Vyvanse

VYVANSE- lisdexamfetamine dimesylate capsule
VYVANSE- lisdexamfetamine dimesylate tablet, chewable
Takeda Pharmaceuticals America, Inc.

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including VYVANSE, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy [see Warnings and Precautions (5.1), and Drug Abuse and Dependence (9.2, 9.3)].

1 INDICATIONS AND USAGE

VYVANSE® is indicated for the treatment of:

Limitations of Use:

  • Pediatric patients with ADHD younger than 6 years of age experienced more long-term weight loss than patients 6 years and older [see Use in Specific Populations (8.4)].
  • VYVANSE is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of VYVANSE for the treatment of obesity have not been established [see Warnings and Precautions (5.2)].

2 DOSAGE AND ADMINISTRATION

2.1 Pre-treatment Screening

Prior to treating patients with CNS stimulants, including VYVANSE, assess for the presence of cardiac disease (e.g., a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2)].

To reduce the abuse of CNS stimulants including VYVANSE, assess the risk of abuse, prior to prescribing. After prescribing, keep careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and re-evaluate the need for VYVANSE use [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9)].

2.2 General Instructions for Use

Take VYVANSE by mouth in the morning with or without food; avoid afternoon doses because of the potential for insomnia. VYVANSE may be administered in one of the following ways:

Information for VYVANSE capsules:

  • Swallow VYVANSE capsules whole, or
  • Open capsules, empty and mix the entire contents with yogurt, water, or orange juice. If the contents of the capsule include any compacted powder, a spoon may be used to break apart the powder. The contents should be mixed until completely dispersed. Consume the entire mixture immediately. It should not be stored. The active ingredient dissolves completely once dispersed; however, a film containing the inactive ingredients may remain in the glass or container once the mixture is consumed.

Information for VYVANSE chewable tablets:

  • VYVANSE chewable tablets must be chewed thoroughly before swallowing.

VYVANSE capsules can be substituted with VYVANSE chewable tablets on a unit per unit/mg per mg basis (for example, 30 mg capsules for 30 mg chewable tablet) [see Clinical Pharmacology (12.3)].

Do not take anything less than one capsule or chewable tablet per day. A single dose should not be divided.

2.3 Dosage for Treatment of ADHD

The recommended starting dosage in adults and pediatric patients 6 years and older is 30 mg once daily in the morning. Dosage may be adjusted in increments of 10 mg or 20 mg at approximately weekly intervals up to maximum recommended dosage of 70 mg once daily [see Clinical Studies (14.1)].

2.4 Dosage for Treatment of Moderate to Severe BED in Adults

The recommended starting dosage in adults is 30 mg once daily to be titrated in increments of 20 mg at approximately weekly intervals to achieve the recommended target dose of 50 mg to 70 mg once daily. The maximum recommended dosage is 70 mg once daily [see Clinical Studies (14.2)]. Discontinue VYVANSE if binge eating does not improve.

2.5 Dosage in Patients with Renal Impairment

In patients with severe renal impairment (GFR 15 to < 30 mL/min/1.73 m2), the maximum dosage should not exceed 50 mg once daily. In patients with end stage renal disease (ESRD, GFR < 15 mL/min/1.73 m2), the maximum recommended dosage is 30 mg once daily [see Use in Specific Populations (8.6)].

2.6 Dosage Modifications due to Drug Interactions

Agents that alter urinary pH can impact urinary excretion and alter blood levels of amphetamine. Acidifying agents (e.g., ascorbic acid) decrease blood levels, while alkalinizing agents (e.g., sodium bicarbonate) increase blood levels. Adjust VYVANSE dosage accordingly [see Drug Interactions (7.1)].

3 DOSAGE FORMS AND STRENGTHS

VYVANSE ( lisdexamfetamine dimesylate) capsules:

  • Capsules 10 mg: pink body/pink cap (imprinted with S489 and 10 mg)
  • Capsules 20 mg: ivory body/ivory cap (imprinted with S489 and 20 mg)
  • Capsules 30 mg: white body/orange cap (imprinted with S489 and 30 mg)
  • Capsules 40 mg: white body/blue green cap (imprinted with S489 and 40 mg)
  • Capsules 50 mg: white body/blue cap (imprinted with S489 and 50 mg)
  • Capsules 60 mg: aqua blue body/aqua blue cap (imprinted with S489 and 60 mg)
  • Capsules 70 mg: blue body/orange cap (imprinted with S489 and 70 mg)

VYVANSE ( lisdexamfetamine dimesylate) chewable tablets:

  • Chewable tablets 10 mg: White to off-white round shaped tablet debossed with ’10’ on one side and ‘S489’ on the other
  • Chewable tablets 20 mg: White to off-white hexagonal shaped tablet debossed with ’20’ on one side and ‘S489’ on the other
  • Chewable tablets 30 mg: White to off-white arc triangular shaped tablet debossed with ’30’ on one side and ‘S489’ on the other
  • Chewable tablets 40 mg: White to off-white capsule shaped tablet debossed with ’40’ on one side and ‘S489’ on the other
  • Chewable tablets 50 mg: White to off-white arc square shaped tablet debossed with ’50’ on one side and ‘S489’ on the other
  • Chewable tablets 60 mg: White to off-white arc diamond shaped tablet debossed with ’60’ on one side and ‘S489’ on the other

4 CONTRAINDICATIONS

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 [see Adverse Reactions (6.2)].
  • 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 [see Warnings and Precautions (5.7) and Drug Interactions (7.1)].

5 WARNINGS AND PRECAUTIONS

5.1 Potential for Abuse and Dependence

CNS stimulants, including VYVANSE, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy [see Drug Abuse and Dependence (9.2, 9.3)].

5.2 Serious Cardiovascular Reactions

Sudden death, stroke, and myocardial infarction have been reported in adults with CNS stimulant treatment at recommended doses. Sudden death has been reported in pediatric patients with structural cardiac abnormalities and other serious heart problems taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during VYVANSE treatment.

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