Vyvanse (Page 2 of 7)

5.2 Psychiatric Adverse Events

Pre-existing Psychosis

Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.

Bipolar Illness

Particular care should be taken in using stimulants to treat ADHD in patients with comorbid bipolar disorder because of concern for possible induction of a mixed/manic episode in such patients. Prior to initiating treatment with a stimulant, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder. Such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.

Emergence of New Psychotic or Manic Symptoms

Treatment-emergent psychotic or manic symptoms, e.g. hallucinations, delusional thinking, or mania in children and adolescents without a prior history of psychotic illness or mania, can be caused by stimulants at usual doses. If such symptoms occur, consideration should be given to a possible causal role of the stimulant, and discontinuation of treatment may be appropriate. In a pooled analysis of multiple short-term, placebo-controlled studies, such symptoms occurred in about 0.1% (4 patients with events out of 3482 exposed to methylphenidate or amphetamine for several weeks at usual doses) of stimulant-treated patients compared to 0 in placebo-treated patients.

Aggression

Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported in clinical trials and the postmarketing experience of some medications indicated for the treatment of ADHD. Although there is no systematic evidence that stimulants cause aggressive behavior or hostility, patients beginning treatment of ADHD should be monitored for the appearance of, or worsening of, aggressive behavior or hostility.

5.3 Seizures

There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.

5.4 Visual Disturbance

Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.

5.5 Tics

Amphetamines have been reported to exacerbate motor and phonic tics and Tourette’s syndrome. Therefore, clinical evaluation for tics and Tourette’s syndrome should precede use of stimulant medications.

5.6 Long-Term Suppression of Growth

‚Äč In a controlled trial of Vyvanse in children ages 6 to 12 years, mean weight loss from baseline after 4 weeks of therapy was -0.9, -1.9, and -2.5 lbs., respectively, for patients receiving 30 mg, 50 mg, and 70 mg of Vyvanse, compared to a 1 lb weight gain for patients receiving placebo. Higher doses were associated with greater weight loss with 4 weeks of treatment. Careful follow-up for weight in children ages 6 to 12 years who received Vyvanse over 12 months suggests that consistently medicated children (i.e. treatment for 7 days per week throughout the year) have a slowing in growth rate, measured by body weight as demonstrated by an age- and sex-normalized mean change from baseline in percentile, of -13.4 over 1 year (average percentiles at baseline and 12 months were 60.6 and 47.2, respectively). In a 4-week controlled trial of Vyvanse in adolescents ages 13 to 17 years, mean weight loss from baseline to endpoint was -2.7, -4.3, and -4.8 lbs., respectively, for patients receiving 30 mg, 50 mg, and 70 mg of Vyvanse, compared to a 2.0 lb weight gain for patients receiving placebo.

Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated children (i.e. treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development. In a controlled trial of amphetamine (d- to l-enantiomer ratio of 3:1) in adolescents, mean weight change from baseline within the initial 4 weeks of therapy was -1.1 lbs. and -2.8 lbs., respectively, for patients receiving 10 mg and 20 mg of amphetamine. Higher doses were associated with greater weight loss within the initial 4 weeks of treatment.

Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining weight as expected may need to have their treatment interrupted.

5.7 Prescribing and Dispensing

The least amount of amphetamine feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. Vyvanse should be used with caution in patients who use other sympathomimetic drugs.

6 ADVERSE REACTIONS

6.1 Clinical Studies Experience

The premarketing development program for Vyvanse included exposures in a total of 995 participants in clinical trials (348 pediatric patients aged 6 to 12 years, 233 adolescent patients aged 13 to 17 years, 358 adult patients and 56 healthy adult subjects). Of these, 348 pediatric (aged 6 to 12) patients were evaluated in two controlled clinical studies (one parallel-group and one crossover), one open-label extension study, and one single-dose clinical pharmacology study, 233 adolescent (aged 13 to 17) patients were evaluated in one controlled clinical study, and 358 adult patients were evaluated in one controlled clinical study and one open-label extension study. The information included in this section is based on data from the 4-week parallel-group controlled clinical studies in pediatric and adult patients with ADHD. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs.

Adverse reactions during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse reactions without first grouping similar types of reactions into a smaller number of standardized reactions categories. In the tables and listings that follow, MedDRA terminology has been used to classify reported adverse reactions.

The stated frequencies of adverse reactions represent the proportion of individuals who experienced a treatment-emergent adverse reaction of the type listed at least once.

Adverse Reactions Associated with Discontinuation of Treatment in Clinical Trials

In the controlled pediatric (aged 6 to 12) trial, 9% (20/218) of Vyvanse-treated patients discontinued due to adverse reactions compared to 1% (1/72) who received placebo. The most frequent adverse events leading to discontinuation and considered to be drug-related (i.e. leading to discontinuation in at least 1% of Vyvanse-treated patients and at a rate at least twice that of placebo) were ECG voltage criteria for ventricular hypertrophy, tic, vomiting, psychomotor hyperactivity, insomnia, and rash (2/218 each; 1%).

