Ca-DTPA (pentetate calcium trisodium inj) 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 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 Ca-DTPA (pentetate calcium trisodium inj) are greatest when 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
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 Ca-DTPA (pentetate calcium trisodium inj) administered
Pediatrics (less than 12 years of age): A single initial dose of 14
mg/kg administered intravenously not exceed 1.0 gram.
Renally impaired patients: No dose adjustment is needed. However, renal
impairment may reduce the rate at which chelators remove radiocontami-nants
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.
If Ca-DTPA (pentetate calcium trisodium inj) is not available, proceed with treatment with Zn-DTPA as initial
AFTER THE INITIAL DOSE, ON THE NEXT DAY, IF ADDITIONAL CHELATION THERAPY
IS INDICATED, IT IS PREFERABLE TO SWITCH TO ZN-DTPA, IF AVAILABLE (SEE ZN-DTPA
LABELING) DUE TO THE SAFETY CONCERNS ASSOCIATED WITH PROLONGED CA-DTPA (pentetate calcium trisodium inj) USE.
IF ZN-DTPA IS NOT AVAILABLE, TREATMENT MAY CONTINUE WITH CA-DTPA (pentetate calcium trisodium inj) , HOWEVER MINERAL
SUPPLEMENTS CONTAINING ZINC SHOULD BE GIVEN CONCOMITANTLY, AS APPROPRIATE.
Adults and Adolescents: The recommended maintenance dose of Ca-DTPA (pentetate calcium trisodium inj)
is 1.0 gram once a day administered intravenously.
Pediatrics (less than 12 years of age): The recommended maintenance
dose of Ca-DTPA (pentetate calcium trisodium inj) 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
Intravenous administration of Ca-DTPA (pentetate calcium trisodium inj) is recommended and should be used if
the route of internal contamination is not known or if multiple routes of internal
contamination are likely. Ca-DTPA (pentetate calcium trisodium inj) 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 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 within the
preceding 24 hours, Ca-DTPA (pentetate calcium trisodium inj) can be administered by nebulized inhalation as an
alternative route of administration. Ca-DTPA (pentetate calcium trisodium inj) should be diluted for neb-ulization
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. (See OVERDOSE)
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 possible, obtain baseline blood and urine samples (CBC with differential,
BUN, serum chemistries and electrolytes, urinalysis, and blood and urine radioassays)
before initiating treatment.
Ca-DTPA (pentetate calcium trisodium inj) must be given with very careful monitoring of serum zinc and complete
blood counts. When appropriate, vitamin or mineral supplements that contain
zinc should be administered. (See WARNINGS)
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 regularly. If the individual is receiving more than one dose
of Ca-DTPA (pentetate calcium trisodium inj) , these laboratory tests should be very carefully monitored and
consider mineral supplementation as appropriate. (See CLINICAL
PHARMACOLOGY, Pharmacodynamics, Adverse Metabolic Effects)
- Record any adverse events from Ca-DTPA (pentetate calcium trisodium inj) .
Ca-DTPA (pentetate calcium trisodium inj) 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 calcium trisodium.
NDC 52919-001-03, 5 mL single-use ampoules, package of 10.
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 attached Pad of Patient Treatment Data Form. In
the case you need additional forms, please see the following web-site: www.ca-dtpa (pentetate calcium trisodium inj) .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 Ca-DTPA (pentetate calcium trisodium inj) 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: [email protected]
Contact person: Dr. Mathias Dewald, Tel.: +49-5151-581-214, Fax.: +49-5151-581-581,
e-mail: [email protected]
Ca-DTPA (pentetate calcium trisodium inj)
Patient treatment Data
Send to: hameln pharmaceuticals gmbh Langes Feld 13, 31789 Hameln, Germany
Date of report:
Unique patient identifier
Date of birth:
Sex: Male Female
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:
Transuranium element(s) confirmed suspected; list element(s):
Route (check all that apply): Skin Inhalation Wound Burn Ingestion
Anatomic area affected:
Initial radioactivity measurement:
External: Skin washed with:
Contraindications to aerosolized treatment
(h/o lung disease, cough, dyspnea, chest tightness, wheezing)?
Ca-DTPA (pentetate calcium trisodium inj) Date/time of initial dose:
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:
ATTACH COPY OF EMERGENCY RECORDS TO THIS FORM
Hameln Pharmaceuticals. Disributed by: AKORN, INC. Buffalo Grove,
IL 60089. FOR PRODUCT INQUIRY: 1-800-93AKORN (1-800-932-5676). FDA Rev date: