Print this page and take it to your pharmacy with your prescription.


This program provides prescription
coverage assistance information and
prescription refill reminders.

004682

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EC85002003

58641579186



PLEASE INCLUDE A MEDICATION GUIDE WITH EACH TROKENDI XR™ PRESCRIPTION.

TERMS & CONDITIONS

This offer is good for commercially insured and cash-paying patients purchasing Tronkendi XR™ extended-release capsules and may not be used for any other product. This offer is not valid for prescriptions purchased under Medicaid, Medicare or other federal or state programs (such as medical assistance programs). Offer not valid where prohibited by law, taxed, or restricted. It is not transferable and may not be combined with any other offer. The amount of the rebate cannot exceed the patient's actual out-of-pocket expenses up to a maximum of $150 per prescription. Offer must be presented along with a valid prescription for Trokendi XR™ at the time of purchase. By enrolling into this program you are consenting to the collection and use of certain personal information including your phone number and/or email address and elements of pharmacy claim information. This information will be collected and used by service providers of Supernus Pharmaceuticals, Inc. (“Supernus”), in order to administer this program. This information is not provided to Supernus directly. If you do not consent, please do not enroll into the program. If you require additional assistance, please call 1-866-398-0833. This offer expires 12/31/2014. Supernus reserves the right to rescind, revoke, or amend this offer without notice at any time.


PATIENT INSTRUCTIONS

This card is provided to you as a service by your doctor and Supernus Pharmaceuticals, Inc. The patient should present a valid prescription for Trokendi XR™ (topiramate) extended-release capsules when redeeming this card. Prescriber ID# required on prescription. This card is valid towards out-of-pocket expenses for Trokendi XR™. If the patient’s total cost per prescription is more than $15, this program will cover the amount above $15 (up to a maximum of $150 per prescription) on each of the next 12 prescriptions for up to a 30-day supply of Trokendi XR™ of any dosage strength filed. Patients with questions please call 1-866-398-0833.


PHARMACY INSTRUCTIONS

Pharmacist instructions for a patient with an Eligible Third Party: Submit the claim to the primary Third Party Payer first, then submit the balance due to Therapy First Plus as a Secondary Payer COB (coordination of benefits) with patient responsibility amount and a valid Other Coverage Code (eg, 8). The patient pays the first $15. This program will cover the amount above $15 (up to a maximum of $150 per prescription) on 12 prescriptions for up to a 30-day supply of Trokendi XR™ of any dosage strength filed. Reimbursement will be received from Therapy First Plus. Please include a Medication Guide with each Trokendi XR™ prescription.


Pharmacist instructions for a cash paying patient: Submit the claim to Therapy First Plus. A valid Other Coverage Code (eg, 1) is required. The patient pays the first $15. This program will cover the amount above $15 (up to a maximum of $150 per prescription) on 12 prescriptions for up to a 30-day supply of Trokendi XR™ of any dosage strength filed. Reimbursement will be received from Therapy First Plus.


For any questions regarding Therapy First Plus online processing, please call the Help Desk at 1-800-422-5604.


Offer expires 12/31/2014. Limit one card per patient. Offer not valid for prescriptions reimbursed under Medicaid, a Medicare drug benefit plan or other federal or state programs (such as medical assistance programs). If you are eligible for drug benefits under any such program, you cannot use this card. Program managed by PSKW, LLC on behalf of Supernus Pharmaceuticals, Inc. The parties reserve the right to amend or terminate this program at any time without notice. Product dispensed only pursuant to program rules and federal and state laws.


This is not insurance.


Patients with questions?


Visit www.TrokendiXR.com


Trokendi XR™ (topiramate) extended-release capsules for oral use

INDICATION
Trokendi XR is indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures and adjunctive therapy in patients 6 years of age and older with partial onset or primary generalized tonic-clonic seizures. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials.
Trokendi XR is indicated as adjunctive therapy in patients 6 years of age and older with seizures associated with Lennox-Gastaut syndrome.
 
