Indium In 111

Rx Only

Diagnostic - For use only in radiolabeling ProstaScintTM (Capromab Pendetide).

Radioimmunotherapy - For use only in radiolabeling ZevalinTM (Ibritumomab Tiuxetan).

FOR SINGLE USE ONLY

Indium In 111 Description

Indium In 111 Chloride Sterile Solution is indicated for radiolabeling ProstaScint preparations used for in vivo diagnostic imaging procedures. It is also indicated for radiolabeling ZevalinTM preparations used for Radioimmunotherapy procedures. It is supplied as a sterile, non-pyrogenic solution of Indium In 111 Chloride in 0.05 molar hydrochloric acid. No carrier has been added to the solution. Each 0.5 milliliter of the solution contains 185 megabequerels (5 millicuries) of Indium In 111 chloride at time of calibration (specific activity of >1.85 GBq/μg Indium; >50 mCi/μg Indium at this time of calibration). The solution pH is 1.1 to 1.4.

Radionuclidic Purity

Indium In 111 is cyclotron produced by the proton irradiation ((p,2n) reaction) of cadmium Cd 112 enriched target. At time of calibration, it contains not less than 99.925% Indium In 111 and, not more than 0.075% indium In 114m and zinc Zn 65 combined. At the time of expiration, it contains not less than 99.85% indium 111 and not more than 0.15% indium In 114m and zinc Zn 65 combined. No carrier has been added.

Radiochemical Purity

At the time of calibration, the Indium In 111 Chloride Sterile Solution contains not less than 95% of the Indium present as ionic In3+.

Chemical Purity

Indium In 111 Chloride Sterile Solution is tested for the following metallic impurities: copper, iron, cadmium, lead, zinc, nickel, and mercury, and contains extremely low levels of these metals. The sum of the individual impurity ratios for the metals listed is not more than 0.60 ppm.

Physical Characteristics

Indium In 111 decays by electron capture to cadmium Cd 111 (stable) with a physical half-life of 67.32 hours (2.81 days) (see Table 2)1. Photons useful for detection and imaging are listed in Table 1.

Table 1. Principal Radiation Emission Data*

Radiation	Mean Percent Per Disintegration	Mean Energy (keV)
*Kocher, David C., "Radioactive Decay Data Tables", DOE/TIC-11026, 115 (1981).
Gamma-2	90.2	171.3
Gamma-3	94.0	245.4

1

From Radiopharmaceutical Internal Dosimetry Information Center, Oak Ridge Associated Universities, Oak Ridge, TN 37831-0117, February 1985.

External Radiation

The exposure rate constant for 37 MBq (1 mCi) of Indium In 111 is 8.3 x 10-4 C/kg/hr (3.21 R/hr) at 1 cm. The specific gamma ray constant for Indium In 111 is 3.21 R/hr-mCi @ 1 cm1. The first half-value thickness of lead (Pb) is 0.023 cm. 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 0.834 cm of Pb will decrease the external radiation exposure by a factor of about 1000.

Table 2. Indium In 111 Radiation Attenuation by Lead Shielding

Shield Thickness (Pb) cm	Coefficient of Attenuation
0.023	0.5
0.203	10-1
0.513	10-2
0.834	10-3
1.12	10-4

These estimates of attenuation do not take into consideration the presence of longer-lived contaminants with higher energy photons, namely Indium In 114m.

To correct for physical decay of Indium In 111, the fractions that remain at selected intervals before and after calibration time are shown in Table 3.

Table 3. Indium In 111 Physical Decay Chart; Half-life 67.32 hours (2.81 days)

*Calibration time
Hours	Fraction Remaining	Hours	Fraction Remaining
-72	2.10	0*	1.00
-60	1.85	6	0.94
-48	1.64	12	0.88
-36	1.45	24	0.78
-24	1.28	36	0.69
-12	1.13	48	0.61
-6	1.06	72	0.48

Indium In 111 - Clinical Pharmacology

Please refer to the package insert for ProstaScint or Zevalin for this information on the final drug product.

Indications and Usage for Indium In 111

Indium In 111 Chloride Sterile Solution is indicated for radiolabeling ProstaScint preparations used for in vivo diagnostic imaging procedures. It is also indicated for radiolabeling Zevalin preparations used for Radioimmunotherapy procedures. Please refer to the package insert for ProstaScint or Zevalin for information on the final drug product.

Contraindications

Please refer to the package insert for ProstaScint or Zevalin for this information on the final drug product.

