Focalin Xr

— THERAPEUTIC CATEGORIES —
  • ADHD
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Focalin Xr Generic Name & Formulations

    Legal Class

    CII

    General Description

    Dexmethylphenidate HCl (single-isomer methylphenidate) 5mg, 10mg, 15mg, 20mg, 25mg, 30mg, 35mg, 40mg; ext-rel caps (contains immediate-release + e-c del-rel beads).

    Pharmacological Class

    CNS stimulant.

    See Also

    How Supplied

    XR caps, tabs—100

    How Supplied

    Focalin XR Capsules are supplied in bottles of 100 and are available in the following strengths:

    • 5 mg capsules: light-blue, imprinted NVR D5

    • 10 mg capsules: light caramel, imprinted NVR D10

    • 15 mg capsules: green, imprinted NVR D15

    • 20 mg capsules, white, imprinted NVR D20

    • 25 mg capsules: light-blue and white, imprinted NVR D25

    • 30 mg capsules: light caramel and white, imprinted NVR D30

    • 35 mg capsules: light-blue and light caramel, imprinted NVR D35

    • 40 mg capsules: green and white, imprinted NVR D40

    Storage

    Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

    Manufacturer

    Novartis Pharmaceuticals Corp

    Generic Availability

    YES

    Mechanism of Action

    Dexmethylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynatic neuron and increase the release of these monoamines into the extraneuronal space. The mode of therapeutic action in ADHD is not known.

    Focalin Xr Indications

    Indications

    Attention deficit hyperactivity disorder.

    Focalin Xr Dosage and Administration

    Prior to Treatment Evaluations

    • Assess for the presence of cardiac disease (eg, a careful history, family history of sudden death or ventricular arrhythmia, and physical exam).

    • Assess the risk of abuse. After prescribing, keep prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and re-evaluate the need for Focalin XR use.

    Adult

    Take in the AM. Swallow whole or sprinkle contents onto applesauce (swallow immediately); do not crush, chew or divide beads. Initially 10mg once daily; may increase by 10mg weekly; max 40mg/day. Switching from racemic methylphenidate: give ½ of total daily racemic methylphenidate dose. Switching from immediate-release dexmethylphenidate: give same total daily dose.

    Children

    <6yrs: not established. Take in the AM. Swallow whole or sprinkle contents onto applesauce (swallow immediately); do not crush, chew or divide beads. Individualize. ≥6yrs: initially 5mg once daily; may increase by 5mg weekly; max 30mg/day. Switching from racemic methylphenidate: give ½ of total daily racemic methylphenidate dose. Switching from immediate-release dexmethylphenidate: give same total daily dose.

    Administration

    Swallow whole or may open and sprinkle contents onto applesauce (swallow immediately); do not crush, chew or divide beads.

    Nursing Considerations

    Swallow whole or may open and sprinkle contents onto applesauce (swallow immediately); do not crush, chew or divide beads. Alert patients or caregivers to monitor for appearance of or worsening of aggressive behavior or hostility.

    Focalin Xr Contraindications

    Contraindications

    During or within 14 days of MAOIs.

    Focalin Xr Boxed Warnings

    Boxed Warning

    Abuse and dependence.

    Boxed Warning

    Abuse and Dependence

    • High potential for abuse and dependence.

    • Assess the risk of abuse prior to prescribing and monitor during therapy.

    Focalin Xr Warnings/Precautions

    Warnings/Precautions

    High potential for abuse and dependence; monitor. Increased risk of sudden death, stroke, and MI; assess for presence of cardiac disease before initiating. Avoid in known structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, coronary artery disease, and other cardiac problems. Pre-existing psychotic disorder. Bipolar disorder. Screen for risk factors of developing a manic episode prior to initiation. Consider discontinuing if new psychotic/manic symptoms occur. Peripheral vasculopathy, including Raynaud's Phenomenon; monitor for digital changes. Monitor growth (esp. children), BP, HR. Reduce dose or discontinue if paradoxical aggravation of symptoms occur. Reevaluate periodically. Pregnancy. Nursing mothers: monitor infants.

    Warnings/Precautions

    Potential for Abuse and Dependence 

    • High potential for abuse and dependence.

    • Assess the risk of abuse prior to prescribing and monitor during therapy.

