INTUNIV XR 1 MG — DIN 02409100

What is INTUNIV XR?

INTUNIV XR 1 MG contains GUANFACINE (GUANFACINE HYDROCHLORIDE) : 1 MG. It is listed in the Health Canada Drug Product Database under DIN 02409100, held by TAKEDA CANADA INC, supplied as TABLET (EXTENDED-RELEASE) for ORAL administration. Health Canada currently lists it as marketed, status dated 24-Aug-2021. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is INTUNIV XR used for?

INTUNIV XR (guanfacine hydrochloride extended-release tablets) is indicated as: • monotherapy for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years. • adjunctive therapy to psychostimulants for the treatment of ADHD in children and adolescents, aged 6 to 17 years, with a sub-optimal response to psychostimulants. Need for Comprehensive Treatment Program INTUNIV XR is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational/vocational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Drug treatment is not intended for use in a patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational/vocational placement is essential for patients with this diagnosis and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe drug treatment will depend upon the physician's assessment of the chronicity and severity of the child's symptoms and on the level of functional impairment. Long-term Use The effectiveness of INTUNIV XR for long-term use, i.e., for more than 9 weeks in 6-12 year olds and more than 15 weeks in 13-17 year olds, has not been systematically evaluated in controlled monotherapy trials, nor has it been systematically evaluated in controlled adjunctive trials for longer than 9 weeks in 6-17 year olds. Therefore the physician electing to use INTUNIV XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

The tablets should not be administered with high-fat meals, due to increased exposure. Do not substitute for immediate-release guanfacine tablets on a milligram for milligram basis, because of differing pharmacokinetic profiles. The safety and efficacy of INTUNIV XR in pediatric patients less than 25 kg/55 lbs in weight have not been studied. Heart rate and blood pressure should be monitored at baseline, after dose adjustments, periodically during treatment and following drug discontinuation. Advise patients that sedation can occur, particularly early in treatment or with dose increases. If sedation is judged to be clinically concerning or persistent, a dose decrease or discontinuation should be considered. Recommended Dose and Dosage Adjustment (Children 6-17 years old): The recommended starting dose for both INTUNIV XR monotherapy and adjunct therapy to psychostimulants is 1 mg, taken orally once a day (morning or evening). The dose should be adjusted, depending on clinical response and tolerability, in increments of no more than 1 mg per week up to a maximum daily dose of 4 mg (6-12 years) or 7 mg (13-17 years), for monotherapy and up to a maximum daily dose of 4 mg for adjunctive therapy to psychostimulants. The recommended dose range, depending on clinical response and tolerability for INTUNIV XR, is 0.05-0.12 mg/kg/day (total daily dose 1-7 mg). Administration: INTUNIV XR is an extended-release tablet and should be dosed once daily. Tablets should not be crushed, chewed or broken before swallowing because this will increase the rate of guanfacine release. The initial starting dose for INTUNIV XR as an adjunctive therapy with psychostimulants is 1 mg, taken orally once a day; evening dosing may be considered. Missed Dose: If two or more consecutive doses are missed, re-titration is recommended based on the patient's tolerability to INTUNIV XR. Discontinuing Treatment: Patients/caregivers should be instructed not to discontinue INTUNIV XR without consulting their physician. The total daily dose should be tapered in decrements of no more than 1 mg every 3 to 7 days to minimize the risk of an increase in blood pressure upon discontinuation. Patients should be monitored during dose downward titration and following INTUNIV XR discontinuation until blood pressure and heart rate have returned to baseline.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

INTUNIV XR is contraindicated in patients with a history of hypersensitivity to this drug, to any ingredient in the formulation, to any other product containing guanfacine, or component of the container.

Warnings and precautions

Somnolence and Sedation: Sedative events, especially during initial use, were commonly reported adverse reactions in clinical trials. INTUNIV XR should be dosed based on clinical response and tolerability. Advise patients that sedation can occur, particularly early in treatment or with dose increases. If sedation is judged to be clinically concerning or persistent, a dose decrease or discontinuation should be considered. Before INTUNIV XR is used with other centrally active depressants (such as phenothiazines, barbiturates, or benzodiazepines), the potential for additive sedative effects should be considered. Patients should avoid use with alcohol. Cardiovascular: INTUNIV XR can cause syncope and dose-dependent decreases in heart rate and blood pressure (systolic and diastolic). Measurements of heart rate and blood pressure should be performed prior to initiating therapy, following dose adjustments, periodically during treatment and following drug discontinuation. Caution is advised if using INTUNIV XR in patients who have a history of hypotension, heart block, bradycardia, or other cardiovascular disease (e.g., arrhythmia, sick sinus syndrome, ischemic heart disease, congestive heart failure, or congenital long QT syndrome), as INTUNIV XR can decrease blood pressure and heart rate. Caution is advised when treating patients with INTUNIV XR who have a history of syncope or a condition that may predispose them to syncope, such as hypotension, orthostatic hypotension, bradycardia, or dehydration. Caution is advised when treating patients with INTUNIV XR who are being treated concomitantly with antihypertensives or other drugs that reduce blood pressure or heart rate, QT prolonging drugs, and drugs that increase the risk of syncope. Patients/caregivers should be advised that patients should avoid becoming dehydrated or overheated. Elevated Blood Pressure and Heart Rate Upon Discontinuation: Patients/caregivers should be instructed not to discontinue INTUNIV XR without consulting their physician since elevations in blood pressure and heart rate above original baseline (i.e., rebound) have been reported. In post-marketing experience, hypertensive encephalopathy has been very rarely reported upon abrupt discontinuation of INTUNIV XR. To minimize the risk of an increase in blood pressure upon discontinuation, the total daily dose of INTUNIV XR should be tapered in decrements of no more than 1 mg every 3 to 7 days. Patients should be monitored during dose downward titration and following INTUNIV XR discontinuation until blood pressure and heart rate have returned to baseline. Patients/caregivers should be informed about the risk of persistent hypertension following discontinuation, how to identify signs and symptoms (e.g. headaches, feeling confused, nervousness, agitation, and tremors) and to seek immediate medical care. Because of the psychostimulant potential for increasing blood pressure and heart rate, there is a theoretical increased risk of rebound or a risk of greater rebound when discontinuing INTUNIV XR treatments in patients on adjunctive therapy. Caution is warranted if a patient stops INTUNIV XR while maintaining its psychostimulant therapy. Use caution when prescribing drugs that can elevate blood pressure and heart rate immediately following INTUNIV XR discontinuation. QTc Interval: QTc increase (placebo-adjusted mean change from baseline approximately 5 msec) has been observed in patients aged 6-17 years with ADHD receiving therapeutic doses of INTUNIV XR at steady-state. In clinical trials of INTUNIV XR in ADHD patients, there were no reports of torsade de pointes. Given the effect of INTUNIV XR on cardiac electrophysiology, consider this observation in clinical decisions to prescribe INTUNIV XR to patients with a known history of QT prolongation, risk factors for torsades de pointes (e.g. heart block, bradycardia, hypokalemia) or patients who are taking medications known to prolong the QT interval. Psychiatric: Ad