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In the U.S. Registry, a total of 646 individuals received at least one dose of either Ca-DTPA (pentetate calcium trisodium inj) or Zn-DTPA. Of these, 632 received Ca-DTPA (pentetate calcium trisodium inj) by one or more routes of administration. Three hundred and twenty-six individuals were dosed by inhalation, 293 by intravenous injection, and 60 by other or unknown routes of administration.

Of the individuals that received Ca-DTPA (pentetate calcium trisodium inj) , 393/632 (62%) received one dose and 65 (10%) received two doses. The remaining 174 individuals received three or more doses. The largest number of Ca-DTPA (pentetate calcium trisodium inj) doses to a single individual was 338 delivered over 6.5 years. Overall, the presence or absence of adverse events was recorded in 310/646 individuals. Of these 19 (6.1%) individuals reported at least one adverse event. The total number of recorded adverse events was 20. Of the 20 adverse events, 18 adverse events occurred after treatment with Ca-DTPA (pentetate calcium trisodium inj) . Adverse events included headache, lightheadedness, chest pain, allergic reaction, dermatitis, metallic taste, nausea and diarrhea, and injection site reactions.

Cough and/or wheezing were experienced by 2 individuals receiving nebu-lized Ca-DTPA (pentetate calcium trisodium inj) , one of whom had a history of asthma.

In the literature, prolonged treatment with Ca-DTPA (pentetate calcium trisodium inj) resulted in depletion of zinc, magnesium, manganese and possibly metalloproteinases.(See WARNINGS)