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Ca-DTPA

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Ca-DTPA

INDICATIONS

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 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).

Initial Dose

Adults and Adolescents: A single 1.0 gram initial dose of Ca-DTPA (pentetate calcium trisodium inj) administered intravenously.

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 therapy.

Maintenance Treatment

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)

Handling

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.

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.

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.

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 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) .

HOW SUPPLIED

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.

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 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: 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.

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

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:

Ca-DTPA (pentetate calcium trisodium inj) 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

Hameln Pharmaceuticals. Disributed by: AKORN, INC. Buffalo Grove, IL 60089. FOR PRODUCT INQUIRY: 1-800-93AKORN (1-800-932-5676). FDA Rev date: 3/15/2005

Last reviewed on RxList: 1/7/2009
This monograph has been modified to include the generic and brand name in many instances.

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