lexiscan
Pharmaranks rates Lexiscan 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Lexiscan (Regadenoson) is a pharmacologic cardiac stress test agent.
Regadenoson · by Astellas
Available as a generic: Regadenoson
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Regadenoson
- Drug class
- Pharmacologic Cardiac Stress Test Agent
- Form
- Injectable
- Strength
- Regadenoson 0.4MG/5ML (0.08MG/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Astellas
- FDA application
- NDA022161
What is Lexiscan?
From the FDA label:Regadenoson is an A 2A adenosine receptor agonist that is a coronary vasodilator [ see Clinical Pharmacology ( 12.1 ) ]. Regadenoson is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1 H -pyrazol-1-yl]-, monohydrate. Its structural formula is: The molecular formula for regadenoson is C 15 H 18 N 8 O 5 • H 2 O and its molecular weight is 408.37. LEXISCAN is a sterile, nonpyrogenic solution for intravenous injection. The solution is clear and colorless. Each 1 mL in the 5 mL pre-filled syringe contains 0.084 mg of regadenoson monohydrate, corresponding to 0.08 mg regadenoson on an anhydrous basis, 10.9 mg dibasic sodium phosphate dihydrate or 8.7 mg dibasic sodium phosphate anhydrous, 5.4 mg monobasic sodium phosphate monohydrate, 150 mg propylene glycol, 1 mg edetate disodium dihydrate, and Water for Injection, with pH between 6.3 and 7.7. Structure
How to use
The recommended dose of LEXISCAN is 5 mL (0.4 mg regadenoson) administered as an intravenous injection within 10 seconds. • Patients should be instructed to avoid consumption of any products containing methylxanthines, including caffeinated coffee, tea or other caffeinated beverages, caffeine-containing drug products, aminophylline and theophylline for at least 12 hours before a scheduled radionuclide MPI [ see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.2 ) ]. • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer LEXISCAN if it contains particulate matter or is discolored. • Administer LEXISCAN as an intravenous injection within 10 seconds into a peripheral vein using a 22 gauge or larger catheter or needle. • Administer a 5 mL saline flush immediately after the injection of LEXISCAN. • Administer the radionuclide myocardial perfusion imaging agent 10–20 seconds after the saline flush. The radionuclide may be injected directly into the same catheter as LEXISCAN. • The recommended dose of LEXISCAN is 5 mL (0.4 mg regadenoson) administered as an intravenous injection within 10 seconds; followed immediately by saline flush and radiopharmaceutical ( 2 ).
Side effects
The following adverse reactions are discussed in more detail in other sections of the labeling. • Myocardial Ischemia [ see Warnings and Precautions ( 5.1 ) ] • Sinoatrial and Atrioventricular Nodal Block [ see Warnings and Precautions ( 5.2 ) ] • Atrial Fibrillation/Atrial Flutter [ see Warnings and Precautions ( 5.3 ) ] • Hypersensitivity, Including Anaphylaxis [ see Warnings and Precautions ( 5.4 ) ] • Hypotension [ see Warnings and Precautions ( 5.5 ) ] • Hypertension [ see Warnings and Precautions ( 5.6 ) ] • Bronchoconstriction [ see Warnings and Precautions ( 5.7 ) ] • Seizure [ see Warnings and Precautions ( 5.8 ) ] • Cerebrovascular Accident (Stroke) [ see Warnings and Precautions ( 5.9 ) ] The most common (incidence ≥ 5%) adverse reactions to LEXISCAN are dyspnea, headache, flushing, chest discomfort, dizziness, angina pectoris, chest pain, and nausea ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Astellas Pharma US, Inc. at 1-800-727-7003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. During clinical development, 1,651 patients were exposed to LEXISCAN, with most…
Warnings
Important safety information
Myocardial Ischemia. Fatal cardiac events have occurred. Avoid use in patients with symptoms or signs of acute myocardial ischemia, for example unstable angina or cardiovascular instability, who may be at greater risk. Cardiac resuscitation equipment and trained staff should be available before administration ( 5.1 ). • Sinoatrial (SA) and Atrioventricular (AV) Nodal Block. Adenosine receptor agonists, including LEXISCAN, can depress the SA and AV nodes and may cause first-, second- or third-degree AV block, or sinus bradycardia ( 5.2 ). • Atrial Fibrillation/Atrial Flutter. New-onset or recurrent atrial fibrillation with rapid ventricular response and atrial flutter have been reported ( 5.3 ). • Hypersensitivity, including anaphylaxis, angioedema, cardiac or respiratory arrest, respiratory distress, decreased oxygen saturation, hypotension, throat tightness, urticaria, and rashes have occurred. Have personnel and resuscitative equipment immediately available ( 5.4 ). • Hypotension. Adenosine receptor agonists, including LEXISCAN, induce vasodilation and hypotension. The risk of serious hypotension may be higher in patients with autonomic dysfunction, stenotic valvular heart disease, pericarditis or pericardial effusions, stenotic carotid artery disease with cerebrovascular insufficiency, or hypovolemia ( 5.5 ). • Hypertension. Adenosine receptor agonists, including LEXISCAN, may induce clinically significant increases in blood pressure particularly in patients with a history of hypertension and when the MPI includes low level exercise ( 5.6 ). • Bronchoconstriction. Adenosine receptor agonists, including LEXISCAN, may induce dyspnea, bronchoconstriction and respiratory compromise in patients with chronic obstructive pulmonary disease (COPD) or asthma. Resuscitative measures should be available ( 5.7 ). • Seizure. LEXISCAN may lower the seizure threshold. New onset or recurrence of convulsive seizures has occurred. Some seizures are prolonged and require urgent anticonvulsive management. Methylxanthine use is not recommended in patients who experience a seizure in association with LEXISCAN ( 5.8 ). • Cerebrovascular Accident (Stroke). Hemorrhagic and ischemic cerebrovascular accidents have occurred ( 5.9 ). 5.1 Myocardial Ischemia Fatal and nonfatal myocardial infarction (MI), ventricular arrhythmias, and cardiac arrest have occurred following LEXISCAN injection. 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 LEXISCAN. Cardiac resuscitation equipment and trained staff should be available before administering LEXISCAN. Adhere to the recommended duration of injection [ see Dosage and Administration ( 2 ) ]. As noted in an animal study, longer injection times may increase the duration and magnitude of increase in coronary blood flow [ see Clinical Pharmacology ( 12.2 ) ]. If serious reactions to LEXISCAN occur, consider the use of aminophylline, an adenosine antagonist, to shorten the duration of increased coronary blood flow induced by LEXISCAN [ see Overdosage ( 10 ) ]. 5.2 Sinoatrial and Atrioventricular Nodal Block Adenosine receptor agonists, including LEXISCAN, can depress the SA and AV nodes and may cause first-, second- or third-degree AV block, or sinus bradycardia requiring intervention. In clinical trials first-degree AV block (PR prolongation > 220 msec) developed in 3% of patients within 2 hours of LEXISCAN administration; transient second-degree AV block with one dropped beat was observed in one patient receiving LEXISCAN. In post-marketing experience, third-degree heart block and asystole within minutes of LEXISCAN administration have occurred [ see Adverse Reactions ( 6.2 ) ]. 5.3 Atrial Fibrillation/Atrial Flutter New-onset or recurrent atrial fibrillation with rapid ventricular response and atrial flutter have been reported following LEXISCAN injection [ see Adverse Reactions ( 6.2 ) ]. 5.4 Hypersensitivity, Including Anaphylaxis Anaphylaxis, angioedema, cardiac or respiratory arrest, respiratory distress, decreased oxygen saturation, hypotension, throat tightness, urticaria and rashes have occurred. In clinical trials, hypersensitivity reactions were reported in fewer than 1 percent of patients [ see Adverse Reactions ( 6.1 ) ]. Have personnel and resuscitative equipment immediately available. 5.5 Hypotension Adenosine receptor agonists, including LEXISCAN, induce arterial vasodilation and hypotension. In clinical trials, decreased systolic blood pressure (> 35 mm Hg) was observed in 7% of patients and decreased diastolic blood pressure (> 25 mm Hg) was observed in 4% of patients within 45 minutes of LEXISCAN administration. The risk of serious hypotension may be higher in patients with autonomic dysfunction, hypovolemia, left main coronary artery stenosis, stenotic valvular heart disease, pericarditis or pericardial effusions, or stenotic carotid artery disease with cerebrovascular insufficiency. In post-marketing experience, syncope, transient ischemic attacks and seizures have been observed [ see Adverse Reactions ( 6.2 ) ]. 5.6 Hypertension Administration of adenosine receptor agonists, including LEXISCAN, may result in clinically significant increases in blood pressure in some patients. Among patients who experienced an increase in blood pressure in clinical trials, the increase was observed within minutes of LEXISCAN administration. Most increases resolved within 10 to 15 minutes, but in some cases, increases were observed at 45 minutes following administration [ see Clinical Pharmacology ( 12.2 ) ]. In post-marketing experience, cases of potentially clinically significant hypertension have been reported, particularly with underlying hypertension and when low-level exercise was included in the MPI [ see Adverse Reactions ( 6.2 ) ]. 5.7 Bronchoconstriction Adenosine receptor agonists, including LEXISCAN, may cause dyspnea, bronchoconstriction, and respiratory compromise. Appropriate bronchodilator therapy and resuscitative measures should be available prior to and following LEXISCAN administration [ see Adverse Reactions ( 6.1 ) , Clinical Pharmacology ( 12.2 ) , Overdosage ( 10 ) and Patient Counseling Information ( 17 ) ]. 5.8 Seizure LEXISCAN may lower the seizure threshold; obtain a seizure history. New-onset or recurrence of convulsive seizures has occurred following LEXISCAN injection. Some seizures are prolonged and require emergent anticonvulsive management. Aminophylline may increase the risk of seizures associated with LEXISCAN injection. Methylxanthine use is not recommended in patients who experience a seizure in association with LEXISCAN administration. 5.9 Cerebrovascular Accident (Stroke) Hemorrhagic and ischemic cerebrovascular accidents have occurred. Hemodynamic effects of LEXISCAN including hypotension or hypertension may be associated with these adverse reactions [ see Warnings and Precautions ( 5.5 ) and ( 5.6 ) ].
