"The US Food and Drug Administration (FDA) today approved the first nucleic acid-based test of cerebrospinal fluid (CSF) that can simultaneously detect 14 pathogens responsible for central nervous system (CNS) infections.
The following adverse reactions are discussed in more detail in other sections of the labeling.
- Myocardial Ischemia [see WARNINGS AND PRECAUTIONS]
- Sinoatrial and Atrioventricular Nodal Block [see WARNINGS AND PRECAUTIONS]
- Atrial Fibrillation/Atrial Flutter [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity, Including Anaphylaxis [see WARNINGS AND PRECAUTIONS]
- Hypotension [see WARNINGS AND PRECAUTIONS]
- Hypertension [see WARNINGS AND PRECAUTIONS]
- Bronchoconstriction [see WARNINGS AND PRECAUTIONS]
- Seizure [see WARNINGS AND PRECAUTIONS]
- Cerebrovascular Accident (Stroke) [see WARNINGS AND PRECAUTIONS]
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 subjects were exposed to Lexiscan, with most receiving 0.4 mg as a rapid ( ≤ 10 seconds) intravenous injection. Most of these subjects received Lexiscan in two clinical studies that enrolled patients who had no history of bronchospastic lung disease as well as no history of a cardiac conduction block of greater than first-degree AV block, except for patients with functioning artificial pacemakers. In these studies (Studies 1 and 2), 2,015 patients underwent myocardial perfusion imaging after administration of Lexiscan (N = 1,337) or Adenoscan® (N = 678). The population was 26–93 years of age (median 66 years), 70% male and primarily Caucasian (76% Caucasian, 7% African American, 9% Hispanic, 5% Asian). Table 1 shows the most frequently reported adverse reactions.
Overall, any adverse reaction occurred at similar rates between the study groups (80% for the Lexiscan group and 83% for the Adenoscan group). Aminophylline was used to treat the reactions in 3% of patients in the Lexiscan group and 2% of patients in the Adenoscan group. Most adverse reactions began soon after dosing, and generally resolved within approximately 15 minutes, except for headache which resolved in most patients within 30 minutes.
Table 1 : Adverse Reactions in Studies 1 and 2 Pooled
(Frequency ≥ 5%)
N = 1,337
N = 678
|Angina Pectoris or ST Segment Depression||12%||18%|
The frequency of rhythm or conduction abnormalities following Lexiscan or Adenoscan is shown in Table 2 [see WARNINGS AND PRECAUTIONS].
Table 2 : Rhythm or
Conduction Abnormalities* in Studies 1 and 2
|Lexiscan N / N evaluable (%)||Adenoscan N / N evaluable (%)|
|Rhythm or conduction abnormalities†||332/1275 (26%)||192/645 (30%)|
|Rhythm abnormalities||260/1275 (20%)||131/645 (20%)|
|PACs||86/1274 (7%)||57/645 (9%)|
|PVCs||179/1274 (14%)||79/645 (12%)|
|First-degree AV block (PR prolongation > 220 msec)||34/1209 (3%)||43/618 (7%)|
|Second-degree AV block||1/1209 (0.1%)||9/618 (1%)|
|AV conduction abnormalities (other than AV blocks)||1/1209 (0.1%)||0/618 (0%)|
|Ventricular conduction abnormalities||64/1152 (6%)||31/581 (5%)|
|* 12-lead ECGs were
recorded before and for up to 2 hrs after dosing
† includes rhythm abnormalities (PACs, PVCs, atrial fibrillation/flutter, wandering atrial pacemaker, supraventricular or ventricular arrhythmia) or conduction abnormalities, including AV block
In a randomized, placebo-controlled trial (Study 3) of 999 subjects with asthma (n= 532) or stable chronic obstructive pulmonary disease (n=467), the overall incidence of pre-specified respiratory adverse reactions was greater in the Lexiscan group compared to the placebo group (p < 0.001).
Most respiratory adverse reactions resolved without therapy; a few subjects received aminophylline or a short acting bronchodilator. No differences were observed between treatment arms in the reduction of > 15% from baseline at two-hours in FEV 1 (Table 3).
Table 3 : Respiratory Adverse Effects in Study 3*
|Asthma Cohort||COPD Cohort|
|Overall Pre-specified Respiratory Adverse Reaction†||12.9%||2.3%||19.0%||4.0%|
|FEVi reduction > 15%‡||1.1%||2.9%||4.2%||5.4%|
|*All subjects continued the use
of their respiratory medications as prescribed prior to administration of
†Patients may have reported more than one type of adverse reaction. Adverse reactions were collected up to 24 hours following drug administration. Pre-specified respiratory adverse reactions included dyspnea, wheezing, obstructive airway disorder, dyspnea exertional, and tachypnea.
‡Change from baseline at 2 hours
In a randomized, placebo-controlled trial of 504 subjects (Lexiscan n=334 and placebo n=170) with a diagnosis or risk factors for coronary artery disease and NKFK/DOQI Stage III or IV renal impairment (defined as GFR 15-59 mL/min/1.73 m²), no serious adverse events were reported through the 24-hour follow-up period.
Myocardial infarction, cardiac arrest, ventricular arrhythmias, supraventricular tachyarrhythmias including atrial fibrillation with rapid ventricular response (new-onset or recurrent), atrial flutter, heart block (including third-degree block), asystole, marked hypertension, symptomatic hypotension in association with transient ischemic attack, seizures and syncope [see WARNINGS AND PRECAUTIONS] have been reported. Some events required intervention with fluids and/or aminophylline [see OVERDOSAGE]. QTc prolongation shortly after Lexiscan administration has been reported.
Central Nervous System
Abdominal pain, occasionally severe, has been reported a few minutes after Lexiscan administration, in association with nausea, vomiting, or myalgias; administration of aminophylline, an adenosine antagonist, appeared to lessen the pain. Diarrhea and fecal incontinence have also been reported following Lexiscan administration.
Anaphylaxis, angioedema, cardiac or respiratory arrest, respiratory distress, decreased oxygen saturation, hypotension, throat tightness, urticaria, rashes have occurred and have required treatment including resuscitation [see WARNINGS AND PRECAUTIONS].
Musculoskeletal pain has occurred, typically 10-20 minutes after Lexiscan administration; the pain was occasionally severe, localized in the arms and lower back and extended to the buttocks and lower legs bilaterally. Administration of aminophylline appeared to lessen the pain.
Respiratory arrest, dyspnea and wheezing have been reported following Lexiscan administration.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to Lexiscan exposure.
Read the Lexiscan (regadenoson injection) Side Effects Center for a complete guide to possible side effects
No formal pharmacokinetic drug interaction studies have been conducted with Lexiscan.
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 and PATIENT INFORMATION]. 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].
- 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.
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.
Read the Lexiscan Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 10/3/2014
Additional Lexiscan Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.