INDIUM IN 111 CHLORIDE

Mallinckrodt Inc.

FULL PRESCRIBING INFORMATION: CONTENTS*

• INDIUM IN 111 CHLORIDE DESCRIPTION
  • Radionuclidic Purity
  • Radiochemical Purity
  • Chemical Purity
  • Physical Characteristics
  • External Radiation
• CLINICAL PHARMACOLOGY
• INDIUM IN 111 CHLORIDE INDICATIONS AND USAGE
• INDIUM IN 111 CHLORIDE CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • General
  • Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Pregnancy Category
  • Nursing Mothers
  • Pediatric Use
• INDIUM IN 111 CHLORIDE ADVERSE REACTIONS
• INDIUM IN 111 CHLORIDE DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

Rx Only

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

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

FOR SINGLE USE ONLY

INDIUM IN 111 CHLORIDE 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 Zevalin™ 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) From Radiopharmaceutical Internal Dosimetry Information Center, Oak Ridge Associated Universities, Oak Ridge, TN 37831-0117, February 1985. . Photons useful for detection and imaging are listed in Table 1.

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

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.

CLINICAL PHARMACOLOGY

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

INDIUM IN 111 CHLORIDE INDICATIONS AND USAGE

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.

INDIUM IN 111 CHLORIDE 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.

INDIUM IN 111 CHLORIDE ADVERSE REACTIONS

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

INDIUM IN 111 CHLORIDE DOSAGE AND ADMINISTRATION

Radiation Dosimetry

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

HOW 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 EUSA Pharma (USA), Inc.
Zevalin is a trademark of RIT Oncology, LLC.

Professional Services: 1-800-325-3688

Manufactured by:
Mallinckrodt Inc.
St. Louis, MO 63134 USA

Distributed in Canada by:
tyco Healthcare
Pointe-Claire, QC, Canada H9R 5H8
Estb. Lic. No.: 100689-A

tyco Healthcare

Mallinckrodt

A132I0
Rev 12/2011

PRINCIPAL DISPLAY PANEL

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
ProstaScint™ (Capromab Pendetide),
and Zevalin™ (Ibritumomab Tiuxetan)
SEE PACKAGE INSERT FOR 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.

Distributed in Canada by:
tyco Healthcare
Pointe-Claire, QC, Canada H9R 5H8
Estb. Lic. No.: 100689-A

Manufactured by:
Mallinckrodt Inc.
St. Louis, MO 63134 USA

Mallinckrodt

CAUTION RADIOACTIVE MATERIAL

A132C0

R12/2011