"The U.S. Food and Drug Administration today allowed marketing of the first medical device based on brain function to help assess attention-deficit/hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old. When used as part of "...
INTUNIV® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications. The efficacy of INTUNIV® was studied for the treatment of ADHD in three controlled monotherapy clinical trials (up to 8 weeks in duration) and one controlled adjunctive trial with psychostimulants (8 weeks in duration) in children and adolescents ages 6-17 who met DSM-IV® criteria for ADHD [see Clinical Studies]. The effectiveness of INTUNIV® for longer-term use (more than 8 weeks) has not been systematically evaluated in controlled trials.
DOSAGE AND ADMINISTRATION
General Instruction for Use
Swallow tablets whole. Do not crush, chew, or break tablets because this will increase the rate of guanfacine release. Do not administer with high fat meals, due to increased exposure.
INTUNIV should be taken once daily, either in the morning or evening, at approximately same time each day. Begin at a dose of 1 mg/day, and adjust in increments of no more than 1 mg/week. Maintain the dose within the range of 1 mg to 4 mg once daily, depending on clinical response and tolerability, for both monotherapy and adjunctive therapy to a psychostimulant. Doses above 4 mg/day have not been systematically studied in controlled clinical studies [see Clinical Studies].
Clinically relevant improvements were observed beginning at doses in the range 0.05-0.08 mg/kg once daily in both mono- and adjunctive therapy. Efficacy increased with increasing weight-adjusted dose (mg/kg). If well tolerated, doses up to 0.12 mg/kg once daily may provide additional benefit.
In clinical trials, there were dose-related and exposure-related risks for several clinically significant adverse reactions (hypotension, bradycardia, sedative events). Thus, consideration should be given to dosing INTUNIV® on a mg/kg basis, in order to balance the exposure-related potential benefits and risks of treatment.
Switching from Immediate-Release Guanfacine to INTUNIV
If switching from immediate-release guanfacine, discontinue that treatment, and titrate with INTUNIV® following above recommended schedule.
Do not substitute for immediate-release guanfacine tablets on a milligram-per-milligram basis, because of differing pharmacokinetic profiles. INTUNIV® has a delayed Tmax, reduced Cmax and lower bioavailability compared to those of the same dose of immediate-release guanfacine [see CLINICAL PHARMACOLOGY].
It is generally agreed that pharmacological treatment of ADHD may be needed for extended period. The effectiveness of INTUNIV® for longer-term use (more than 9 weeks) has not been systematically evaluated in controlled trials. Therefore the physician electing to use INTUNIV® for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
Infrequent, transient elevations in blood pressure above original baseline (i.e., rebound) have been reported to occur upon abrupt discontinuation of guanfacine. To minimize these effects, the dose should generally be tapered in decrements of no more than 1 mg every 3 to 7 days.
When reinitiating patients to the previous maintenance dose after two or more missed consecutive doses, physicians should consider titration based on patient tolerability.
Dose Adjustment with Concomitant Use of Strong CYP3A4 Inhibitors or Inducers
Dosage adjustments for INTUNIV® are recommended with concomitant use of strong CYP3A4 inhibitors (e.g., boceprevir, clarithromycin, conivaptan, grapefruit juice, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, and voriconazole), or CYP3A4 inducers (e.g., avasimibe, carbamazepine, phenytoin, rifampin, and St.John's wort) (Table 1) [see DRUG INTERACTIONS].
Table 1: Dose Adjustments in Patients Taking
Concomitant CYP3A4 Inhibitors or Inducers
|Initiate INTUNIV® when taking comedications||Continue INTUNIV® when adding a comedication||Stop a comedication when continuing INTUNIV®|
|Strong CYP3A4 Inhibitors||INTUNIV® dose should be limited to 2 mg/day||INTUNIV® dose should be decreased by half.||INTUNIV® dose should be doubled based on patient tolerability. The maximum dose should not exceed 4 mg/day|
|Strong CYP3A4 Inducers||INTUNIV® dose may be titrated up to 8 mg/day. Consider faster titration (e.g. in increments of 2 mg/week)||Consider increase INTUNIV® dose gradually in 1-2 weeks to 2 fold of the original dose based on patient tolerability.||INTUNIV® dose should be decreased by half in 1-2 weeks based on patient tolerability. The maximum dose should not exceed 4 mg/day|
Dosage Forms And Strengths
1 mg, 2 mg, 3 mg and 4 mg extended-release tablets
Storage And Handling
INTUNIV® is supplied in 1 mg, 2 mg, 3 mg, and 4 mg strength extended-release tablets in 100 count bottles.
|1 mg||2 mg||3 mg||4 mg|
|Debossment (top/bottom)||503 / 1mg||503 / 2mg||503 / 3mg||503 / 4mg|
Storage - Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). See USP Controlled Room Temperature.
Manufactured for Shire US Inc., Wayne, PA 19087. Revised: 02/2013
Last reviewed on RxList: 9/9/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Intuniv Information
Intuniv - User Reviews
Intuniv User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.