Corlanor Generic Name: ivabradine tablets Brand Name: Corlanor Corlanor (Ivabradine Tablets) side effects drug center Related Drugs Amiodarone HCl Injection Cordarone Inspra Mavik Microzide Monopril Monopril HCT Norvasc Prinivil Verquvo Zaroxolyn Zebeta Health Resources Congestive Heart Failure (CHF) Heart Failure PROFESSIONAL CONSUMER SIDE EFFECTS Overview Professional Information Corlanor Side Effects Center What Is Corlanor? Corlanor (ivabradine) is a hyperpolarization-activated cyclic nucleotide-gated channel blocker used to reduce the risk of hospitalization for worsening heart failure in patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction (LVEF) =35 percent, who are in sinus rhythm with resting heart rate =70 beats per minute (bpm) and either are on maximally tolerated doses of beta blockers or have a contraindication to beta blocker use. What Are Side Effects of Corlanor? Common side effects of Corlanor include: slow heart rate (bradycardia), increased or high blood pressure (hypertension), atrial fibrillation, and temporary vision disturbance (flashes of light) Tell your doctor if you experience side effects of Corlanor including dizziness, weakness, or fatigue. Dosage for Corlanor The recommended starting dose of Corlanor is a 5 mg tablet twice daily with meals. What Drugs, Substances, or Supplements Interact with Corlanor? Corlanor may interact with CYP3A4 inhibitors and inducers. Tell your doctor all medications and supplements you use. Corlanor During Pregnancy and Breastfeeding Corlanor is not recommended for use during pregnancy. It may harm a fetus. Women should use birth control while taking Corlanor. Breastfeeding is not recommended while using this drug. Additional Information Our Corlanor (ivabradine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Corlanor Consumer Information Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out); very slow heartbeats; severe headache, blurred vision, pounding in your neck or ears; racing heartbeats with dizziness, tiredness, or a lack of energy; chest tightness; or shortness of breath that is worse than usual. If your baby is taking ivabradine, watch for symptoms of feeding problems, trouble breathing, or turning blue. Ivabradine can cause a temporary brightness in your vision, especially during the first 2 months of treatment. This can make you see halos around lights, see colors within lights, or see multiple images while looking at an object. You may also see kaleidoscope colors or flashes of movement in certain parts of your vision. Sudden bright light can make these vision changes more noticeable. These effects usually go away as you continue taking ivabradine or after you stop taking it. Common side effects may include: slow or irregular heartbeats; high blood pressure; or your eyes may be more sensitive to light. 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 Corlanor (Ivabradine Tablets) Corlanor Professional Information SIDE EFFECTS Clinically significant adverse reactions that appear in other sections of the labeling include: Atrial Fibrillation [see WARNINGS AND PRECAUTIONS] Bradycardia and Conduction Disturbances [see WARNINGS AND PRECAUTIONS] 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 the Systolic Heart failure treatment with the If inhibitor ivabradine Trial (SHIFT), safety was evaluated in 3260 patients treated with Corlanor and 3278 patients given placebo. The median duration of Corlanor exposure was 21.5 months. The most common adverse drug reactions in the SHIFT trial are shown in Table 2 [see WARNINGS AND PRECAUTIONS]. Table 2: Adverse Drug Reactions with Rates ≥ 1.0% Higher on Ivabradine than Placebo occurring in > 1% on Ivabradine in SHIFT Ivabradine N = 3260 Placebo N = 3278 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. Corlanor can cause phosphenes, thought to be mediated through Corlanor's effects on retinal photoreceptors [see CLINICAL PHARMACOLOGY]. Onset is generally within the first 2 months of treatment, after which they may occur repeatedly. Phosphenes were generally reported to be of mild to moderate intensity and led to treatment discontinuation in < 1% of patients; most resolved during or after treatment. Pediatric Patients With Heart Failure The safety of Corlanor in pediatric patients 6 months to less than 18 years of age is based on a clinical trial [see Clinical Studies] in symptomatic heart failure patients with dilated cardiomyopathy and elevated heart rate. This trial provides experience in 73 patients treated with Corlanor for a median duration of 397 days, and 42 patients given placebo. Bradycardia (symptomatic and asymptomatic) occurred at rates similar to those in adults. Phosphenes were observed in pediatric patients treated with Corlanor. Postmarketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or establish a causal relationship to drug exposure. The following adverse reactions have been identified in adults during post-approval use of Corlanor: syncope, hypotension, torsade de pointes, ventricular fibrillation, ventricular tachycardia, angioedema, erythema, rash, pruritus, urticaria, vertigo, and diplopia, and visual impairment. Read the entire FDA prescribing information for Corlanor (Ivabradine Tablets) &Copy; Corlanor Patient Information is supplied by Cerner Multum, Inc. and Corlanor Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
