ADREVIEW- iobenguane i-123 injection

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

IOBENGUANE I-123 (UNII: P2TH1XYZ84) (IOBENGUANE I-123 - UNII:P2TH1XYZ84)

Boleh didapati daripada:

Medi-Physics Inc.

INN (Nama Antarabangsa):

Iobenguane I-123

Komposisi:

Iobenguane I-123 2 mCi in 1 mL

Laluan pentadbiran:

INTRAVENOUS

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

AdreView is a radiopharmaceutical indicated for use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests. AdreView is indicated for scintigraphic assessment of sympathetic innervation of the myocardium by measurement of the heart to mediastinum (H/M) ratio of radioactivity uptake in patients with New York Heart Association (NYHA) class II or class III heart failure and left ventricular ejection fraction (LVEF) ≤ 35%. Among these patients, AdreView may be used to help identify patients with lower one and two year mortality risks, as indicated by an H/M ratio ≥ 1.6. Limitations of Use: In patients with congestive heart failure, AdreView utility has not been established for: - selecting a therapeutic intervention or for monitoring the response to therapy; - using the H/M ratio to identify a patient with a high risk for death. AdreView is contraindicated in patients with known hypersensitivity to iobenguane or iobenguane sulfate. Risk Summary Radioactive iodine products cross the placenta and can permanently impair fetal thyroid function. Administration of an appropriate thyroid blocking agent is recommended before use of AdreView in a pregnant woman to protect the woman and fetus from accumulation of I 123 [see Dosage and Administration (2.2) ]. There are no available data on AdreView use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with iobenguane I 123. All radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. Advise pregnant women of the potential risks of fetal exposure to radiation doses with administration of AdreView. AdreView contains 10.3 mg/mL of benzyl alcohol. Because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely. However, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs [see Warnings and Precautions (5.3) and Use in Specific Populations (8.4)]. The estimated background risk of major birth defects and miscarriage for the indicated population(s) 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. Risk Summary Iodine 123 (I 123), the radionuclide in AdreView, is present in human milk. There is no information on the effects on the breastfed infant or on milk production. Advise a lactating woman to interrupt breastfeeding and pump and discard breastmilk for at least 6 days (>10 physical half-lives) after AdreView administration in order to minimize radiation exposure to a breastfed infant. The safety and effectiveness of AdreView have been established in the age groups 1 month to 16 years in patients with known or suspected neuroblastoma [see Clinical Studies (14.1)] . Safety and effectiveness in pediatric patients below the age of 1 month or in any pediatric patient with congestive heart failure have not been established. Serious adverse reactions including fatal reactions and the "gasping syndrome" occurred in premature neonates and infants in the neonatal intensive care unit who received drugs containing benzyl alcohol as a preservative. In these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 to 1.378 mmol/L). Additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. When administering AdreView in infants consider the combined daily metabolic load of benzyl alcohol from all sources including AdreView (contains 10.3 mg of benzyl alcohol per mL) and other drugs containing benzyl alcohol. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known [see Warnings and Precautions (5.3)] . In clinical studies of AdreView in heart disease, 27% of subjects were 65-74 years of age and 17% of subjects were 75 years of age or over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. AdreView is excreted by the kidneys, and the risks of adverse reactions, increased radiation dose, and occurrence of falsely negative imaging results, may be greater in patients with severely impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and image interpretation. Consider assessment of renal function in elderly patients prior to AdreView administration.

Ringkasan produk:

AdreView is supplied in 10 mL glass vials containing a total volume of 5 mL of solution with a total radioactivity of 370 MBq (10 mCi) at calibration time. Each vial is enclosed in a lead container of appropriate thickness. NDC 17156-235-01 Storage Store AdreView at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP]. This product does not contain a preservative. Store within the original lead container or equivalent radiation shielding. In accordance with USP recommendations Iobenguane I 123 Injection preparations should not be used after the expiration date and time stated on the label. Handling This preparation is approved for use by persons licensed by the Illinois Emergency Management Agency pursuant to 32 IL. Adm. Code Section 330.260(a) and 335.4010 or equivalent licenses of the Nuclear Regulatory Commission or an Agreement State.

Status kebenaran:

New Drug Application

Ciri produk

ADREVIEW- IOBENGUANE I-123 INJECTION
MEDI-PHYSICS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ADREVIEW SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ADREVIEW.
ADREVIEW (IOBENGUANE I 123 INJECTION) FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2008
INDICATIONS AND USAGE
AdreView is a radiopharmaceutical agent for gamma-scintigraphy
indicated for:
use in the detection of primary or metastatic pheochromocytoma or
neuroblastoma as an adjunct to
other diagnostic tests (1.1)
scintigraphic assessment of sympathetic innervation of the myocardium
by measurement of the heart
to mediastinum (H/M) ratio of radioactivity uptake in patients with
New York Heart Association (NYHA)
class II or class III heart failure and left ventricular ejection
fraction (LVEF) ≤ 35%. Among these
patients, AdreView may be used to help identify patients with lower
one and two year mortality risks, as
indicated by an H/M ratio ≥ 1.6. (1.2)
Limitations of Use: In patients with congestive heart failure,
AdreView utility has not been established for:
selecting a therapeutic intervention or for monitoring the response to
therapy;
using the H/M ratio to identify a patient with a high risk for death.
DOSAGE AND ADMINISTRATION
AdreView emits radiation and must be handled with appropriate safety
measures. (2.1, 2.6)
Administer thyroid blockade medications to patients at risk for
thyroid accumulation of AdreView. (2.2,
5.6)
Measure patient dose by a suitable radioactivity calibration system
immediately prior to administration.
(2.4)
For patients ≥ 16 years of age or < 16 years of age and ≥ 70 kg:
administer 10 mCi (370 MBq). (2.4,
2.5)
For patients < 16 years of age and < 70 kg: amount scaled to the adult
reference activity based on
weight. (2.5)
DOSAGE FORMS AND STRENGTHS
5 mL of sterile solution for intravenous injection in a single use
vial (2 mCi/mL at calibration time) (3)
CONTRAINDICATIONS
Known hypersensitivity to iobenguane or iobenguane sulfate. (4)
WAR