    Serious Cardiovascular Reactions 

    • Sudden death, stroke, and myocardial infarction have been reported in adults receiving CNS stimulants. Sudden death has been reported in pediatric patients with structural cardiac abnormalities and other serious heart problems receiving CNS stimulants.

    • Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, and other serious heart problems.

    • Evaluate further if exertional chest pain, unexplained syncope, or arrhythmias develop during treatment.

    Blood Pressure and Heart Rate Increases

    • Monitor all patients for potential tachycardia and hypertension.

    Psychiatric Adverse Reactions

    • Exacerbation of pre-existing psychosis: May exacerbate symptoms of behavior disturbance and thought disorders in patients with pre-existing psychotic behavior.

    • Induction of a manic episode in patients with bipolar disorder: May induce a mixed/manic episode in patients with bipolar disorder. Screen for risk factors for developing a manic episode prior to treatment (eg, comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, and depression).

    • New psychotic or manic symptoms: May cause psychotic or manic symptoms in patients without a history of psychotic illness or mania. Consider discontinuing if symptoms occur.

    Priapism

    • Prolonged and painful erections, sometimes requiring surgical intervention, have been reported.

    • Priapism has not been reported during drug initiation but developed after some time on the drug.

    • Seek immediate medical attention if priapism occurs.

    Peripheral Vasculopathy, including Raynaud’s Phenomenon

    • Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown.

    • These signs and symptoms generally improve after reduction in dose or discontinuation.

    • Observe carefully for digital changes during treatment. Evaluate further (eg, rheumatology referral) for certain patients.

    Long-Term Suppression of Growth 

    • In pediatric patients, closely monitor growth (weight and height).

    • May need to interrupt treatment in patients who are not growing or gaining height or weight as expected.

    Pregnancy Considerations

    Pregnancy Exposure Registry 

    • There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including Focalin XR, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visit https://womensmentalhealth.org/adhd-medications/.

    Risk Summary

    • Use in pregnant women have not identified a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. 

    • The estimated background risk of major birth defects and miscarriage is unknown.

    Clinical Considerations

    • Fetal/Neonatal Adverse Reactions: May cause vasoconstriction and may decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported, but premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. 

    Nursing Mother Considerations

    Risk Summary  

    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Focalin XR and any potential adverse effects on the breastfed infant from Focalin XR or from the underlying maternal condition. 

    Clinical Considerations

    • Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain. 

    Pediatric Considerations

    • The safety and efficacy of Focalin XR in pediatric patients less than 6 years have not been established.

    • The long-term efficacy of Focalin XR in pediatric patients has not been established.

    • Long-Term Suppression of Growth: Monitor growth during treatment with stimulants, including Focalin XR. May need to interrupt treatment in pediatric patients who are not growing or gaining weight as expected.

    Geriatric Considerations

    Focalin XR has not been studied in the geriatric population.

    Focalin Xr Pharmacokinetics

    Absorption

    Capsules

    • Time to first peak concentration: 1.5 hours (typical range, 1 to 4 hours). Mean time to the interpeak minimum and time to the second peak concentration: ~6.5 hours (range, 4.5 to 7 hours).

    Distribution

    Plasma protein binding of dexmethylphenidate is not known. Racemic methylphenidate is bound to plasma proteins by 12% to 15% (concentration-independent). Dexmethylphenidate has a volume of distribution of 2.65 ± 1.11 L/kg.

    Metabolism

    Hepatic. Dexmethylphenidate is metabolized primarily via de-esterification.

    Elimination

    Renal. Half-life: ~2.2 hours (tabs); 2–3 hours (XR caps).

    Focalin Xr Interactions

    Interactions

    See Contraindications. Hypertensive crisis with MAOIs. Avoid concomitant use with halogenated anesthetics (eg, halothane). Risk of serotonin syndrome with serotonergic drugs. May antagonize antihypertensive drugs (eg, K+-sparing or thiazide diuretics, CCBs, ACE inhibitors, ARBs, beta blockers, centrally acting alpha-2 receptor agonists); monitor and adjust dose of antihypertensives as needed. Concomitant risperidone may increase risk of extrapyramidal symptoms; monitor.

    Focalin Xr Adverse Reactions

    Adverse Reactions

    Dyspepsia, dry mouth, decreased appetite, headache, anxiety, pharyngolaryngeal pain, anorexia, nausea, abdominal pain, fever; weight loss, hypertension, tachycardia, priapism.

