VYVANSE® is indicated for the treatment of:
- Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older.
- Moderate to severe binge eating disorder (BED) in adults.
There are limitations of use, please check with product insert.
General Administration and Dosage Information
Vyvanse is taken orally in the morning with or without food. Afternoon doses should be avoided because of the potential for insomnia. Whole Vyvanse capsule should be swallowed, or it can be opened, the entire contents are mixed with yogurt, water or orange juice, till until completely dispersed. Then the entire mixture consumed immediately. While Vyvanse chewable tablets must be chewed thoroughly before swallowing. Dosage for treatment depends mainly on the type of disease, and the age of users. Please check with product insert for details.
API solubility and PK Information
Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL).
Following single-dose oral administration of VYVANSE capsule in patients ages 6 to 12 years with ADHD under fasted conditions, Tmax of lisdexamfetamine and dextroamphetamine was reached at approximately 1 hour and 3.5 hours post dose, respectively. Neither food (a high fat meal or yogurt) nor orange juice affects the observed AUC and Cmax of dextroamphetamine in healthy adults after single-dose oral administration of 70 mg of VYVANSE capsules. But, food prolongs Tmax by approximately 1 hour (from 3.8 h at fasted state to 4.7 h after a high fat meal or to 4.2 h with yogurt).
After a single dose administration of 60 mg VYVANSE chewable tablet in healthy subjects under fasted conditions, Tmax of lisdexamfetamine and dextroamphetamine were about 1 h and 4.4 h, respectively. Compared to 60 mg VYVANSE capsule, exposure (Cmax and AUC) to lisdexamfetamine was about 15% lower. The exposure (Cmax and AUCinf) of dextroamphetamine is similar between VYVANSE chewable tablet and VYVANSE capsule. Administration of 60 mg VYVANSE chewable tablet with food (a high-fat meal) decreases the exposure (Cmax and AUCinf) of dextroamphetamine by about 5% to 7%, and prolongs mean Tmax by about 1 hour.
Warnings and Adverse Reactions
Warnings and adverse reactions are listed in the product insert. Here is a summary of the adverse reactions:
- Known hypersensitivity to amphetamine products or other ingredients of VYVANSE
- Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors
- Abuse, Misuse, and Addiction
- Risks to Patients with Serious Cardiac Disease
- Increased Blood Pressure and Heart Rate
- Psychiatric Adverse Reactions
- Long-Term Suppression of Growth in Pediatric Patients
- Peripheral Vasculopathy, including Raynaud's phenomenon
- Serotonin Syndrome
- Motor and Verbal Tics, and Worsening of Tourette's Syndrome
Table below: Adverse Reactions Reported by 2% or More of Pediatric Patients Ages 6 to 12 Years with ADHD Taking VYVANSE and Greater than or Equal to Twice the Incidence in Patients Taking Placebo in a 4-Week Clinical Trial (Study 1)
| VYVANSE (n=218) | Placebo (n=72) |
|
|---|---|---|
| Decreased Appetite | 39% | 4% |
| Insomnia | 22% | 3% |
| Abdominal Pain Upper | 12% | 6% |
| Irritability | 10% | 0% |
| Vomiting | 9% | 4% |
| Weight Decreased | 9% | 1% |
| Nausea | 6% | 3% |
| Dry Mouth | 5% | 0% |
| Dizziness | 5% | 0% |
| Affect lability | 3% | 0% |
| Rash | 3% | 0% |
| Pyrexia | 2% | 1% |
| Somnolence | 2% | 1% |
| Tic | 2% | 0% |
| Anorexia | 2% | 0% |
Table 2 Adverse Reactions Reported by 2% or More of Pediatric Patients Ages 13 to 17 Years with ADHD Taking VYVANSE and Greater than or Equal to Twice the Incidence in Patients Taking Placebo in a 4-Week Clinical Trial (Study 4)
| VYVANSE (n=233) | Placebo (n=77) |
|
|---|---|---|
| Decreased Appetite | 34% | 3% |
| Insomnia | 13% | 4% |
| Weight Decreased | 9% | 0% |
| Dry Mouth | 4% | 1% |
| Palpitations | 2% | 1% |
| Anorexia | 2% | 0% |
| Tremor | 2% | 0% |
Table 3 Adverse Reactions Reported by 2% or More of Adult Patients with ADHD Taking VYVANSE and Greater than or Equal to Twice the Incidence in Patients Taking Placebo in a 4-Week Clinical Trial (Study 7)
| VYVANSE (n=358) | Placebo (n=62) |
|
|---|---|---|
| Decreased Appetite | 27% | 2% |
| Insomnia | 27% | 8% |
| Dry Mouth | 26% | 3% |
There are more study results for adverse reactions, please check with product insert. Anyway, it seems that decreased appetite and insomnia are the most common adverse reactions.
According to a source, taking a higher dose of Vyvanse can increase the likelihood of experiencing side effects such as insomnia.
