ADENOSINE

ADENOSINE- adenosine injection, solution
HF Acquisition Co LLC, DBA HealthFirst

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ADENOSINE INJECTION, USP safely and effectively. See full prescribing information for ADENOSINE INJECTION, USP.
ADENOSINE INJECTION, USP for intravenous use
Initial U.S. Approval: 1995

RECENT MAJOR CHANGES

Warnings and Precautions: Cardiac Arrest, Ventricular
Arrhythmias, and Myocardial Infarction ( 5-5.1) 10/2013
Warnings and Precautions: Cerebrovascular Accidents ( 5-5.5)
8/2014
Warnings and Precautions: Seizures ( 5-5.6) 8/2014
Warnings and Precautions: Hypersensitivity ( 5-5.7) 8/2014

INDICATIONS AND USAGE

Adenosine Injection, a pharmacologic stress agent, is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately ( 1)

DOSAGE AND ADMINISTRATION

Recommended dose is 0.14 mg/kg/min infused over six minutes as a continuous peripheral intravenous infusion (total dose of 0.84 mg/kg) ( 2)

DOSAGE FORMS AND STRENGTHS

For Injection: 3 mg/mL in single-dose vials ( 3)

CONTRAINDICATIONS

•
Second- or third-degree AV block (except in patients with a functioning artificial pacemaker) ( 4)
•
Sinus node disease, such as sick sinus syndrome or symptomatic bradycardia (except in patients with a functioning artificial pacemaker) ( 4)
•
Known or suspected bronchoconstrictive or bronchospastic lung disease (e.g., asthma) ( 4)
•
Known hypersensitivity to adenosine injection ( 4)

WARNINGS AND PRECAUTIONS

•
Cardiac Arrest, Ventricular Arrhythmias, and Myocardial Infarction. Fatal cardiac events have occurred. Avoid use in patients with symptoms or signs of acute myocardial ischemia. Appropriate resuscitative measures should be available ( 5-5.1)
•
Sinoatrial (SA) and Atrioventricular (AV) Nodal Block. First-, second- or third-degree AV block, or sinus bradycardia can occur. Discontinue adenosine injection if patient develops persistent or symptomatic high-grade AV block ( 5-5.2)
•
Bronchoconstriction. Can induce dyspnea, bronchoconstriction, and respiratory compromise, especially in patients with obstructive pulmonary disease. Discontinue adenosine injection if patient develops severe respiratory difficulties ( 5-5.3)
•
Hypotension. Significant hypotension can occur. Discontinue adenosine injection if patient develops persistent or symptomatic hypotension ( 5-5.4)
•
Cerebrovascular Accidents. Hemorrhagic and ischemic cerebrovascular accidents have occurred ( 5-5.5)
•
Seizures. New onset or recurrence of convulsive seizures have occurred. Use of methylxanthines (e.g., caffeine, aminophylline and theophylline) is not recommended in patients who experience a seizures in association with adenosine injection ( 5-5.6)
•
Hypersensitivity. Dyspnea, throat tightness, flushing, erythema, rash, and chest discomfort have occurred. Have personnel and resuscitative equipment immediately available ( 5-5.7)
•
Atrial Fibrillation. Reported in patients with or without a history of atrial fibrillation ( 5-5.8)
•
Hypertension. Clinically significant increases in systolic and diastolic pressure have been observed ( 5-5.9)

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥10%) are: flushing; chest discomfort; shortness of breath; headache; throat, neck or jaw discomfort; gastrointestinal discomfort; and dizziness ( 6-6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

•
Methylxanthines interfere with the activity of adenosine injection ( 7-7.1, 10)
•
Nucleoside transport inhibitors such as dipyridamole can increase the activity of adenosine injection ( 7-7.1)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 7/2018

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Cardiac Arrest, Ventricular Arrhythmias, and Myocardial Infarction
5.2 Sinoatrial and Atrioventricular Nodal Block
5.3 Bronchoconstriction
5.4 Hypotension
5.5 Cerebrovascular Accident
5.6 Seizures
5.7 Hypersensitivity, including Anaphylaxis
5.8 Atrial Fibrillation
5.9 Hypertension
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Post-Marketing Experience
7 DRUG INTERACTIONS
7.1 Effects of Other Drugs on Adenosine injection
7.2 Effects of Adenosine Injection on Other Drugs
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.

1 INDICATIONS & USAGE

Adenosine Injection is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.

2 DOSAGE & ADMINISTRATION

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

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

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

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

Table 1 Dosage Chart for Adenosine Injection

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 (mL/min)
Adenosine injection concentration (3 mg/mL)