Intravenous Milk Thistle (Silibinin-Legalon) for Hepatic Failure Induced by Amatoxin/Amanita Mushroom Poisoning
Intravenous Milk Thistle (Silibinin-Legalon) for Hepatic Failure Induced by Amatoxin/Amanita Mushroom Poisoning
Legalon® SIL will be administered to patients with amatoxin poisoning diagnosed by history,
 gastrointestinal symptoms, elevated liver enzymes, and/or diagnostic assay (should one become
 available). Patients may or may not also demonstrate abnormalities in bilirubin and/or
 creatinine. Treatment consists of a 5 mg/kg loading dose followed by 20 mg/kg/day via
 continuous infusion. The treating physician is expected to administer supportive therapy of
 his/her choosing but consistent with best practices. Legalon® SIL will be stopped when
 coagulopathy is no longer present, and when liver function tests have returned significantly
 towards the normal range. Patients will be followed 7-14 days after the end of Legalon® SIL
 therapy with follow up lab studies.
Patients with suspected amatoxin poisoning are reviewed for enrollment in the study by
 contacting the Legalon SIL study hotline (866) 520-4412.
Inclusion Criteria:

 1. Signed Informed Consent(s) for clinical trial participation (due to the potential
 critical status of the subject upon presentation, consent may need to be obtained from
 Legally Authorized Representative (LAR) per sites consenting policy and ICH/GCP
 guidance) Signed Informed Consent for Clinical Trial participation

 2. History of eating foraged mushrooms

 3. Gastrointestinal symptoms suggestive of amatoxin poisoning (cramping abdominal pain,
 nausea, vomiting, and / or watery diarrhea) usually 24-48 hours after of mushroom
 ingestion

 4. Liver function tests suggestive of amatoxin poisoning: AST or ALT above the
 institutions upper limit of normal after mushroom ingestion

 Exclusion criteria:

 1. Evidence of significant medical illness or any other abnormal laboratory finding that,
 in the Investigator's judgment, will substantially increase the risk associated with the
 subject's participation in, and completion of the study or could preclude the evaluation of
 the subject's response.