Efficacy in combination with stimulant1
When added to stimulant therapy, clonidine XR showed up to 37% improvement over placebo in ADHD-RS-IV scores.1 ONYDA™ XR (clonidine HCI) can improve ADHD symptom control in patients treated with stimulants.2
Significant improvement when added to stimulant therapy1
Study design: 8-week randomized, double-blind, placebo-controlled, parallel-group flexible dose study in pediatric patients 6 to 17 years (N=198) with ADHD, who had an inadequate stimulant medication response after at least 4 weeks on a stable stimulant regimen. Patients were randomly assigned to receive clonidine XR or placebo in addition to the patient’s normal regimen of stimulant. Patients underwent 8 weeks of flexible dose escalation and dose tapering. The primary efficacy endpoint was met, as patients in the clonidine XR + stimulant group had significant greater improvement from baseline to week 5 in ADHD-RS-IV total score versus placebo + stimulant (p = 0.009).1
Power-up with significant improvements in inattention and hyperactivity/impulsivity
Significant improvements in efficacy assessment from baseline to week 5 when added to stimulant1
Pair-up with either stimulant class
Efficacy assessment from baseline to week 5 for clonidine XR vs placebo when added to stimulant therapy1
ADHD, Attention Deficit Hyperactivity Disorder; ADHD-RS-IV, ADHD Rating Scale-IV
REFERENCES: 1. Kollins SH, Jain R, Brams M, Segal S, Findling RL, Wigal SB, Khayrallah M. Clonidine extended-release tablets as add-on therapy to psychostimulants in children and adolescents with ADHD. Pediatrics. 2011 Jun;127(6):e1406-13. 2. ONYDA XR [package insert]. Tris Pharma, Inc., Monmouth Junction, NJ.
Efficacy as monotherapy
Studies of clonidine XR showed improvement over placebo in ADHD-RS-IV scores.1 ONYDA™ XR (clonidine HCI) can improve symptom control in patients.2
Significant improvements when used as monotherapy1
Study design: 8-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study, with primary efficacy endpoint measured at 5 weeks. A total of 236 children and adolescents (6-17 years of age) who met DSM-IV criteria for ADHD hyperactive or combined inattentive/hyperactive subtypes were randomized to 1 of 3 treatment groups: clonidine XR 0.2 mg/day (n=78), clonidine XR 0.4 mg/day (n=80), or placebo (n=78). Dosing for the clonidine XR groups started at 0.1 mg/day and a weekly titration schedule was used to escalate patients to their respective fixed dose. Patients were maintained at their dose levels for a minimum period of 2 weeks before being gradually tapered down to 0.1 mg/day at the last week of treatment. At both doses, improvements in ADHD-RS-IV total score from baseline to week 5 were statistically significantly greater in patients treated with clonidine XR compared with those taking placebo (p < 0.0001).1
ADHD, Attention Deficit Hyperactivity Disorder; ADHD-RS-IV, ADHD Rating Scale-IV
REFERENCES: 1. Jain R, Segal S, Kollins SH, Khayrallah M. Clonidine extended-release tablets for pediatric patients with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2011 Feb;50(2):171-9. 2. ONYDA XR [package insert]. Tris Pharma, Inc., Monmouth Junction, NJ.
ONYDA™ XR (clonidine HCI) is a centrally acting alpha2-adrenergic agonist indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to central nervous system (CNS) stimulant medications in pediatric patients 6 years of age and older.
See Additional Important Safety Information.INDICATION
ONYDA™ XR (clonidine HCI) is a centrally acting alpha2-adrenergic agonist indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to central nervous system (CNS) stimulant medications in pediatric patients 6 years of age and older.
IMPORTANT SAFETY INFORMATION
Contraindications:
ONYDA XR is contraindicated in patients with history of a hypersensitivity reaction to clonidine.
