Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Clinically significant adverse reactions that appear in other sections of the labeling include: Atrial Fibrillation [see Warnings and Precautions (5.2) ] Bradycardia and Conduction Disturbances [see Warnings and Precautions (5.3) ] Most common adverse reactions occurring in ≥ 1% of patients are bradycardia, hypertension, atrial fibrillation and luminous phenomena (phosphenes).
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Ingenus Pharmaceuticals, LLC at 1-877-748-1970 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.
Adult Patients with Heart Failure In SHIFT, safety was evaluated in 3,260 patients treated with ivabradine tablets and 3,278 patients given placebo.
The median duration of ivabradine tablets exposure was 21.5 months.
The most common adverse drug reactions in the SHIFT trial are shown in Table 2 [see Warnings and Precautions (5.2) , ( 5.3 )].
Adverse Drug Reactions with Rates ≥ 1.0% Higher on Ivabradine than Placebo occurring in > 1% on Ivabradine in SHIFT Ivabradine N = 3,260 Placebo N = 3,278 Bradycardia 10 % 2.2 % Hypertension, Blood Pressure Increased 8.9 % 7.8 % Atrial fibrillation 8.3 % 6.6 % Phosphenes, visual brightness 2.8 % 0.5 % Luminous Phenomena (Phosphenes) Phosphenes are phenomena described as a transiently enhanced brightness in a limited area of the visual field, halos, image decomposition (stroboscopic or kaleidoscopic effects), colored bright lights, or multiple images (retinal persistency).
Phosphenes are usually triggered by sudden variations in light intensity.
Ivabradine tablets can cause phosphenes, thought to be mediated through ivabradine tablets effects on retinal photoreceptors [see Clinical Pharmacology (12.1) ].
Onset is generally within the first 2 months of treatment, after which they may occur repeatedly.
5 WARNINGS AND PRECAUTIONS Fetal toxicity: Females should use effective contraception.
( 5.1 ) Monitor patients for atrial fibrillation.
( 5.2 ) Monitor heart rate decreases and bradycardia symptoms during treatment.
( 5.3 ) Not recommended in patients with 2 nd degree AV block.
( 5.3 ) 5.1 Fetal Toxicity Ivabradine tablets may cause fetal toxicity when administered to a pregnant woman based on findings in animal studies.
Like all medications, Ivabradine can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: