Dosage	Target Maintenance Dose
	Weeks 1 and 2	Weeks 3 and 4	Weeks 5 and 6	Target Maintenance Dose
20 to <30 kg	25 mg	25 mg	50 mg	75 mg
30 to <40 kg	50 mg	100 mg	100 mg	100 mg
40 to <65 kg	50 mg	100 mg	150 mg	150 mg
65 to <100 kg	100 mg	150 mg	200 mg	250 mg
100 to <135 kg	100 mg	200 mg	250 mg	300 mg
≥135 kg	100 mg	200 mg	300 mg	325 mg

. (

2.5 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 1or 2, as appropriate

[see Dosage and Administration (2.2, 2.4)]

Treatment with VYKAT XR can be discontinued without tapering.

)

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Vykat Prescribing Information

Prior to initiation, test fasting plasma glucose and HbA1c; optimize blood glucose in patients who have hyperglycemia. (
2.1 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
[see Warnings and Precautions (5.1)]
.
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
[see Clinical Pharmacology (12.3)]
.
)
Do not substitute with diazoxide oral suspension. (
2.1 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
[see Warnings and Precautions (5.1)]
.
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
[see Clinical Pharmacology (12.3)]
.
)

Administer orally once daily. (

2.2 Dosage and Administration Recommendations

Administer VYKAT XR orally with or without food once daily

[see Clinical Pharmacology (12.3)]

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.

Table 1: Recommended Starting Dosage and Titration Regimen in Adults and Pediatric Patients 4 Years of Age and Older
Weight	Recommended Once Daily Dosage
	Starting Dosage	Titration Dosage	Titration Dosage	Target Maintenance Dose
	Weeks 1 and 2	Weeks 3 and 4	Weeks 5 and 6	Target Maintenance Dose
20 kg to <30 kg	25 mg	50 mg	75 mg	100 mg
30 kg to <40 kg	75 mg	150 mg	150 mg	150 mg
40 kg to <65 kg	75 mg	150 mg	225 mg	225 mg
65 kg to <100 kg	150 mg	225 mg	300 mg	375 mg
100 kg to <135 kg	150 mg	300 mg	375 mg	450 mg
≥135 kg	150 mg	300 mg	450 mg	525 mg

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.

)

Recommended starting dosage and titration schedule is based on patient’s body weight. (

2.2 Dosage and Administration Recommendations

Administer VYKAT XR orally with or without food once daily

[see Clinical Pharmacology (12.3)]

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.

Table 1: Recommended Starting Dosage and Titration Regimen in Adults and Pediatric Patients 4 Years of Age and Older
Weight	Recommended Once Daily Dosage
	Starting Dosage	Titration Dosage	Titration Dosage	Target Maintenance Dose
	Weeks 1 and 2	Weeks 3 and 4	Weeks 5 and 6	Target Maintenance Dose
20 kg to <30 kg	25 mg	50 mg	75 mg	100 mg
30 kg to <40 kg	75 mg	150 mg	150 mg	150 mg
40 kg to <65 kg	75 mg	150 mg	225 mg	225 mg
65 kg to <100 kg	150 mg	225 mg	300 mg	375 mg
100 kg to <135 kg	150 mg	300 mg	375 mg	450 mg
≥135 kg	150 mg	300 mg	450 mg	525 mg

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.

)

Weight	Starting Dosage	Titration Dosage	Titration Dosage	Target Maintenance Dose
Weight	Weeks 1 and 2	Weeks 3 and 4	Weeks 5 and 6	Target Maintenance Dose
20 to <30 kg	25 mg	50 mg	75 mg	100 mg
30 to <40 kg	75 mg	150 mg	150 mg	150 mg
40 to <65 kg	75 mg	150 mg	225 mg	225 mg
65 to <100 kg	150 mg	225 mg	300 mg	375 mg
100 to <135 kg	150 mg	300 mg	375 mg	450 mg
≥135 kg	150 mg	300 mg	450 mg	525 mg

The maximum recommended dosage is 5.8 mg/kg/day or 525 mg per day. (

2.2 Dosage and Administration Recommendations

Administer VYKAT XR orally with or without food once daily

[see Clinical Pharmacology (12.3)]

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.

Table 1: Recommended Starting Dosage and Titration Regimen in Adults and Pediatric Patients 4 Years of Age and Older
Weight	Recommended Once Daily Dosage
	Starting Dosage	Titration Dosage	Titration Dosage	Target Maintenance Dose
	Weeks 1 and 2	Weeks 3 and 4	Weeks 5 and 6	Target Maintenance Dose
20 kg to <30 kg	25 mg	50 mg	75 mg	100 mg
30 kg to <40 kg	75 mg	150 mg	150 mg	150 mg
40 kg to <65 kg	75 mg	150 mg	225 mg	225 mg
65 kg to <100 kg	150 mg	225 mg	300 mg	375 mg
100 kg to <135 kg	150 mg	300 mg	375 mg	450 mg
≥135 kg	150 mg	300 mg	450 mg	525 mg

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.

)

Interrupt VYKAT XR or reduce dosage for clinically significant elevations in fasting glucose or HbA1c; consider dosage reduction or interruption for clinically significant fluid overload. (
2.3 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
[see Warnings and Precautions (5.1)]
.
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
[see Warnings and Precautions (5.2)]
.
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)
.
)

See full prescribing information for VYKAT XR dosage modifications due to drug interactions (

2.4 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

[see Drug Interactions (7)]

Table 2: VYKAT XR Dosage Modifications for Concomitant Use with Strong CYP1A2 Inhibitors
Weight	VYKAT XR Recommended Once Daily Dosage
	Starting Dosage	Titration Dosage	Titration Dosage	Target Maintenance Dose
	Weeks 1 and 2	Weeks 3 and 4	Weeks 5 and 6	Target Maintenance Dose
20 to <30 kg	25 mg	25 mg	50 mg	75 mg
30 to <40 kg	50 mg	100 mg	100 mg	100 mg
40 to <65 kg	50 mg	100 mg	150 mg	150 mg
65 to <100 kg	100 mg	150 mg	200 mg	250 mg
100 to <135 kg	100 mg	200 mg	250 mg	300 mg
≥135 kg	100 mg	200 mg	300 mg	325 mg

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.

)

Following dosage interruption or a missed dose of 7 days or more, re-titrate according to

Table 1: Recommended Starting Dosage and Titration Regimen in Adults and Pediatric Patients 4 Years of Age and Older
Weight	Recommended Once Daily Dosage
	Starting Dosage	Titration Dosage	Titration Dosage	Target Maintenance Dose
	Weeks 1 and 2	Weeks 3 and 4	Weeks 5 and 6	Target Maintenance Dose
20 kg to <30 kg	25 mg	50 mg	75 mg	100 mg
30 kg to <40 kg	75 mg	150 mg	150 mg	150 mg
40 kg to <65 kg	75 mg	150 mg	225 mg	225 mg
65 kg to <100 kg	150 mg	225 mg	300 mg	375 mg
100 kg to <135 kg	150 mg	300 mg	375 mg	450 mg
≥135 kg	150 mg	300 mg	450 mg	525 mg

Table 2: VYKAT XR Dosage Modifications for Concomitant Use with Strong CYP1A2 Inhibitors
Weight	VYKAT XR Recommended Once Daily Dosage
	Starting Dosage	Titration Dosage	Titration Dosage	Target Maintenance Dose
	Weeks 1 and 2	Weeks 3 and 4	Weeks 5 and 6	Target Maintenance Dose
20 to <30 kg	25 mg	25 mg	50 mg	75 mg
30 to <40 kg	50 mg	100 mg	100 mg	100 mg
40 to <65 kg	50 mg	100 mg	150 mg	150 mg
65 to <100 kg	100 mg	150 mg	200 mg	250 mg
100 to <135 kg	100 mg	200 mg	250 mg	300 mg
≥135 kg	100 mg	200 mg	300 mg	325 mg

. (

2.5 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 1or 2, as appropriate
[see Dosage and Administration (2.2, 2.4)]

Treatment with VYKAT XR can be discontinued without tapering.

)

VYKAT XR is contraindicated in patients with known hypersensitivity to diazoxide, other components of VYKAT XR, or to thiazides. Erythema multiforme has been reported with VYKAT XR

[see

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:

Hyperglycemia
[see Warnings and Precautions (5.1)]
Risk of Fluid Overload
[see Warnings and Precautions (5.2)]

Adverse Reactions from Clinical Studies of VYKAT XR in Patients with PWS

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In the clinical study development program for treatment of hyperphagia in patients aged 4 years and older with PWS, a total of 125 patients received at least 1 dose of VYKAT XR. Patients received dosages of VYKAT XR up to 5.8 mg/kg/day (up to a maximum dosage of 525 mg/day) for up to 4.86 years (median: 3.0 years) in the following studies:

Study 1: 13-week, randomized, double-blind, placebo-controlled, parallel-arm study in which 126 patients were randomized in a 2:1 ratio to VYKAT XR or placebo and received at least one dose of VYKAT XR.
Study 2-OLE: A long-term, open-label, maintenance treatment period in 115 patients (mean duration 2.6 years; maximum duration 4.3 years) who had previously been enrolled in Study 1.
Study 2-RWP: A 16-week, double-blind, placebo-controlled, randomized withdrawal treatment period, in which 77 patients who had completed Study 1 and Study 2-OLE were randomized in a 1:1 ratio to VYKAT XR or placebo
[see Clinical Studies (14)]
.
Study 3: A long-term, open-label, maintenance study in 77 patients who had completed Study 1 and Study 2-OLE.

Adverse reactions leading to discontinuation in VYKAT XR-treated patients included aggression, diabetes mellitus, fluid retention, hirsutism, hyperglycemia, lower respiratory tract infection, peripheral edema, pulmonary edema, and papular rash.

The primary safety analyses are based on Study 1. The most common adverse reactions (10% or more and at least 2% greater than in placebo) in Study 1 were hypertrichosis, edema, hyperglycemia, and rash.

Table 3presents adverse reactions that occurred in at least 5% of patients in Study 1 receiving VYKAT XR and 2% more frequently in VYKAT XR-treated patients than placebo.

Table 3: Adverse Reactions Occurring in ≥5% of Patients with PWS Receiving VYKAT XR and at Least 2% Greater than Placebo in Study 1
Adverse Reaction	VYKAT XR (N=84)	Placebo (N=42)
Hypertrichosis	36%	14%
EdemaEdema includes peripheral edema, periorbital edema, swelling face, pulmonary edema, and peripheral swelling.	27%	12%
HyperglycemiaHyperglycemia includes type 2 diabetes mellitus.	17%	5%
RashRash includes contact dermatitis, erythema multiforme, maculo-papular rash, papular rash, and urticaria.	12%	2%
Pyrexia	6%	0%
Arthralgia	5%	2%
Influenza	5%	2%
Nasopharyngitis	5%	2%

In Study 2-RWP, the adverse reactions that occurred most frequently (at least 5%) and to a greater extent than placebo included:

Immune System Disorders:

Seasonal allergy

Investigations:

Increased weight

Nervous System Disorders:

Hyperphagia, anxiety, affect lability, anger, compulsive hoarding, suicidal ideation

Respiratory Disorders:

Streptococcal pharyngitis, upper respiratory infection

Skin and Subcutaneous Tissue Disorders:

Hirsutism

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

Adverse Reactions from Clinical Trials or Postmarketing Experience of Diazoxide in An Unapproved Population

The following adverse reactions associated with use of diazoxide for an unapproved population have been identified in clinical studies or post-marketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune System Disorders:

Hypersensitivity

Investigations:

Increased serum uric acid, transient neutropenia, thrombocytopenia, decreased hemoglobin/hematocrit, eosinophilia

Respiratory Disorders:

Pulmonary hypertension

Special Senses:

Cataracts

Musculoskeletal and Connective Tissue Disorders:

Abnormal facial features

Most common adverse reactions (incidence ≥10% and at least 2% greater than in placebo) are hypertrichosis, edema, hyperglycemia, and rash.

