Please See Important Safety Information, Including Boxed Warning Below Congratulations! Eligible patients may pay a minimum of $20 and receive up to $100 off their copay or out-of-pocket expenses for a 30 day supply, $150 off a 60 day supply, or $200 off a 90 day supply of Equetro® (carbamazepine) Extended-Release Capsules or Marplan® (isocarboxazid) Tablets. That’s a maximum savings of up to $200. Here’s how it works: You pay the first $20 of your co-pay, and then we’ll pay up to the next $100. 08635260261 To print your savings card click here and present your card whenever you fill your prescription at the pharmacy. If you have any questions about your eligibility, call 1-866-297-6945. Patient Instructions: In order to redeem this coupon you must have a valid prescription for Equetro® (carbamazepine) Extended-Release Capsules or Marplan® (isocarboxazid) Tablets. Follow the dosage instructions given by the doctor. You will be required to pay the first $20 of your co-pay, after which an amount of $100 for a 30 day supply, $150 for a 60 day supply, or $200 for a 90 day supply will be deducted from your remaining balance. The pharmacist will process your insurance information and this Validus Coupon and then inform you of your co-pay amount. This offer may not be redeemed for cash. By using this offer, you are certifying that you meet the eligibility criteria and will comply with the terms and conditions described in the Restrictions section indicated below. If you have any questions about the use of your Validus Coupon, please call 1-866-297-6945. Pharmacist Instructions for a Patient paying 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 for COB [coordination of benefits] with patient responsibility amount and a valid Other Coverage Code, (e.g. 8). Patients are responsible for the first $20, after which an amount of $100 for a 30 day supply, $150 for a 60 day supply, or $200 for a 90 day supply of Equetro or Marplan will be deducted from their remaining balance. Reimbursement will be received from Therapy First Plus. Pharmacist Instructions for a Cash-Paying Patient: Submit this claim to Therapy First Plus. A valid Other Coverage Code (e.g. 1) is required. Patients are responsible for the first $20, after which an amount of $100 for a 30 day supply, $150 for a 60 day supply, or $200 for a 90 day supply of Equetro or Marplan will be deducted from their remaining balance. Reimbursement will be received from Therapy First Plus. Valid Other Coverage Code required. For any questions regarding Therapy First Plus online processing, please call the Help Desk at 1-800-422-5604. RESTRICTIONS: This offer is valid in the United States. OFFER NOT VALID FOR PRESCRIPTIONS REIMBURSED UNDER MEDICAID, MEDICARE, OR ANY OTHER FEDERAL HEALTH PROGRAMS. If the patient is eligible for drug benefits under any such program, the patient cannot use this offer. By using this offer, the patient certifies that he or she will comply with any terms of his or her health insurance contract requiring notification to his or her payor of the existence and/or value of this coupon. It is illegal to (or offer to) sell, purchase, or trade this coupon. Program expires 12/31/2018. Patient is allowed a total of 3 uses (30 day supply=1use, 60 day supply = 2 uses, and 90 day supply = 3 uses). This offer is not transferable. Not valid if reproduced. Void where prohibited by law. Program managed by PSKW, LLC on behalf of Validus Pharmaceuticals LLC. The parties reserve the right to rescind, revoke or amend this offer without notice at any time. © 2016 PSKW, LLC. VAL-010-16 HIGHLIGHTS OF PRESCRIBING INFORMATION FOR EQUETRO These highlights do not include all the information needed to use EQUETRO safely and effectively. See full prescribing information for EQUETRO. Equetro® (carbamazepine) Extended-Release Capsules 100mg-200mg-300mg DRUG FACTS HIGHLIGHTS OF PRESCRIBING INFORMATION FOR MARPLAN Marplan® (isocarboxazid) Tablets 10mg DRUG FACTS Uses: Marplan is used for the treatment of depression where other treatment options have failed WARNING: SERIOUS DERMATOLOGIC REACTIONS and APLASTIC ANEMIA AND AGRANULOCYTOSIS See full prescribing information for complete boxed warning Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Marplan or any other antidepressant in a child, adolescent or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Marplan