Pentetate zinc trisodium INJECTION, SOLUTION, CONCENTRATE

Get an overview of PENTETATE ZINC TRISODIUM (injection, solution, concentrate), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Pentetate zinc trisodium can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Pentetate zinc trisodium.

Drug Basics

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)

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.

drug interactions

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
Nexus
Gloucester Business Park
Gloucester, GL3 4AG
United Kingdom
Tel: + 44 / 1452 / 621661
Fax: +44 / 1452 / 632732
e-mail: drugsafety@hameln.co.uk

Contact person: Richard Wysocki
Phone: +44 / 1452 / 621661
Fax: +44 / 1452 / 632732
Email: r.wysocki@hameln.co.uk

Revised: 10/2016

44640/17/16

Zn-DTPA
Patient treatment Data
Send to: hameln pharmaceuticals ltd, Nexus, Gloucester Business Park, Gloucester, GL3 4AG, United Kingdom
zndtpa 04.jpg

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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