Corlanor

Ivabradine comes as a tablet to take by mouth. It is usually taken with food twice a day. Take ivabradine at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ivabradine exactly as directed. Do not take more or less of it, or take it more often than prescribed by your doctor.

Some ivabradine tablets come with a line down the middle. If your doctor tells you to take half a tablet, break it carefully on the line. Take half the tablet as directed, and save the other half for your next dose.

Your doctor may increase or decrease your dose after 2 weeks depending on how well the medication works for you, and the side effects you experience. Be sure to tell your doctor how you are feeling during your treatment with ivabradine.

Ivabradine controls the symptoms of heart failure but does not cure it. Continue to take ivabradine even if you feel well. Do not stop taking ivabradine without talking to your doctor.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with ivabradine and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Pregnancy

May cause fetal toxicity when administered to a pregnant woman, based on findings in animal studies

Advise females of childbearing potential to use effective contraception

Embryo-fetal toxicity and cardiac teratogenic effects were observed in fetuses of pregnant rats treated during organogenesis at exposures 1-3 times the human exposures (AUC 0-24hr) at the maximum recommended human dose

In pregnant rabbits, oral administration of ivabradine during the period of organogenesis (gestation day 6­18) at doses of 7, 14, or 28 mg/kg/day resulted in fetal toxicity and teratogenicity

Treatment with all doses ≥7 mg/kg/day (equivalent to human exposure) caused an increase in post implantation loss

Lactation

Unknown if distributed in human breast milk

Animal studies have shown, however, that ivabradine is present in rat milk

Because of the potential risk to breastfed infants, breastfeeding is not recommended

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Mechanism of Action

Blocks the hyperpolarization-activated cyclic nucleotide-gated (HCN) channel responsible for the cardiac pacemaker I(f) ‘funny’ current, which regulates heart rate

In clinical electrophysiology studies, the cardiac effects were most pronounced in the sinoatrial (SA) node, but prolongation of the AH interval has occurred on the surface ECG, as has PR interval prolongation

There was no effect on ventricular repolarization and no effects on myocardial contractility

Absorption

Bioavailability: ~40% (because of first-pass elimination in the gut and liver)

Peak plasma time: 1 hr (fasting)

Food delays absorption by ~1 hr and increases plasma exposure by 20-40%

Ivabradine should be taken with meals

Distribution

Protein bound: 70%

Vd: 100 L

Metabolism

Extensively metabolized in the liver and intestines by CYP3A4-mediated oxidation

Major metabolite: N-desmethylated derivative (S 18982), which is equipotent to ivabradine and circulates at concentrations ~40% that of ivabradine

The N-desmethylated derivative is also metabolized by CYP3A4

Elimination

Distribution half-life: 2 hr

Effective half-life: ~6 hr

Total clearance: 24 L/hr

Renal clearance: 4.2 L/hr

Excretion: 4% unchanged in urine; excretion of metabolites occurs to a similar extent via feces and urine

Corlanor is the brand name of the medicine ivabradine, which is given to reduce the risk of hospitalization in certain people with worsening heart failure.

This medicine belongs to a class of drugs called hyperpolarization-activated cyclic-nucleotide-gated (HCN) channel blockers. It works by regulating your heart rate.

The Food and Drug Administration (FDA) approved Corlanor in 2015. It's marketed by Amgen.

Corlanor Warnings

Before starting treatment with Corlanor, tell your doctor if you have, or have ever had:

• A slow or irregular heartbeat
• Low blood pressure
• A pacemaker or defibrillator
• Symptoms of heart failure that have recently worsened
• Other heart problems
• Liver disease
• Allergies to medicines

Let your doctor know you're taking Corlanor before having any type of medical or dental procedure.

Corlanor may affect your vision, causing you to see bright spots, circles, or colored lights. This side effect is usually more common when you first start taking the medicine and typically goes away after a few months of treatment.

Tell your doctor if you experience vision problems.

Your doctor will want to perform frequent monitoring to check your body's response to Corlanor. Keep all appointments with your doctor's office and laboratory.

Some medicines shouldn't be used along with Corlanor. Be sure to let your doctor know if you're taking any of the following:

• Clarithromycin (in brands Biaxin and Prevpac)
• Ketek (telithromycin)
• Nefazodone
• Nizoral (ketoconazole)
• Onmel or Sporanox (itraconazole)
• Viracept (nelfinavir)

Pregnancy and Corlanor

Corlanor may harm a fetus if taken during pregnancy.

Tell your doctor if you're pregnant, or might become pregnant, before using this medicine.

Call your healthcare provider right away if you think you might be pregnant while you're taking Corlanor.

Use an effective form of birth control if you could become pregnant while taking this medicine.

It's not known whether Corlanor passes into breast milk. Don't breastfeed a baby while taking this drug.

