For the treatment of infantile spasms

DOSING AND ADMINISTRATION

Young Doctor Examining Baby Young doctor examing baby

VIGAFYDE™ is the first and only liquid vigabatrin formulation

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.

Dosing

The VIGAFYDE dosing regimen depends on the patient’s weight.

VIGAFYDE is a concentrated, 100 mg/mL oral solution intended for oral use only. Verify the strength and the dose of the product prior to prescribing, dispensing, and administering.

VIGAFYDE should be withdrawn if a substantial clinical benefit is not observed within 2 to 4 weeks. If, in the clinical judgment of the prescriber, evidence of treatment failure becomes obvious earlier than 2 to 4 weeks, treatment should be discontinued at that time.

Infant Dosing Table

Volume of the 100 mg/mL dosing solution that should be administered as individual doses in infants of various weights

Weight
(kg)
Starting dose
(50 mg/kg/day)
Maximum dose
(150 mg/kg/day)
3 75 mg (0.75 mL) twice daily 225 mg (2.25 mL) twice daily
4 100 mg (1 mL) twice daily 300 mg (3 mL) twice daily
5 125 mg (1.25 mL) twice daily 375 mg (3.75 mL) twice daily
6 150 mg (1.5 mL) twice daily 450 mg (4.5 mL) twice daily
7 175 mg (1.75 mL) twice daily 525 mg (5.25 mL) twice daily
8 200 mg (2 mL) twice daily 600 mg (6 mL) twice daily
9 225 mg (2.25 mL) twice daily 675 mg (6.75 mL) twice daily
10 250 mg (2.5 mL) twice daily 750 mg (7.5 mL) twice daily
11 275 mg (2.75 mL) twice daily 825 mg (8.25 mL) twice daily
12 300 mg (3 mL) twice daily 900 mg (9 mL) twice daily
13 325 mg (3.25 mL) twice daily 975 mg (9.75 mL) twice daily
14 350 mg (3.5 mL) twice daily 1050 mg (10.5 mL) twice daily
15 375 mg (3.75 mL) twice daily 1125 mg (11.25 mL) twice daily
16 400 mg (4 mL) twice daily 1200 mg (12 mL) twice daily
VIGAFYDE medicine bottle and syringe

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

Additional Important Dosing Considerations

Use the lowest dosage and shortest exposure to VIGAFYDE consistent with clinical objectives.

VIGAFYDE is primarily eliminated through the kidney. Information about how to adjust the dose in infants with renal impairment is unavailable.

If a decision is made to discontinue VIGAFYDE, the dose should be gradually reduced.

If switching between other vigabatrin products and VIGAFYDE, ensure the correct volume for the correct dosage is prescribed, dispensed, and administered.

How to Give the Ready-to-Use
VIGAFYDE Dose

A specialty pharmacist will review how to prepare and give the VIGAFYDE dose with the caregiver. You may review this video with the caregiver so they understand the importance of giving the VIGAFDYE dose correctly.

VIGAFYDE Instructions for Use frame

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.