Adenoscan

ADENOSCAN- adenosine solution
Astellas Pharma US, Inc.

1 INDICATIONS AND USAGE

Adenoscan (adenosine) is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.

2 DOSAGE AND ADMINISTRATION

The recommended Adenoscan dose is 0.14 mg/kg/min infused over six minutes (total dose of 0.84 mg/kg) (Table 1).

Administer Adenoscan only as a continuous peripheral intravenous infusion
Inject Thallium-201 at the midpoint of the Adenoscan infusion (i.e., after the first three minutes of Adenoscan)
Thallium-201 is physically compatible with Adenoscan and may be injected directly into the Adenoscan infusion set
Inject Thallium-201 as close to the venous access as possible to prevent an inadvertent increase in the dose of Adenoscan (the contents of the intravenous tubing) being administered

Visually inspect Adenoscan for particulate matter and discoloration prior to administration. Do not administer Adenoscan if it contains particulate matter or is discolored.

There are no data on the safety or efficacy of alternative Adenoscan infusion protocols. The safety and efficacy of Adenoscan administered by the intracoronary route have not been established.

Table 1. Dosage Chart for Adenoscan

Patient Weight

(kilograms)

Infusion Rate

(mL per minute over 6 minutes for total dose of 0.84 mg/kg)

45

2.1

50

2.3

55

2.6

60

2.8

65

3

70

3.3

75

3.5

80

3.8

85

4

90

4.2

The nomogram displayed in Table 1 was derived from the following general formula:

0.14 (mg/kg/min) x
total body weight (kg) = Infusion rate
Adenoscan concentration (mL/min)
(3 mg/mL)

3 DOSAGE FORMS AND STRENGTHS

Adenoscan for injection is supplied as 20 mL and 30 mL single-dose vials containing a sterile, nonpyrogenic, clear solution of adenosine 3 mg/mL.

4 CONTRAINDICATIONS

Adenoscan is contraindicated in patients with:

Second- or third-degree AV block (except in patients with a functioning artificial pacemaker) [see Warnings and Precautions (5.2)]
Sinus node disease, such as sick sinus syndrome or symptomatic bradycardia (except in patients with a functioning artificial pacemaker) [see Warnings and Precautions (5.2)]
Known or suspected bronchoconstrictive or bronchospastic lung disease (e.g., asthma) [see Warnings and Precautions (5.3)]
Known hypersensitivity to Adenoscan [see Warnings and Precautions (5.7)]

5 WARNINGS AND PRECAUTIONS

5.1 Cardiac Arrest, Ventricular Arrhythmias, and Myocardial Infarction

Fatal and nonfatal cardiac arrest, sustained ventricular tachycardia (requiring resuscitation), and myocardial infarction have occurred following Adenoscan infusion. Avoid use in patients with symptoms or signs of acute myocardial ischemia, for example, unstable angina or cardiovascular instability; these patients may be at greater risk of serious cardiovascular reactions to Adenoscan. Appropriate resuscitative measures should be available [see Overdosage (10)].

5.2 Sinoatrial and Atrioventricular Nodal Block

Adenoscan exerts a direct depressant effect on the SA and AV nodes and may cause first-, second- or third-degree AV block, or sinus bradycardia. In clinical trials, approximately 6% of patients developed AV block following Adenoscan administration (first-degree heart block developed in 3%, second-degree in 3%, and third-degree in 0.8% of patients) [see Clinical Trials Experience (6.1)].

Use Adenoscan with caution in patients with pre-existing first-degree AV block or bundle branch block. Do not use in patients with high-grade AV block or sinus node dysfunction (except in patients with a functioning artificial pacemaker). Discontinue Adenoscan in any patient who develops persistent or symptomatic high-grade AV block.

5.3 Bronchoconstriction

Adenoscan administration can cause dyspnea, bronchoconstriction, and respiratory compromise. Adenoscan should be used with caution in patients with obstructive lung disease not associated with bronchoconstriction (e.g., emphysema, bronchitis). Do not use in patients with bronchoconstriction or bronchospasm (e.g., asthma). Discontinue Adenoscan in any patient who develops severe respiratory difficulties. Resuscitative measures should be available prior to Adenoscan administration [see Clinical Trials Experience (6.1), Overdosage (10), and Clinical Pharmacology (12.2)].

5.4 Hypotension

Adenoscan is a potent peripheral vasodilator and can induce significant hypotension. The risk of serious hypotension may be higher in patients with autonomic dysfunction, hypovolemia, stenotic valvular heart disease, pericarditis or pericardial effusions, or stenotic carotid artery disease with cerebrovascular insufficiency. Discontinue Adenoscan in any patient who develops persistent or symptomatic hypotension.

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