Consent for Off-Label Use of Leucovorin

Consent for Off-Label Use of Leucovorin

Rising Star Pediatrics  ·  Fax: 561-916-0414  ·  rspeds.com

Form v1.1 — Effective Mar 2026
1Patient
2About
3Regimen
4Risks
5Acknowledge
6Signature
7Review
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Patient Information

Patient name is required.
Date of birth is required.
Phone number is required.
To receive a copy of the completed form.
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About Off-Label Use of Leucovorin

What is off-label use?
The FDA requires that drugs used in the United States be both safe and effective. A drug approved for a specific condition carries labeling with approved uses, dosing, and administration guidelines. When a prescriber uses a drug for a condition, dose, or route not listed on the package insert, this is considered "off-label" use — a decision made based on the prescriber's professional judgment, knowledge, and emerging research, after discussion with the patient or their representative.
Important Notice About Leucovorin & Autism
Leucovorin is not an evidence-based treatment for autism. Some studies have indicated improvement in communication, social interactions, and/or behavioral regulation; however, these studies have been short-term, and most participants received concurrent therapies. Long-term side effect data is limited. Most studies collected data for only 3 months.
Possible side effects include:
  • Stomach upset
  • Fatigue
  • Irritability
  • Rash
  • Fast heart rate
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Medication Regimen & Follow-Up

Dosing: Leucovorin maximum dosing is 25 mg twice a day OR 2 mg/kg/day divided twice a day. The dose will be slowly increased to your child's maximum to assess for side effects.
Follow-Up Schedule: We will follow up after 1 month of treatment and again at 3 months. If there is no improvement after 3 months at maximum dose, we will discuss whether further treatment is indicated.
Dietary Requirements:
  • A complete dairy-free diet and vitamin B12 supplement should be continued throughout treatment.
  • This regimen will be tailored to your child's needs based on diet and baseline lab results.
  • Your child's speech therapy should continue throughout treatment.
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Risks & Side Effects

Please initial each item below to confirm you understand the risks associated with off-label Leucovorin use.

I understand that the person taking this medication for an off-label use may have reactions or side effects that have not yet been identified, including but not limited to severe allergic reaction and life-threatening side effects.
I understand and accept that the most likely material risks and complications may include but are not limited to: increased aggressiveness, increased self-injurious behavior, increased anxiety, gastrointestinal discomfort, and sleeping difficulty (insomnia).
The details of this treatment including anticipated benefits, material risks, and disadvantages have been explained to me in terms I understand.
Alternative treatments, prescriptions, and therapies — and their benefits, material risks, and disadvantages — have been explained to me in terms I understand.
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Acknowledgments

Please initial each statement to confirm your understanding.

I am aware and accept that there are no guarantees about the results and efficacy of this medication for an off-label indication.
I understand that on this medication the patient should ideally completely eliminate dairy. Some dairy protein counteracts the mechanism of action of Leucovorin. In some cases, processed milk products (cheeses, yogurt) that use heat and enzyme to denature targeted proteins may be tolerated — this will be discussed for your individual child.
I understand that it is recommended to concurrently start a methylated vitamin B12 supplement (generally determined after obtaining baseline labs).
I understand that it is highly encouraged that the patient be in concurrent speech therapy for best effect.
My healthcare provider has answered all of my questions regarding this treatment/medication.
Please list allergies or write NKDA.
Please list current medications or write None.
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Acknowledgment & Signature

Authorization Statement:
I authorize and direct the prescriber to prescribe Folinic Acid (Leucovorin) for the patient's non-verbal autism spectrum disorder with the goal of improving communication (expressive and receptive language), attention, and stereotypy. I understand this is an off-label usage and the duration of treatment, full side-effect profile, and risks may not be fully elucidated until further studies are performed and the FDA investigates this medication for this specific condition.
☑  I certify that I have read and understand this treatment agreement and that all blanks were filled in prior to my signature.

☑  I certify that a provider at Rising Star Pediatrics has explained the nature, purpose, anticipated benefits, material risks, complications, and alternatives to the proposed therapy. My questions have been answered fully and I understand all of the above information.

☑  By typing my name below, I understand that this electronic signature has the same legal force and effect as a handwritten signature.
The Rising Star Pediatrics provider who explained this treatment to you.
Provider name is required.
Legal representative name is required.
Please select relationship.
Signature is required.
Date is required.
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Review & Submit

Please review your information before submitting.

By clicking Submit Consent, you confirm all information is accurate and consent to the off-label use of Leucovorin (Folinic Acid) as described in this form.

✓ Consent Form Submitted

Your form has been received by Rising Star Pediatrics and a notification has been sent to the care team.

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