Pentetate Calcium Trisodium

1 INDICATIONS AND USAGE Ca-DTPA is indicated for treatment of individuals with known or suspected internal contamination with plutonium, americium, or curium to increase the rates of elimination. Pentetate calcium trisodium injection is a radiomitigation chelator indicated for treatment of individuals with known or suspected internal contamination with plutonium, americium, or curium to increase the rates of elimination. ( 1 )

6 ADVERSE REACTIONS In the U.S. Registry, a total of 646 individuals received at least one dose of either Ca-DTPA or Zn-DTPA. Of these, 632 received Ca-DTPA 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, 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 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.

8.1 Pregnancy Pregnancy Category C Risk Summary There are no adequate and well-controlled studies of Ca-DTPA use in pregnant women. Ca-DTPA chelation therapy causes depletion of body stores of zinc, a trace metal essential for fetal development [see Warnings and Precautions (5.2) ] . The consequences of zinc depletion and results of animal studies suggest a teratogenic risk in humans.

WARNING: ASTHMA EXACERBATION WITH NEBULIZATION and DEPLETION OF TRACE METALS DURING THERAPY Nebulized Ca-DTPA may be associated with asthma exacerbation. ( 5.1 ) Ca-DTPA is associated with depletion of trace metals such as zinc. The magnitude of depletion increases with split daily dosing, with increasing dose and with increased treatment duration. Only a single dose of Ca-DTPA is recommended. Use Zn-DTPA if additional chelation therapy is indicated. 5 WARNINGS AND PRECAUTIONS Nebulized Ca-DTPA may be associated with exacerbation of asthma. Monitor patients for signs and symptoms of asthma exacerbation when administering Ca-DTPA by the inhalation route. ( 5.1 ) Ca-DTPA is associated with depletion of endogenous trace metals (e.g., zinc, magnesium, manganese). ( 5.2 ) Take appropriate safety measures to minimize contamination of care-takers by contaminated body fluids. ( 5.3 ) Use Ca-DTPA with caution in individuals with severe hemochromatosis. ( 5.4 ) 5.1 Asthma Exacerbation Nebulized Ca-DTPA is associated with asthma exacerbation. Monitor patients for signs and symptoms of asthma exacerbation when administering Ca-DTPA by the inhalation route. 4 CONTRAINDICATIONS None. None ( 4 )