Madaus Inc. (via Meda Pharmaceutical, Inc.) is currently recruiting patients for an open label Phase2/3 study (FDA IND 105,960) for a mushroom poisoning antidote Legalon® SIL.
Legalon® SIL (the study drug) will be administered to patients with amatoxin poisoning diagnosed by history, gastrointestinal symptoms, elevated liver enzymes, and/or assay of mushroom specimen, if available. Patients may or may not also demonstrate abnormalities in bilirubin and/or creatinine.
The drug will be provided at no charge to treat patients enrolled in the study with suspected amatoxin poisoning due to the ingestion of Amanita phalloides or other amatoxin containing mushrooms.
Physicians treating patients with
suspected amatoxin poisoning should call the Legalon SIL study’s 24 hour toll
When a physician calls the hotline and leaves the required contact information, they will be contacted by the Study Principal Investigator (Study PI). Once the Study PI determines that the patient meets the Legalon® SIL study criteria, the patient will be enrolled in the study and a supply Legalon SIL be sent via expedited shipment to the hospital pharmacy. Upon enrollment, the physician must ensure completion of regulatory requirements for a clinical study. Upon the completion of treatment, the attending physician will submit all relevant data to the Study PI for inclusion in the study file.
Treatment consists of a 5 mg/kg loading dose of Legalon® SIL 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 approximately 7-14 days after the end of Legalon® SIL therapy with follow up lab studies.
Amatoxin Mushroom Poisoning (AMP)
Amanita phalloides (aka Death Caps) and other amatoxin producing mushrooms (A. ocreata, A. bisporigera, A. virosa, Galerinas, Lepiotas) are often mistaken for safe edible mushrooms in the wild. They are known to taste very good and initial symptoms are delayed by six hours or more. Within 24 hours of ingestion patients develop a syndrome similar to food poisoning with severe diarrhea and vomiting. Depending on the amount ingested and the degree of dehydration at presentation, fulminant hepatic and renal failure may ensue resulting in death or the need for liver transplantation.
Legalon® SIL (Silibinin-C-2’,
3-dihydrogen succinate disodium salt)
Legalon® SIL is a highly purified intravenous (IV) preparation of silibinin, a constituent of the common milk thistle, Silybum marianum. The pharmacological effects of Legalon® SIL have been studied and it has a well elucidated mechanism of action in amatoxin poisoning. Legalon® SIL blocks hepatocyte uptake of amatoxin allowing the poison to be cleared more quickly from the body. Legalon® SIL has been used in the treatment of amatoxin mushroom poisoning for more than 20 years and it is currently approved for use in many European countries, but not in the US.
Meda Pharmaceuticals is the U.S. subsidiary of Meda AB.
Meda is a leading international specialty pharma company with a broad product portfolio and its own sales organizations in almost 60 countries. Including those markets where sales are managed by distributors, Meda's products are sold in more than 120 different countries.
IMMEDIATELY CALL THE LEGALON® SIL HOTLINE: 866-520-4412. IF YOU HAVE A SUSPECTED CASE OF AMATOXIN-MUSHROOM POISONING.