is not approved for use in pediatric patients. (See Warnings: Clinical Worsening and Suicide Risk, Precautions: Information for Patients, and Precautions: Pediatric Use) Serious Dermatologic Reactions • Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson Syndrome (SJS), have occurred with EQUETRO • Patients of Asian ancestry have a 10-fold greater risk of TEN/SJS, compared to other populations. In genetically at-risk patients, test for the HLA-B*1502 allele prior to initiating EQUETRO • Discontinue EQUETRO if these reactions occur Aplastic Anemia and Agranulocytosis • Aplastic anemia and agranulocytosis occurred with EQUETRO • Obtain complete pretreatment hematological testing. Consider discontinuing EQUETRO if significant bone marrow depression develops Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials. Uses: EPILEPSY: Equetro is used for the treatment of acute mixed or manic episodes associated with bipolar I disorder, partial seizures with complex symptomatology, generalized tonic-clonic seizures, mixed seizures, and pain associated with trigeminal neuralgia. Limitations of Usage: Equetro is not indicated for the treatment of absence seizures (petit mal). BIPOLAR I DISORDER: Equetro is used for the treatment of acute manic and mixed episodes of Bipolar I Disorder. TRIGEMINAL NEURALGIA: Equetro is used for the treatment of the pain associated with trigeminal neuralgia. Your Doctor Will Take a Detailed History and Perform a Physical Exam Prior to Initiating Equetro. If You Are of Asian Descent, Your Doctor May Test You For Certain Genetic Traits, as Individuals of Asian Descent are More Susceptible to Serious Dermatologic Reactions Than Other Individuals. Your Doctor May Also Run Certain Laboratory Tests, Including Blood, Liver, Eye and Urinalysis Tests Prior to Starting Equetro to Determine if You Are a Candidate for Equetro Therapy or During Treatment to Monitor How You Are Responding to Equetro Treatment. Tell Your Doctor if You Have Any of These Conditions and Do Not Use Equetro If: ☐ You Have A History of Low Blood Cell Counts (Bone Marrow Depression) ☐ You Are Intolerant to Carbamazepine or Any Anti-Depression Medicines ☐ If You Are Also Taking Delavirdine or Other Non-Nucleoside Reverse Transcriptase Inhibitors, Monoamine Oxidase Inhibitors (MAOI’s), or Nefazodone, or Have Taken an MAOI within 14 days of taking Equetro ☐ You Have Liver Dysfunction (Including Liver Enzyme Deficiency) or Liver Disease Warnings: If You Develop The Following, Tell Your Doctor Immediately. You May Need to Discontinue Taking Equetro: ☐ mucous membrane ulcers, fever, or painful rash ☐ An External or Internal Allergic Reaction that Includes Rash, Fever, Pain When You Press on Your Internal Organs, Swelling of Your Lymph Nodes, Fatigue, Weakness or Shortness of Breath, and Infections ☐ Increased Thoughts of Suicide ☐ Do Not Discontinue This Medicine Abruptly – You Must Taper Your Dose When You are Discontinuing Treatment ☐ Do Not Drive or Operate Machinery Until You have Gained Enough Experience on Equetro to Understand if it Affects These Activities Your Doctor May Require You to Discontinue Equetro Therapy If You Develop Serious Symptoms or if Ongoing Laboratory Monitoring Shows That You Are At Risk of Developing Serious Symptoms Ask Your Doctor Before Using Equetro If: ☐ You are Pregnant – This Medicine May Cause Risks To Unborn Children ☐ If You Are Nursing - This Medicine Passes Through Breast Milk And Can Cause Serious Reactions in Nursing Infants ☐ You Have a History of Heart Blockage or Any Other Heart Problems ☐ You Have Glaucoma or a History of Pressure in Your Eyes ☐ If You Have Low Levels of Sodium In Your Blood Tell Your Doctor About All Medicines You Are Taking, Including All Over-The-Counter Medicines and Supplements Equetro has not been approved for treating children and adolescents with Bipolar I Disorder or Trigeminal Neuralgia. Equetro has only been approved for children and adolescents for the treatment of Epilepsy. When Using Equetro You May Have: ☐ Dizziness ☐ Drowsiness ☐ Nausea ☐ Vomiting ☐ Loss of Muscle Control ☐ Constipation ☐ Rash or Itching ☐ Dry Mouth ☐ Weakness ☐ Blurred Vision ☐ Speech Disorder To minimize the possibility of such reactions, You Should Take Equetro at the lowest possible dose Do Not Use Marplan If you are taking: ☐ other