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Kit For The Preparation Of Technetium Tc 99M Albumin Aggregated

FDA Drug Information • Also known as: Draximage Maa, Pulmotech Maa

Brand Names
Draximage Maa, Pulmotech Maa
Route
INTRAVENOUS
Dosage Form
INJECTION, POWDER, FOR SOLUTION
Product Type
HUMAN PRESCRIPTION DRUG

Description

11 DESCRIPTION 11.1 Product Characteristics PULMOTECH MAA contains albumin aggregated obtained by fractionating material (source blood, plasma, serum, or placentas) from healthy human donors. The macroaggregated albumin (MAA) particles are formed by heat denaturation of stannous chloride treated albumin human under controlled conditions. Each vial contains 2,000,000 to 4,000,000 particles. The particle size distribution of the aggregated albumin is such that not less than 90% are 10 to 90 micrometers in size. There are no aggregated albumin particles greater than 150 micrometers in size as determined by circular equivalents. PULMOTECH MAA (kit for the preparation of technetium Tc 99m albumin aggregated) injection provides a sterile, non-pyrogenic, non-radioactive, white lyophilized powder in a multiple-dose reaction vial, sealed under an atmosphere of nitrogen, for radiolabeling with Sodium Pertechnetate Tc 99m Injection to prepare Technetium Tc 99m Albumin Aggregated Injection, a radioactive diagnostic agent, for intravenous or intraperitoneal use. Each reaction vial contains 2 mg of albumin aggregated, albumin human (7.1 mg), stannous chloride (0.1 mg minimum; 0.22 mg maximum stannous and stannic), sodium chloride (9 mg). Hydrochloric acid may have been added for pH adjustment. The pH is between 5 and 7. It contains no preservatives. 11.2 Physical Characteristics Technetium-99m decays by isomeric transition with a physical half-life of 6.02 hours. The principal photon that is useful for detection and imaging is listed in Table 4. Table 4 – Principal Radiation Emission Data for Technetium-99m Radiation Mean % per Disintegration Energy (keV) Gamma-2 89.07 140.5 11.3 External Radiation The specific gamma ray constant for technetium-99m is 0.78 R/mCi-hr at 1 cm. The first half-value thickness of lead (Pb) for technetium-99m is 0.017 cm. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of...

What Is Kit For The Preparation Of Technetium Tc 99M Albumin Aggregated Used For?

1 INDICATIONS AND USAGE PULMOTECH MAA, after radiolabeling with technetium-99m, is indicated for: Lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients. Peritoneovenous shunt scintigraphy as an aid in the evaluation of its patency in adults. PULMOTECH MAA, after radiolabeling with technetium-99m is a radioactive diagnostic agent indicated for: Lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients. ( 1 ) Peritoneovenous shunt scintigraphy as an aid in the evaluation of its patency in adults. ( 1 )

Dosage and Administration

2 DOSAGE AND ADMINISTRATION For lung perfusion scintigraphy, the following recommended activity is administered by intravenous injection.

  • Adults : 37 MBq to 148 MBq (1 mCi to 4 mCi) and 200,000 particles to 700,000 particles. ( 2.3 )
  • Pediatric patients aged 4 weeks and older : 0.925 MBq/kg to 1.85 MBq/kg of body weight (0.025 mCi/kg to 0.05 mCi/kg); the minimum activity is 7.4 MBq (0.2 mCi). The number of particles will vary with age and body weight of the pediatric patient. ( 2.3 )
  • Pediatric patients aged less than 4 weeks : 7.4 MBq to 18.5 MBq (0.2 mCi to 0.5 mCi); 10,000 particles to 50,000 particles. ( 2.3 ) For peritoneovenous shunts scintigraphy in adults: 37 MBq to 111 MBq (1 mCi to 3 mCi) and 200,000 particles to 700,000 particles by intraperitoneal injection. ( 2.4 ) See Full Prescribing Information for radiation safety, patient preparation, drug preparation, administration, imaging, and radiation dosimetry information. ( 2.1 , 2.2 , 2.5 , 2.6 , 2.7 ) 2.1 Radiation Safety – Drug Handling After radiolabeling of PULMOTECH MAA, the vial contains Technetium Tc 99m Albumin Aggregated Injection. Handle Technetium Tc 99m Albumin Aggregated Injection with appropriate safety measures to minimize radiation exposure [see Warnings and Precautions ( 5.4 )] . Use waterproof gloves, effective radiation shielding, and other appropriate safety measures when preparing and handling Technetium Tc 99m Albumin Aggregated Injection. Radiopharmaceuticals should be used by or under the control of healthcare providers who are qualified by specific 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. 2.2 Patient Preparation Instruct patients to drink a sufficient amount of water to ensure adequate hydration prior to administration of Technetium Tc 99m Albumin Aggregated Injection and to continue to drink and void frequently following administration to reduce radiation exposure [see Warnings and Precautions ( 5.4 )] . 2. 3 Recommended Dosage for Lung Perfusion Scintigraphy Adult Patients The recommended activity for lung perfusion scintigraphy in adult patients is 37 MBq to 148 MBq (1 mCi to 4 mCi) by intravenous injection. The range of particle numbers per single injection should be 200,000 to 700,000 with the recommended number of approximately 350,000. Depending on the activity added and volume of the final radiolabeled product, the volume of the dose may vary from 0.2 mL to 1.9 mL. The number of particles available per dose of Technetium Tc 99m Albumin Aggregated Injection will vary depending on the physical decay of technetium-99m that has occurred. The number of particles in any dose and volume to be administrated may be calculated as follows: Where: V a = volume to be administered in mL D = desired activity to be administered in MBq (mCi) C = concentration at calibration time of Sodium...

