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warnings and cautions
5 WARNINGS AND PRECAUTIONS ECG Changes and Potential for Cardiac Arrhythmias : Not recommended in patients with pre-existing cardiac disease, long QT syndrome, and concomitant use of Class IA and Class III antiarrhythmics. ( 5.1 ) 5.1 ECG Changes and Potential for Cardiac Arrhythmias CERDELGA is predicted to cause increases in ECG intervals (PR, QTc, and QRS) at substantially elevated eliglustat plasma concentrations and may increase the risk of cardiac arrhythmias. Use of CERDELGA is contraindicated, to be avoided, or requires dosage adjustment in patients taking CYP2D6 or CYP3A inhibitors, depending on CYP2D6 metabolizer status, type of inhibitor, or degree of hepatic impairment [see Dosage and Administration (2.3) , Contraindications (4) , Drug Interactions (7.1) ] . Use of CERDELGA in patients with pre-existing cardiac conditions has not been studied during clinical trials. Avoid use of CERDELGA in patients with: pre-existing cardiac disease (congestive heart failure, recent acute myocardial infarction, bradycardia, heart block, ventricular arrhythmia) long QT syndrome in combination with Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications [see Clinical Pharmacology (12.2) ]
6 ADVERSE REACTIONS Most common adverse reactions (≥10%) are: fatigue, headache, nausea, diarrhea, back pain, pain in extremities, and upper abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genzyme Corporation at 1-800-745-4447 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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. The most common adverse reactions to CERDELGA (occurring in ≥10% of the 126 GD1 patients treated with CERDELGA across Trials 1 and 2) were fatigue, headache, nausea, diarrhea, back pain, pain in extremities, and upper abdominal pain. The adverse reaction profile of CERDELGA is based on two controlled studies, Trials 1 and 2 [see Clinical Studies (14.1 , 14.2) ] . Table 3 presents the profile from the 9-month double-blind, randomized, placebo-controlled trial of 40 treatment-naive patients (Trial 1). Patients were between the ages of 16 and 63 on the date of the first dose of study drug, and included 20 males and 20 females. Table 3: Adverse Reactions Occurring in ≥10% of Treatment-Naive GD1 Patients and More Frequently than Placebo (Trial 1) CERDELGA (N=20) Placebo (N=20) Adverse Reaction Patients n (%) Patients n (%) Arthralgia 9 (45) 2 (10) Headache 8 (40) 6 (30) Migraine 2 (10) 0 (0) Flatulence 2 (10) 1 (5) Nausea 2 (10) 1 (5) Oropharyngeal pain 2 (10) 1 (5) Table 4 presents the profile from the 12-month open-label, randomized, imiglucerase-controlled trial of 159 treated patients switching from enzyme replacement therapy (ERT) (Trial 2). Patients were between the ages of 18 and 69 on the date of the first dose of CERDELGA, and included 87 females and 72 males. Table 4: Adverse Reactions Occurring in ≥5% of GD1 Patients Switching from Enzyme Replacement Therapy to CERDELGA and More Frequently than Imiglucerase (Trial 2) Trial 2 was not designed to support comparative claims for CERDELGA for the adverse reactions reported in this table. CERDELGA (N=106) Imiglucerase (N=53) Adverse Reaction Patients n (%) Patients n (%) Fatigue 15 (14) 1 (2) Headache 14 (13) 1 (2) Nausea 13 (12) 0 (0) Diarrhea 13 (12) 2 (4) Back pain 13 (12) 3 (6) Pain in extremity 12 (11) 1 (2) Upper abdominal pain 11 (10) 0 (0) Dizziness 9 (8) 0 (0) Asthenia 9 (8) 0 (0) Cough 7 (7) 2 (4) Dyspepsia 7 (7) 1 (2) Gastroesophageal reflux disease 7 (7) 0 (0) Constipation 5 (5) 0 (0) Palpitations 5 (5) 0 (0) Rash 5 (5) 0 (0) In a separate uncontrolled study, with up to 4 years of treatment in 26 naive GD1 patients, the types and incidences of adverse reactions were similar to Trials 1 and 2.