Focalin (Page 5 of 6)

14 CLINICAL STUDIES

The efficacy of Focalin for the treatment of ADHD was established in two double-blind, parallel-group, placebo-controlled trials in untreated or previously treated patients (ages 6 to 17 years old) who met The Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD inattentive, hyperactive-impulsive, or combined inattentive/hyperactive-impulsive subtypes. The sample was predominantly younger (ages 6 to 12 years); thus, the findings are most pertinent to this age group.

In Study 1, patients were randomized to receive either Focalin (5, 10, or 20 mg/day total dose), racemic methylphenidate HCl (10, 20, or 40 mg/day total dose), or placebo in a multicenter, 4-week, parallel group study in 132 pediatric patients. Patients received study medication twice daily separated by a 3.5 to 5.5 hours interval. Treatment was initiated with the lowest dose, and doses could be doubled at weekly intervals, depending on clinical response and tolerability, up to the maximum dose. The primary outcome was change from baseline to week 4 of the average score (an average of 2 ratings during the week) of the teacher’s version of the Swanson, Nolan and Pelham (SNAP)-ADHD Rating Scale. This 18 item scale measures ADHD symptoms of inattention and hyperactivity/impulsivity, rated on a scale of 0 (Not at All) to 3 (Very Much). Patients treated with Focalin showed a statistically significant improvement in symptom scores from baseline over patients who received placebo (Table 3).

Table 3: Summary of Efficacy Results from ADHD Acute-Phase Study in Pediatric Patients (6 – 17 years) (Study 1)
Abbreviations: ADHD, attention deficit hyperactivity disorder; SD, standard deviation; SNAP; swanson, Nolan and Pelham; n, number of patients available at the assessment time point.a Average of two ratings.b Statistically significantly different from placebo.
Study Number Treatment Group Primary Efficacy Measure: Teacher SNAP-ADHD Total Scorea
Mean Baseline Score (SD) Mean Change from Baseline Week 4 Score (SD)
Study 1 Focalin 5-20 mg/dayb (n = 44) 1.4 (0.7) (n = 42) – 0.7 (0.7) (n = 42)
Placebo (n = 42) 1.6 (0.7) (n = 41) – 0.2 (0.7) (n = 39)

Study 2 was a multicenter, placebo-controlled, double-blind, 2-week treatment withdrawal study in 75 children (ages 6 to 12 years) who were responders during a 6-week, open-label initial treatment period. Children took study medication twice a day separated by a 3.5 to 5.5 hour interval. The primary outcome was proportion of treatment failures at the end of the 2-week withdrawal phase, where treatment failure was defined as a rating of 6 (much worse) or 7 (very much worse) on the Investigator Clinical Global Impression — Improvement (CGI-I). Patients continued on Focalin showed a statistically significant lower rate of failure over patients who received placebo (Table 4).

Table 4: Summary of Efficacy Results from ADHD Randomized Withdrawal Study in Pediatric Patients (6 – 17 years) (Study 2)
Abbreviation: ADHD, attention deficit hyperactivity disorder.a One patient did not have the value at Visit 10 and hence not included in this analysis.b Statistically significantly different from placebo.
Study Number Treatment Group Primary Efficacy Measure: Proportion of Treatment Failurea
Number of Treatment Failures / Number of Randomized Patients Percentage
Study 2 Focalin 5-20 mg/dayb 6/35 17.1%
Placebo 25/40 62.5%

16 HOW SUPPLIED/STORAGE AND HANDLING

Focalin (dexmethylphenidate hydrochloride) tablets (D-shaped, embossed “D” on upper convex face and dosage strength on lower convex face) are available as follows:

  • 2.5 mg tablets (NDC 0078-0380-05) blue, supplied in bottles of 100
  • 5 mg tablets (NDC 0078-0381-05) yellow, supplied in bottles of 100
  • 10 mg tablets (NDC 0078-0382-05) white, supplied in bottles of 100

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].

