Dosing information
In the monotherapy trials, INTUNIV was dosed once daily in the morning1
- Begin at a dose of 1 mg/day.1
- Titrate in increments of no more than 1 mg/week, depending on clinical response and tolerability.1
- Maintain dose within the range of 1 mg/day to 4 mg/day. Doses above 4 mg/day have not been studied in controlled studies.1
INTUNIV dosage strengths
- In the monotherapy trials, INTUNIV was dosed once daily in the morning1
- Tablets should not be crushed, chewed, or broken before swallowing, as this will increase the rate of guanfacine release1
- Do not administer with high-fat meals due to increased exposure to guanfacine1
- Do not substitute INTUNIV for immediate-release guanfacine on a mg-per-mg basis because of differing pharmacokinetic profiles1
- When discontinuing INTUNIV (guanfacine), taper the dose in decrements of no more than 1 mg every 3 to 7 days because of the potential for increases in blood pressure and heart rate after abrupt discontinuation1
Safety information
- Use caution when INTUNIV is administered to patients taking CYP3A4/5 inhibitors as the rate and extent of guanfacine exposure may increase. Consider a dose increase of INTUNIV when used concomitantly with CYP3A4 inducers as the rate and extent of guanfacine exposure may decrease. When INTUNIV is coadministered with valproic acid, monitor patients for potential additive CNS effects and consider monitoring for an increase in serum valproic acid concentrations. In these cases, dose adjustment may be necessary. Use caution when INTUNIV is administered concomitantly with antihypertensive drugs or CNS depressant drugs due to the potential for additive pharmacodynamic effects.
- INTUNIV is in Pregnancy Category B. INTUNIV should be used during pregnancy only if the potential benefit to the mother outweighs the potential risk to the fetus. It is not known whether guanfacine is excreted in human milk. Caution should be exercised when INTUNIV is administered to a nursing woman.
- Dose reduction may be required in patients with clinically significant hepatic or renal impairment.
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 (guanfacine) 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.