DATSCAN- ioflupane i-123 injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ioflupane I-123 (UNII: 3MM99T8R5Q) (ioflupane I-123 - UNII:3MM99T8R5Q)

Available from:

Medi-Physics Inc. dba GE Healthcare.

INN (International Name):

ioflupane I-123

Composition:

ioflupane I-123 2 mCi in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

DATSCAN is indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with: - suspected Parkinsonian syndromes (PS) or - suspected dementia with Lewy bodies (DLB). DATSCAN is contraindicated in patients with known serious hypersensitivity to ioflupane I 123 [see Warnings and Precautions (5.1)] . 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 DATSCAN in a pregnant woman to protect the woman and fetus from accumulation of iodine-123 [see Dosage and Administration (2.2)] . There are no available data on DATSCAN 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 ioflupane 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. Administration of DATSCAN at a dose of 185 MBq (5 mCi) results in an absorbed radiation dose to the uterus of 0.3 rad (3.0 mGy). Radiation doses greater than 15 rad (150 mGy) have been associated with congenital anomalies but doses under 5 rad (50 mGy) generally have not. Advise pregnant women of the potential risks of fetal exposure to radiation doses with administration of DATSCAN. 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, the radionuclide in DATSCAN, 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 DATSCAN administration in order to minimize radiation exposure to a breastfed infant. The safety and efficacy of DATSCAN have not been established in pediatric patients. In the two principal clinical studies of DATSCAN for suspected Parkinsonian syndromes, 45% of the subjects were aged 65 and over, while 10% were 75 and over [see Clinical Studies (14.1)] . No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. DATSCAN is excreted by the kidney and patients with severe renal impairment may have increased radiation exposure and altered DATSCAN images.

Product summary:

How Supplied DATSCAN (ioflupane I 123 injection) is a clear, colorless solution supplied in single-dose glass vials containing 185 MBq (5 mCi) in 2.5 mL at a concentration of 74 MBq/mL (2 mCi/mL) of ioflupane I 123 at calibration date and time. Each vial is enclosed in a lead container of appropriate thickness. NDC 17156-210-01 Storage and Handling Store DATSCAN at 20° to 25°C (68° to 77°F). This product does not contain a preservative. Store DATSCAN within the original lead container or equivalent radiation shielding. Do not use DATSCAN preparations after the expiration date and time stated on the label. 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 the relevant regulatory authority of an Agreement State.

Authorization status:

New Drug Application

Summary of Product characteristics

DATSCAN- IOFLUPANE I-123 INJECTION, SOLUTION
MEDI-PHYSICS INC. DBA GE HEALTHCARE.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DATSCAN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DATSCAN.
DATSCAN (IOFLUPANE I 123 INJECTION), FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2011
RECENT MAJOR CHANGES
Indications and Usage (1)
11/2022
Contraindications (4)
11/2022
Warnings and Precautions, Radiation Risk (5.3)
11/2022
INDICATIONS AND USAGE
DATSCAN is a radioactive diagnostic agent indicated as an adjunct to
other diagnostic evaluations for
striatal dopamine transporter visualization using single photon
emission computed tomography (SPECT)
brain imaging in adult patients with:
suspected Parkinsonian syndromes (PS) or
suspected dementia with Lewy bodies (DLB). (1)
DOSAGE AND ADMINISTRATION
Administer a thyroid-blocking agent at least one hour before the dose
of DATSCAN. (2.2)
The recommended dose of DATSCAN in adult patients is 111 MBq to 185
MBq (3 mCi to 5 mCi)
administered intravenously over at least 20 seconds. (2.3)
Measure patient dose using a dose calibrator immediately prior to
administration. (2.4)
Begin SPECT imaging between 3 hours and 6 hours post-injection. (2.6)
DOSAGE FORMS AND STRENGTHS
Injection: 185 MBq (5 mCi) in 2.5 mL at a concentration of 74 MBq/mL
(2 mCi/mL) of ioflupane I 123 at
calibration date and time supplied in single-dose vials. (3)
CONTRAINDICATIONS
Known serious hypersensitivity to ioflupane I 123 (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: Hypersensitivity reactions including
dyspnea, edema, rash, erythema, and
pruritus have been reported. Have treatment measures available prior
to DATSCAN administration.
(5.1)
Thyroid Accumulation of Iodine-123: Thyroid uptake of iodine-123 may
result in an increased long-term
risk for thyroid neoplasia. (2.2, 5.2)
Radiation Risk: Ensure safe handling to minimize radiation exposure to
the patient and healthcare
providers. Advise patients to hydrate before and