Dispense in tight, light-resistant container (USP).

Disposal

Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired Focalin by a medicine take-back program or by an authorized collector registered with the Drug Enforcement Administration. If no take-back program or authorized collector is available, mix Focalin with an undesirable, nontoxic substance to make it less appealing to children and pets. Place the mixture in a container, such as a sealed plastic bag and discard Focalin in the household trash.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Controlled Substance Status/High Potential for Abuse and Dependence

Advise patients that Focalin is a controlled substance, and it can be abused and lead to dependence. Instruct patients that they should not give Focalin to anyone else. Advise patients to store Focalin in a safe place, preferably locked, to prevent abuse. Advise patients to comply with laws and regulations on drug disposal. Advise patients to dispose of remaining, unused, or expired Focalin by a medicine take-back program if available [see Boxed Warning, Warnings and Precautions (5.1), Drug Abuse and Dependence (9.1, 9.2, 9.3), How Supplied/Storage and Handling (16)].

Serious Cardiovascular Risks

Advise patients that there is a potential serious cardiovascular risk, including sudden death, myocardial infarction, stroke, and hypertension with Focalin use. Instruct patients to contact a healthcare provider immediately if they develop symptoms, such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [see Warnings and Precautions (5.2)].

Blood Pressure and Heart Rate Increases

Instruct patients that Focalin can cause elevations of their blood pressure and pulse rate [see Warnings and Precautions (5.3)].

Psychiatric Risks

Advise patients that Focalin, at recommended doses, can cause psychotic or manic symptoms, even in patients without prior history of psychotic symptoms or mania [see Warnings and Precautions (5.4)].

Priapism

Advise patients of the possibility of painful or prolonged penile erections (priapism). Instruct them to seek immediate medical attention in the event of priapism [see Warnings and Precautions (5.5)].

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

Instruct patients beginning treatment with Focalin about the risk of 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.

Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking Focalin. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients [see Warnings and Precautions (5.6)].

Suppression of Growth

Advise patients that Focalin may cause slowing of growth and weight loss [see Warnings and Precautions (5.7)].

Pregnancy Registry

Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to ADHD medications, including Focalin, during pregnancy [see Use in Specific Populations (8.1)].

Distributed by:
Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936

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This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: June 2021
MEDICATION GUIDEFOCALIN® (foh-kuh-lin) (dexmethylphenidate hydrochloride) tablets CII
What is the most important information I should know about FOCALIN? FOCALIN is a federal controlled substance (CII) because it can be abused or lead to dependence. Keep FOCALIN in a safe place to prevent misuse and abuse. Selling or giving away FOCALIN may harm others, and is against the law. Tell your doctor if you or your child have abused or been dependent on alcohol, prescription medicines, or street drugs. The following have been reported with use of methylphenidate hydrochloride and other stimulant medicines: 1. Heart-related problems:• sudden death in patients who have heart problems or heart defects • stroke and heart attack in adults • increased blood pressure and heart rate Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.Your doctor should check you or your child carefully for heart problems before starting FOCALIN.Your doctor should check you or your child’s blood pressure and heart rate regularly during treatment with FOCALIN.Call your doctor right away if you or your child has any signs of heart problems, such as chest pain, shortness of breath, or fainting while taking FOCALIN. 2. Mental (psychiatric) problems:All Patients • new or worse behavior and thought problems • new or worse bipolar illness • new or worse aggressive behavior or hostility • new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking FOCALIN, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.
What is FOCALIN?
  • FOCALIN is a central nervous system stimulant (CNS) prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). FOCALIN may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
  • FOCALIN should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
Who should not take FOCALIN: FOCALIN should not be taken if you or your child:
  • are allergic to methylphenidate hydrochloride, or any of the ingredients in FOCALIN. See the end of this Medication Guide for a complete list of ingredients in FOCALIN.
  • are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor (MAOI).
FOCALIN may not be right for you or your child. Before starting FOCALIN, tell your or your child’s doctor about all health conditions (or a family history of), including:
  • heart problems, heart defects, high blood pressure
  • mental problems, including psychosis, mania, bipolar illness, or depression
  • circulation problems in fingers or toes
  • if you are pregnant or plan to become pregnant. It is not known if FOCALIN will harm your unborn baby.
    • There is a pregnancy registry for females who are exposed to ADHD medications, including FOCALIN during pregnancy. The purpose of the registry is to collect information about the health of females exposed to FOCALIN and their baby. If you or your child becomes pregnant during treatment with FOCALIN, talk to your healthcare provider about registering with the National Pregnancy Registry of ADHD medications at 1-866-961-2388 or visit online at https://womensmentalhealth.org/adhd-medications/.
  • if you are breastfeeding or plan to breastfeed. FOCALIN passes into your breast milk. Talk to your healthcare provider about the best way to feed the baby during treatment with FOCALIN.