IMPORTANT SAFETY INFORMATION


CONTRAINDICATIONS
Trokendi XR is contraindicated in patients with recent alcohol use (within 6 hours prior to and 6 hours after Trokendi XR use), and also in patients with metabolic acidosis who are taking concomitant metformin.

WARNINGS & PRECAUTIONS
A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving topiramate. Symptoms can include acute onset of decreased visual acuity and/or ocular pain, myopia, anterior chamber shallowing, ocular hyperemia, and increased intraocular pressure. Symptoms typically occur within 1 month of initiating topiramate therapy. The primary treatment to reverse symptoms is discontinuation of Trokendi XR as rapidly as possible. Elevated intraocular pressure of any etiology, if left untreated, can lead to serious sequelae including permanent vision loss.
Oligohydrosis resulting in hospitalization has been reported in some cases in association with topiramate use. The majority of reports have been in pediatric patients. Patients, especially pediatric patients, should be monitored closely for evidence of decreased sweating and increased body temperature, especially in hot weather. Caution should be used when Trokendi XR is prescribed with other drugs that predispose patients to heat-related disorders.
Hyperchloremic, non-anion gap, and metabolic acidosis has been reported in adults and pediatric patients treated with topiramate. This metabolic acidosis is caused by renal bicarbonate loss due to the inhibitory effect of topiramate on carbonic anhydrase. Conditions that predispose patients to acidosis may be additive to the bicarbonate lowering effects of topiramate. Although Trokendi XR is not approved for children under 6 years of age, a study of topiramate as adjunctive treatment in patients under 2 produced metabolic acidosis of a notably greater magnitude than in older children and adults. Measurement of baseline and periodic serum bicarbonate during topiramate treatment is recommended. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing topiramate.
In vitro data show that, in the presence of alcohol, the pattern of topiramate release from Trokendi XR capsules is significantly altered. Alcohol use should be completely avoided within 6 hours prior to and 6 hours after Trokendi XR administration.
Antiepileptic drugs (AEDs) increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED, including Trokendi XR for any indication, should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Anyone prescribing Trokendi XR must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which antiepileptic drugs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during Trokendi XR treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated. Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.
Adverse reactions most often associated with use of topiramate, and therefore expected to be associated with the use of Trokendi XR, were related to the central nervous system (CNS) and were observed in the epilepsy population. In adults, the most frequent of these can be classified into three general categories: cognitive-related dysfunction, psychiatric/behavioral disturbances, and somnolence or fatigue. Additional nonspecific CNS events observed with topiramate in the adjunctive epilepsy population include dizziness or ataxia. In double-blind adjunctive and monotherapy epilepsy clinical studies conducted with topiramate, the incidence of cognitive/neuropsychiatric adverse reactions in pediatric patients were generally lower than observed in adults.
Topiramate can cause fetal harm when administered to a pregnant woman. Use during pregnancy and data from pregnancy registries indicate that infants exposed to topiramate in utero can have increased risk of cleft lip and/or cleft palate. Trokendi XR should only be used during pregnancy if the potential benefit outweighs the potential risk. Patients should be informed of the potential hazard to the fetus.
Antiepileptic drugs, including Trokendi XR, should be gradually withdrawn to minimize the potential for seizures or increased seizure frequency.
Hyperammonemia with and without encephalopathy has been observed in post-marketing reports in patients who were taking topiramate with or without concomitant valproic acid (VPA); hyperammonemia appears more common when used concomitantly with VPA. Although Trokendi XR is not indicated for use in infants or toddlers, topiramate with concomitant VPA produced a dose-related increase in hyperammonemia in this population.
The concomitant use of Trokendi XR with any other drug producing metabolic acidosis, or potentially in patients on a ketogenic diet, may increase the risk of kidney stone formation, and should therefore be avoided.
Hypothermia has been reported in association with topiramate use with concomitant valproic acid (VPA) both in the presence and in the absence of hyperammonemia. Consideration should be given to stopping topiramate or valproate in patients who develop hypothermia; clinical management should include examination of blood ammonia levels.
Paresthesia, an effect associated with the use of other carbonic anhydrase inhibitors, appears to be a common effect of topiramate, and was more frequently reported in monotherapy epilepsy trials with topiramate than adjunctive therapy epilepsy trials.
Topiramate is a CNS depressant. Concomitant administration of topiramate with other CNS depressant drugs can result in significant CNS depression. Patients should be watched carefully when Trokendi XR is coadministered with other CNS depressant drugs.

