Zn-DTPA is indicated for treatment of individuals with known or suspected internal contamination with plutonium, americium, or curium to increase the rates of elimination.

Chelation treatment is most effective if administered within the first 24 hours after internal contamination and should be started as soon as possible after suspected or known internal contamination. However, even when treatment cannot be started right away, individuals should be given chelation treatment as soon as it becomes available. Chelation treatment is still effective even after time has elapsed following internal contamination, however the chelating effects of Zn-DTPA are greatest when the radiocontaminants are still circulating or are in interstitial fluids. The effectiveness of chelation decreases with time following internal contamination as the radiocontaminants become sequestered in liver and bone.

Individuals should drink plenty of fluids and void frequently to promote dilution of the radioactive chelate in the urine and minimize radiation exposure directly to the bladder.

If internal contamination with radiocontaminants other than plutonium, americium, or curium, or unknown radiocontaminants is suspected, additional therapies may be needed (e.g., Prussian blue, potassium iodide).

Adults and Adolescents: A single 1.0 gram initial dose of Zn-DTPA administered intravenously.

Pediatrics (less than 12 years of age): A single initial dose of 14 mg/kg administered intravenously not to exceed 1.0 gram.

Renally impaired patients: No dose adjustment is needed. However, renal impairment may reduce the rate at which chelators remove radiocontaminants from the body. In heavily contaminated patients with renal impairment, dialysis may be used to increase the rate of elimination. High efficiency high flux dialysis is recommended. Because dialysis fluid will become radioactive, radiation precautions must be taken to protect personnel, other patients, and the general public.

Adults and Adolescents: The recommended maintenance dose of Zn-DTPA is 1.0 gram once a day administered intravenously.

Pediatrics (less than 12 years of age): The recommended maintenance dose of Zn-DTPA is 14 mg/kg once a day administered intravenously. The maximum daily dose should not exceed 1.0 gram per day.

Renally impaired patients: No dose adjustment is needed.

The duration of chelation treatment depends on the amount of internal contamination and individual response to treatment. (See Monitoring)

The intravenous route is recommended and should be used if the route of internal contamination is not known or if multiple routes of internal contamination are likely. Zn-DTPA solution (1 gram in 5 mL) should be administered either with a slow intravenous push over a period of 3-4 minutes or by intravenous infusion over 30 minutes diluted in 100-250 mL of 5% dextrose in water (D₅W), Ringers Lactate, or Normal Saline.

In individuals whose internal contamination is only by inhalation, Zn-DTPA can be administered by nebulized inhalation as an alternative route of administration. Zn-DTPA should be diluted for nebulization at a 1:1 ratio with sterile water or saline. After nebulization, individuals should be encouraged to avoid swallowing any expectorant. Some individuals may experience respiratory adverse events after inhalation therapy. (See WARNINGS) The safety and effectiveness of the nebulized route of administration has not been established in the pediatric population.

The safety and effectiveness of the intramuscular route of injection have not been established.

OPC ampoule: to open, turn so that the point faces upward and break off the neck with a downward movement.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The product may be filtered using a sterile filter if particles are seen subsequent to opening of the ampoule.

When possib le, obtain baseline blood and urine samples (CBC with differential, BUN, serum chemistries and electrolytes, urinalysis and blood and urine radioassays) before initiating treatment.

To establish an elimination curve, a quantitative baseline estimate of the total internalized transuranium element(s) and measures of elimination of radioactivity should be obtained by appropriate whole-body counting, by bioassay (e.g., biodosimetry), or fecal/urine sample whenever possible.

Measure the radioactivity in blood, urine, and fecal samples weekly to monitor the radioactive contaminant elimination rate.

Monitor CBC with differential, BUN, serum chemistries and electrolytes, and urinalysis measurements regularly.

Record any adverse events from Zn-DTPA.

Zn-DTPA is supplied as a sterile solution in 5 mL single-use clear glass ampoules at a concentration of 200 mg/mL for intravenous use. Each ampoule contains the equivalent of 1000 mg of pentetate zinc trisodium.

NDC 52919-002-003, 5 mL single-use ampoules, package of 10.

Store between 15 - 30°C (59 - 86°F).

To develop long-term response data and information on the risk of developing late malignancy, detailed information on patient treatment should be provided to the manufacturer (see attached Pad of Patient Treatment Data Forms. In the case you need additional forms, please see the following website: www.hameln-pharmaceuticals.com). These data should include a record of the radioactive body burden and bioassay results at defined time intervals, a description of measurement methods to facilitate analysis of data, and adverse events.

Zn-DTPA

Patient treatment Data

Send to: hameln pharmaceuticals gmbh, Langes Feld 13, 31789 Hameln, Germany

Questions regarding the use of Zn-DTPA for the treatment of internal contamination with transuranium elements may be referred to:

hameln pharmaceuticals gmbh, Langes Feld 13, 31789 Hameln, Germany Tel.: +49-5151-581-0, Fax.: +49-5151-581-258, e-mail: welcome@hm-ph.com, contact person: Dr. Mathias Dewald, Tel.: +49-5151-581-214, Fax.: +49-5151-581-581, e-mail: m.dewald@hm-ph.com

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