Grapefruit and grapefruit juice may interact with Corlanor and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Skip the missed dose and take the medicine when it is time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

General

• Individualize dosage according to patient's heart rate response and tolerance (target resting heart rate 50–60 bpm).1

Administration

Oral Administration

Administer twice daily with meals.1

If a dose is missed, take next dose at the regularly scheduled time; do not double the dose.1 (See Advice to Patients.)

Dosage

Available as ivabradine hydrochloride; dosage expressed in terms of ivabradine.1

Adults

Initially, 5 mg twice daily.1

Initiate dosage of 2.5 mg twice daily in patients with history of conduction defects, or patients in whom bradycardia could lead to hemodynamic compromise.1

Allow 2 weeks to assess response to initial dosage.1 After initial adjustment period, adjust dosage as needed based on resting heart rate and tolerability to achieve resting heart rate of 50–60 beats/minute.1

If heart rate is >60 beats/minute, increase dosage by 2.5 mg (given twice daily) up to maximum of 7.5 mg twice daily.1

If heart rate is <50 beats/minute or patient is experiencing signs and symptoms of bradycardia, decrease dosage by 2.5 mg (given twice daily).1

Discontinue therapy if patient is receiving ivabradine 2.5 mg twice daily and heart rate is <50 beats/minute or patient is experiencing signs and symptoms of bradycardia.1

Dosages of 2.5–10 mg twice daily have been used.21 23 25 26 31 In clinical trials, ivabradine initiated at dosages of 5 or 7.5 mg twice daily and titrated after 2–4 weeks to a target heart rate of 50–60 beats/minute.25 26

In clinical trials, dosage was titrated downward in patients with resting heart rate <50 beats/minute or if signs or symptoms of bradycardia were present.25

Special Populations

Hepatic Impairment

No dosage adjustment required in patients with mild or moderate hepatic impairment.1 40

Contraindicated in patients with severe hepatic impairment (Child-Pugh class C); safety and efficacy not established in this population but increase in systemic exposure expected.1 40 (See Contraindications under Cautions.)

Renal Impairment

No dosage adjustment required for patients with Clcr 15–60 mL/minute.1

Data lacking on use in patients with Clcr <15 mL/minute.1 7 16

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

In the U.S.

• Corlanor

Available Dosage Forms:

• Tablet

Therapeutic Class: Cardiovascular Agent

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ivabradine in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ivabradine in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amifampridine
• Amisulpride
• Bepridil
• Boceprevir
• Cisapride
• Clarithromycin
• Cobicistat
• Conivaptan
• Dronedarone
• Fluconazole
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Mesoridazine
• Nefazodone
• Nelfinavir
• Pimozide
• Piperaquine
• Posaconazole
• Ritonavir
• Saquinavir
• Sparfloxacin
• Telaprevir
• Telithromycin
• Terfenadine
• Thioridazine
• Voriconazole
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfuzosin
• Amiodarone
• Amitriptyline
• Anagrelide
• Apomorphine
• Aprepitant
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Buserelin
• Carbamazepine
• Ceritinib
• Chloroquine
• Chlorpromazine
• Citalopram
• Clomipramine
• Clozapine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Diltiazem
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Ebastine
• Efavirenz
• Enzalutamide
• Eribulin
• Erythromycin
• Escitalopram
• Famotidine
• Felbamate
• Fingolimod
• Flecainide
• Fluoxetine
• Formoterol
• Fosaprepitant
• Foscarnet
• Fosphenytoin
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imatinib
• Imipramine
• Lapatinib
• Leuprolide
• Levofloxacin
• Lumacaftor
• Lumefantrine
• Mefloquine
• Methadone
• Metronidazole
• Mifepristone
• Mitotane
• Mizolastine
• Moxifloxacin
• Nafarelin
• Nilotinib
• Norfloxacin
• Octreotide
• Olanzapine
• Ondansetron
• Paliperidone
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Phenytoin
• Pimavanserin
• Pitolisant
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Ranolazine
• Ribociclib
• Rifampin
• Risperidone
• Sertindole
• Sevoflurane
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• St John's Wort
• Sulpiride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telavancin
• Tetrabenazine
• Tizanidine
• Tolterodine
• Toremifene
• Trazodone
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Verapamil
• Vilanterol
• Vinflunine
• Vorinostat
• Zuclopenthixol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Atrial fibrillation or
• Bradycardia (slow heartbeat) or
• Heart rhythm problems (eg, heart block, sinus arrest)—Use with caution. May make these conditions worse.

• Heart failure, decompensated or
• Heart rhythm problem (eg, AV block, sinoatrial block, sick sinus syndrome), without a pacemaker or
• Hypotension (low blood pressure) or
• Liver disease, severe or
• Pacemaker dependence—Should not be used in patients with these conditions.

