Vigabatrin (FOR CHILDREN) (vie-GAB-a-trin)

 

Generic Name: Vigabatrin (FOR CHILDREN) (vie-GAB-a-trin)

Used to Treat: Infantile spasms

Seizure Type: Infantile spasms

Forms of the medicine:
Powder for oral solution

Dosing:
50 mg/kg/day in two divided doses and can be titrated by 25 to 50 mg/kg/day increments every 3 days up to a maximum of 150 mg/kg/day.

General Info:

What is Sabril?
Sabril® (vigabatrin) was approved by the FDA in August 2009 as a monotherapy for children one month to two years of age with infantile spasms (IS) where the potential benefits outweigh the risk of vision loss.

What are the usual dosages?
Dosage for children with infantile spasms is 50 mg/kg/day in two divided doses and can be titrated by 25 to 50 mg/kg/day increments every 3 days up to a maximum of 150 mg/kg/day.

What are some possible side effects?

  • Black Box Warning Label: VISION LOSS
  • Sabril causes progressive and permanent bilateral concentric visual field constriction in a
    high percentage of patients. In some cases, Sabril may also reduce visual acuity.
  • Risk increases with total dose and duration of use, but no exposure to Sabril is known that
    is free of risk of vision loss.
  • Risk of new and worsening vision loss continues as long as Sabril is used, and possibly
    after discontinuing Sabril.
  • Periodic vision testing is required for patients on Sabril, but cannot reliably prevent vision
    damage.
  • Because of the risk of permanent vision loss, Sabril is available only through a special
    restricted distribution program.

Some other possible side effects are abnormal MRIs, anemia, sleepiness, fatigue, numbness of extremities, weight gain, swelling and hyperactivity.

Not everyone experiences side effects. There may be other side effects not appearing above. For a complete list, consult your doctor, nurse or pharmacist. More detailed sources of information on side effects include the drug’s prescribing information sheet, the Physician’s Desk Reference or the pharmaceutical company which produces the drug.

Is Sabril approved for other types of seizures?
Sabril, as add-on therapy, is also indicated as a new therapeutic option for adults with complex partial seizures (CPS) whose seizures remain uncontrolled despite treatment with other therapies and for whom the potential benefits outweigh the risk of vision loss. Sabril is not indicated as a first line agent for adults with CPS.

For more information on Sabril, contact your health care professional.

Side Effects