From the FDA Drug Label
The safety and effectiveness of vigabatrin as monotherapy for pediatric patients with infantile spasms (1 month to 2 years of age) have been established [see Dosage and Administration (2.3), Clinical Studies (14.2)].
The immediate treatment for an infant presenting with infantile spasms in the emergency department is vigabatrin.
- Key points:
- The safety and effectiveness of vigabatrin for infantile spasms have been established in pediatric patients 1 month to 2 years of age.
- Vigabatrin should be used with caution due to the risk of permanent vision loss.
- The duration of therapy for infantile spasms was evaluated in a post hoc analysis, suggesting that a total duration of 6 months of vigabatrin therapy is adequate for the treatment of infantile spasms 1.
- Important consideration: Prescribers must use their clinical judgment as to the most appropriate duration of use.
From the Research
The immediate treatment for an infant presenting with infantile spasms in the emergency department is administration of adrenocorticotropic hormone (ACTH) or high-dose oral corticosteroids, typically prednisolone, as supported by the most recent and highest quality study available 2.
Treatment Options
- ACTH is often given at a dose of 150 units/m² daily for 2 weeks, followed by a gradual taper over 2-3 months.
- Alternatively, oral prednisolone can be administered at 40-60 mg/day (2-4 mg/kg/day) for 2 weeks, followed by a gradual taper.
- Vigabatrin is another first-line option, especially effective in infants with tuberous sclerosis complex, given at 50-150 mg/kg/day divided into two doses.
Diagnostic Considerations
While initiating treatment, it's essential to obtain an urgent EEG to confirm the diagnosis and brain MRI to identify any underlying structural abnormalities.
- Continuous EEG monitoring may be necessary if the diagnosis is uncertain.
Rationale
These treatments work by suppressing the abnormal electrical activity in the developing brain that causes the characteristic spasms and hypsarrhythmia pattern on EEG.
- Early intervention is critical as delays in treatment can lead to worse developmental outcomes for the infant, as highlighted in studies such as 3 and 2.
Additional Considerations
Other treatment options, such as topiramate and felbamate, may also be considered, but their efficacy and safety profiles are less well-established compared to ACTH, prednisolone, and vigabatrin, as noted in studies like 4 and 5.