Clinically significant adverse reactions that appear in other sections of the labeling include:

• Fetal Toxicity [see Warnings and Precautions (5.1)]
  
• Atrial Fibrillation [see Warnings and Precautions (5.2)]
  
• Bradycardia and Conduction Disturbances [see Warnings and Precautions (5.3)]

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.

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 also Warnings and Precautions (5.2), (5.3)].

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 (12.1)]. 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.  

6.2       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 during post-approval use of Corlanor: syncope, hypotension, angioedema, erythema, rash, pruritus, urticaria, vertigo, diplopia, and visual impairment.

8.1       Pregnancy

Risk Summary

Based on findings in animals, Corlanor may cause fetal harm when administered to a pregnant woman.  There are no adequate and well-controlled studies of Corlanor in pregnant women to inform any drug-associated risks. In animal reproduction studies, oral administration of ivabradine to pregnant rats during organogenesis at a dosage providing 1 to 3 times the human exposure (AUC0-24hr) at the MRHD resulted in embryo-fetal toxicity and teratogenicity manifested as abnormal shape of the heart, interventricular septal defect, and complex anomalies of primary arteries. Increased postnatal mortality was associated with these teratogenic effects in rats. In pregnant rabbits, increased post-implantation loss was noted at an exposure (AUC0-24hr) 5 times the human exposure at the MRHD. Lower doses were not tested in rabbits. The background risk of major birth defects for the indicated population is unknown. The estimated background risk of major birth defects in the U.S. general population is 2 to 4%, however, and the estimated risk of miscarriage is 15 to 20% in clinically recognized pregnancies. Advise a pregnant woman of the potential risk to the fetus.

Clinical Considerations

Disease-associated maternal and/or embryo/fetal risk

Stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester. Pregnant patients with left ventricular ejection fraction less than 35% on maximally tolerated doses of beta-blockers may be particularly heart-rate dependent for augmenting cardiac output. Therefore, pregnant patients who are started on Corlanor, especially during the first trimester, should be followed closely for destabilization of their congestive heart failure that could result from heart rate slowing.

Monitor pregnant women with chronic heart failure in 3rd trimester of pregnancy for preterm birth.

Data

Animal Data

In pregnant rats, oral administration of ivabradine during the period of organogenesis (gestation day 6-15) at doses of 2.3, 4.6, 9.3, or 19 mg/kg/day resulted in fetal toxicity and teratogenic effects. Increased intrauterine and post-natal mortality and cardiac malformations were observed at doses ≥ 2.3 mg/kg/day (equivalent to the human exposure at the MRHD based on AUC0-24hr). Teratogenic effects including interventricular septal defect and complex anomalies of major arteries were observed at doses ≥ 4.6 mg/kg/day (approximately 3 times the human exposure at the MRHD based on AUC0-24hr).

In pregnant rabbits, oral administration of ivabradine during the period of organogenesis (gestation day 6-18) at doses of 7, 14, or 28 mg/kg/day resulted in fetal toxicity and teratogenicity. Treatment with all doses ≥ 7 mg/kg/day (equivalent to the human exposure at the MRHD based on AUC0-24hr) caused an increase in post-implantation loss. At the high dose of 28 mg/kg/day (approximately 15 times the human exposure at the MRHD based on AUC0-24hr), reduced fetal and placental weights were observed, and evidence of teratogenicity (ectrodactylia observed in 2 of 148 fetuses from 2 of 18 litters) was demonstrated.

In the pre- and postnatal study, pregnant rats received oral administration of ivabradine at doses of 2.5, 7, or 20 mg/kg/day from gestation day 6 to lactation day 20. Increased postnatal mortality associated with cardiac teratogenic findings was observed in the F1 pups delivered by dams treated at the high dose (approximately 15 times the human exposure at the MRHD based on AUC0-24hr).

8.2       Lactation

Risk Summary

There is no information regarding the presence of ivabradine in human milk, the effects of ivabradine on the breastfed infant, or the effects of the drug on milk production. Animal studies have shown, however, that ivabradine is present in rat milk [see Data]. Because of the potential risk to breastfed infants from exposure to Corlanor, breastfeeding is not recommended.

Data

Lactating rats received daily oral doses of [14C]-ivabradine (7 mg/kg) on post-parturition days 10 to 14; milk and maternal plasma were collected at 0.5 and 2.5 hours post-dose on day 14. The ratios of total radioactivity associated with [14C]-ivabradine or its metabolites in milk vs. plasma were 1.5 and 1.8, respectively, indicating that ivabradine is transferred to milk after oral administration.

8.3       Females and Males of Reproductive Potential

Contraception

Females

Corlanor may cause fetal harm, based on animal data. Advise females of reproductive potential to use effective contraception during Corlanor treatment [see Use in Specific Populations (8.1)].

