Lung imaging: IV: 200 to 500 μCi (7.4 to 18.5 MBq) per dose; minimum dose: 200 μCi (7.4 MBq).
Lung imaging: Note: Dosing ranges provided; the number of particles will vary with age and weight.
Infants, Children, and Adolescents: IV: 25 to 50 μCi/kg (0.925 to 1.85 MBq/kg); usual dose: 30 μCi/kg (1.11 MBq/kg).
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Technetium Tc-99m aggregated albumin: Drug information")
Lung Imaging: IV (based on 70 kg patient): 1 to 4 mCi (37 to 148 MBq)
Peritoneovenous shunt patency evaluation:
Intraperitoneal injection (based on 70 kg patient): 1 to 3 mCi (37 to 111 MBq)
Percutaneous transtubal injection (based on 70 kg patient): 0.3 to 1 mCi (12 to 37 MBq); volume not to exceed 0.5 mL
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
The following adverse drug reactions are derived from product labeling unless otherwise specified.
Postmarketing:
Hypersensitivity: Hypersensitivity reaction (including anaphylaxis)
Local: Injection-site reaction
Hypersensitivity (eg, anaphylaxis) to albumin; patients with severe pulmonary hypertension.
Concerns related to adverse effects:
• Hypersensitivity reactions: Acute hypersensitivity reactions, including anaphylaxis, may occur; emergency treatment should be immediately available.
Disease-related concerns:
• Cor pulmonale: Use may be hazardous in patients with cor pulmonale or other conditions of severely impaired pulmonary blood flow due to interruption of blood flow.
• Heart shunts: In patients with right-to-left heart shunts, mechanical impediment of blood flow may occur due to an increased risk of rapid albumin aggregation into systemic circulation; administer the lowest possible number of particles in patients with right-to-left heart shunts.
• Pulmonary hypertension: Deaths have been reported after administration in patients with severe pulmonary hypertension; emergency treatment should be immediately available. Administer the lowest possible number of particles in patients with severe pulmonary hypertension.
Special populations:
• Neonates: The lowest possible number of particles should be used in right-to-left shunting and in severe pulmonary disease.
Special handling:
• Radiopharmaceutical: Use appropriate precautions for handling, disposal, and minimizing exposure to patients and health care personnel. Use only under supervision of individuals with experience/training in the handling of radioactive materials approved by the applicable regulatory authority. Note: Contents of kit are not radioactive; however, adequate shielding is required after addition of radioactive material.
Other warnings/precautions:
• Appropriate use: Patients should be adequately hydrated prior to dosing; instruct patients to void frequently following administration to decrease radiation exposure to the bladder.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, powder for reconstitution [kit]:
Draximage MAA: Aggregated albumin 2.5 mg per vial (30s) [contains human albumin; vial contents to be combined with sodium pertechnetate Tc 99m injection solution (not included)]
Pulmotech MAA: Aggregated albumin 2 mg per vial (5s, 30s) [contains human albumin; vial contents to be combined with sodium pertechnetate Tc 99m injection solution (not included)]
No
Radiopharmaceutical; use appropriate precautions for handling and disposal. Use waterproof gloves and effective radiation shielding when handling.
Parenteral: IV: Contents of kit are used to prepare technetium Tc 99m albumin aggregated and are not for direct IV injection; only reconstituted technetium Tc 99m albumin aggregated may be administered IV. Mix contents of dosing syringe by gentle inversion immediately prior to injection. Administer by slow IV injection. Imaging may begin immediately following injection. See manufacturer's labeling for complete administration procedure.
IV: Not for direct IV injection; only reconstituted technetium Tc 99m albumin aggregated may be administered IV. Ensure adequate hydration before and after administration; void frequently to minimize radiation exposure. See manufacturer’s prescribing information for complete administration procedure.
Radiopharmaceutical; use appropriate precautions for handling and disposal. Use waterproof gloves and effective radiation shielding when handling.
Store intact vials at 2°C to 25°C (36°F to 77°F). Store reconstituted product at 2ºC to 8ºC (36ºF to 46ºF); discard within 12 hours (Draximage MAA) or 18 hours (Pulmotech MAA).
Lung imaging agent as an adjunct in the evaluation of pulmonary perfusion (FDA approved in all ages); imaging agent to aid in the evaluation of peritoneovenous shunt patency (FDA approved in adults).
Radiopharmaceutical: Use appropriate precaution for handling, disposal, and minimizing exposure to patients and healthcare personnel. Use under supervision of experienced personnel. Should be stored in original lead container or adequate radiation shield.
None known.
There are no known significant interactions.
Pregnancy status should be evaluated prior to use in women of reproductive potential (SNM 2010).
The manufacturer recommends elective studies be conducted during the first 10 days of the menstrual cycle in women of reproductive potential.
Technetium Tc 99m can be detected in fetal tissue; the amount depends upon the specific formulation, route of administration, and stage of pregnancy (Adelstein 1999).
In general, the potential for a radiopharmaceutical to cause fetal harm depends on the dose absorbed by the fetus and the stage of pregnancy. High doses of radiopharmaceuticals used for therapeutic procedures are more likely to result in fetal harm. A medically required diagnostic procedure can usually be modified to decrease fetal risk. Elective diagnostic procedures should be delayed until after delivery (ACR–SPR 2018; Adelstein 1999; ICRP 2000; SNM 2010).
The aggregated particles are formed by denaturation of Human Albumin in a heating and aggregation process.
Onset of action: Immediate.
Distribution: Pulmonary alveolar capillary bed (80%).
Metabolism: Decays by isomeric transition.
Half-life elimination: Lungs: 2 to 3 hours (Draximage MAA); 10.8 hours (range: 6.9 to 19 hours) (Pulmotech MAA).
Excretion: Urine (20% after 24 hours).
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