HELP ELIGIBLE
PATIENTS
SAVE
WITH A
$10 CO-PAY.*

*Limitations apply. Up to $720 annual
limit. Offer not valid under
Medicare,
Medicaid, or any other federal or state
program. Novartis
reserves the right to
rescind, revoke, or amend this program
without
notice. Limitations apply. Offer
not valid in MA and CA. See
complete
Terms & Conditions for details.

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FOCALIN XR® IS A CNS† STIMULANT PRESCRIPTION MEDICINE.

It is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). FOCALIN XR may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD. FOCALIN XR should be used as part of a total treatment program for ADHD that may include counseling or other therapies.

†Central Nervous System

FREQUENTLY ASKED QUESTIONS

What is the FOCALIN XR Co-Pay
Card Program?

If eligible, patients may pay as little as $10 out of pocket for their prescription by using the FOCALIN XR Co-Pay Card.

Patients can register and activate their co-pay card and present it along with a valid prescription for their medication at any participating pharmacy.

Reimbursement limited to $60 for a 30-day supply. If eligible, your patient pays $10 towards their co-pay, and Novartis will pay the next $60 of your patient's co-pay for a 30-day supply. Patients are then responsible for any additional remaining co-pay costs for that 30-day supply. The Novartis co-pay support of $60 per month cannot exceed an annual maximum of $720. For example: If the co-pay for FOCALIN XR is $80, your patient pays the initial $10, Novartis will then pay $60, and your patient will be responsible for the remaining co-pay balance of $10.

Novartis reserves the right to rescind, revoke, or amend the Program and discontinue support at any time without notice.

Where can my patient get a
FOCALIN XR Co-Pay Card?

Direct your patient to focalinxr.com to fill out the co-pay card registration form. If your patients are eligible, they can print a co-pay card.

Is everyone eligible for the FOCALIN
XR Co-Pay Card?

This offer is valid only for those with private insurance. This offer is not valid for:

  • Patients using Medicare, Medicaid, TRICARE, VA, DoD, or any other federal or state health care program

  • Residents of Massachusetts or California

  • Patients whose insurance plan reimburses for the entire cost of their prescription drug

This offer is not valid where prohibited by law. This offer is valid only in the United States and Puerto Rico.

Are there any other program
disclaimers my patient should be
aware of?

This program is not health insurance. The Program may not be combined with any third-party rebate, coupon, or offer. Novartis reserves the right to rescind, revoke, or amend the Program and discontinue support at any time without notice. The patient certifies responsibility for complying with any applicable limitations and requirements of their health plan related to the use of the Program.

My patient filled their prescription at
a pharmacy, but forgot to present
their
FOCALIN XR Co-Pay Card. Can
they be reimbursed?

In order to be reimbursed for a past prescription, patients must use the reimbursement form. Please remind your patients to save their pharmacy receipt, as this will be needed to receive a refund. The form includes instructions on where to send the completed information.

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IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION
AND INDICATIONS

WARNING: ABUSE AND DEPENDENCE

  • CNS stimulants, including FOCALIN XR, other methylphenidate-containing products, and amphetamines have a high potential for abuse and dependence

  • Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy

INDICATION

FOCALIN XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

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IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION
AND INDICATIONS

WARNING: ABUSE AND DEPENDENCE

  • CNS stimulants, including FOCALIN XR, other methylphenidate-containing products, and amphetamines have a high potential for abuse and dependence

  • Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy

INDICATION

FOCALIN XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

CONTRAINDICATIONS

  • Known hypersensitivity to methylphenidate or other components of FOCALIN XR. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate.

  • Concomitant treatment with monamine oxidase inhibitors (MAOIs) or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crises.

WARNINGS AND PRECAUTIONS

  • Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulant treatment at recommended doses. Sudden death has been reported in pediatric patients with structural cardiac abnormalities and other serious heart problems taking CNS stimulants at recommended doses. Avoid use in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, and other serious heart problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during treatment.

  • CNS stimulants cause an increase in blood pressure (mean increase approximately 2 to 4 mmHg) and heart rate (mean increase approximately 3 to 6 bpm). Individuals may have larger increases. Monitor all patients for hypertension and tachycardia.

  • Exacerbation of Preexisting Psychosis: CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychotic disorder.

    Induction of a Manic Episode in Patients with Bipolar Disorder: CNS stimulants may induce a manic or mixed mood episode. Prior to initiating treatment, screen patients for risk factors for developing manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression).

    New Psychotic or Manic Symptoms: CNS stimulants, at recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. If such symptoms occur, consider discontinuing FOCALIN XR.

  • Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products in both pediatric and adult patients. Priapism was not reported with drug initiation but developed after some time on the drug, often subsequent to an increase in dose. Priapism has also appeared during a period of drug withdrawal (drug holidays or during discontinuation). Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.

  • Stimulants, including FOCALIN XR, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud's phenomenon. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (including referral) may be appropriate.

  • CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor growth (weight and height) in pediatric patients. Patients not growing or gaining height or weight as expected may need to have their treatment interrupted.

ADVERSE REACTIONS

  • The most common adverse reactions (≥5% and twice the rate of placebo-treated patients):

    • Pediatric patients 6 to 17 years: dyspepsia, decreased appetite, headache, and anxiety

    • Adults: dry mouth, dyspepsia, headache, pharyngolaryngeal pain, and anxiety

USE IN SPECIFIC POPULATIONS

  • Pregnancy: FOCALIN XR used during pregnancy may cause fetal harm.

  • Lactation: Long-term neurodevelopmental effects on infants from stimulant exposure are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for FOCALIN XR and any potential adverse effects on the breastfed infant.

  • Pediatric Use: FOCALIN XR should not be used in children under 6 years of age, since safety and efficacy in this age group have not been established.

INDICATION

FOCALIN XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Please see full Prescribing Information, including Boxed WARNING, and Medication Guide.