In the controlled adolescent (aged 13 to 17) trial, 4% (10/233) of Vyvanse-treated patients discontinued due to adverse events compared to 1% (1/77) who received placebo. The most frequent adverse reactions leading to discontinuation and considered to be drug-related were irritability (3/233; 1%), decreased appetite (2/233; 1%), and insomnia (2/233; 1%).

In the controlled adult trial, 6% (21/358) of Vyvanse-treated patients discontinued due to adverse events compared to 2% (1/62) who received placebo. The most frequent adverse events leading to discontinuation and considered to be drug-related (i.e. leading to discontinuation in at least 1% of Vyvanse-treated patients and at a rate at least twice that of placebo) were insomnia (8/358; 2%), tachycardia (3/358; 1%), irritability (2/358; 1%), hypertension (4/358; 1%), headache (2/358; 1%), anxiety (2/358; 1%), and dyspnea (3/358; 1%).

Adverse Reactions Occurring at an Incidence of 2% or More Among Vyvanse Treated Patients in Clinical Trials

Adverse reactions reported in the controlled trials in pediatric (aged 6 to 17 years) and adult patients treated with Vyvanse or placebo are presented in Tables 1, 2, and 3 below. The prescriber should be aware that these figures cannot be used to predict the incidence of adverse reactions in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatment uses and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse reaction incidence rate in the population studied.

Pediatric

Table 1 Adverse Reactions Reported by 2% or More of Children (Aged 6 to 12 Years) Taking Vyvanse in a 4-Week Clinical Trial

Body System Preferred Term Vyvanse (n=218) Placebo (n=72)
Gastrointestinal Disorders Abdominal Pain Upper 12% 6%
Vomiting 9% 4%
Nausea 6% 3%
Dry Mouth 5% 0%
General Disorder and Administration Site Conditions Pyrexia 2% 1%
Investigations Weight Decreased 9% 1%
Metabolism and Nutrition Decreased Appetite 39% 4%
Nervous System Disorders Dizziness 5% 0%
Somnolence 2% 1%
Psychiatric Disorders Insomniaa 23% 3%
Irritability 10% 0%
Affect lability 3% 0%
Tic 2% 0%
Skin and Subcutaneous Tissue Disorders Rash 3% 0%

a Insomnia includes the following preferred terms reported in the study: Initial Insomnia, Insomnia.

Note: This table includes those reactions for which the incidence in patients taking Vyvanse is at least twice the incidence in patients taking placebo.

Table 2 Adverse Reactions Reported by 2% or More of Adolescent (Aged 13 to 17 Years) Patients Taking Vyvanse in a 4-Week Clinical Trial
Body System Preferred Term Vyvanse (n=233) Placebo (n=77)
b Insomnia includes the following preferred terms reported in the study: Initial Insomnia, Insomnia.Note: This table includes those reactions for which the incidence in patients taking Vyvanse is at least twice the incidence in patients taking placebo.
Gastrointestinal Disorders Dry Mouth 4% 1%
Investigations Weight Decreased 9% 0%
Metabolism and Nutrition Decreased Appetite 34% 3%
Psychiatric Disorders Insomniab 13% 4%

Adult

Table 3 Adverse Reactions Reported by 2% or More of Adult Patients Taking Vyvanse in a 4-Week Clinical Trial

Body System Preferred Term Vyvanse (n=358) Placebo (n=62)
Gastrointestinal Disorders Dry Mouth 26% 3%
Diarrhea 7% 0%
Nausea 7% 0%
General Disorder and Administration Site Conditions Feeling Jittery 4% 0%
Investigations Blood Pressure Increased 3% 0%
Heart Rate Increased 2% 0%
Metabolism and Nutrition Disorders Decreased Appetite 27% 3%
Anorexia 5% 0%
Nervous System Disorders Tremor 2% 0%
Psychiatric Disorders Insomniac 27% 8%
Anxiety 6% 0%
Agitation 3% 0%
Restlessness 3% 0%
Respiratory, Thoracic, and Mediastinal Disorders Dyspnea 2% 0%
Skin and Subcutaneous Tissue Disorders Hyperhidrosis 3% 0%

c Insomnia includes the following preferred terms reported in the study: Initial Insomnia, Insomnia, Middle Insomnia.

Note: This table includes those events for which the incidence in patients taking Vyvanse is at least twice the incidence in patients taking placebo.

In addition, adverse reactions observed at a rate of less than 2% included decreased libido and erectile dysfunction.

Vital Signs

Weight Loss — In the controlled adult trial, mean weight loss after 4 weeks of therapy was 2.8 lbs, 3.1 lbs, and 4.3 lbs, for patients receiving final doses of 30 mg, 50 mg, and 70 mg of Vyvanse, respectively, compared to a mean weight gain of 0.5 lbs for patients receiving placebo.

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