Lexiscan Side Effects

Generic Name: regadenoson

Please note - some side effects for Lexiscan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Lexiscan Side Effects - for the Professional

Lexiscan

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%)

	Lexiscan N = 1,337	Adenoscan N = 678
Dyspnea	28%	26%
Headache	26%	17%
Flushing	16%	25%
Chest Discomfort	13%	18%
Angina Pectoris or ST Segment Depression	12%	18%
Dizziness	8%	7%
Chest Pain	7%	10%
Nausea	6%	6%
Abdominal Discomfort	5%	2%
Dysgeusia	5%	7%
Feeling Hot	5%	8%

ECG Abnormalities

The frequency of rhythm or conduction abnormalities following Lexiscan or Adenoscan is shown in Table 2 [see Warnings and Precautions (5.2)].

Table 2 Rhythm or Conduction Abnormalities* in Studies 1 and 2

* 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
	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%)

Respiratory Abnormalities

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 FEV1 (Table 3)

Table 3 Respiratory Adverse Effects in Study 3*

	Asthma Cohort		COPD Cohort
* All subjects continued the use of their respiratory medications as prescribed prior to administration of Lexiscan. † Subjects 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 including dyspnea, wheezing, obstructive airway disorder, dyspnea exertional, and tachypnea. ‡ Change from baseline at 2 hours
	Lexiscan (N=356)	Placebo (N=176)	Lexiscan (N=316)	Placebo (N=151)
Overall Pre-specified Respiratory Adverse Reaction†	12.9%	2.3%	19.0%	4.0%
Dyspnea	10.7%	1.1%	18.0%	2.6%
Wheezing	3.1%	1.1%	0.9%	0.7%
FEV1 reduction >15%‡	1.1%	2.9%	4.2%	5.4%

Renal Impairment

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.

Post-Marketing Experience

Cardiovascular

Heart block (including third degree block), asystole, marked hypertension, symptomatic hypotension in association with transient ischemic attack, seizures and syncope [see Warnings and Precautions (5)], requiring intervention with fluids and/or aminophylline have occurred. QTc prolongation shortly after Lexiscan administration has been reported.

Central Nervous System

Tremor, seizure (particularly with a history of seizure)

Gastrointestinal

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.

Hypersensitivity

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 (5.3)].

Musculoskeletal

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

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.

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Side Effects by Body System - for Healthcare Professionals

Respiratory

Respiratory side effects including dyspnea (28%) have been reported.

Nervous system

Nervous system side effects including headache (26%) and dizziness (8%) have been reported.

Cardiovascular

Cardiovascular side effects have included tachycardia (22%), flushing (16%), premature ventricular contractions (14%), chest discomfort (13%), angina or ST segment depression (12%), Chest pain (7%), premature atrial contractions (7%), systolic blood pressure decreased greater than 35 mm Hg (7%), ventricular conduction abnormalities (6%) diastolic blood pressure decreased more than 25 mm Hg (4%), first-degree AV block (PR prolongation greater than 220 msec; 3%), second-degree AV block (less than 1%), AV conduction abnormalities (other than AV blocks; less than 1%).

Gastrointestinal

Gastrointestinal side effects including nausea (6%), abdominal discomfort (5%), and dysgeusia (5%) have been reported.

General

General side effects including feeling hot (5%) have been reported.

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