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Zn-DTPA

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Zn-DTPA

Indications
Dosage
How Supplied

INDICATIONS

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

DOSAGE AND ADMINISTRATION

Chelation treatment is most effective if administered within the frst 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 (pentetate zinc trisodium injection) are greatest when the radiocontaminants are still circulating or are in interstitial fuids. The effectiveness of chelation decreases with time following internal contamination as the radiocontaminants become sequestered in liver and bone.

Individuals should drink plenty of fuids 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).

Initial Dose

IT IS PREFERABLE TO ADMINISTER CA-DTPA, IF AVAILABLE, AS THE INITIAL DOSE DURING THE FIRST 24 HOURS AFTER INTERNAL CONTAMINATION BECAUSE CA-DTPA IS MORE EFFECTIVE THAN ZN-DTPA (pentetate zinc trisodium injection) DURING THIS TIME PERIOD. AFTER 24 HOURS, ZN-DTPA (pentetate zinc trisodium injection) AND CA-DTPA ARE EQUALLY EFFECTIVE.

Adults and Adolescents

A single 1.0 gram initial dose of Zn-DTPA (pentetate zinc trisodium injection) 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 effciency high fux dialysis is recommended. Because dialysis fuid will become radioactive, radiation precautions must be taken to protect personnel, other patients, and the general public.

Maintenance Treatment Adults and Adolescents

The recommended maintenance dose of Zn-DTPA (pentetate zinc trisodium injection) is 1.0 gram once a day administered intravenously.

Pediatrics (less than 12 years of age)

The recommended maintenance dose of Zn-DTPA (pentetate zinc trisodium injection) 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)

Methods of Administration

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 (pentetate zinc trisodium injection) 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 (pentetate zinc trisodium injection) can be administered by nebulized inhalation as an alternative route of administration. Zn-DTPA (pentetate zinc trisodium injection) 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.

Handling

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

OPC ampoule - opening: Illustration

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

Monitoring

When possible, 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.

During Treatment

  • 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 (pentetate zinc trisodium injection) .

HOW SUPPLIED

Zn-DTPA (pentetate zinc trisodium injection) 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 52919-002-03, 5 mL single-use ampoules, package of 10.

Storage

Store between 15 - 30°C (59 - 86°F).

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. In the case you need additional forms, please use the enclosed form as a template or see the following website: www.zn-dtpa (pentetate zinc trisodium injection) .com). These data should include a record of the radioactive body burden and bioassay results at defned time intervals, a description of measurement methods to facilitate analysis of data, and adverse events.

Zn-DTPA (pentetate zinc trisodium injection)

Patient treatment Data

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

Date of report : Unique patient identifier:
Patient ID
Name: ........... Date of birth: ....... Sex: Male /Female
Address: ....................................
Phone: (...) ....... Hospitalization: No Yes Where? .............
Criteria for Diagnosis
Date/time of exposure: .............................
Geographic location/details of exposure: ......................
Lab/field confirmed exposure; method: ........................
Symptoms of Acute Radiation Syndrome: ......................
Contamination
Transuranium element(s): confirmed suspected; list element(s): ..............
Route (check all that apply): Skin Inhalation Wound Burn Ingestion
Anatomic area affected: ..............................
Initial radioactivity measurement: ..........................
How measured: ...............................
Decontamination
External: Skin washed with: ..........................
Wound excised/washed: ........................
Contraindications to aerosolized treatment
(h/o lung disease, cough, dyspnea, chest tightness, wheezing)? .............
Internal:
Zn-DTPA (pentetate zinc trisodium injection) Date/time of initial dose: ..../.. Amount: .... Total doses: .. Route: ..
Adverse Reaction to Treatment
Adverse Reaction(s) to treatment? No Yes; provide details: ...............
......................................Vital signs: Baseline Stable Unstable: ......................
Subsequent (if abnormal): ......................
Disposition of patient/outcome of treatment: ....................
Treatment Team Data
Report completed by: ................ Title: ............
Organization/affiliation: .............................
Phone: (..) ......... Email: .......... @ ...........
Comments
.......................................
.......................................
.....................
Attach Copy of Emergency Records to this Form

Questions regarding the use of Zn-DTPA (pentetate zinc trisodium injection) 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.

Last reviewed on RxList: 3/9/2009
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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