DaTscan

You should not receive this medicine if you have ever had any type of reaction to another contrast agent, or to iodine.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

The safety and efficacy of DaTscan were evaluated in two multicenter, single-arm studies (Study 1 and Study 2) that evaluated 284 adult patients with tremor. In the studies, DaTscan image outcomes were compared to a reference clinical diagnostic standard of "PS" or "non-PS". The reference clinical diagnostic standard for "PS" consisted of the following diagnoses: Parkinson's disease (PD), multiple system atrophy (MSA), and progressive supranuclear palsy (PSP). These three conditions have been associated with dopaminergic neurodegeneration and DaTscan imaging was not designed to distinguish among the conditions. The reference clinical diagnostic standard for "non-PS" consisted of an essential tremor (ET) diagnosis or other non-PS diagnosis. Three to 6 hours after DaTscan administration, subjects underwent SPECT imaging with a variety of multi-headed cameras or a multi-detector single-slice systems. The median administered activity evaluated in clinical studies was 173 MBq (4.7 mCi) [range, 88 to 287 MBq (2.4 to 7.8 mCi)].

DaTscan images were evaluated by readers blinded to clinical information. Study 1 readers had no other role in patient assessment; Study 2 readers included site investigators. The reference clinical diagnostic standards were the clinical diagnoses established by a consensus panel of movement disorder specialists that evaluated data inclusive through 36 months of follow-up (Study 1) or the investigator-determined baseline clinical diagnosis (Study 2). Study 1 consisted of patients with early features of Parkinsonism; patients with features suggestive of MSA or PSP were excluded. Study 2 consisted of patients with clinically established diagnosis of PS (PD, MSA, PSP) or ET.

Among the 99 patients in Study 1, 44% were female, 42% were aged 65 or over and all were Caucasian; among the 185 patients in Study 2, 35% were female, 48% were aged 65 or over and 99% were Caucasian. Among the patients in Study 1, the baseline clinical diagnoses consisted of: probable PD (44%), possible PD (31%), "benign" PD (6%), possible ET (11%), and other diagnoses (7%). Among the patients in Study 2, the baseline clinical diagnoses consisted of: PD (70%), ET (15%), MSA (10%), and PSP (5%).

Table 4 shows the positive percent agreement and negative percent agreement of the DaTscan image results with the reference clinical diagnostic standard. Positive percent agreement represents the percent of patients with abnormal DaTscan images among all the patients with a clinical diagnostic reference standard of PS. The negative percent agreement represents the percent of patients with normal DaTscan images among the patients with a non-PS clinical diagnostic reference standard.

The effectiveness of DaTscan as a screening or confirmatory test and for monitoring disease progression or response to therapy has not been established.

You should not receive DaTscan if you are allergic to ioflupane. Tell your doctor if you have ever had any type of reaction to another contrast agent, or to iodine.

To make sure DaTscan is safe for you, tell your doctor if you have:

• kidney disease;

• liver disease; or

• a thyroid disorder.

FDA pregnancy category C. It is not known whether DaTscan will harm an unborn baby. Tell your doctor if you are pregnant before receiving this medication.

It is not known whether ioflupane I-123 passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are receiving DaTscan.

Older adults may need kidney function tests before receiving DaTscan. Your kidney function may also need to be watched closely after you have received this medication.

DaTscan is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. It is usually given about 3 to 6 hours before your radiologic test.

At least 1 hour before you are treated with DaTscan, you will be given a liquid drink that contains medicine to protect your thyroid from harmful radioactive effects of ioflupane I-123.

Drink plenty of liquid before you receive DaTscan, and for at least 48 hours afterward. Follow your doctor's instructions about the types and amount of liquids you should drink before and after your test. Ioflupane I-123 is radioactive and it can cause dangerous effects on your bladder if it is not properly eliminated from your body through urination.

Expect to urinate often during the first 48 hours after your test. You will know you are getting enough extra fluid if you are urinating more than usual during this time. Urinating often will help rid your body of the radioactive iodine.

Get emergency medical help if you have any of these signs of an allergic reaction to DaTscan: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Common DaTscan side effects may include:

• pain, swelling, burning, or irritation around the IV needle;

• headache;

• dizziness, spinning sensation;

• dry mouth; or

• nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may need to stop using certain drugs for a short time before you receive DaTscan. Tell your doctor about all other medicines you use. Other drugs may interact with ioflupane I-123, including prescription and over-the-counter medicines, vitamins, and herbal products.

Applies to ioflupane I 123: intravenous solution

Hypersensitivity

Postmarketing reports: Rash, pruritus[Ref]

Gastrointestinal

Uncommon (0.1% to 1%): Nausea, dry mouth[Ref]

Nervous system

Uncommon (0.1% to 1%): Headache, vertigo, dizziness[Ref]

Local

Postmarketing reports: Injection site pain[Ref]

Some side effects of DaTscan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: -The effects in the nursing infant are unknown. -Consider interrupting nursing and pumping and discarding breast milk for 6 days after administration of this drug in order to minimize risks to a nursing infant.