Indiclor

Indiclor Indium In-111 Chloride is a diagnostic radiopharmaceutical intended for radiolabeling ProstaScint (capromab pendetide) used for in vivo diagnostic imaging procedures and for radiolabeling Zevalin (ibritumomab tiuxetan) in preparations used for radioimmunotherapy procedures. It is supplied as a sterile, pyrogen-free solution of Indium (111In) Chloride in 0.04M HCl. Each milliliter is supplied at a radioactive concentration of 370 MBq, 10 mCi of Indium In-111 Chloride at time of calibration (no carrier added, with specific activity of > 1.85 GBq/µg Indium, > 50 mCi/µg Indium at time of calibration). The pH of the solution is about 1.4.

RADIONUCLIDIC PURITY

A Cadmium Cd-112 enriched target is bombarded in a cyclotron to produce Indium In-111 by the (p,2n) reaction. The bombardment conditions, the energy of the proton beam and the length of the bombardment are chosen to ensure an Indium In-111 yield of high radionuclidic purity. Radionuclidic purity is checked at release particularly for the presence of Indium In-114. The relative proportion of this impurity increases, after release of the batch, as a result of its longer half-life. Because of its beta-emitting component and its potentially high organ dose contribution, Indium In-114m is particularly important if present above carefully controlled levels.

Release specifications:

RADIOCHEMICAL PURITY

Release specification: Not less than 95% Indium present as ionic In3+.

PHYSICAL CHARACTERISTICS

Indium In-111 decays by electron capture with a physical half-life of 67.2 hours (2.8 days). The energies of the photons that are useful for detection and imaging studies are listed in Table 1.

EXTERNAL RADIATION

The exposure rate constant for 37 MBq, 1 mCi Indium In-111 is 8.3 × 10-4 C/kg/hr, 3.21 R/hr at 1 cm. The first half value thickness of lead (Pb) for Indium In-111 is 0.023 cm. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from the interposition of various thicknesses of Pb is shown in Table 2. For example, the use of 0.834 cm of lead will decrease the external radiation exposure by a factor of about 1,000.

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

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

The contents of the vial of Indiclor Indium In-111 Chloride solution are intended only to be used as an ingredient for radiolabeling ProstaScint used for in vivo diagnostic imaging procedures and for radiolabeling Zevalin in preparations used for radioimmunotherapy procedures.

Indiclor is not to be administered directly to humans.

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

Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Consult your pharmacist.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Missed Dose

Consult your pharmacist.

Storage

Consult your pharmacist.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.