Pronunciation:

re-ga-DEN-oh-son

Brand Names:

• Lexiscan

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Diagnostic Agent, Cardiac Function

Pharmacologic—

Adenosine A2a Receptor Agonist

Uses of This Medicine:

Regadenoson injection is used as a pharmacologic stress agent for radionuclide myocardial perfusion imaging (MPI) 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 This Medicine:

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.

Children—

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

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of regadenoson injection in the elderly. However, elderly patients are more likely to have low blood pressure, which may require caution in patients receiving regadenoson injection.

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.

Other 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
• Bamifylline
• Dimenhydrinate
• Dyphylline
• Pentoxifylline
• Theophylline

Other interactions—

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 drug may increase the risk for heart attack.

• Breathing problems or lung disease (eg, asthma, bronchoconstriction, COPD) or
• Heart rhythm problems (eg, atrial fibrillation, atrial flutter) 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 dysfunction (type of abnormal heart rhythm), without a pacemaker—Should not be used in patients with these conditions, unless patients have a pacemaker that works.

• Heart or blood vessel disease (eg, coronary artery stenosis, ischemia, pericarditis) or
• Heart valve disease or
• Hypovolemia (low blood volume)—May increase risk for more serious side effects.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed into one of your veins.

Precautions While Using This Medicine:

It is very important that your doctor check your progress very closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you start having a rash, itching, increased heart rate, lightheadedness or fainting, trouble breathing, trouble swallowing, swelling of your hands, face, mouth, or throat, or chest pain after you receive the medicine.

Heart attack, stroke, and death may occur after receiving this medicine. Make sure your doctor knows if you have any heart problems (eg, unstable angina or cardiovascular instability) before you have a heart stress test. Check with your doctor right away if you have chest pain or discomfort, nausea, pain or discomfort in arms, jaw, back or neck, sweating, or vomiting.

Make sure your doctor knows if you are using dipyridamole (Persantine®) before you receive this medicine. You may need to stop using dipyridamole for at least 2 days before the test, if possible.

Make sure your doctor knows if you are using aminophylline or theophylline (Theo-24®, Uniphyl®) before you receive this medicine. You may need to stop using aminophylline or theophylline for at least 12 hours before the test.

Do not take anything that contains caffeine for at least 12 hours before you receive this medicine. This includes medicines, foods, and beverages with caffeine, such as coffee, tea, and cola drinks.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Arm, back, or jaw pain

chest pain or discomfort

difficult or labored breathing

fast or irregular heartbeat

nausea

sweating

tightness in the chest

Incidence not known

Confusion

difficulty swallowing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fainting

irregular heartbeat recurrent

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

rash, hives, or itching skin

trembling or shaking of the hands or feet

unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Dizziness

feeling of warmth

increased heart rate

redness of the face, neck, arms, and occasionally, upper chest

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Headache

Less common

Change in taste

loss of taste

stomach soreness or discomfort

Incidence not known

Diarrhea

difficulty with moving

joint pain

muscle aching or cramping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.