Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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
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.
Like all medications, Pentetate Zinc Trisodium can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: