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VIGAFYDE™ is the

FIRST AND ONLY
READY-TO-USE
VIGABATRIN ORAL SOLUTION

for patients with infantile spasms

Ready-to-use. No mixing required and is designed to:

  • Provide a consistently correct concentration
  • Help eliminate mixing errors
  • Limit risk of contamination*
*Discard the unused portion 90 days after first opening.
How to prescribe VIGAFYDE
Doctor holding baby Doctor holding baby
VIGAFYDE medicine bottle and syringe

Note: Not actual size.
Syringe and bottle adapter provided by pharmacy.

Helping to eliminate errors in dosing preparation

VIGAFYDE 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.

For patients with infantile spasms, VIGAFYDE provides a consistently correct concentration (100 mg/mL vigabatrin oral solution).
No reconstitution (mixing) by the caregiver is needed, which means reduced dose preparation time, no medication waste, and may help reduce the risk of preparation errors.

Note: Not actual size.
Syringe and bottle adapter provided by pharmacy.

VIGAFYDE 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.

For patients with infantile spasms, VIGAFYDE provides a consistently correct concentration (100 mg/mL vigabatrin oral solution).
No reconstitution (mixing) by the caregiver is needed, which means reduced dose preparation time, no medication waste, and may help reduce the risk of preparation errors.

See the VIGAFYDE difference

CONCENTRATION
PREPARATION
STABILITY
FLAVOR
SUPPLIES
Drop and ripples icon VIGAFYDE
100 mg/mL
No mixing required
Room temperature stable for up to 90 days once opened
Mild sweet mint
2*
Powder medicine packet icon Powder for
oral solution
50 mg/mL
Reconstitution
Immediate use once prepared
No added flavor
8-10†
CONCENTRATION
Drop and ripples icon VIGAFYDE
100 mg/mL
Powder medicine packet icon Powder for
oral solution
50 mg/mL
PREPARATION
Drop and ripples icon VIGAFYDE
No mixing required
Powder medicine packet icon Powder for
oral solution
Reconstitution
STABILITY
Drop and ripples icon VIGAFYDE
Room temperature stable for up to 90 days once opened
Powder medicine packet icon Powder for
oral solution
Immediate use once prepared
FLAVOR
Drop and ripples icon VIGAFYDE
Mild sweet mint
Powder medicine packet icon Powder for
oral solution
No added flavor
SUPPLIES
Drop and ripples icon VIGAFYDE
2*
Powder medicine packet icon Powder for
oral solution
8-10†

*After one-time insertion of the adaptor, supplies include an oral syringe and a 150 mL bottle of ready-to-use oral solution.

† Vigabatrin powder for oral solution. Supplies include the number of product packets needed for each dose; 2 clean cups, 1 for mixing and 1 for water (the cup used for mixing vigabatrin should be clear in order to see if the powder is dissolved); water to mix the vigabatrin powder; one small 3 mL oral syringe and one large 10 mL oral syringe, which are provided by the pharmacy; a small spoon or other clean utensil to stir the mixture; and scissors to cut the powder packet. The number of product packets needed for each dose will vary by prescribed dosage.

See Dosing and Administration

Starting patients on VIGAFYDE

Healthcare providers must be certified in the Vigabatrin REMS Program in order to prescribe VIGAFYDE.

The US Food and Drug Administration (FDA) has approved a single shared system Risk Evaluation and Mitigation Strategy (REMS) for all vigabatrin products, called the Vigabatrin REMS Program.

The Vigabatrin REMS Program is required by the FDA to ensure informed risk-benefit decisions before initiating treatment, and to ensure appropriate use of vigabatrin while patients are treated. If you are already certified for vigabatrin products, you are ready to prescribe VIGAFYDE.

VIGAFYDE can be e-prescribed through your EMR, or you can complete the Prescription and Enrollment form to start the process.

Two ways to prescribe
E-prescribe through EMR
OR
Prescription and Enrollment Form
How to Prescribe VIGAFYDE

Savings and Support

The Upsher-Smith Promise of Support™ Program helps to ensure a rapid start of treatment.
Learn more about the
Promise of Support™ Program

Support for you and
your practice

Specialist Examining Baby
How to Prescribe
Baby taking VIGAFYDE
Dosing Information
Mother talking to doctor
Resources and FAQs

INDICATION

INDICATION AND IMPORTANT SAFETY INFORMATION FOR VIGAFYDETM (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.

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