From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
For children with autism who have folate receptor autoantibodies (FRAs), the primary recommended treatment is high-dose folinic acid (leucovorin calcium), typically starting at 0.5-2 mg/kg/day divided into two daily doses, with a maximum of 50 mg/day. This treatment bypasses the blocked folate receptors by utilizing alternative transport mechanisms to deliver folate to the brain, as supported by the most recent and highest quality study 1. The dosage may be adjusted based on clinical response, with some children requiring higher doses for optimal benefit. Treatment is typically long-term as the antibodies often persist. Regular monitoring of folate levels and clinical symptoms is important, with dosage adjustments made accordingly. A milk-free diet is often recommended alongside folinic acid supplementation, as milk proteins can trigger or worsen folate receptor antibodies in susceptible individuals. This dietary modification may enhance treatment effectiveness. This approach addresses the underlying folate deficiency in the central nervous system caused by the antibodies, which can impair neurodevelopment, neurotransmitter synthesis, and methylation processes critical for brain function. Some children show improvements in communication, attention, and behavior within weeks to months of starting treatment.
Key points to consider:
- Folate receptor autoantibodies are common in children with autism, with a prevalence of 75.3% reported in one study 2
- High-dose folinic acid treatment has been shown to improve symptoms in children with autism and FRAs, with significant improvements in verbal communication, receptive and expressive language, attention, and stereotypical behavior 1, 2
- The treatment is generally well-tolerated, with a low incidence of adverse effects 1, 2
- Regular monitoring of folate levels and clinical symptoms is essential to adjust the dosage and ensure optimal treatment response 3, 1
Overall, the evidence supports the use of high-dose folinic acid as a primary treatment for children with autism who have folate receptor autoantibodies, with the goal of improving symptoms and quality of life.