Resources
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Resources


VIGPODER Prescription and Enrollment Form
VIGPODER Prescription and Enrollment Form (page 1) and Patient Authorization (page 2)

The completed VIGPODER Prescription and Enrollment Form is all it takes to begin the process of getting your patient started.

Reference guide to starting patients on VIGPODER
Your convenient reference guide to
STARTING PATIENTS ON VIGPODER

This is a step-by-step resource for healthcare providers on how to initiate the process of prescribing and delivery of VIGPODER to the caregiver.

How to prepare and give the VIGPODER dose
How to prepare and give the VIGPODER dose

Our specialty pharmacists will review how to prepare and give the VIGPODER dose. Our specialty care pharmacist will share this video with the caregiver. You may review it with the caregiver so they understand the importance of measuring, mixing, and giving the dose correctly.

VIGPODER full Prescribing Information
VIGPODER full Prescribing Information

The package insert provides comprehensive labeling information, including BOXED WARNING, the Medication Guide, and Instructions for Use for VIGPODER.

Pyros Total Care Brochure
Pyros Total Care Brochure

Review the comprehensive services available through Pyros Total Care.

Pyros Pharmaceuticals Brochure
Pyros Pharmaceuticals Brochure

Get to know Pyros and our vision of the future for patients with infantile spasms.

Ketogenic Diet
Ketogenic Diet

Information for parents if you deem a ketogenic diet may be appropriate for their baby.

Frequently asked questions


What is the Quick-Start Program?

Pyros is fiercely committed to accelerating time to treatment. For patients* newly initiated on vigabatrin therapy, Pyros Total Care will provide a free starter supply of up to 30 days, so your patient can start treatment without having to wait for insurance approvals.

*Upon receipt of valid prescription, REMS (risk evaluation and mitigation strategies) program enrollment, and successful confirmatory phone conversation with caregiver.
Qualifying criteria will apply.

What comes with Pyros Total Care?

PYROS Total Care is your dedicated partner in providing support for your patients. Once we receive the completed VIGPODER Prescription and Enrollment Form, AnovoRx will initiate the Quick-Start Program so your patient* does not have to wait for insurance approvals. The first supply of VIGPODER will be sent to the caregiver by courier so that time to treatment initiation is minimized. See more here.

*Upon receipt of valid prescription, REMS (risk evaluation and mitigation strategies) program enrollment, and successful confirmatory phone conversation with caregiver.
Qualifying criteria will apply.

How do I submit the VIGPODER Prescription and Enrollment Form?

You can do so by e-script via Electronic Health Record or by faxing the completed and signed VIGPODER Prescription and Enrollment Form to 855-813-2039. Call 888-760-8330 if you have any questions regarding the form.

What forms does the parent/legal guardian need to sign?

The parent/legal guardian should sign the Patient Authorization form, if in person in the office. If the parent/legal guardian is unavailable to provide a signature, PYROS Total Care will follow up and get the required authorization.

How will my patient get their VIGPODER medicine?

VIGPODER will be shipped directly to the caregiver by courier.

What is required of me with regard to the REMS program?

Healthcare providers must obtain certification in the Vigabatrin REMS Program to be allowed to prescribe vigabatrin. Visit vigabatrinREMS.com for certification.

INDICATION

VIGPODER™ (vigabatrin) is indicated as monotherapy for pediatric patients with infantile spasms 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss.

Please refer to the full Prescribing Information to view other approved indications.

IMPORTANT SAFETY INFORMATION FOR VIGPODER™ (vigabatrin)
WARNING: PERMANENT VISION LOSS
  • VIGPODER can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, VIGPODER also can damage the central retina and may decrease visual acuity.
  • The onset of vision loss from VIGPODER is unpredictable and can occur within weeks of starting treatment or sooner, or at any time after starting treatment, even after months or years.
  • Symptoms of vision loss from VIGPODER are unlikely to be recognized by patients or caregivers before vision loss is severe. Vision loss of milder severity, while often unrecognized by the patient or caregiver, can still adversely affect function.
  • The risk of vision loss increases with increasing dose and cumulative exposure, but there is no dose or exposure known to be free of risk of vision loss.
  • Vision assessment is recommended at baseline (no later than 4 weeks after starting VIGPODER), at least every 3 months during therapy, and about 3 to 6 months after the discontinuation of therapy.
  • Once detected, vision loss due to VIGPODER is not reversible. It is expected that, even with frequent monitoring, some patients will develop severe vision loss.
  • Consider drug discontinuation, balancing benefit and risk, if vision loss is documented.
  • Risk of new or worsening vision loss continues as long as VIGPODER is used. It is possible that vision loss can worsen despite discontinuation of VIGPODER.
  • Because of the risk of vision loss, VIGPODER should be withdrawn from patients with infantile spasms who fail to show a substantial clinical benefit within 2-4 weeks of initiation or sooner if treatment failure becomes obvious. Patients’ response to and continued need for VIGPODER should be periodically reassessed.
  • VIGPODER should not be used in patients with, or at high risk of, other types of irreversible vision loss unless the benefits of treatment clearly outweigh the risks.
  • VIGPODER should not be used with other drugs associated with serious ophthalmic effects such as retinopathy or glaucoma unless the benefits clearly outweigh the risks.
  • Use the lowest dosage and shortest exposure to VIGPODER consistent with clinical objectives.

Because of the risk of permanent vision loss, VIGPODER is available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Vigabatrin REMS Program. Further information is available at www.vigabatrinREMS.com or 1-866-244-8175.

WARNINGS AND PRECAUTIONS
  • Permanent Vision Loss: VIGPODER can cause permanent vision loss. Because of this risk and because, when it is effective, VIGPODER provides an observable symptomatic benefit, patient response and continued need for treatment should be periodically assessed.
    Monitoring of vision by an ophthalmic professional with expertise in visual field interpretation and the ability to perform dilated indirect ophthalmoscopy of the retina is recommended. Because vision testing in infants is difficult, vision loss may not be detected until it is severe.
  • VIGPODER is available only through a restricted program called the Vigabatrin REMS Program.
  • Magnetic Resonance Imaging (MRI) Abnormalities in Infants: Abnormal MRI signal changes characterized by increased T2 signal and restricted diffusion in a symmetric pattern involving the thalamus, basal ganglia, brain stem, and cerebellum have been observed in some infants treated with vigabatrin.
  • Neurotoxicity: Intramyelinic edema (IME) has been reported in postmortem examination of infants being treated for IS with vigabatrin.
  • Withdrawal of Antiepileptic Drugs (AEDs) As with all AEDs, VIGPODER should be withdrawn gradually. However, if withdrawal is needed because of a serious adverse event, rapid discontinuation can be considered. Patients and caregivers should be told not to suddenly discontinue VIGPODER therapy.
  • Anemia: Monitor for symptoms of anemia.
  • Somnolence and Fatigue: VIGPODER causes somnolence and fatigue.
  • Peripheral Neuropathy and Edema: Vigabatrin causes symptoms of peripheral neuropathy and edema in adults. In pediatric clinical trials (pooled data), the incidence of peripheral neuropathy and edema observed in pediatric patients was similar on vigabatrin and placebo.
ADVERSE REACTIONS

The most common (>5%) adverse reactions that occurred more frequently than in placebo patients were somnolence, bronchitis, ear infection, and acute otitis media.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 or Pyros at 1-855-406-1010.

Please see full Prescribing Information, including BOXED WARNING, for additional Important Safety Information.