ADJUNCTIVE THERAPY
Treatment overview »
Some patients with ADHD may need more than a stimulant alone2-4
Efficacy information »
Once-daily INTUNIV in combination with a stimulant—significant ADHD symptom improvement vs. a stimulant alone1
Safety information »
Review the adverse event profile for INTUNIV as adjunctive therapy
Dosing information »
Learn how to dose and titrate once-daily INTUNIV as adjunctive therapy
MONOTHERAPY
Efficacy information »
Clinicians reported significant reduction of ADHD symptoms vs placebo based on ADHD-RS-IV total score, the primary efficacy measure1
Safety information »
Review the adverse event profile for INTUNIV as monotherapy
Dosing information »
Learn how to dose and titrate once-daily INTUNIV as monotherapy
Indication
- INTUNIV is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications in children and adolescents ages 6 to 17. The effectiveness of INTUNIV for more than 9 weeks has not been systematically evaluated. The physician electing to use INTUNIV for extended periods should periodically reevaluate its long-term usefulness for the individual patient.
- INTUNIV is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social).
Important Safety Information
- Patients with a history of hypersensitivity to INTUNIV, its inactive ingredients, or other products containing guanfacine (eg, TENEX®) should not take INTUNIV.
- Hypotension, bradycardia, and syncope were observed in clinical trials. Use INTUNIV with caution in treating patients who have experienced hypotension, heart block, bradycardia, or syncope, or who may have a condition that predisposes them to syncope; are treated concomitantly with antihypertensives or other drugs that can reduce blood pressure or heart rate or increase the risk of syncope. Heart rate and blood pressure should be measured prior to initiation of therapy, following dose increases, and periodically while on therapy. Advise patients to avoid becoming dehydrated or overheated.
- Somnolence and sedation were commonly reported adverse reactions in clinical studies (38% for INTUNIV vs. 12% for placebo in monotherapy studies and 18% for INTUNIV vs. 7% for placebo in the adjunctive study). The potential for additive sedative effects with CNS depressant drugs should be considered. Patients should be cautioned against operating heavy equipment or driving until they know how they respond to INTUNIV. Advise patients to avoid use with alcohol.
- Guanfacine, the active ingredient in INTUNIV, is also approved as an antihypertensive. Do not use INTUNIV in patients concomitantly taking other guanfacine-containing products (eg, TENEX®).
- The most common adverse reactions (incidence ≥5% and at least twice the rate for placebo) in the monotherapy trials with INTUNIV were somnolence, fatigue, nausea, lethargy, and hypotension, and in the adjunctive trial with INTUNIV were somnolence, fatigue, insomnia, dizziness, and abdominal pain.
Please see Full Prescribing Information.
REFERENCES
- INTUNIV [package insert]. Wayne, PA: Shire US Inc.
- Pliszka S and AACAP Work Group on Quality Issues. Practice parameter for the assessment and treatment of children and adolescents with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2007;46(7):894-921.
- American Academy of Pediatrics. Clinical practice guideline: treatment of the school-aged child with attention-deficit/hyperactivity disorder. Pediatrics. 2001;108(4):1033-1044.
- Pliszka SR, Crimson ML, Hughes CW, et al. The Texas Children’s Medication Algorithm Project: revision of the algorithm for pharmacotherapy of attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2006;45(6):642-657.