DRAXIMAGE MAA- kit for the preparation of technetium tc 99m albumin aggregated injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALBUMIN AGGREGATED (UNII: 799C8VF17R) (ALBUMIN AGGREGATED - UNII:799C8VF17R)

Available from:

Jubilant DraxImage Inc

INN (International Name):

Albumin Aggregated

Composition:

Albumin Aggregated 2.5 mg

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

DRAXIMAGE MAA, after radiolabeling with sodium pertechnetate Tc 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 adult patients. DRAXIMAGE 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)] . Risk Summary   Available data with Technetium Tc 99m Albumin Aggregated Injection use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects and miscarriage. Animal reproduction studies with technetium Tc 99m albumin aggregated have not been conducted 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 0.5 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 defects, 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 are 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. Risk Summary Technetium-99m is present in breast milk. There are no data on the effects of technetium Tc 99m albumin aggregated on the breastfed infant or the effects on milk production. DRAXIMAGE MAA is used for imaging in infants with lung disease; exposure to technetium-99m via breastmilk is expected to be lower. Based on clinical guidelines, exposure of technetium Tc 99m albumin aggregated to a breastfed infant may be minimized by advising a lactating woman to temporarily discontinue breastfeeding and to pump and discard breast milk for a minimum of at least 24 hours after administration of Technetium Tc 99m Albumin Aggregated Injection. The developmental and health benefits of breastfeeding should be considered along with a mother’s clinical need for DRAXIMAGE MAA, any potential adverse effects on the breastfed child from technetium Tc 99m albumin aggregated or from the underlying maternal condition. DRAXIMAGE MAA, after radiolabeling with technetium-99m, is indicated for lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in pediatric patients (birth to less than 17 years of age). The safety profile of Technetium Tc 99m Albumin Aggregated Injection in pediatric patients is similar to adults. The safety and efficacy of DRAXIMAGE MAA have not been established for peritoneovenous shunt scintigraphy in pediatric patients.  No formal studies of DRAXIMAGE MAA in subjects aged 65 and over were performed to determine whether they respond differently from younger adult subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger adult patients. In general, dose selection for an elderly patient should be cautious; administering the low end of the particle dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Product summary:

How Supplied DRAXIMAGE MAA (kit for the preparation of technetium Tc 99m albumin aggregated) injection contains 2.5 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. It contains no preservative. DRAXIMAGE MAA is supplied in a carton (NDC 65174-270-30) containing 30 multiple-dose reaction vials (NDC 65174-270-01) and 30 radioassay information labels. Storage and Handling Before radiolabeling, store the supplied reaction vials at 2 ºC to 25ºC (36 ºF to 77 ºF). 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 ºC to 8 ºC (36 ºF to 46 ºF) when not in use. Use within 12 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. 

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

DRAXIMAGE MAA - KIT FOR THE PREPARATION OF TECHNETIUM TC 99M ALBUMIN
AGGREGATED INJECTION, POWDER, FOR SOLUTION
JUBILANT DRAXIMAGE INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DRAXIMAGE® MAA SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DRAXIMAGE MAA.
DRAXIMAGE MAA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M ALBUMIN
AGGREGATED)
INJECTION, FOR INTRAVENOUS OR INTRAPERITONEAL USE
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
DRAXIMAGE MAA, after radiolabeling with sodium pertechnetate Tc 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
For lung scintigraphy, the following recommended activity is
administered by intravenous injection:
Adults: 37 MBq to 148 MBq (1 mCi to 4 mCi); 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 scintigraphy of peritoneovenous shunts in adults: 37 MBq to 111
MBq (1 mCi to 3 mCi); 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)
DOSAGE FORMS AND STRENGTHS
Kit for the preparation of Technetium Tc 99m Albumin Aggregated
Injection: 2.5 mg of albumin aggregated
as a lyophilized powder in a multiple-dose reaction vial. Upon
radiolabeling, it provides a suspension of
Technetium Tc 99m Albumin