For the treatment of infantile spasms

HOW TO PRESCRIBE
VIGAFYDE™

Young Doctor Examining Baby

Young doctor examing baby

Starting patients on VIGAFYDE

We believe every patient deserves access to the treatments they need. That’s why we’ve worked to secure broad coverage for VIGAFYDE across national, regional, and government health plans.

Our commitment extends beyond coverage. VIGAFYDE is backed by the Upsher-Smith Promise of Support™ Program designed to remove barriers to access and simplify prescribing to give you peace of mind.

**99% of all Promise of Support™ patients pay $0 for their prescription,** including both commercial and government insurance.^1*

*Based on data for all vigabatrin formulations supported by the Promise of Support™ program from April 2024-April 2025.

1

Enroll in the Vigabatrin REMS Program by filling out the REMS Prescriber Enrollment and Agreement Form.

If previously enrolled, please disregard and skip to step #2.

REMS Prescriber Enrollment and Agreement Form »

2

Complete REMS Patient/Parent/Legal Guardian – Physician Agreement Form

and then fax to:

1-866-205-3072

3

Two Ways to Prescribe

E-prescribe through your EMR system to our specialty pharmacy partner:

PANTHERx Specialty Pharmacy
1120 Stevenson Mill Road, Suite 400
Coraopolis, PA 15108
NCPDP ID: 6008002

or

Download, print, complete, and fax the VIGAFYDE Prescription Form to:

l-877-788-4948

(Monday-Friday 8 _AM-8 _PM ET)

If you are sending the prescription on a weekend or after hours, fax to

l-877-827-0395 Prescription and Enrollment Form

Support for you and your practice

Savings and Promise of Support™ »

Dosing Information »

Resources and FAQs »

INDICATION

INDICATION AND IMPORTANT SAFETY INFORMATION FOR VIGAFYDE^TM (vigabatrin) ORAL SOLUTION

INDICATION

VIGAFYDE™ (vigabatrin) Oral Solution is indicated for Infantile Spasms (IS) as monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss.

WARNING: PERMANENT VISION LOSS

See full Prescribing Information for complete Boxed Warning.

VIGAFYDE™ (vigabatrin) can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, VIGAFYDE may also decrease visual acuity.
Risk increases with increasing dose and cumulative exposure, but there is no dose or exposure known to be free of risk of vision loss.
Risk of new and worsening vision loss continues as long as VIGAFYDE is used, and possibly after discontinuing.
Baseline and periodic vision assessment is recommended for patients. However, this assessment cannot always prevent vision damage.
The onset of vision loss is unpredictable and can occur within weeks of starting treatment or sooner, or at any time after starting treatment, even after months or years.
Because of the risk of permanent vision loss, VIGAFYDE is available only 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 call 1-866-244-8175.

WARNINGS & PRECAUTIONS

Permanent Vision Loss. VIGAFYDE can cause permanent vision loss. The risk of vision loss increases with increasing the dose and cumulative exposure, but there is no dose or exposure known to be free of risk of vision loss. Patient response should be periodically assessed. Patients can be affected with bilateral concentric visual field constriction ranging in severity from mild to severe. Severe cases may be characterized by tunnel vision, which can result in disability. VIGAFYDE also can damage the central retina and may decrease visual acuity. Symptoms of vision loss from VIGAFYDE 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.
Monitoring of Vision. 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. For patients receiving VIGAFYDE, vision assessment is recommended at baseline, at least every 3 months while on therapy, and about 3 to 6 months after the discontinuation of therapy. Once detected, vision loss due to VIGAFYDE is not reversible. It is expected that even with frequent monitoring, some patients will develop severe vision loss.
Magnetic Resonance Imaging (MRI) Abnormalities in Infants. Abnormal MRI signal changes have been reported in some infants with infantile spasms receiving vigabatrin. These changes generally resolved with discontinuation of treatment.
Neurotoxicity. Intramyelinic edema (IME) has been reported in postmortem examination of patients being treated for infantile spasms with vigabatrin. IME has been seen in animals at doses within the human therapeutic range.
Suicidal Behavior and Ideation. VIGAFYDE is approved for use in patients 1 month to 2 years of age [see Indication]. VIGAFYDE is not approved for use in adolescents or adults. Antiepileptic drugs (AEDs), including vigabatrin, increase the risk of suicidal thoughts and behavior in adolescents and adults. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
Withdrawal of AEDS. VIGAFYDE should be withdrawn gradually.
Anemia. VIGAFYDE may cause anemia.
Somnolence and Fatigue. VIGAFYDE causes somnolence and fatigue.
Weight Gain. VIGAFYDE causes weight gain in pediatric patients.

DRUG INTERACTIONS

VIGAFYDE may decrease phenytoin plasma levels; dosage adjustment may be needed.

ADVERSE REACTIONS

In patients with Infantile Spasms (incidence >5% and greater than on placebo): Somnolence, bronchitis, ear infection, and acute otitis media.

The most serious adverse reactions are listed above in the WARNINGS AND PRECAUTIONS section.

Refer to the DOSAGE AND ADMINISTRATION section of the full Prescribing Information for recommended dosing guidelines for VIGAFYDE.

VIGAFYDE is a concentrated solution as compared to other vigabatrin products. Verify strength and the dose of the product prior to prescribing, dispensing, and administering. VIGAFYDE does not require additional reconstitution or dilution prior to administration.

This safety information is not comprehensive. Please refer to the full Prescribing Information, including Boxed Warning for vision loss, WARNINGS AND PRECAUTIONS and Medication Guide. You can also visit www.VIGAFYDE.com, www.upsher-smith.com or call 1-888-650-3789.

You are encouraged to report suspected adverse reactions to Upsher-Smith Laboratories, LLC at 1-855-899-9180 or to the FDA by visiting www.fda.gov/medwatch.