Starting Patients
on VIGPODER

Pyros is fiercely committed to accelerating time to treatment
in infantile spasms.

With our Quick-Start Program, your eligible patients* on vigabatrin therapy will get expedited access to a free starter supply of up to 30 days of treatment with VIGPODER as fast as 24-48 hours. This will be shipped directly to the caregiver by courier so that time to treatment initiation is minimized.

*Additional qualifying criteria may apply.

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

You start the process, we’ll do the rest

At Pyros Total Care, we work hard to ensure that you and your patients get the best support possible. AnovoRx is the only pharmacy that can fill VIGPODER. This allows us to be sure every patient receives our high standard of support and care.

The completed VIGPODER Prescription and Enrollment Form is all it takes to begin the process of getting your patient started on VIGPODER through the Quick-Start Program.

1
Complete the VIGPODER
Prescription and Enrollment Form.
or
or
2
Get signatures.
All signatures must be handwritten.
and if possible
3
Submit the completed
documents.

Provide insurance information and clinical notes.

AnovoRx is the only specialty pharmacy that can dispense VIGPODER

Comprehensive services from
our dedicated, experienced team

Support begins upon receipt of valid prescription, REMS program enrollment,
and successful confirmatory phone conversation with caregiver.

Pyros Total Care will:

After receiving prescription and enrollment form

  • Call the parent/guardian
  • Confirm all documentation is received and signed
  • Obtain patient consent, if Patient Authorization was not signed
  • Confirm the submitted information
  • Explain VIGPODER will be sent directly to their home via overnight courier
  • Confirm address and let them know they will receive a text with the tracking information, if enrolled in FedEx Delivery Manager. To enroll, they can sign up at FedEx.com

Within 24-48 hours

  • Send free starter supply of VIGPODER to the patient’s home by overnight courier
  • Confirm receipt of medication
  • Ensure parent is trained and confident in preparing the VIGPODER dose accurately
  • Educate about potential permanent vision loss and other possible side effects
  • Provide information about VIGPODER. An AnovoRx Pharmacist or Nurse can train the caregiver on how to prepare the VIGPODER dose and/or direct the caregiver to the VIGPODER Instructions for Use video
  • Begin benefits investigation and access support

Over the course of treatment

  • Ongoing, personalized support to help families throughout the treatment journey
  • Continue the administration and/or make adjustments in the coverage approval process
  • Gather appropriate financial assistance options, as needed
time

Quick-Start Program

Patients will receive a free starter supply (up to 30 days) of VIGPODER as fast as 24-48 hours, so treatment can begin without delay.

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

Eligible, commercially insured patients may pay as little as $0 co-pay for VIGPODER.

Must not be eligible for or enrolled in a government-funded program that provides
prescription drug coverage. Limits, terms, and conditions apply.

Our access experts are here to support you

doctor, woman, child

Pyros Total Care will initiate, follow up, and respond to prescription insurance requirements, and will help resolve access issues until the coverage is approved.

If a Prior Authorization, Medical Exception, and/or appeal is required, we will contact you, provide appropriate forms, and work with you.

Connecting patients with financial assistance

For patients who do not have insurance, or in situations where VIGPODER is not covered by the insurance plan, Pyros Total Care will assess options and provide available alternatives.

For caregivers,
We provide ongoing, personalized support

pharmacy
Specialty Pharmacist

Our pharmacists are
knowledgeable in infantile spasms
and VIGPODER. They will:

  • Ensure caregiver is comfortable and confident in mixing and administering VIGPODER properly
  • Video chat with caregiver to teach how to prepare the VIGPODER dose, if desired
  • Review the Medication Guide, including the BOXED WARNING, and review Instructions for Use with the caregiver
nurse
Nurse Educators§

Our nurses will support families throughout
the treatment journey, providing a single
point of contact for the caregiver. They will:

  • Be available to answer questions and give guidance
  • Educate about potential side effects
  • Proactively reach out to caregiver to check in on how they are doing
  • Make adjustments if coverage, patient’s insurance, or financial situation changes
§Communications, answers, and/or guidance will be limited based on the questions provided. Conversations with the Nurse Educators are informational and do not substitute for advice from the patient's primary care physician.
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.