Brand Name
Vyvanse
Generic Name
Lisdexamfetamine Dimesylate
View Brand Information FDA approval date: February 23, 2007
Classification: Central Nervous System Stimulant
Form: Tablet, Capsule
What is Vyvanse (Lisdexamfetamine Dimesylate)?
Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of: Attention Deficit Hyperactivity Disorder in adults and pediatric patients 6 years and older [see Clinical Studies ( 1.
Approved To Treat
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Brand Information
Vyvanse (lisdexamfetamine dimesylate)
WARNING: ABUSE, MISUSE, AND ADDICTION
VYVANSE has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including VYVANSE, can result in overdose and death
Before prescribing VYVANSE, assess each patient's risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout VYVANSE treatment, reassess each patient's risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction
1INDICATIONS AND USAGE
VYVANSE
- Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older
- Moderate to severe binge eating disorder (BED) in adults
2CONTRAINDICATIONS
VYVANSE is contraindicated in patients with:
- Known hypersensitivity to amphetamine products or other ingredients of VYVANSE. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have been observed in postmarketing reports
- Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis
3ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- 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
3.1Clinical Trials Experience
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.
3.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of VYVANSE. Because these reactions are 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. These events are as follows: cardiomyopathy, mydriasis, diplopia, difficulties with visual accommodation, blurred vision, eosinophilic hepatitis, anaphylactic reaction, hypersensitivity, dyskinesia, dysgeusia, motor and verbal tics, bruxism, depression, dermatillomania, alopecia, aggression, Stevens-Johnson Syndrome, chest pain, angioedema, urticaria, seizures, libido changes, frequent or prolonged erections, constipation, rhabdomyolysis, and intestinal ischemia.
4DESCRIPTION
VYVANSE (lisdexamfetamine dimesylate), a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-
Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL).
5PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
6PRINCIPAL DISPLAY PANEL - 10 mg Capsule Bottle Label
NDC 59417-101-10
Vyvanse®
(lisdexamfetamine
(lisdexamfetamine
10 mg
CII
100 CAPSULES
Takeda
7PRINCIPAL DISPLAY PANEL - 20 mg Capsule Bottle Label
NDC 59417-102-10
Vyvanse®
(lisdexamfetamine
(lisdexamfetamine
20 mg
CII
100 CAPSULES
Takeda
8PRINCIPAL DISPLAY PANEL - 30 mg Capsule Bottle Label
NDC 59417-103-10
Vyvanse®
(lisdexamfetamine
(lisdexamfetamine
30 mg
CII
100 CAPSULES
Takeda
9PRINCIPAL DISPLAY PANEL - 40 mg Capsule Bottle Label
NDC 59417-104-10
Vyvanse®
(lisdexamfetamine
(lisdexamfetamine
40 mg
CII
100 CAPSULES
Takeda
10PRINCIPAL DISPLAY PANEL - 50 mg Capsule Bottle Label
NDC 59417-105-10
Vyvanse®
(lisdexamfetamine
(lisdexamfetamine
50 mg
CII
100 CAPSULES
Takeda
11PRINCIPAL DISPLAY PANEL - 60 mg Capsule Bottle Label
NDC 59417-106-10
Vyvanse®
(lisdexamfetamine
(lisdexamfetamine
60 mg
CII
100 CAPSULES
Takeda
12PRINCIPAL DISPLAY PANEL - 70 mg Capsule Bottle Label
NDC 59417-107-10
Vyvanse®
(lisdexamfetamine
(lisdexamfetamine
70 mg
CII
100 CAPSULES
Takeda
13PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label
NDC 59417-115-01
Vyvanse®
(lisdexamfetamine
(lisdexamfetamine
10 mg
100 CHEWABLE
Chew tablets completely Do
not swallow tablets whole.
not swallow tablets whole.
CII
Takeda
14PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Label
NDC 59417-116-01
Vyvanse®
(lisdexamfetamine
(lisdexamfetamine
20 mg
100 CHEWABLE
Chew tablets completely Do
not swallow tablets whole.
not swallow tablets whole.
CII
Takeda
15PRINCIPAL DISPLAY PANEL - 30 mg Tablet Bottle Label
NDC 59417-117-01
Vyvanse®
(lisdexamfetamine
(lisdexamfetamine
30 mg
100 CHEWABLE
Chew tablets completely Do
not swallow tablets whole.
not swallow tablets whole.
CII
Takeda
16PRINCIPAL DISPLAY PANEL - 40 mg Tablet Bottle Label
NDC 59417-118-01
Vyvanse®
(lisdexamfetamine
(lisdexamfetamine
40 mg
100 CHEWABLE
Chew tablets completely Do
not swallow tablets whole.
not swallow tablets whole.
CII
Takeda
17PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Label
NDC 59417-119-01
Vyvanse®
(lisdexamfetamine
(lisdexamfetamine
50 mg
100 CHEWABLE
Chew tablets completely Do
not swallow tablets whole.
not swallow tablets whole.
CII
Takeda
18PRINCIPAL DISPLAY PANEL - 60 mg Tablet Bottle Label
NDC 59417-120-01
Vyvanse®
(lisdexamfetamine
(lisdexamfetamine
60 mg
100 CHEWABLE
Chew tablets completely Do
not swallow tablets whole.
not swallow tablets whole.
CII
Takeda
