ility. The maximum dose should not exceed 4 mg/day ( and ). 2.77
USE IN SPECIFIC POPULATIONS
Hepatic or Renal Impairment: dose reduction may be required in patients with clinically significant impairment of hepatic or renal function ( ). 8.6
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 10/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 General Instruction for Use
2.2 Dose Selection
2.3 Switching from Immediate-Release Guanfacine to INTUNIV
2.4 Maintenance Treatment
2.5 Discontinuation
2.6 Missed Doses
2.7 Dose Adjustment with Concomitant Use of Strong CYP3A4 Inhibitors or Inducers
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypotension, Bradycardia, and Syncope
5.2 Sedation and Somnolence
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Post-marketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Use in Patients with Renal or Hepatic Impairment
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Safety and Efficacy Studies
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed.
1 INDICATIONS AND USAGE
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 [ ]. The effectiveness of INTUNIV for longer-term use (more than 8 weeks) has not been systematically eva luated in controlled trials. ®®®SEE CLINICAL STUDIES (14)®
2 DOSAGE AND ADMINISTRATION
2.1 General Instruction for Use
Do not administer with high fat meals, due to increased exposure. Swallow tablets whole. Do not crush, chew, or break tablets because this will increase the rate of guanfacine release.
2.2 Dose Selection
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 (14.1)
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 se |
