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IMPORTANT SAFETY INFORMATION
Serious adverse events that may be associated with the use of NUVIGIL® (armodafinil) Tablets [C-IV] include: serious
rash, including Stevens-Johnson Syndrome, requiring hospitalization and discontinuation of treatment; angioedema
and hypersensitivity, including fatal multi-organ hypersensitivity reactions; psychiatric adverse experiences; persistent
sleepiness; and cardiovascular adverse events.
Read more Important Safety Information

The support you need is here

Getting patients their medication can be complicated and time consuming. This page is dedicated to providing you
with resources and information that you and your patients may find useful.


CoverMyMeds®


CoverMyMeds is a FREE online service that makes finding and submitting prior authorization (PA) forms fast and easy.
Features of your CoverMyMeds account include


Be sure to look for a CoverMyMeds PA fax
CoverMyMeds can help you quickly complete a PA request. Participating pharmacies will initiate the PA process with
an auto-generated PA form for NUVIGIL. Keep an eye out for this CoverMyMeds PA fax from your pharmacy to ensure
a fast and easy PA process.


Reimbursement assistance for NUVIGIL


A toll-free hotline is available to help you with questions about reimbursement assistance for NUVIGIL.

You can have your questions about reimbursement answered by calling the NUVIGIL Reimbursement Assistance Hotline
at 1-877-NUV-2122 (1-877-688-2122) or faxing to 1-877-727-6888.

By calling 1-877-NUV-2122 (Monday through Friday, from 9 AM to 8 PM ET), our specialists can provide you with assistance in verifying prescription coverage for NUVIGIL for patients under private insurance, Medicaid, and Medicare managed care plans.

Patients will need to complete a Patient Consent Form prior to requesting coverage options through the Reimbursement
Assistance Hotline.

Teva Pharmaceuticals does not formally make appeals for callers, nor does it guarantee success in obtaining insurance
authorizations or payments. Third-party payment for medical products and services is affected by numerous factors,
not all of which can be anticipated or resolved by the Reimbursement Assistance Hotline staff.


Patient Assistance Program

Through the Teva Cares® Foundation, we help patients who do not have prescription drug coverage get the medicine they need.

For more information, please visit www.cephaloncares.com or call the number listed below. We are staffed to assist you
Monday through Friday, 9 AM to 8 PM ET.

1-877-CEPH-881 (1-877-237-4881)

Patient Assistance Program application forms for NUVIGIL
Patients and physicians: click here for an application form and instructions on how to submit.

Other Resources
The Partnership for Prescription Assistance, a program sponsored by pharmaceutical research companies in the United States, connects people who are uninsured or have limited coverage with programs that provide prescription
medications at no or minimal cost. For more information, visit the Partnership for Prescription Assistance website.

IMPORTANT SAFETY INFORMATION

Contraindications: NUVIGIL is contraindicated in patients with a known hypersensitivity to modafinil or armodafinil or its inactive ingredients.

Serious rash: Serious rash, including Stevens-Johnson Syndrome, requiring hospitalization and discontinuation of treatment has been reported in association with the use of NUVIGIL or modafinil. There are no factors, including duration of therapy, that are known to predict the risk of occurrence or the severity of rash. Although benign rashes also occur with NUVIGIL, it is not possible to reliably predict which rashes will prove to be serious. NUVIGIL should ordinarily be discontinued at the first sign of rash unless the rash is clearly not drug-related.

NUVIGIL has not been studied in pediatric patients in any setting and is not approved for use in pediatric patients for any indication.

Angioedema and hypersensitivity reactions: Angioedema and hypersensitivity (with rash, dysphagia, and bronchospasm) were observed with NUVIGIL. Multi-organ hypersensitivity reactions, including at least one fatality in post-marketing experience, have occurred in close temporal association to the initiation of modafinil. Patients should be advised to discontinue NUVIGIL and immediately report to their physician any signs or symptoms suggesting multi-organ hypersensitivity, angioedema or anaphylaxis.

Psychiatric symptoms: Psychiatric adverse experiences have been reported in patients treated with NUVIGIL and modafinil. In controlled trials in adults administered NUVIGIL, psychiatric symptoms resulting in treatment discontinuation were anxiety, agitation, nervousness, irritability, and depression. Cases of suicidal ideation, mania, delusions, hallucinations, and aggression, some resulting in hospitalization, have been reported in patients treated with NUVIGIL or modafinil. Caution should be exercised when NUVIGIL is given to patients with a history of psychosis, depression, or mania. Consider discontinuing NUVIGIL if psychiatric symptoms develop.

Persistent sleepiness and CNS effects: Patients should be advised that their level of wakefulness may not return to normal. Although NUVIGIL has not been shown to produce functional impairment, any drug affecting the CNS may alter judgment, thinking or motor skills. Patients should be frequently reassessed for their degree of sleepiness and functional impairment and, if appropriate, advised to avoid driving or any other potentially dangerous activity.

Cardiovascular effects: Patients with a recent history of myocardial infarction or unstable angina should be treated with caution. NUVIGIL should not be used in patients with a history of left ventricular hypertrophy or in patients with mitral valve prolapse who have experienced mitral valve prolapse syndrome when previously receiving CNS stimulants. Small average increases in blood pressure and heart rate were observed in clinical trials. Increased monitoring of heart rate and blood pressure may be appropriate in patients on NUVIGIL. Caution should be exercised when prescribing NUVIGIL to patients with known cardiovascular disease.

Drug interactions: NUVIGIL may interact with drugs that are substrates for CYP3A4/5 or CYP2C19. Dose adjustment of these drugs may be required. The effectiveness of steroidal contraceptives may be reduced when used with NUVIGIL and for one month after discontinuation of therapy.

Common adverse reactions: In clinical trials, the most commonly reported adverse events (≥5%) associated with the use of NUVIGIL were headache, nausea, dizziness, and insomnia.

Drug abuse and dependence: NUVIGIL is a Schedule IV controlled substance because it has the potential to be abused or lead to dependence. Physicians should follow patients closely, especially those with a history of drug and/or stimulant abuse.

Physicians should be aware and inform their patients of the availability of the Medication Guide for NUVIGIL.

Please see Full Prescribing Information for NUVIGIL.