    • Side Effects (Adverse Reactions)

    6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Patients with Pulmonary Hypertension [ see Warnings and Precautions ( 5.1 ) ] . Hypersensitivity Reactions [ see Warnings and Precautions ( 5.2 ) ] . The following adverse reactions associated with the use of technetium Tc 99m albumin aggregated products including PULMOTECH MAA have been identified in clinical studies or postmarketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular Disorders : Deaths in patients with severe pulmonary hypertension Immune System Disorders : Hypersensitivity reactions such as anaphylaxis, impairment of cardiac and circulatory functions in the form of changes in respiration, pulse, and blood pressure, chest pain, and syncope, urticaria, reddening of the face, sweating, and nausea Skin and Subcutaneous Tissue Disorders : Injection site reactions The following adverse reactions have been reported: Death in patients with severe pulmonary hypertension, anaphylaxis, impairment of cardiac and circulatory functions in the form of changes in respiration, pulse, and blood pressure, chest pain, and possible syncope, urticaria, reddening of the face, sweating, nausea, and injection site reaction. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact CURIUM US LLC at 1-866-789-2211 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Contraindications

    4 CONTRAINDICATIONS PULMOTECH MAA is contraindicated in patients with: Severe pulmonary hypertension [see Warnings and Precautions ( 5.1 ) ]. A history of hypersensitivity to albumin human. Reactions have included anaphylaxis [see Warnings and Precautions ( 5.2 )]. Severe pulmonary hypertension. ( 4 ) A history of hypersensitivity reactions to albumin human. ( 4 )

    Pregnancy and Breastfeeding

    8.1 Pregnancy Risk Summary Available data from case reports on Technetium Tc 99m Albumin Aggregated Injection use 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 have not been conducted. Although all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose, the radiation exposure to the fetus from technetium Tc 99m albumin aggregated is expected to be low (less than 0.50 mGy) (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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. Data Human Data No adverse fetal effects of radiation risks have been identified for diagnostic procedures involving less than 50 mGy, which represents less than 10 mGy fetal doses.

    How Supplied

    16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied PULMOTECH MAA (kit for the preparation of technetium Tc 99m albumin aggregated) injection contains 2 mg of albumin aggregated as a white lyophilized powder in a multiple-dose reaction vial, sealed under an atmosphere of nitrogen, for radiolabeling with Sodium Pertechnetate Tc 99m Injection to prepare Technetium Tc 99m Albumin Aggregated Injection. PULMOTECH MAA is supplied as: a carton (clam shell) of 5 vials (NDC 69945-139-20) a carton of 30 vials (NDC 69945-139-40) Each 5-vial carton contains 5 multiple-dose reaction vials and 5 radioassay information labels. Each 30-vial carton contains 30 multiple-dose reaction vials and 30 radioassay information labels. Storage and Handling Before radiolabeling, store supplied reaction vials at 2°C to 25°C (36°F to 77ºF). After radiolabeling with Sodium Pertechnetate Tc 99m Injection, store Technetium Tc 99m Albumin Aggregated Injection in a lead vial shield with cap in place, refrigerated at 2°C to 8°C (36°F to 46ºF) when not in use. Use within 18 hours after radiolabeling [ see Dosage and Administration ( 2.5 )] . Dispose unused Technetium Tc 99m Albumin Aggregated Injection in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide. This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.

    About This Information

    This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

    What are side effects?

    Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

    What are drug interactions?

    Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.