Approved Drug Label (PDF)
7
Drug Interactions
Additions and/or
revisions underlined:
.
. .
In
patients taking venlafaxine or desvenlafaxine prior to DATSCAN administration,
there have been cases of altered DATSCAN uptake that impacted image
interpretation. The mechanism of interference of these drugs with DATSCAN
imaging is not known.
Whether
discontinuation of any of the above drugs prior to DATSCAN administration may
minimize the impact on image interpretation is unknown; however, if use of
these drugs can be safely suspended, consider discontinuing for at least 5
biological half-lives before administration of DATSCAN [see Dosage and Administration (2.3)].
.
. .
Approved Drug Label (PDF)
4
Contraindications
Additions
and or revisions underlined
DATSCAN
is contraindicated in patients with known serious hypersensitivity to
ioflupane I 123 [see Warnings and
Precautions (5.1)].
5
Warnings and Precautions
5.1 Hypersensitivity Reactions
Additions and/or
revisions underlined
Hypersensitivity reactions, including dyspnea,
edema, rash, erythema, and pruritus, have been reported following DATSCAN
administration [see Adverse Reactions
(6.2)]. The reactions have generally occurred within minutes of DATSCAN administration
and have either resolved spontaneously or following the administration of
corticosteroids and antihistamines.
DATSCAN is contraindicated in patients with
known serious hypersensitivity to ioflupane I 123 [see Contraindications
(4)].
Have treatment measures available and monitor patients
for symptoms or signs of a hypersensitivity reaction.
5.2 Thyroid Accumulation of Iodine-123
Additions and/or revisions
underlined
DATSCAN may contain up to 6% of free iodide
(iodine-123). Thyroid uptake of iodine-123 may result in an increased
long-term risk for thyroid neoplasia. To decrease thyroid accumulation of
iodine-123, block the thyroid gland before administration of DATSCAN [see Dosage
and Administration (2.2)].
5.3 Radiation Risk
New subsection
added
DATSCAN contributes to a patient’s overall
long-term cumulative radiation exposure. Long-term cumulative radiation
exposure is associated with an increased risk for cancer. Ensure safe handling
to minimize radiation exposure to patients and healthcare providers. Advise
patients to hydrate before and after administration and to void frequently
after administration [see Dosage and
Administration
(2.1)].
6
Adverse Reactions
Additions and/or revisions underlined
The following clinically significant adverse
reaction is described elsewhere in the labeling:
Hypersensitivity Reactions [see Warnings and Precautions (5.1)]
6.1 Clinical
Trials Experience
Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical trials of
DATSCAN cannot be directly compared to rates in the clinical trials of another
drug and may not reflect the rates observed in practice.
The data from clinical trials reflect exposure to
DATSCAN in 942 subjects with a mean age of 66 years (range 25 years to 90
years). Among these subjects, 42% were female and 99% White.
Subjects received 88 MBq to 287 MBq (2 mCi to 8 mCi)
[median 173 MBq (4.7 mCi)] intravenously as a single dose. The recommended dose
of DATSCAN is 111 MBq to 185 MBq (3 mCi to 5 mCi) [see Dosage and Administration (2.3)].
The following adverse reactions were reported at a
rate of 1% or less: headache, nausea, vertigo, dry mouth, and dizziness.
6.2 Postmarketing
Experience
The
following adverse reactions have been identified during postapproval use of
DATSCAN. Because these reactions are reported voluntarily from a population
of uncertain size, it is not always possible to reliably estimate their
frequency or establish a causal relationship to drug exposure.
Immune system
disorders: Hypersensitivity,
including dyspnea, edema, rash, erythema, and pruritus
General disorders and administration site conditions: Injection site
pain
7
Drug Interactions
Additions
and/or revisions underlined
Ioflupane
I 123 binds to the dopamine transporter [see
Clinical
Pharmacology (12.1)]. Drugs that bind
to the dopamine transporter with high affinity may interfere with the image
obtained following DATSCAN administration. These potentially interfering drugs
consist of: amoxapine, amphetamine, armodafinil, benztropine, bupropion,
buspirone, cocaine, mazindol, methamphetamine, methylphenidate, modafinil,
norephedrine, phentermine, phenylpropanolamine, selegiline, and sertraline.
Selective serotonin reuptake inhibitors (paroxetine and citalopram) may
increase or decrease ioflupane binding to the dopamine transporter. Whether
discontinuation of these drugs prior to DATSCAN administration may minimize the
interference with a DATSCAN image is unknown.
The
impact of dopamine agonists and antagonists upon DATSCAN imaging results has
not been established.
8
Use in Specific Populations
8.5 Geriatric Use
Additions
and/or revisions underlined
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.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Additions and/or revisions underlined
Hypersensitivity
Reactions
Inform the
patient that hypersensitivity reactions, including dyspnea, edema, rash,
erythema and pruritus, have been reported following DATSCAN administration [see Warnings and Precautions (5.1)].
Adequate
Hydration
Instruct patients
to drink a sufficient amount of water prior to and after receiving DATSCAN and
to void frequently for the first 48 hours following DATSCAN administration [see Dosage
and Administration (2.1)].
…
Approved Drug Label (PDF)
8
Use in Specific Populations
8.1 Pregnancy
(PLLR conversion)
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 I .
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.
8.2 Lactation
(PLLR conversion)
Risk
Summary
Iodide
123 (I 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.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
(additions
underlined)
Instruct
patients to inform their physician or healthcare provider if they:
are pregnant. Advise a pregnant woman of the potential
risks of fetal exposure to radiation doses with DaTscan.
are
breast feeding. 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.
are
sensitive to DaTscan.
are sensitive to Potassium Iodide Oral Solution, or
Lugol’s Solution.
have
reduced renal or hepatic function.
Instruct
patients to increase their level of hydration prior to and after receiving
DaTscan and to void frequently for the first 48 hours following DaTscan
administration.
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