Lexiscan (Regadenoson) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

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	Adenoscan
	N = 1,337	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 ].

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

	Lexiscan N / N evaluable (%)	Adenoscan N / N evaluable (%)
Rhythm or conduction abnormalities 2	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%)
1st degree AV block (PR prolongation > 220 msec)	34/1209 (3%)	43/618 (7%)
2nd 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%)

REPORTS OF SUSPECTED LEXISCAN SIDE EFFECTS / ADVERSE REACTIONS

Possible Lexiscan side effects / adverse reactions in 73 year old female

Reported by a pharmacist from United States on 2011-10-31

Patient: 73 year old female

Reactions: Injection Site Extravasation, Fasciotomy, Hypotension

Adverse event resulted in: hospitalization

Suspect drug(s):
Lexiscan

Possible Lexiscan side effects / adverse reactions in 43 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-01

Patient: 43 year old male

Reactions: Arteriospasm Coronary

Suspect drug(s):
Lexiscan

Possible Lexiscan side effects / adverse reactions in 84 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-14

Patient: 84 year old female

Reactions: Death

Adverse event resulted in: death

Suspect drug(s):
Lexiscan