INDIUM IN-111 OXYQUINOLINE Solution for injection Ref.[27549] Active ingredients: Indium ¹¹¹In oxyquinoline

The recommended adult (70 kg) dose of indium In-111 oxyquinoline labeled autologous leukocytes is 7.4 to 18.5 MBq, 200-500 µCi. Indium In-111 oxyquinoline solution is intended for the radiolabeling of autologous leukocytes. The indium In-111 oxyquinoline labeled autologous leukocytes are administered intravenously.

Imaging is recommended at approximately 24 hours post injection. Typically, anterior and posterior views of the chest, abdomen and pelvis should be obtained with other views as required.

Aseptic procedures and a shielded syringe should be employed in the withdrawal of indium In-111 oxyquinoline from the vial. Similar procedures should be employed during the labeling procedure and the administration of the labeled leukocytes to the patient. The user should wear waterproof gloves during the entire procedure. The patient’s dose should be measured by a suitable radioactivity calibration system immediately before administration. At this time, the leukocyte preparation should be checked for gross clumping and red blood cell contamination.

Radiation dosimetry

The estimated absorbed radiation doses to an adult patient weighing 70 kg from an intravenous dose of 18.5 MBq, 500 µCi of indium In-111 oxyquinoline labeled leukocytes including contributions from indium In 114m/114 as a radionuclidic impurity are shown in Table 4.

Table 4. Radiation Dose Estimate in a 70 kg Human for 18.5 MBq, 500 µCi at Expiry of Indium In-111 (99.75%) Oxyquinoline labeled leukocytes with Indium In 114m/114 (0.25%):

Assumptions: 30% to spleen, 30% to liver, 34% to red marrow, 6% to remainder of body, with no excretion.
The dose of radiation absorbed by the organs will vary with the distribution of the blood cells in the organs, which in turn will depend on the predominance of the cell types labeled and their condition.

Labeling procedure

Sterile technique must be used throughout. It is important that all equipment used for the preparation of reagents be thoroughly cleaned to assure the absence of trace metal impurities. The user should wear waterproof gloves during the handling and administration procedure.

• The following equipment is recommended:

One (1) 60 mL or two (2) 30 mL sterile disposable plastic syringes with a 19 or 20 gauge needle (NOTE: Do not use a smaller gauge needle).
Ring stand and clamp(s).
Three (3) 50 mL sterile conical plastic centrifuge tubes with screw caps. Label each set with patient ID and “WBC”, “LPP” and “Wash” respectively (NOTE: 3 centrifuge tubes per patient).
Clinical Centrifuge with horizontal, 4 place rotor or equivalent.
Sodium Chloride 0.9% Injection, USP.
Three (3) disposable 5 or 10 mL syringes and 19 gauge needles.
Syringe shield to dispense indium In-111 oxyquinoline.
A dose calibrator.
Butterfly catheter infusion set.
Test tube rack.
Lab timer.
10 mL syringe with a 19 gauge or 20 gauge needle.
19 gauge needle with filter (optional).

• Withdraw from the patient 30-50 mL blood [preferably fifty (50) mL] using aseptic venipuncture technique using the 60 mL syringe fitted with a 19 gauge or 20 gauge needle and containing approximately 1000-1500 units heparin in 1-2 mL. Blood withdrawal should be smooth and slow so as not to produce bubbles or foaming.
• Remove and dispose of the needle and replace with a syringe cap. Gently mix the contents of the syringe and label with the patient’s ID, date and time.
• Upon receipt of the full syringe for processing, the contents should again be gently mixed.
• Clamp the syringe barrel to the ring stand in an upright (needle side up) position and tilt the syringe 10-20 degrees from its position perpendicular to the bench.
• Allow the red cells to sediment 30-60 minutes, depending upon when the supernatant [leukocyte rich plasma (LRP)] looks clear of red blood cells.
• Replace the syringe cap with an infusion set.
• Collect the plasma (LRP) in the centrifuge tube marked “WBC” by expressing the LRP through the catheter tubing making sure not to get any red cells into the WBC tube.
• Immediately centrifuge the capped WBC tube at 400-450 g for 5 minutes.
• Transfer the supernatant to the leukocyte poor plasma (LPP) tube leaving behind 0.5-1.0 mL supernatant to cover the white cell button (NOTE: the button often contains a small number of red cells and may appear red).
• Wash the white cell button with 4-6 mL Sodium Chloride (0.9%) Injection, USP. Resuspend the button by gentle swirling.
• Centrifuge the capped WBC tube at 400-450 g for 5 minutes (alternatively, 150 g for 8 minutes) and discard all but 0.5-1.0 mL of the supernate to cover the cells.
• Add 5.0 mL Sodium Chloride (0.9%) Injection, USP. Resuspend the cells by gentle swirling.
• With the shielded syringe, draw up approximately 22.2 MBq, 600 µCi indium In-111 oxyquinoline. Check the amount of radioactivity in a dose calibrator set for indium In-111 and record for labeling efficiency calculations.

Parenteral drug products should be inspected visually for particulate matter and discoloration before administration.

• In several additions, add the indium In-111 oxyquinoline to the WBC tube, gently swirling after each addition.
• Set the lab timer for 15 minutes and allow the capped WBC tube to incubate. Swirl the cell preparation several times during the incubation.
• With a sterile plastic syringe, add half of the saved LPP (or about 8 mL) from the LPP tube. Cap and gently swirl the contents of WBC tube to resuspend the cells.
• Centrifuge the WBC tube at 450 g for 5 minutes (or 150 g for 8 minutes). Decant supernatant into the wash tube leaving behind about 0.5 mL of the supernate to cover the cells.
• Assay the activity in the WBC tube and in the wash tube in a dose calibrator and record.
• With a sterile plastic syringe add the remaining LPP to the cell button and gently resuspend by swirling. With a sterile syringe fitted with a 19 gauge needle, resuspend the cells by drawing the cells up into the syringe and expressing the suspension against the tube gently once or twice. Alternatively, draw up the cells into a syringe fitted with the filtered 19 gauge needle, and replace the needle with an unfiltered 19 or 20 gauge needle.
• Reserve in the WBC tube a minimum amount of white cell suspension for a WBC count. A microscopic examination should also be completed to observe for clumping. Draw up the patient’s dose (7.4 to 18.5 MBq, 200-500 µCi) and check the syringe in the dose calibrator. Record the measurement.

Quality control

It is generally advantageous to record any observations on cell abnormalities (e.g., cell clumping). A trypan blue exclusion test may also be performed.

It is recommended that the preparation be used within one hour of labeling (See Precautions).

Indium In-111 oxyquinoline solution should be stored at room temperature (15-25°C, 59-77°F).

Indium In-111 oxyquinoline labeled autologous leukocytes should preferably be reinjected within one hour of labeling. The labeled cells may be stored at room temperature (15-25°C, 59-77°F) tor up to three hours following completion of the cell labeling procedure. Reinjection of indium In-111 oxyquinoline labeled autologous leukocytes more than 5 hours after initial blood drawing is not recommended.

Sterile technique must be used throughout the collection, labeling and re-injection procedures.