    Focalin Xr Clinical Trials

    Clinical Trials

    Pediatric Patients – Study 1

    The efficacy and safety of Focalin XR was established in a randomized, double-blind, placebo-controlled, parallel-group study in 103 pediatric patients aged 6 to 17 who met DSM-IV criteria for ADHD inattentive, hyperactive-impulsive or combined inattentive/hyperactive-impulsive subtypes. 

    Patients were randomly assigned to receive either a flexible-dose of Focalin XR (5 to 30mg/day) or placebo once daily for 7 weeks. The primary efficacy outcome measure was the mean change from baseline to endpoint using the DSM-IV total subscale score of the Conners ADHD/DSM-IV Scales for teachers (CADS-T), which includes the ADHD Index and the DSM-IV total subscale.

    Results showed that treatment with Focalin XR achieved a statsticalliy significant treatment effect for the CADS-T total scores compared with placebo (placebo-subtracted difference, 10.64 [95% CI, 5.38-15.91]).

     

    Pediatric Patients – Studies 2 and 3

    In the 2 crossover studies (Studies 2 and 3), pediatric patients aged 6 to 12 years received Focalin XR 20mg or placebo. Findings showed treatment with Focalin XR achieved statistically significant treatment effect compared with placebo according to the Swanson, Kotkin, Agler, M-Flynn & Pelham (SKAMP) rating scale total scores at all-time points after dosing in each study (0.5, 1, 3, 4, 5, 7, 9, 10, 11, and 12 hours in Study 2 and 1, 2, 4, 6, 8, 9, 10, 11, and 12 hours in the study 3). 

    In an additional study, the treatment effect of Focalin XR 20mg was seen 0.5 hours after administration in patients aged 6 to 12 years with ADHD.

     

    Adult Patients - Study 4

    The efficacy and safety of Focalin XR was established in a randomized, double-blind, placebo-controlled, parallel-group study in 221 adult patients aged 18 to 60 who met DSM-IV criteria for ADHD inattentive, hyperactive-impulsive or combined inattentive/hyperactive-impulsive subtypes. 

    Patients were randomly assigned to receive either a flexible-dose of Focalin XR (20, 30, or 40mg/day) or placebo once daily for 5 weeks. The primary efficacy outcome measure was the mean change from baseline to endpoint using the investigator-administered DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS).

    Results showed that all 3 Focalin XR doses achieved a statistically significant treatment effect compared with placebo.

    • Focalin XR 20mg/day: Placebo-subtracted difference, 5.71 (95% CI, 1.64-9.78).

    • Focalin XR 30mg/day: Placebo-subtracted difference, 5.31 (95% CI, 1.18-9.44).

    • Focalin XR 40mg/day: Placebo-subtracted difference, 8.96 (95% CI, 4.83-13.08).

    Focalin Xr Note

    Not Applicable

    Focalin Xr Patient Counseling

    Patient Counseling

    Controlled Substance Status/High Potential for Abuse and Dependence

    • Advise patients that Focalin XR can be abused and lead to dependence. Do not give Focalin XR to anyone else. Store Focalin XR in a safe place, preferably locked, to prevent abuse.

    Serious Cardiovascular Risks

    • Advise patients that there is a potential serious cardiovascular risk, including sudden death, myocardial infarction, stroke, and hypertension with Focalin XR use. Contact healthcare provider if patients experience symptoms, such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease.

    Blood Pressure and Heart Rate Increases 

    • May cause elevations to blood pressure and pulse rate.

    Psychiatric Risks

    • May cause psychotic or manic symptoms, even in patients without prior history of psychotic symptoms or mania.

    Priapism

    • May cause painful or prolonged penile erections. Seek immediate medical attention in the event of priapism.

    Circulation Problems in Fingers and Toes [Peripheral Vasculopathy, Including Raynaud’s Phenomenon] 

    • May cause peripheral vasculopathy, including Raynaud’s phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red. Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes. 

    • Contact physician immediately if any signs of unexplained wounds appear on fingers or toes during treatment.

    Suppression of Growth

    • May cause slowing of growth and weight loss.

    Pregnancy Registry

    • Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to ADHD medications, including Focalin XR, during pregnancy.

    Cost Savings Program

    Focalin XR Savings Card

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