Warnings & Precautions:
- Hypotension/Bradycardia: Treatment with ONYDA XR can cause dose-related decreases in blood pressure and heart rate. Titrate slowly and monitor vital signs frequently in patients at risk for hypotension, heart block, bradycardia, syncope, cardiovascular disease, vascular disease, cerebrovascular disease, or chronic renal failure. In patients who have a history of syncope or may have a condition that predisposes them to syncope, such as hypotension, orthostatic hypotension, bradycardia, or dehydration, advise patients to avoid becoming dehydrated or overheated.
- Somnolence/Sedation: Somnolence and sedation were commonly reported adverse reactions in clinical studies with clonidine hydrochloride extended-release tablets. Caution patients against operating heavy equipment or driving until they know how they respond to treatment with ONYDA XR. Advise patients to avoid use with alcohol.
- Rebound Hypertension: Abrupt discontinuation of ONYDA XR can cause rebound hypertension. Withdrawal symptoms include headache, tachycardia, nausea, flushing, warm feeling, brief lightheadedness, tightness in chest, and anxiety. To minimize the risk of rebound hypertension, gradually reduce the dose of ONYDA XR in decrements of no more than 0.1 mg every 3 to 7 days Patients should be instructed not to discontinue ONYDA XR therapy without consulting their physician due to the potential risk of withdrawal effects.
- Cardiac Conduction Abnormalities:: The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs. There have been post-marketing reports of patients with conduction abnormalities and/or taking other sympatholytic drugs who developed severe bradycardia requiring intravenous (IV) atropine, IV isoproterenol, and temporary cardiac pacing while taking clonidine. Titrate ONYDA XR slowly and monitor vital signs frequently in patients with cardiac conduction abnormalities or patients concomitantly treated with other sympatholytic drugs.
Adverse Reactions:
- Most common adverse reactions (incidence at least 5% and twice the rate of placebo) as monotherapy in ADHD: somnolence, fatigue, irritability, nightmare, insomnia, constipation, dry mouth.
- Most common adverse reactions (incidence at least 5% and twice the rate of placebo) as adjunct therapy to psychostimulant in ADHD: somnolence, fatigue, decreased appetite, dizziness.
Clinically Important Drug Interactions:
- CNS Depressants: Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates, or other sedating drugs. Avoid concomitant use of CNS depressants with ONYDA XR.
- Tricyclic Antidepressants: Concomitant use of tricyclic antidepressants with clonidine can increase blood pressure and may counteract the hypotensive effects of clonidine. Monitor blood pressure and adjust dosage of ONYDA XR as needed.
- Drugs Known to Affect Sinus Node Function or AV Nodal Conduction: Avoid use of ONYDA XR with agents known to affect sinus node function or AV nodal conduction (e.g., digitalis, calcium channel blockers, and beta-blockers) due to a potential for additive effects such as bradycardia and AV block.
- Antihypertensive Drugs: Concomitant use of antihypertensive drugs with clonidine potentiates the hypotensive effects of clonidine. Monitor blood pressure and heart rate and adjust dosage of ONYDA XR accordingly in patients treated concomitantly with antihypertensives.
Use in Specific Populations:
- Use in Patients with Renal Impairment: The impact of renal impairment on the pharmacokinetics of clonidine in pediatric patients has not been assessed. The dosage of ONYDA XR must be adjusted according to the degree of impairment, and patients should be carefully monitored.
- Use During Pregnancy: Prolonged experience with clonidine in pregnant women over several decades, based on published literature—including controlled trials, a retrospective cohort study, and case reports—has not identified a drug-associated risk of major birth defects, miscarriage, and adverse maternal or fetal outcomes.
To monitor pregnancy outcomes in women exposed to ADHD medications, including ONYDA XR, during pregnancy, healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/adhd-medications/. - Use During Lactation: The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ONYDA XR and any potential adverse effects on the breastfed child from ONYDA XR or from the underlying maternal condition. Monitor breastfeeding infants exposed to ONYDA XR through breast milk for symptoms of hypotension and/or bradycardia such as sedation, lethargy, tachypnea, and poor feeding.
To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at 1-732-940-0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see ONYDA XR PI for Full Prescribing Information.
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