Label Changes for:
Lexiscan (regadenoson) injection
Changes have been made to the ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
WARNINGS AND PRECAUTIONS
Hypersensitivity, including Anaphylaxis
- Anaphylaxis, angioedema, cardiac or respiratory arrest, respiratory distress, decreased oxygen saturation, hypotension, throat tightness, urticaria and rashes have occurred. In clinical trials, hypersensitivity reactions were reported in fewer than 1 percent of patients. Have personnel and resuscitative equipment immediately available.
- Adenosine receptor agonists, including Lexiscan, may cause dyspnea, bronchoconstriction, and respiratory compromise. Appropriate bronchodilator therapy and resuscitative measures should be available prior to 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.
USE IN SPECIFIC POPULATIONS
- Lexiscan was assessed in a randomized, placebo-controlled trial of patients with NKFK/DOQI Stage III or IV renal impairment (defined as a GFR 15-59 mL/min/1.73 m2). No serious adverse events were reported through the 24-hour follow-up period.
WARNINGS and PRECAUTIONS
- In postmarketing experience...attacks and seizures -(seizures added to sentence)
- Administration of adenosine receptor agonists, including Lexiscan, may result in clinically significant increases in blood pressure in some patients. Among patients who experienced an increase in blood pressure in clinical trials, the increases were observed within minutes of Lexiscan administration. Most increases resolved within 10 to 15 minutes, but in some cases, increases were observed at 45 minutes following administration. In post-marketing experience, cases of potentially clinically significant hypertension have been reported, particularly with underlying hypertension and when low-level exercise was included in the MPI.
- Cadiovascular: revisions made to include hypertension, transient ischemic attack, seizures and syncope
Central Nervous System
- tremors and seizure