To report SUSPECTED ADVERSE REACTIONS, contact Soleno Therapeutics, Inc. at 1-833-765-3661 or FDA at 1-800-FDA-1088 or

www.fda.gov/medwatch.

]

Hyperglycemia
: Hyperglycemia, including diabetic ketoacidosis, has been reported. During treatment, monitor fasting glucose and HbA1c. Monitor fasting glucose more frequently during first few weeks of treatment in patients with risk factors for hyperglycemia. (
2.3 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
[see Warnings and Precautions (5.1)]
.
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
[see Warnings and Precautions (5.2)]
.
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)
.
,
5.1 Hyperglycemia
VYKAT XR increases blood glucose, due primarily to an inhibition of insulin release from the pancreas. Hyperglycemia, including severe adverse reactions associated with diabetic ketoacidosis, occurred in VYKAT XR-treated patients during clinical trials
[see Adverse Reactions (6)]
.
Precipitating conditions for diabetic ketoacidosis may include reduction in the dosages of concomitant antihyperglycemic medications, increase in the dosages of concomitant growth hormone, intercurrent illness, surgery, volume depletion or alcohol abuse. Signs and symptoms of ketoacidosis include nausea, vomiting, abdominal pain, generalized malaise and shortness of breath.
Before initiating VYKAT XR, test fasting plasma glucose (FPG) and HbA1c; optimize blood glucose in patients who have hyperglycemia. After initiating treatment with VYKAT XR, regularly monitor fasting glucose (FPG or fasting blood glucose) and HbA1c
[see Dosage and Administration (2.3)]
. Monitor fasting glucose more frequently for the first few weeks of treatment with VYKAT XR in patients with risk factors for hyperglycemia, such as obesity, elevated FPG, HbA1c at the upper limit of normal or above, concomitant use of growth hormone, or concomitant use of systemic corticosteroids.
Advise patients of the signs and symptoms of hyperglycemia (e.g., excessive thirst, urinating more often than usual or higher amount of urine than usual, or increased appetite with weight loss). If a patient experiences hyperglycemia after initiating treatment with VYKAT XR, monitor fasting glucose as clinically indicated, and at least twice weekly until fasting glucose decreases to normal levels. Consider monitoring ketones in patients with worsening hyperglycemia.
If hyperglycemia is treated with anti-hyperglycemic medication during VYKAT XR treatment, continue monitoring fasting glucose at least once a week for 8 weeks, followed by once every 2 weeks and as clinically indicated. Consider consultation with a healthcare provider with expertise in the treatment of hyperglycemia and counsel patients on lifestyle changes. Based on the severity of the hyperglycemia, VYKAT XR may require dosage interruption, reduction, or discontinuation in order to avoid progression to ketoacidosis
[see Dosage and Administration (2.3)]
.
)
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. (
2.3 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
[see Warnings and Precautions (5.1)]
.
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
[see Warnings and Precautions (5.2)]
.
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)
.
,
5.2 Risk of Fluid Overload
Edema, including general, localized, and peripheral edema, occurred in 27% of VYKAT XR-treated patients versus 12% of placebo-treated patients in the placebo-controlled trial with treatment-naïve
subjects (Study 1). Severe adverse reactions associated with fluid overload, including pulmonary edema, were reported in VYKAT XR-treated patients during clinical trials
[see Adverse Reactions (6)]
.
The antidiuretic property of diazoxide may lead to significant fluid retention, which may precipitate congestive heart failure in patients with compromised cardiac reserve. VYKAT XR has not been studied in patients with compromised cardiac reserve and should be used with caution in these patients.
Monitor for signs or symptoms of edema or fluid overload and consider appropriate clinical management, which may include VYKAT XR dosage reduction or treatment interruption, if clinically significant
[see Dosage and Administration (2.3)]
.
)

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