monoamine oxidase inhibitors (MAOI’s) or dibenzazepine derivatives or have taken these drugs 7 days or less before starting Marplan ☐ sympathomimetics (including amphetamines) ☐ certain central nervous system depressants (including narcotics, barbiturates, and alcohol) ☐ antihypertensive, diuretic, antihistaminic, sedative or anesthetic drugs ☐ buproprion HCL ☐ buspirone HCL ☐ dextromethorphan ☐ any selective serotonin reuptake inhibitor (SSRI) ☐ meperidine For additional information on the use of Marplan with other drug combinations, please refer to the “Contraindicated MAOI-Drug Combination” section of the full prescribing information Do Not Use Marplan If: ☐ you have eaten aged cheese or other foods with a high tyramine content ☐ you have ingested excessive amounts of caffeine • E xtremely high blood pressure (hypertensive crisis) can occur, which sometimes has been fatal, when Marplan is given with the drugs or foods listed above Tell Your Doctor if You Have Any of These Conditions: ☐ a suspected or confirmed cerebrovascular defect ☐ cardiovascular disease, high blood pressure (hypertension) or history of headache ☐ known hypersensitivity to isocarboxazid ☐ pheochromocytoma ☐ liver disease or if you have had abnormal liver function test results ☐ impaired kidney function Your doctor may test your liver function periodically during treatment with Marplan Caution is required when eating aged cheese or other foods with a high tyramine content as extremely high blood pressure (hypertensive crisis) can occur. Do Not Eat the Following: ☐ cheese (particularly strong or aged varieties) ☐ sour cream ☐ chianti wine ☐ sherry ☐ beer (including non-alcoholic beer) ☐ liqueurs ☐ pickled herring ☐ anchovies ☐ caviar ☐ liver ☐ canned figs ☐ raisins ☐ bananas or avocados ☐ chocolate ☐ soy sauce ☐ sauerkraut ☐ the pods of broad beans (fava beans) ☐ yeast extracts ☐ yogurt ☐ meat extracts ☐ meat prepared with tenderizers ☐ dry sausage Warnings: You may experience a worsening of depression or thoughts of suicide, especially in the early phases of your treatment. If you experience any of these symptoms tell your doctor immediately Your family and caregivers should monitor you for worsening of depression and suicidal thoughts If You Develop The Following, Tell Your Doctor Immediately: ☐ headache ☐ heart palpitations or fast heartbeat ☐ sense of constriction in throat or chest ☐ sweating ☐ dizziness ☐ neck stiffness ☐ nausea ☐ vomiting ☐ low blood pressure and/or faintness Ask Your Doctor Before Using Equetro If: ☐ you are pregnant – this medicine may cause risks to unborn children ☐ you are nursing – this medicine passes through breast milk and can cause serious reactions in nursing infants ☐ you have a seizure disorder as Marplan may lower your seizure threshold • Y our doctor should screen you for bipolar disorder prior to starting treatment with Marplan • T ell your doctor about all medicines you Are taking, including all over-the-counter medicines and supplements VAL-010-16 HIGHLIGHTS OF PRESCRIBING INFORMATION FOR EQUETRO continued HIGHLIGHTS OF PRESCRIBING INFORMATION FOR MARPLAN continued Drug Interactions: May occur between Equetro and any drug that metabolizes cytochrome P450 (CYP)3A4. See the Full Prescribing Information for Potential Drug Interactions. Marplan can cause serious side effects – It should only be used if you have not responded satisfactorily to other antidepressants The risk information provided here is not comprehensive. To learn more, talk about Equetro with your doctor or pharmacist. The FDA-approved product labeling can be found at http://equetro.com/full-prescribing-information/ or 1-866-9VALIDUS (1-866-982-5438) The use of Marplan has not been studied in children and adolescents When Using Marplan You May Have: ☐ Dizziness ☐ Drowsiness ☐ Nausea ☐ Dry Mouth ☐ Constipation ☐ Headache ☐ Insomnia ☐ Sleep Disturbance ☐ Tremor Drug Interactions: Marplan should not be taken with disulfiram (Antabuse® or any other psychotropic drugs The risk information provided here is not comprehensive. To learn more, talk about Marplan with your doctor or pharmacist. The FDA-approved product labeling can be found at http://marplan.com/full-prescribing-information/ or 1-866-9VALIDUS (1-866-982-5438) © 2016 Validus Pharmaceuticals LLC. VAL-010-16
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