Tell your doctor about all of the medicines that you or your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. FOCALIN and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking FOCALIN.

Your doctor will decide whether FOCALIN can be taken with other medicines.

Especially tell your doctor if you or your child takes:

  • anti-depression medicines, including MAOIs
  • blood pressure medicines (anti-hypertensives)

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.

  • You should not take FOCALIN on the day of your operation if a certain type of anesthetic is used. This is because there is a chance of a sudden rise in blood pressure and heart rate during the operation.

Do not start any new medicine while taking FOCALIN without talking to your doctor first.

How should FOCALIN be taken?
  • Take FOCALIN exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
  • Take FOCALIN twice daily, at least 4 hours apart.
  • FOCALIN may be taken with or without food.
  • From time-to-time, your doctor may stop FOCALIN treatment for a while to check ADHD symptoms.
  • Your doctor may do regular checks of the blood, heart, and blood pressure while taking FOCALIN.
  • Children should have their height and weight checked often while taking FOCALIN. FOCALIN treatment may be stopped if a problem is found during these check-ups.
  • In case of poisoning, call your poison control center at 1-800-222-1222 right away, or go to the nearest hospital emergency room.
What are the possible side effects of FOCALIN? FOCALIN may cause serious side effects, including: • see “What is the most important information I should know about FOCALIN?” for information on reported heart and mental problems.• painful and prolonged erections (priapism) have occurred with methylphenidate. If you or your child develops priapism, seek medical help right away. Because of the potential for lasting damage, priapism should be evaluated by a doctor immediately. • circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon): ◦ fingers or toes may feel numb, cool, painful ◦ fingers or toes may change color from pale, to blue, to red Tell your doctor if you or your child have, numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.• Call your doctor right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking FOCALIN. • Slowing of growth (height and weight) in children Common side effects include:
• abdominal pain • fever • anorexia • nausea
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store FOCALIN?
  • Store FOCALIN in a safe place and in a tightly closed container at room temperature between 68°F to 77°F (20°C to 25°C).
  • Protect from light.
  • Dispose of remaining, unused, or expired FOCALIN by a medicine take-back program at authorized collection sites, such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix FOCALIN with an undesirable, nontoxic substance, such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container, such as a sealed plastic bag and throw away (discard) FOCALIN in the household trash.
  • Keep FOCALIN and all medicines out of the reach of children.
General information about the safe and effective use of FOCALIN. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or doctor for information about FOCALIN that is written for healthcare professionals. Do not use FOCALIN for a condition for which it was not prescribed. Do not give FOCALIN to other people, even if they have the same symptoms that you have. It may harm them and it is against the law.
What are the ingredients in FOCALIN? Active ingredient: dexmethylphenidate hydrochlorideInactive ingredients: D&C Yellow Lake #10 (5 mg tablets), FD&C Blue No.1 #5516 aluminum lake (2.5 mg tablets), lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate; the 10 mg tablet contains no dye. Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936© NovartisFor more information, call 1-888-669-6682.

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