Technetium Tc 99m Albumin Aggregated Injection

Technetium Tc 99m albumin aggregated injection is a radioactive diagnostic agent indicated for lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients and for scintigraphy of peritoneovenous shunt as an aid in the evaluation of its patency in adults.

• Technetium Tc 99m albumin aggregated injection is available under the following different brand names: Pulmotech MAA

Common side effects of Technetium Tc 99m albumin aggregated injection include:

• confusion
• faintness
• fast heartbeat
• fever and chills
• hives, itching, skin rash
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• redness of the skin
• swelling of the eyelids, face, lips, hands, or feet
• tightness in the chest
• troubled breathing or swallowing

Serious side effects of Technetium Tc 99m albumin aggregated injection include:

• pain
• itching 
• burning 
• swelling, or a lump at the injection site

Rare side effects of Technetium Tc 99m albumin aggregated injection include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to the FDA at 1-800-FDA-1088.

Adult and pediatric dosage

• Kit for the preparation of technetium Tc 99m albumin aggregated injection
• Each multiple-dose vial contains 2 mg of albumin aggregated as lyophilized powder
• Each 5-vial kit contains 5 multiple-dose Pulmotech MAA vials, 1 prescribing information, and 5 radio assay information labels
• Each 30-vial carton contains 30 multiple-dose Pulmotech MAA vials, 1 prescribing information, and 30 radio assay information labels

Lung scintigraphy

Adult dosage

• 37-148 MBq (1-4 mCi) and 200,000-700,000 particles of Technetium Tc 99m albumin aggregated injection after preparation with oxidant-free sodium pertechnetate Tc 99m injection

Pediatric dosage

• Newborn: 7.4-18.5 MBq (0.2-0.5 mCi) and 10,000-50,000 particles of Technetium Tc 99m albumin aggregated injection after preparation with oxidant-free sodium pertechnetate Tc 99m injection; no less than 7.4 MBq (0.2 mCi) should be used for this procedure
• Children and adolescents: 0.925-1.85 MBq/kg (0.025-0.05 mCi/kg) and 50,000-700,000 particles of Technetium Tc 99m albumin aggregated injection after preparation with oxidant-free sodium pertechnetate Tc 99m injection; a usual dose is 1.11 MBq/kg (0.03 mCi/kg)
• Scintigraphy of peritoneovenous shunt

Peritoneovenous shunt patency evaluation

Adult dosage

• Intraperitoneal dosage range: 37-111 MBq (1-3 mCi) and 200,000-700,000 particles OR
• Alternatively, may be administered by percutaneous transtubal injection
• Percutaneous transtubal dosage range: 12-37 MBq (0.3-1 mCi) in a volume not to exceed 0.5 mL

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Technetium Tc 99m albumin aggregated injection has no noted severe interactions with any other drugs
• Technetium Tc 99m albumin aggregated injection has no noted serious interactions with any other drugs
• Technetium Tc 99m albumin aggregated injection has no noted moderate interactions with any other drugs
• Technetium Tc 99m albumin aggregated injection has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Severe pulmonary hypertension
• Hypersensitivity to products containing human serum albumin

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Technetium Tc 99m albumin aggregated injection?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Technetium Tc 99m albumin aggregated injection?”

Cautions

• Serious adverse reactions have been reported; assess patients for history or signs of pulmonary hypertension, administer the lowest number of particles possible, have emergency resuscitation equipment available, and monitor for adverse reactions
• Serious reactions have been reported; obtain a history of allergy or hypersensitivity reactions and always have emergency resuscitation equipment and trained personnel available before administration; monitor for hypersensitivity reactions
• Radiation risk
  • Contents of Pulmotech MAA vials are not radioactive
  • However, after adding sodium pertechnetate Tc 99m injection solution to the vial, maintain adequate shielding of the final preparation
  • As in the use of any radioactive material, ensure minimized radiation exposure to the patient and occupational workers
  • Radiopharmaceuticals should be used only by qualified and trained physicians who are experienced in the safe use and handling of radionuclides

Pregnancy and Lactation

• Available data from case reports are insufficient to evaluate drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• All radiopharmaceuticals have the potential to cause fetal harm, depending on the fetal stage of development and the magnitude of the radiation dose
• Advise patients about the potential for adverse pregnancy outcomes based on the radiation dose and the gestational timing of exposure
• Lactation
  • Data available in the published literature demonstrate the presence of pertechnetate in human milk
  • No data available on the effects of Tc-99m albumin aggregated injection on the breastfed infant or the effects on milk production
  • Temporary discontinuation of breastfeeding may minimize exposure of pertechnetate to a breastfed infant
  • Clinical considerations
  • To decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breast milk after the administration for 13 hours, where the duration corresponds to the typical range of administered activity, 37-148 MBq (1-4 mCi)
  • During the period of interruption, empty the breasts regularly and completely; discard any pumped milk by the mother
  • Refrigerate or give the pumped milk to the infant after 10 physical half-lives, or about 60 hours, have elapsed