Adenoscan

Name: Adenoscan

Uses For Adenoscan

Adenosine injection is used in combination with Thallium-201 as a pharmacologic stress agent for myocardial perfusion scintigraphy in patients unable to undergo adequate exercise stress. This medicine works by dilating the arteries of the heart and increase blood flow to help identify coronary artery disease.

This medicine is to be given only by or under the direct supervision of a doctor.

Before Using Adenoscan

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of adenosine injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of adenosine injection in the elderly.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aminophylline
  • Carbamazepine
  • Dimenhydrinate
  • Dyphylline
  • Pentoxifylline
  • Theophylline
  • Verapamil

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Dipyridamole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Caffeine

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Angina, unstable or
  • Unstable heart or blood vessel problem (eg, cardiovascular instability)—Avoid use, as this medicine may increase the risk for heart attack.
  • Atrial fibrillation (heart rhythm problem), or history of or
  • Breathing problems or lung disease (eg, bronchitis, emphysema) or
  • Hypertension (high blood pressure) or
  • Hypotension (low blood pressure) or
  • Seizures or
  • Stroke, history of—Use with caution. May make these conditions worse.
  • Heart block, second or third degree (type of abnormal heart rhythm), without a pacemaker or
  • Sinus node disease (such as sick sinus syndrome), without a pacemaker—Should not be used in patients with these conditions, unless patients have a pacemaker that works.
  • Breathing problems or lung disease (eg, asthma)—Should not be used in patients with these conditions.
  • Heart or blood vessel disease (eg, coronary artery stenosis, ischemia, pericardial effusion, pericarditis) or
  • Heart valve disease or
  • Hypovolemia (low blood volume), uncorrected—May increase risk for more serious side effects.

How is this medicine (Adenoscan) best taken?

Use Adenoscan as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as a shot into a vein.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

What are some other side effects of Adenoscan?

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 any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.
  • Flushing.
  • Headache.
  • Belly pain.

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.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies in animals have not been performed to evaluate adenosine’s carcinogenic potential or potential effects on fertility. Adenosine was negative for genotoxic potential in the Salmonella (Ames Test) and Mammalian Microsome Assay.

Adenosine, however, like other nucleosides at millimolar concentrations present for several doubling times of cells in culture, is known to produce a variety of chromosomal alterations.

Patient Counseling Information

• Advise patients that they may be at increased risk of fatal and nonfatal heart attacks, abnormal heart rhythms, cardiac arrest, heart block, significant increase or decrease in blood pressure, bronchoconstriction, hypersensitivity reactions, seizures, or cerebrovascular accidents with the use of Adenoscan [see Warnings and Precautions (5.1-5.9)]. • Advise patients with COPD or asthma to discuss their respiratory history with their clinician before scheduling a myocardial perfusion imaging study with Adenoscan [see Warnings and Precautions (5.3)]. • Methylxanthines have the potential to impact the effects of Adenoscan. Instruct patients to avoid consumption of any products containing methylxanthines, including caffeinated coffee, tea or other caffeinated beverages, caffeine-containing drug products, aminophylline, and theophylline prior to the myocardial perfusion imaging study. Question patients about a history of seizures [see Warnings and Precautions (5.6), Drug Interactions (7.1), and Overdosage (10)].

Rx only

Product of Germany

Marketed by:
Astellas Pharma US, Inc.
Northbrook, IL 60062 USA

Manufactured by:
Hospira, Inc.
Lake Forest, IL 60045 USA

14H059-ADS

© 2014 Astellas Pharma US, Inc.

Adenoscan® is a registered trademark of Astellas US LLC.

Indications and Usage

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

Contraindications

Intravenous Adenoscan (adenosine injection) should not be administered to individuals with:

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