NEPHROSCAN- succimer injection, powder, lyophilized, for solution

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

SUCCIMER (UNII: DX1U2629QE) (SUCCIMER - UNII:DX1U2629QE)

Prieinama:

Theragnostics Inc

Vartojimo būdas:

INTRAVENOUS

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

NEPHROSCAN, after radiolabeling with technetium Tc 99m, is indicated for use as an aid in the scintigraphic evaluation of renal parenchymal disorders in adult and pediatric patients including term neonates. None Risk Summary Available data with technetium Tc 99m succimer 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 succimer 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 succimer 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 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 10mGy fetal doses. Risk Summary Technetium Tc 99m succimer is present in breast milk. There are no data on the effects of technetium Tc 99m succimer on the breastfed infant or the effects on milk production. NEPHROSCAN is used for imaging in infants with renal disease; exposure to technetium Tc 99m succimer via breast milk is expected to be lower. Based on clinical guidelines, exposure of technetium Tc 99m succimer 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 Succimer Injection. The developmental and health benefits of breastfeeding should be considered along with a mother's clinical need for NEPHROSCAN, any potential adverse effects on the breastfed child from technetium Tc 99m succimer or from the underlying maternal condition. NEPHROSCAN, after radiolabeling with technetium Tc 99m, is indicated for use as an aid in the scintigraphic evaluation of renal parenchymal disorders in pediatric patients, including term neonates. Use of NEPHROSCAN in this age group for this indication is supported by evidence from effectiveness established in adult studies and data from published pediatric studies supporting the safety and effectiveness of weight-based dosing of Technetium Tc 99m Succimer Injection in renal parenchymal imaging in pediatric patients including term neonates [see Dosage and Administration (2.3)] . The recommended amount of radioactivity in pediatric patients, 1.85 MBq/kg (0.05 mCi/kg) with a range of 19 MBq to 74 MBq (0.5 mCi to 2 mCi), is based on published studies that used technetium Tc 99m succimer for the evaluation of acute pyelonephritis, renal scarring, and split renal function in pediatric patients [see Dosage and Administration (2.2)] . Hypersensitivity reactions, including urticaria, rash, pruritus, and erythema have been reported with the use of technetium Tc 99m succimer in pediatric patients [see Warnings and Precautions (5.1) and Adverse Reactions (6)] . Clinical studies of technetium Tc 99m succimer did not include sufficient numbers of subjects 65 years of age and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious usually administering the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with decreased renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Produkto santrauka:

How Supplied NEPHROSCAN (kit for the preparation of technetium Tc 99m succimer injection), containing 1 mg succimer, is supplied as a white-yellowish to off-white lyophilized powder packaged in a sterile, single-dose vial as a carton of 5 vials (NDC 71083-0020-5). Storage and Handling Before radiolabeling, store NEPHROSCAN in a refrigerator at 2°C to 8°C (36°F to 46°F) in original carton. Do not freeze. After radiolabeling, store Technetium Tc 99m Succimer Injection upright, shielded, for up to 4 hours, at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see Dosage and Administration (2.4)]. This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.

Autorizacija statusas:

New Drug Application

Prekės savybės

NEPHROSCAN- SUCCIMER INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
THERAGNOSTICS INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NEPHROSCAN™ SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NEPHROSCAN.
NEPHROSCAN (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M SUCCIMER
INJECTION), FOR
INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1982
INDICATIONS AND USAGE
NEPHROSCAN, after radiolabeling with technetium Tc 99m, is a
radioactive diagnostic agent indicated for
use as an aid in the scintigraphic evaluation of renal parenchymal
disorders in adults and pediatric
patients including term neonates. (1)
DOSAGE AND ADMINISTRATION
Instruct patients to drink a sufficient amount of water before
administration and to continue to drink
and to void frequently following administration (2.2)
The recommended amount of radioactivity by intravenous injection
(bolus) is:
For adults: 74 MBq to 222 MBq (2 mCi to 6 mCi) (2.3)
For pediatric patients: 1.85 MBq/kg (0.05 mCi/kg) of body weight with
a range of 19 MBq to 74 MBq
(0.5 mCi to 2 mCi). (2.3)
Begin image acquisition 1 hour to 4 hours after administration (2.7)
Delay imaging up to 6 hours to 24 hours in patients with severely
reduced eGFR (2.7)
See Full Prescribing Information for radiation safety, drug
preparation, administration, and radiation
dosimetry information (2.1, 2.4, 2.5, 2.6, 2.8)
DOSAGE FORMS AND STRENGTHS
For Injection: NEPHROSCAN contains 1 mg succimer as a white-yellowish
to off-white lyophilized powder in
a single dose vial. Upon radiolabeling with technetium Tc 99m, it
provides a clear, colorless solution
containing up to 1,480 MBq (40 mCi) technetium Tc 99m succimer in
approximately 5 mL volume at
calibration time. (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: Have appropriate instruments and
medications necessary for immediate
treatment of allergic reactions and monitor patients for
hypersensitivity reactions during and after
administration (5.1)
Radiat