DOSING GUIDELINES & CONSIDERATIONS
Refer to the Trokendi XR - DOSAGE AND ADMINISTRATION section of the full prescribing information for recommended dosing guidelines for Trokendi XR monotherapy and adjunctive therapy use.
In patients with renal impairment (creatinine clearance less than 70 mL/min/1.73 m2), one-half of the usual adult dose is recommended. Such patients will require a longer time to reach steady-state at each dose.
In patients undergoing hemodialysis, to avoid rapid drops in topiramate plasma concentration, a supplemental dose of topiramate may be required. The actual adjustment should take into account the duration of dialysis period, clearance rate of the dialysis system being used, and the effective renal clearance of topiramate in the patient being dialyzed.
Addition or withdrawal of phenytoin and/or carbamazepine during adjunctive therapy with Trokendi XR may require adjustment of the dose of Trokendi XR.
Trokendi XR can be taken without regard to meals. Swallow capsule whole and intact. Do not sprinkle on food, chew, or crush.

ADVERSE REACTIONS
Trokendi XR has not been studied in a randomized, placebo-controlled phase 3 clinical study in the epilepsy patient population; however, it is expected that Trokendi XR would produce a similar adverse reaction profile as that of immediate-release topiramate. See the ADVERSE REACTIONS section of the Trokendi XR full prescribing information for further adverse reaction rates from the clinical trials conducted under widely varying conditions.
In adjunctive therapy trials, the most common adverse reactions of topiramate at dosages of 200 to 400 mg/day in adults that did not appear to be dose-related were somnolence (29% v 12%, 200 to 400 mg/day v placebo, respectively), ataxia (16% v 7%), speech disorders/related speech problems (13% v 2%), psychomotor slowing (13% v 2%), vision abnormal (13% v 2%), difficulty with memory (12% v 3%), paresthesia (11% v 4%), and diplopia (10% v 5%). The most common dose-related adverse reactions at dosages of 400 mg/day in adults with partial onset seizures were fatigue (12% v 13%, topiramate v placebo, respectively), nervousness (18% v 7%), difficulty with concentration/attention (9% v 1%), confusion (10% v 4%), depression (7% v 6%), anorexia (6% v 4%), language problems (9% v <1%), anxiety (3% v 6%), mood problems (6% v 2%), and weight decrease (9% v 3%). The most common adverse reactions at dosages of 5 mg/kg/day to 9 mg/kg/day in pediatric patients were fatigue (16% v 5%, topiramate v placebo, respectively), somnolence (26% v 16%), anorexia (24% v 15%), nervousness (14% v 7%), difficulty with concentration/attention (10% v 2%), difficulty with memory (5% v 0%), aggressive reaction (9% v 4%), and weight decrease (9% v 1%).
In monotherapy trials, the most common adverse reactions of topiramate in adults were paresthesia (40% v 21%, 400 mg/day v 50 mg/day, respectively), weight decrease (16% v 6%), somnolence (15% v 9%), anorexia (14% v 4%), dizziness (14% v 13%), and difficulty with memory (10% v 5%); and in pediatric patients were weight decrease (21% v 7%), upper respiratory tract infection (18% v 16%), paresthesia (16% v 2%), anorexia (14% v 11%), diarrhea (11% v 5%), and mood problems (11% v 2%).
Other worldwide postmarketing adverse experiences that have been reported with the use of immediate-release topiramate are bullous skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), hepatic failure (including fatalities), hepatitis, maculopathy, pancreatitis, and pemphigus.