Lexiscan

Lexiscan

Lexiscan Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Lexiscan (regadenoson) injection is given in preparation for a radiologic (x-ray) examination of blood flow through the heart to test for coronary artery disease. It is a stress agent that works by increasing blood flow in the arteries of the heart. Common side effects include headache, dizziness, nausea, stomach discomfort, decreased sense of taste, mild chest discomfort, or warmth, redness, or tingly feeling under your skin.

The recommended intravenous dose of Lexiscan is 5 mL, administered as a rapid (approximately 10 seconds) injection into a peripheral vein. Lexiscan may interact with dipyridamole or theophylline. Tell your doctor all medications you use. During pregnancy, Lexiscan should be used only if prescribed. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breast-feeding.

Our Lexiscan (regadenoson) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Lexiscan in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have a serious side effect such as:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, shortness of breath, uneven heart rate);
  • seizure (convulsions);
  • wheezing, trouble breathing; or
  • feeling like you might pass out.

Less serious side effects may include:

  • headache;
  • dizziness;
  • nausea, stomach discomfort, decreased sense of taste;
  • mild chest discomfort; or
  • warmth, redness, or tingly feeling under your skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1 800 FDA 1088.

Read the entire detailed patient monograph for Lexiscan (Regadenoson Injection) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Lexiscan FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of the labeling.

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].

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

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
Lexiscan
(N=356)
Placebo
(N=176)
Lexiscan
(N=316)
Placebo
(N=151)
Overall Pre-specified Respiratory Adverse Reaction† 12.90% 2.30% 19.00% 4.00%
  Dyspnea 10.70% 1.10% 18.00% 2.60%
  Wheezing 3.10% 1.10% 0.90% 0.70%
FEV1 reduction > 15%‡ 1.10% 2.90% 4.20% 5.40%
*All subjects continued the use of their respiratory medications as prescribed prior to administration of Lexiscan.
†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

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

Myocardial infarction, cardiac arrest, ventricular arrythmias, supraventricular tachyarrythmias including atrial fibrillation or 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. 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].

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.

Read the entire FDA prescribing information for Lexiscan (Regadenoson Injection) »

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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.


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