Pulmotech MAA (Page 2 of 4)

2.3 Directions for Preparation

Procedural Precautions

• Perform all transfer and vial stopper entries using aseptic techniques.
  
• Wear waterproof gloves during the entire preparation procedure and during subsequent patient dose withdrawals from the Pulmotech MAA vial.
  
• Make all transfers of sodium pertechnetate Tc 99m injection solution during the preparation procedure with an adequately shielded syringe.
  
• Keep the Radioactive Preparation in the Dispensing Vial Shield described below (with cap in place) during the useful life of the Radioactive Preparation. Make all withdrawals and injections of the Radioactive Preparation with an adequately shielded syringe.

Procedure f or the P reparation of Technetium Tc 99m Albumin Aggregated

1. If Pulmotech MAA vials are stored in the refrigerator, remove a vial and allow the contents to come to room temperature for approximately 5 minutes.

2. Remove the protective disc from the Pulmotech MAA vial and swab the rubber septum with an alcohol swab or a suitable bacteriostatic agent to disinfect the surface.

3. Place the vial in a suitable dispensing vial shield fitted with a shielded cap.

4. Calculate the amount of sodium pertechnetate Tc 99m injection solution (2 mL to 13 mL) to be added to the Pulmotech MAA vial. During or prior to addition of technetium Tc 99m solution do not vent the Pulmotech MAA vial. In choosing the amount of technetium Tc 99m radioactivity to be used in the preparation of technetium Tc 99m albumin aggregated ensure that the radioactive dose will contain the desired number of MAA particles, while taking into account the number of patients, administered radioactive dose, and radioactive decay. The recommended maximum amount of technetium Tc 99m to be added to the Pulmotech vial is 6.85 GBq (185 mCi). Calculate (see section 2.1) the amount of radioactivity per vial required to be added to maintain the number of particles per dose within a recommended range [for adults 200,000 to 700,000, and for pediatric patients as per Table 1].

5. After adding sodium pertechnetate Tc 99m injection solution to the Pulmotech MAA vial in the dispensing Vial shield (with cap in place), mix the contents by agitation and allow to stand for a minimum of 15 minutes at room temperature. Once prepared the product will have a turbid white appearance.

6. Assay the product in a suitable dose calibrator and record the activity of the technetium Tc 99m albumin aggregated, total suspension volume, number of Tc 99m MAA particles, radioactive concentration, time and date of preparation, onto the radioassay information label and attach it to the dispensing vial shield. 0.9% Sodium Chloride Injection, USP may be used as a diluent for the radiolabeled product to achieve the desired number of particles and radioactivity.

7. Prior to withdrawing a dose, gently agitate the contents of the radiolabeled Pulmotech MAA vial to resuspend any settled technetium Tc 99m albumin aggregated particles. Failure to mix the reaction vial contents adequately before use may result in a non-homogenous suspension with a resulting non-uniform distribution of radioactivity in the lung. Withdrawals for administration must be made aseptically using a sterile needle (18 to 21 gauge) and syringe. Since the vials contain nitrogen to prevent oxidation of the complex, the vials should not be vented. If repeated withdrawals are made from the vial, the contents should not be replaced with air.

8. Store the radiolabeled Pulmotech MAA vial in the dispensing vial shield in a refrigerator at 2° to 8°C (36° to 46°F). Use radiolabeled Pulmotech MAA within 18 hours from the time of preparation. Discard unused product.

3 DOSAGE FORMS AND STRENGTHS

Pulmotech MAA multiple-dose vial contains 2 mg of albumin aggregated as lyophilized powder. Radiolabeling with sodium pertechnetate Tc 99m injection solution provides an injectable suspension of technetium Tc 99m albumin aggregated. The radioactive dose for an adult is intended to contain 200,000 particles to 700,000 particles of technetium Tc 99m albumin aggregated with the target dose of approximately 350,000. Depending on the activity added and volume of the final reconstituted product, the volume of the dose may vary from 0.2 mL to 1.9 mL.

4 CONTRA IN DIC A TIONS

Technetium Tc 99m Albumin Aggregated Injection is contraindicated in patients with:

• Severe pulmonary hypertension [see Adverse Reaction s ( 6 )].
• Prior hypersensitivity to products containing human serum albumin [see Adverse Reaction s ( 6 )].

5 WARNINGS AND PRECAUTIONS

5.1 Pulmonary Hypertension

Serious adverse reactions have been reported in patients with pulmonary hypertension after Technetium Tc 99m Albumin Aggregated Injection. Assess patients for history or signs of pulmonary hypertension, administer the lowest number of particles possible, have emergency resuscitation equipment available and monitor patients for adverse reactions. [see Adverse Reactions ( 6 )].

5.2 Hypersensitivity Reactions

Serious reactions have been reported in patients with hypersensitivity to products containing human serum albumin, including Technetium Tc 99m Albumin Aggregated Injection. Obtain a history of allergy or hypersensitivity reactions and always have emergency resuscitation equipment and trained personnel available prior to administration of Technetium Tc 99m Albumin Aggregated Injection. Monitor all patients for hypersensitivity reactions.

5.3 Radiation Risks

The contents of the supplied Pulmotech MAA vials are not radioactive. However, after adding sodium pertechnetate Tc 99m injection solution to the vial, adequate shielding of the final preparation must be maintained.

As in the use of any radioactive material, care should be taken to minimize radiation exposure to the patient and to insure minimum radiation exposure to occupational workers.

Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.

6 ADVERSE REACTIONS

Deaths occurring after the administration of aggregated albumin to patients with severe pulmonary hypertension and serious hypersensitivity reactions to preparations of Technetium Tc 99m Albumin Aggregated Injection have been reported.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Available data from case reports on Technetium Tc 99m Albumin Aggregated Injection are insufficient to evaluate drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies with technetium Tc 99m Albumin Aggregated Injection have not been conducted. All radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. If considering Technetium Tc 99m Albumin Aggregated Injection administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from Technetium Tc 99m Albumin Aggregated Injection and the gestational timing of exposure.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

8.2 Lactation

Risk Summary

Data available in the published literature demonstrate the presence of pertechnetate in human milk. There are no data available on the effects of Tc-99m Albumin Aggregated Injection on the breastfed infant or the effects on milk production. Exposure of pertechnetate to a breast fed infant can be minimized by temporary discontinuation of breastfeeding (see Clinical Considerations). The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for a Technetium Tc 99m Albumin Aggregated Injection, any potential adverse effects on the breastfed child from radioactivity and from the underlying maternal condition.

Clinical Considerations

To decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breast milk after the administration of Technetium Tc 99m Albumin Aggregated Injection for 13 hours, where the duration corresponds to the typical range of administered activity, 37 to 148 MBq (1 to 4 mCi). During the period of interruption, the breasts should be emptied regularly and completely. The milk that is pumped by the mother during the time of breastfeeding interruption can either be discarded or stored refrigerated and given to the infant after 10 physical half-lives, or about 60 hours, have elapsed.