Warnings

CONTENTS OF THE VIAL OF Indium In 111 CHLORIDE SOLUTION ARE INTENDED ONLY TO BE USED AS AN INGREDIENT FOR RADIOLABELING PROSTASCINT FOR USE IN IN VIVO DIAGNOSTIC IMAGING PROCEDURES OR TO BE USED AS AN INGREDIENT FOR RADIOLABELING ZEVALIN™ FOR USE IN RADIOIMMUNOTHERAPY PROCEDURES, AND ARE NOT TO BE ADMINISTERED DIRECTLY TO HUMANS.

Precautions

General

Caution must be used to maintain proper aseptic technique while withdrawing and transferring contents of the Indium Chloride solution vial.

Do not use after expiration time and date indicated on vial label.

Contents of the vial are radioactive and adequate shielding and handling precautions must be maintained at all times.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Please refer to the package insert for ProstaScint or Zevalin for this information on the final drug product.

Pregnancy Category

Please refer to the package insert for ProstaScint or Zevalin for this information on the final drug product.

Nursing Mothers

Please refer to the package insert for ProstaScint or Zevalin for this information on the final drug product.

Pediatric Use

Please refer to the package insert for ProstaScint or Zevalin for this information on the final drug product.

Adverse Reactions

Please refer to the package insert for ProstaScint or Zevalin for this information on the final drug product.

Indium In 111 Dosage and Administration

Radiation Dosimetry

Please refer to the package insert for ProstaScint or Zevalin for this information on the final drug product.

How is Indium In 111 Supplied

Indium In 111 Chloride Sterile Solution is supplied in 10 mL vials containing 0.5 mL of solution. It is a sterile non-pyrogenic solution in 0.05 molar hydrochloric acid. No carrier is added to the solution. Each 0.5 mL contains 185 megabequerels (5 millicuries) of Indium In 111 Chloride at time of calibration. The pH of the solution is 1.1 to 1.4.

Special Storage and Handling

The contents of the vial are radioactive and adequate shielding and handling precautions must be maintained. Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Storage and disposal of Indium In 111 Chloride Sterile Solution should be controlled in a manner that is in compliance with the appropriate regulations of the government agency authorized to license the use of the radionuclide.

The vial should be kept inside its transportation shield whenever possible and should be handled with forceps when contents are being removed.

ProstaScint™ is a trademark of Cytogen Corporation. Zevalin™ is a trademark of IDEC Pharmaceuticals Corporation.

Professional Services: 1-800-325-3688

Mallinckrodt Inc.

St. Louis, MO 63134

tycoHealthcare

Mallinckrodt

A132I0

Revised 011907

PRINCIPAL DISPLAY PANEL - A132C0

Indium In 111 CHLORIDE STERILE SOLUTION


Sterile, Non-Pyrogenic Solution

Contains no Bacteriostatic Preservative

Store at Controlled Room Temperature 20-25°C (68-77°F)


SINGLE DOSE - NOT FOR DIRECT ADMINISTRATION

NO CARRIER ADDED

FOR USE ONLY IN RADIOLABELING

OncoScint® CR/OV (Satumomab Pendetide),

ProstaScint™ (Capromab Pendetide),

and Zevalin™ (Ibritumomab Tiuxetan)

SEE PACKAGE INSERT FOR MORE INFORMATION


Rx Only.


WARNING: Radioactive drugs must be handled only by qualified personnel in conformity with regulations of the U.S. Nuclear Regulatory Commission or state regulatory agencies where applicable. Bottle containing drug should be kept in this container or within heavier shield.


In Canada:

Mallinckrodt Canada Inc.

Pointe-Claire, Qc

Est. Lic. No. 100107-A


Mallinckrodt Inc.

St. Louis, MO 63134 USA


MALLINCKRODT


CAUTION RADIOACTIVE MATERIAL


A132C0

R10/2001

Indium In 111 CHLORIDE  Indium In 111 chloride  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0019-9132 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength INDIUM IN-111 CHLORIDE (INDIUM CATION IN-111) INDIUM IN-111 CHLORIDE 10 mCi  in 1 mL

Inactive Ingredients Ingredient Name Strength HYDROCHLORIC ACID

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0019-9132-06 1 VIAL In 1 CAN contains a VIAL, GLASS 1 0.5 mL In 1 VIAL, GLASS This package is contained within the CAN (0019-9132-06)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019841	12/07/2007

Labeler - Mallinckrodt Inc. (047021092)

Establishment
Name	Address	ID/FEI	Operations
Mallinckrodt Inc.		557570652	manufacture, analysis, api manufacture

Revised: 02/2011Mallinckrodt Inc.

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