Regadenoson

FDA label, HF Acquisition Co LLC, DBA HealthFirst, intravenous, effective 2024-01-28. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Adenosine Receptor Agonist

Dosing in kidney impairment

Renal Impairment No dose adjustment is needed in patients with renal impairment including patients with end stage renal disease and/or dependent on dialysis [see Pharmacokinetics ( 12- 12.3)].

Preparation and administration

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Basis

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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.

Drug interactions

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Label text (4 paragraphs)

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 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.

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)].

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for regadenoson. Check the label's hepatic warnings.

Pregnancy and lactation

Breastfeeding (LactMed)

No information is available on the use of regadenoson during breastfeeding. To avoid exposure of the infant to regadenoson, nursing mothers should avoid breastfeeding for 10 hours after drug administration.

Source: LactMed: Regadenoson (NICHD, public domain)Revised Feb 15, 2025

Supply and cost

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