Pentetate zinc trisodium INJECTION, SOLUTION, CONCENTRATE
Refer to the “Also Known As” section to reference different products that include the same medication as Pentetate zinc trisodium.
Brand Name: Pentetate zinc trisodium
Generic Name: PENTETATE ZINC TRISODIUM
Drug Type: HUMAN PRESCRIPTION DRUG
Route: RESPIRATORY (INHALATION), INTRAVENOUS
Dosage Form: INJECTION, SOLUTION, CONCENTRATE
Data Current As Of: 2020-02-03
indications & usage
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.
Pentetate zinc 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)
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.
To report SUSPECTED ADVERSE REACTIONS, contact the hameln Pharmacovigilance Department at +44 (0) 7706 210 133 or email@example.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Adequate and well-controlled drug-drug interaction studies in humans were not identified in the literature. When an individual is contaminated with multiple radiocontaminants, or when the radiocontaminants are unknown, additional therapies may be needed (e.g., Prussian blue, potassium iodide).
Adequate and well-controlled drug-drug interaction studies in humans were not identified in the literature. (7)
patient counseling information
Instruct patients to:
- 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.
- use a toilet instead of a urinal, and flush several times after each use.
- clean up spilled urine or feces completely and wash hands thoroughly. Wash clothing or linens separately if blood or urine comes in contact.
- dispose of any expectorant carefully. Avoid swallowing the expectorant if possible.
IInstruct parents and child-care givers to take extra precaution in handling the urine, feces, and expectorants of children to avoid any additional exposure to either the care-giver or to the child.
Instruct nursing mothers to take extra precaution in disposing of breast milk. [See Use in Specific Populations (8.3)]
collection of patient treatment data
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 Patient Treatment Data Form). To obtain additional forms, please use the enclosed form as a template or see the following website: www.zn-dtpa.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.
Questions regarding the use of Zn-DTPA for the treatment of internal contamination with transuranium elements may be referred to:
hameln pharmaceuticals ltd
Gloucester Business Park
Gloucester, GL3 4AG
Tel: + 44 / 1452 / 621661
Fax: +44 / 1452 / 632732
Contact person: Richard Wysocki
Phone: +44 / 1452 / 621661
Fax: +44 / 1452 / 632732
|Patient treatment Data|
|Send to: hameln pharmaceuticals ltd, Nexus, Gloucester Business Park, Gloucester, GL3 4AG, United Kingdom|