Congratulations! - Validus Pharmaceuticals LLC

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