About

This information guide provides context for using the Vyvanse® Dose Calculator. The calculator is designed to assist healthcare professionals by providing dosing recommendations based on FDA-approved prescribing information for Attention-Deficit/Hyperactivity Disorder (ADHD) and moderate to severe Binge Eating Disorder (BED) in adults. The guidance covers initial dosing, titration schedules, adjustments for renal impairment, and estimations for converting from other stimulants.

Outputs

Upon entering the patient’s clinical parameters, the calculator provides the following information:

• Standard Dosing: Recommended starting dose, titration schedule, and maximum daily dose based on the selected indication (ADHD or BED) and age group.
• Renal Impairment Adjustment: Specific maximum dose recommendations for patients with severe renal impairment or end-stage renal disease (ESRD).
• Stimulant Conversion Estimate: An approximate starting dose of Vyvanse for patients switching from Mixed Amphetamine Salts XR (Adderall XR®) or Methylphenidate ER (Concerta®). This is an estimation and requires clinical judgment.

How to Use

To use the calculator, follow these steps:

1. Select Indication: Choose either ADHD or Binge Eating Disorder. Note that BED is only indicated for adults.
2. Select Patient Age Group: Choose between Pediatric (6-17 years) or Adult (18+ years). This option is disabled if BED is selected.
3. (Optional) Add Renal Impairment: If applicable, check the box and select the patient’s level of renal function (Severe or ESRD) to see adjusted dose maximums.
4. (Optional) Add Stimulant Conversion: If switching from another medication, check the box and provide the previous stimulant and its total daily dose in milligrams.

Dosing Overview

Dosing should be individualized according to the therapeutic needs and response of the patient.

• ADHD (Adults and Pediatric Patients age 6 and older): The recommended starting dose is 30 mg once daily in the morning. The dose may be titrated in 10 mg or 20 mg increments at approximately weekly intervals. The maximum recommended dose is 70 mg/day.
• Binge Eating Disorder (Adults): The recommended starting dose is 30 mg once daily, titrated in 20 mg increments at weekly intervals to reach the target dose of 50 mg/day to 70 mg/day. The maximum recommended dose is 70 mg/day.

Switching

When switching from other stimulants, such as methylphenidate or other amphetamine products, discontinuation of the previous treatment is typically followed by titration with Vyvanse starting at 30 mg/day. The dose should then be adjusted based on clinical response. The calculator provides an estimate for conversion, but this is not a substitute for careful clinical assessment and monitoring during the transition period.

Missed Dose

If a dose of Vyvanse is missed, the patient should take the dose as soon as they remember. However, if it is late in the afternoon or evening, the missed dose should be skipped to avoid potential interference with sleep. The patient should not take an extra dose to make up for the missed one and should resume their regular schedule the next day.

Safety Alerts

Vyvanse has a high potential for abuse and dependence. Healthcare providers should assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence during therapy. Additionally, prescribers should be aware of key warnings and precautions, including:

• Serious Cardiovascular Reactions: Sudden death has been reported in association with CNS stimulant treatment at recommended doses in pediatric and adult patients with structural cardiac abnormalities or other serious heart problems.
• Blood Pressure and Heart Rate Increases: Stimulants cause an increase in blood pressure and heart rate; monitor all patients for potential tachycardia and hypertension.
• Psychiatric Adverse Reactions: May cause psychotic or manic symptoms in patients with no prior history, or exacerbate symptoms of pre-existing psychiatric illness.

Frequently Asked Questions

1. Why is the pediatric option disabled for Binge Eating Disorder?
   Vyvanse is only FDA-approved for the treatment of moderate to severe Binge Eating Disorder in adults. Its safety and efficacy have not been established in pediatric patients for this indication.
2. What is the maximum dose for a patient with severe renal impairment?
   According to the prescribing information, the maximum recommended dose for patients with severe renal impairment (eGFR 15 to < 30 mL/min/1.73 m²) is 50 mg/day.
3. What is the maximum dose for a patient with ESRD?
   For patients with End-Stage Renal Disease (eGFR < 15 mL/min/1.73 m²), the maximum recommended dose is 30 mg/day.
4. How does the calculator estimate the conversion from Concerta®?
   The estimation is based on approximate dose equivalency principles where Vyvanse potency is compared to methylphenidate. It serves as a clinical reference point, not a direct substitution. The standard recommendation is to begin Vyvanse at 30 mg and titrate regardless of the prior stimulant dose.
5. Can I use this calculator for patients switching from Adderall® IR?
   The calculator specifically models conversions from extended-release formulations (Adderall XR® and Concerta®). Clinical judgment is required for converting from immediate-release stimulants.
6. What are the available strengths of Vyvanse?
   Vyvanse is available as capsules and chewable tablets in strengths of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg.
7. Does the tool account for hepatic impairment?
   No, the tool does not provide adjustments for hepatic impairment as no specific guidance is provided in the FDA-approved prescribing information.
8. Is this information a substitute for the full prescribing information?
   No. This tool and its accompanying information are for educational purposes only and are not a substitute for clinical judgment or the full, official FDA-approved prescribing information, which should always be consulted.

References

1. VYVANSE® (lisdexamfetamine dimesylate) Prescribing Information. Takeda Pharmaceuticals America, Inc. U.S. Food and Drug Administration. Revised: 10/2023.
2. Vyvanse® for Healthcare Professionals. Takeda Pharmaceuticals. Accessed 2024.
3. Drugs@FDA: FDA-Approved Drugs – Vyvanse (NDA 021977). U.S. Food and Drug Administration.
4. Goodman, D. W. (2010). Lisdexamfetamine Dimesylate (Vyvanse), A Prodrug Stimulant for Attention-Deficit/Hyperactivity Disorder. Pharmacy and Therapeutics, 35(5), 273–287.