Nebulized chelation therapy may be associated with exacerbation of asthma. Caution should be exercised when administering Zn-DTPA by the inhalation route. (See ADVERSE REACTIONS)

Treatment over several months with Zn-DTPA could lead to depletion of body stores of endogenous metals (e.g., magnesium, manganese). These elements should be monitored routinely and, if appropriate, mineral or vitamin plus mineral supplements should be provided.

Serum electrolytes and essential metals should be closely monitored during Zn-DTPA treatment. Mineral or vitamin plus mineral supplements may be given as appropriate. (See PRECAUTIONS)

Studies with Zn-DTPA to evaluate carcinogenesis, mutagenesis and impairment of fertility have not been performed. Data for Zn-DTPA effects on spermatogenesis are not available.

There are no human pregnancy outcome data from which to assess the risk of Zn-DTPA exposure on fetal development. Reproduction studies have been performed in pregnant mice at doses up to 11.5 mmol/kg (31 times the recommended daily dose of 1 gram based on body surface area [BSA] adjusted dose) and have revealed no evidence of impaired fertility or harm to the fetus. There was a slight reduction in the average birth weight.

Studies to determine if Zn-DTPA is excreted in breast milk have not been conducted.

Radiocontaminants are known to be excreted in breast milk. Women with known or suspected internal contamination with radiocontaminants should not breast feed, whether or not they are receiving chelation therapy. Precautions should be taken when discarding breast milk. (See PRECAUTIONS, Information for Patients)

The safety and effectiveness of Zn-DTPA was established in the adult population and efficacy was extrapolated to the pediatric population for the intravenous route based on the comparability of pathophysiologic mechanisms. The dose is based on body size adjustment for an intravenous drug that is renally cleared. The safety and effectiveness of the nebulized route of administratio n has not been established in the pediatric population.

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