LEXISCAN(R) (REGADENOSON) .08 mg/mL
LEXISCAN(R) (REGADENOSON) · INJECTION, SOLUTION · HF Acquisition Co LLC, DBA HealthFirst
Lexiscan (regadenoson) is an injectable medication that works by activating adenosine receptors and is used during cardiac stress testing to help evaluate how well your heart is working. It is administered intravenously by a healthcare provider as part of a diagnostic procedure to assess blood flow to the heart muscle.
Key Facts
- Brand Name
- LEXISCAN(R) (REGADENOSON)
- Generic Name
- LEXISCAN(R) (REGADENOSON)
- NDC Code (Product)
51662-1448- Manufacturer
- HF Acquisition Co LLC, DBA HealthFirst
- Strength
- .08 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- HUMAN PRESCRIPTION DRUG
- Application #
- NDA022161
- Drug Class
- Adenosine Receptor Agonists [MoA]; Pharmacologic Cardiac Stress Test Agent [EPC]
- Marketing Start
- 12/10/2019
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS & USAGE LEXISCAN® (regadenoson) injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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- 7.1) and Clinical Pharmacology ( 12- 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.
Contraindications
4 CONTRAINDICATIONS 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- 5.2)].
Drug Interactions
7 DRUG INTERACTIONS No formal pharmacokinetic drug interaction studies have been conducted with LEXISCAN. 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- 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 i…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling. • Myocardial Ischemia [see Warnings and Precautions ( 5- 5.1)] • Sinoatrial and Atrioventricular Nodal Block [see Warnings and Precautions ( 5- 5.2)] • Atrial Fibrillation/Atrial Flutter [see Warnings and Precautions ( 5- 5.3)] • Hypersensitivity, Including Anaphylaxis [see Warnings and Precautions ( 5- 5.4)] • Hypotension [see Warnings and Precautions ( 5- 5.5)] • Hypertension [see Warnings and Precautions ( 5- 5.6)] • Bronchoconstriction [see Warnings and Precautions ( 5- 5.7)] • Seizure [see Warnings and Precautions ( 5- 5.8)] • Cerebrovascular Accident (Stroke) [see Warnings and Precautions ( 5- 5.9)] 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 receiving 0.4 mg as a rapid (≤ 10 seconds) intravenous injection. Most of these patients receive…
Frequently Asked Questions
What is LEXISCAN(R) (REGADENOSON) used for?
Lexiscan (regadenoson) is an injectable medication that works by activating adenosine receptors and is used during cardiac stress testing to help evaluate how well your heart is working. It is administered intravenously by a healthcare provider as part of a diagnostic procedure to assess blood flow to the heart muscle.
Is LEXISCAN(R) (REGADENOSON) a controlled substance?
LEXISCAN(R) (REGADENOSON) is not classified as a controlled substance by the DEA.
What is the generic name for LEXISCAN(R) (REGADENOSON)?
The generic name for LEXISCAN(R) (REGADENOSON) is LEXISCAN(R) (REGADENOSON). There are no other listed brand versions of LEXISCAN(R) (REGADENOSON).
What is the NDC code for LEXISCAN(R) (REGADENOSON) .08 mg/mL?
The NDC (National Drug Code) for LEXISCAN(R) (REGADENOSON) .08 mg/mL is 51662-1448, listed by HF Acquisition Co LLC, DBA HealthFirst.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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