Indium In-111 Pentetate Disodium

Description

DESCRIPTION GE Healthcare (Medi-Physics, Inc.) Indium DTPA In 111 is a diagnostic drug for intrathecal use. It is available as a sterile, pyrogen-free, isotonic, aqueous solution, buffered to pH 7 to 8. At calibration time, each milliliter contains 37 MBq, 1 mCi of Pentetate Indium Disodium In 111 (no-carrier-added), 20 to 50 µ g of pentetic acid, and sodium bicarbonate for pH adjustment. The drug is to be discarded after single use. Radionuclidic purity at calibration time is at least 99.88% with less than 0.06% Indium In 114m and 0.06% Zinc Zn 65. The concentration of each radionuclidic contaminant changes with time. Graph 1 shows maximum concentration of each radionuclidic impurity as a function of time. Graph 1 - Radionuclidic Impurities The chemical names are 1. Indate(2-)- 111 In -[ N,N -bis[2-[bis-(carboxymethyl)amino]ethyl]glycinato(5-)]-disodium; and 2. Disodium [ N,N -bis[2-(carboxymethyl)amino]glycinato(5-)]-indate (2-) 111 In. Molecular formula: C 14 H 18 O 10 N 3 111 In Na 2 Molecular weight: 545.29 Structural formula: PHYSICAL CHARACTERISTICS Indium 111 decays by electron capture with a physical half-life of 67.9 hours. The energies of the photons that are useful for detection and imaging studies are listed in Table 1. Table 1. Principal Radiation Emission Data Kocher, David C.,"Radioactive Decay Data Tables,"DOE/TIC-11026, 115, (1981). Radiation Mean %/Disintegration Mean Energy (keV) Gamma-2 90.2 171.3 Gamma-3 94.0 245.4 EXTERNAL RADIATION The specific gamma ray constant for Indium In 111 is 3.3 R/hr-mCi at 1 cm. The half-value thickness of lead (Pb) for Indium In 111 is 0.021 cm. To facilitate control of the radiation exposure from millicurie amounts of this radionuclide, a range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 2. For example, the use of a 0.8 cm thickness of Pb will attenuate the radiation emitted by a factor of about...

What Is Indium In-111 Pentetate Disodium Used For?

INDICATIONS AND USAGE Pentetate Indium Disodium In 111 is recommended for use in radionuclide cisternography.

Dosage and Administration

DOSAGE AND ADMINISTRATION Extreme care must be exercised to assure aseptic conditions in intrathecal injections. The maximum recommended intrathecal dose in the average patient (70 kg) is 18.5 MBq, 500 µ Ci. The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Side Effects (Adverse Reactions)

ADVERSE REACTIONS Aseptic meningitis and pyrogenic reactions have been rarely (less than 0.4%) observed following cisternography with Pentetate lndium Disodium In 111. One death has been reported to have occurred within 20 minutes following the administration of Pentetate Indium Disodium In 111 and appears to be drug related. In addition, two cases of septic meningitis have also been reported. There have also been reports of skin reactions and vomiting following administration of Pentetate lndium Disodium In 111. Relationship of the drug to these latter occurrences has not been established.

Contraindications

CONTRAINDICATIONS None known.

Pregnancy and Breastfeeding

Pregnancy Category C Animal reproduction studies have not been conducted with GE Healthcare (Medi-Physics, Inc.) Indium DTPA In 111. Also, it is not known whether Pentetate Indium Disodium In 111 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pentetate Indium Disodium In 111 should be given to a pregnant woman only if clearly needed. Ideally, examinations using radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses.

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, formula feedings should be substituted for breast feedings when Pentetate Indium Disodium In 111 is administered to a nursing mother.

How Supplied

HOW SUPPLIED Pentetate Indium Disodium In 111 (no-carrier-added) is supplied in single-dose glass vials, each containing 1.5 mL of solution with a concentration of 37 MBq, 1 mCi per mL and a total activity of 55.5 MBq, 1.5 mCi per vial at calibration time. Vials are packaged in individual lead shields with plastic outer containers. NDC 17156-251-08 Storage Store vial in its lead shield at a temperature of 5°-30°C (41°-86°F). Do not freeze. Disposal The residual materials may be discarded in ordinary trash provided the vials and syringes read no greater than background with an appropriate low-range survey meter. All identifying labels should be destroyed before discarding. This radiopharmaceutical is licensed by Illinois Emergency Management Agency for distribution to persons licensed pursuant to 32 III. Adm. Code 330.260(a) and Part 335, Subpart E, 335.4010, or under equivalent licenses of an Agreement State or a Licensing State.