Who should not take Lexiscan
Do not administer LEXISCAN to patients with: • Second- or third-degree AV block, or • sinus node dysfunction unless these patients have a functioning artificial pacemaker [ see Warnings and Precautions ( 5.2 ) ]. Do not administer LEXISCAN to patients with: • Second- or third-degree AV block, or • sinus node dysfunction unless the patients have a functioning artificial pacemaker ( 4 ).
Overdose — what happens if you take too much
LEXISCAN overdosage may result in serious reactions [ see Warnings and Precautions ( 5 ) ]. In a study of healthy volunteers, symptoms of flushing, dizziness and increased heart rate were assessed as intolerable at LEXISCAN doses greater than 0.02 mg/kg. Aminophylline to Reverse Effects Methylxanthines, such as caffeine, aminophylline, and theophylline, are competitive adenosine receptor antagonists and aminophylline has been used to terminate persistent pharmacodynamic effects. Aminophylline may be administered in doses ranging from 50 mg to 250 mg by slow intravenous injection (50 mg to 100 mg over 30–60 seconds). Methylxanthine use is not recommended in patients who experience a seizure in association with LEXISCAN administration [ see Warnings and Precautions ( 5.8 ) ].
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
No formal pharmacokinetic drug interaction studies have been conducted with LEXISCAN. • Methylxanthines, e.g., caffeine, aminophylline and theophylline, interfere with the activity of LEXISCAN ( 7.1 , 12.2 ). • Aminophylline may be used to attenuate severe and/or persistent adverse reactions to LEXISCAN ( 7.1 , 10 ). • Dipyridamole may increase the activity of LEXISCAN. When possible, withhold dipyridamole for at least two days prior to LEXISCAN administration ( 7.1 ). 7.1 Effects of Other Drugs on LEXISCAN • Methylxanthines (e.g., caffeine, aminophylline and theophylline) are non-specific adenosine receptor antagonists that interfere with the vasodilation activity of LEXISCAN [ see Clinical Pharmacology ( 12.2 ) and Patient Counseling Information ( 17 ) ]. Patients should avoid consumption of any products containing methylxanthines as well as any drugs containing theophylline or aminophylline for at least 12 hours before LEXISCAN administration. Aminophylline may be used to attenuate severe or persistent adverse reactions to LEXISCAN [ see Overdosage ( 10 ) ]. • In clinical studies, LEXISCAN was administered to patients taking other cardioactive drugs (i.e., β-blockers, calcium channel blockers, ACE inhibitors, nitrates, cardiac glycosides, and angiotensin receptor blockers) without reported adverse reactions or apparent effects on efficacy. • Dipyridamole may change the effects of LEXISCAN. When possible, withhold dipyridamole for at least two days prior to LEXISCAN administration. 7.2 Effect of LEXISCAN on Other Drugs Regadenoson does not inhibit the metabolism of substrates for CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4 in human liver microsomes, indicating that it is unlikely to alter the pharmacokinetics of drugs metabolized by these cytochrome P450 enzymes.
Storing Lexiscan, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Lactation Advise a woman to pump and discard breast milk for 10 hours after LEXISCAN administration [ see Use in Specific Populations ( 8.”
Drug class
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- How is Lexiscan rated?
- pharmaranks gives Lexiscan a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Lexiscan?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Lexiscan. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Lexiscan?
- Lexiscan is marketed by Astellas. You can see Astellas's full profile, rating, and other products on pharmaranks.
- Is Lexiscan a brand-name or generic drug?
- Lexiscan is a brand-name product with the active ingredient Regadenoson. Lower-cost generic equivalents containing Regadenoson are available — ask your pharmacist.
- Is Lexiscan available over the counter?
- No. Lexiscan is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Lexiscan come in?
- Lexiscan is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Lexiscan?
- Lexiscan is classified as pharmacologic cardiac stress test agent, per the FDA's Established Pharmacologic Class.
- Is Lexiscan FDA-registered?
- Lexiscan is on record with the U.S. FDA under application number NDA022161. You can verify this on its official FDA label.
- Has Lexiscan been recalled by the FDA?
- Lexiscan has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Lexiscan safe?
- There's no single safe-or-not verdict. pharmaranks gives Lexiscan a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Lexiscan?
- Lexiscan's side effects are taken directly from its FDA label. From the label: The following adverse reactions are discussed in more detail in other sections of the labeling. • Myocardial Ischemia [ see Warnings and Precautions ( 5.1 ) ] • Sinoatrial and Atrioventricular Nodal Block [ see Warnings and Precautions ( 5.2 ) ] • Atrial Fibrillation/Atrial Flutter [ see Warnings an… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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lexiscan
72/100