WARNING: ASTHMA EXACERBATION WITH NEBULIZATION and DEPLETION OF TRACE METALS DURING THERAPY Nebulized Zn-DTPA may be associated with asthma exacerbation. ( 5.1 ) Zn-DTPA is associated with depletion of trace metals. The risk for depletion increases when Zn-DTPA is administered over several months. Monitor serum zinc levels, serum creatinine, BUN, electrolytes, urinalysis and blood cell counts during Ca-DTPA or Zn-DTPA therapy. ( 2.4 , 5.2 ) WARNING: ASTHMA EXACERBATION WITH NEBULIZATION and DEPLETION OF TRACE METALS DURING THERAPY See full prescribing information for complete boxed warning. Nebulized Zn-DTPA may be associated with asthma exacerbation. ( 5.1 ) Zn-DTPA is associated with depletion of trace metals. The risk for depletion increases when Zn-DTPA is administered over several months. Monitor serum zinc levels, serum creatinine, BUN, electrolytes, urinalysis and blood cell counts during Ca-DTPA or Zn-DTPA therapy. ( 2.4 , 5.2 )
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warnings and cautions
5 WARNINGS AND PRECAUTIONS Nebulized chelation therapy may be associated with exacerbation of asthma. Monitor patients for signs and symptoms of asthma exacerbation when administering Zn-DTPA by the inhalation route. ( 5.1 ) Zn-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 ) 5.1 Asthma Exacerbation Nebulized chelation therapy is associated with asthma exacerbation. Monitor patients for signs and symptoms of asthma exacerbation when administering Zn-DTPA by the inhalation route. [See Adverse Reactions (6) ] 5.2 Depletion of Body Trace Mineral Stores Zn-DTPA treatment may lead to depletion of body stores of endogenous metals (e.g. magnesium, manganese). The risk for depletion increases when Zn-DTPA is administered over several months. Monitor serum zinc levels, electrolytes and blood cell counts during Ca-DTPA or Zn-DTPA therapy. Give mineral or vitamin plus mineral supplements as appropriate. [See Dosage and Administration (2.4) ] 5.3 Risks to Care-takers Radioactive metals are known to be excreted in the urine, feces, and breast milk. In individuals with recent internal contamination with plutonium, americium, or curium, Zn-DTPA treatment increases excretion of radioactivity in the urine. Take appropriate safety measures to minimize contamination of others. [See Patient Counseling Information (17) ]
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, 62 received Zn-DTPA by one or more routes of administration. Forty-eight individuals were dosed by intravenous administration, 18 by inhalation and 8 by other or unknown routes of administration. Of the individuals that received Zn-DTPA, 23/62 (37%) received one dose and 8 (13%) received two doses. The remaining 31 individuals received three or more doses. The largest number of Zn-DTPA doses to a single individual was 574 doses delivered over 3.5 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, 1 individual treated with Zn-DTPA reported headache, lightheadedness, and pelvic pain. Two individuals experienced cough and/or wheezing with nebulized Ca-DTPA therapy however there was no report of such events with nebulized Zn-DTPA. There is limited experience with Zn-DTPA. Nebulized chelation therapy may be associated with exacerbation of asthma. Headache, light headedness, and pelvic pain have been reported. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact the hameln Pharmacovigilance Department at +44 (0) 7706 210 133 or drugsafety@hameln.co.uk or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.