8.4       Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

8.5       Geriatric Use

No pharmacokinetic differences have been observed in elderly (≥ 65 years) or very elderly
(≥ 75 years) patients compared to the overall population.  However, Corlanor has only been studied in a limited number of patients ≥ 75 years of age.

8.6       Hepatic Impairment

No dose adjustment is required in patients with mild or moderate hepatic impairment. Corlanor is contraindicated in patients with severe hepatic impairment (Child-Pugh C) as it has not been studied in this population and an increase in systemic exposure is anticipated [see Contraindications (4) and Clinical Pharmacology (12.3)].

8.7       Renal Impairment 

No dosage adjustment is required for patients with creatinine clearance 15 to 60 mL/min. No data are available for patients with creatinine clearance below 15 mL/min [see Clinical Pharmacology (12.3)].

Overdose may lead to severe and prolonged bradycardia. In the event of bradycardia with poor hemodynamic tolerance, temporary cardiac pacing may be required. Supportive treatment, including intravenous (IV) fluids, atropine, and intravenous beta-stimulating agents such as isoproterenol, may be considered.

Usual Adult Dose for Congestive Heart Failure:

Initial dose: 5 mg orally twice a day with meals
Maximum dose: 7.5 mg orally twice a day

Comments:
-In patients with a history of conduction defects or in patients whom bradycardia could lead to hemodynamic compromise, start with 2.5 mg orally twice a day.
-Assess after 2 weeks and adjust dose to maintain tolerability and achieve resting heart rate between 50 and 60 beats per minute (bpm); if resting heart rate is greater than 60 bpm, increase by 2.5 mg twice daily to a maximum of 7.5 mg twice daily; if resting heart rate is less than 50 bpm or bradycardia signs and symptoms occur, decrease by 2.5 mg twice daily (discontinue if current dose is 2.5 mg orally twice a day).

Use: To reduce worsening heart failure hospitalization risk in patients with stable, symptomatic chronic heart failure and left ventricular ejection fraction (LVEF) at or below 35%, who are in sinus rhythm with resting heart rate at or above 70 bpm and are either unable to tolerate or have a contraindication to beta-blockers.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Applies to ivabradine: oral tablet

General

The most common side effects were cardiac failure, phosphene-like events, and bradycardia.[Ref]

Cardiovascular

Very common (10% or more): Cardiac failure (21.7%), bradycardia (up to 10%)
Common (1% to 10%): Hypertension, blood pressure increased, atrial fibrillation, ventricular extrasystoles, atrioventricular block first degree, unstable angina, angina pectoris aggravated, myocardial ischemia, blood pressure inadequately controlled, sinus tachycardia, supraventricular extrasystoles, atrial flutter, ventricular tachycardia, bradycardia symptomatic, bradycardia asymptomatic, angina pectoris, acute myocardial infarction, myocardial infarction, hypotension, sudden cardiac death
Uncommon (0.1% to 1%): Palpitations, sinus arrhythmia, ECG prolonged QT interval
Very rare (less than 0.01%): Atrioventricular block second degree, atrioventricular block third degree, sick sinus syndrome
Postmarketing reports: Torsade de pointes, ventricular fibrillation[Ref]

Ocular

Very common (10% or more): Phosphene-like events (14.5%)
Common (1% to 10%): Phosphenes, visual brightness, blurred vision
Uncommon (0.1% to 1%): Diplopia, visual impairment[Ref]

Phosphenes generally occur within the first 2 months of treatment and may occur repeatedly afterward. They were generally reported as mild to moderate in intensity and led to discontinuation in less than 1% of patients. Most cases resolved during or after treatment.[Ref]

Respiratory

Common (1% to 10%): Pneumonia, bronchitis acute, bronchitis, nasopharyngitis, upper respiratory tract infection, respiratory tract infection, influenza, cough, chronic obstructive pulmonary disease
Uncommon (0.1% to 1%): Dyspnea[Ref]

Metabolic

Common (1% to 10%): Diabetes mellitus inadequately controlled, diabetes mellitus, hypercholesterolemia, hypokalemia, hyperuricemia[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness, ischemic stroke
Uncommon (0.1% to 1%): Syncope[Ref]

Other

Common (1% to 10%): Sudden death, fall
Uncommon (0.1% to 1%): Vertigo, asthenia, fatigue
Rare (less than 0.1%): Malaise[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, gastritis
Uncommon (0.1% to 1%): Nausea, constipation, abdominal pain[Ref]

Hematologic

Common (1% to 10%): Blood creatinine increased, anemia
Uncommon (0.1% to 1%): Eosinophilia[Ref]

Renal

Common (1% to 10%): Renal failure[Ref]

Hepatic

Common (1% to 10%): Transaminases increased[Ref]

Dermatologic

Uncommon (0.1% to 1%): Angioedema, rash
Rare (less than 0.1%): Erythema, pruritus, urticaria[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Muscle cramps[Ref]

Some side effects of Corlanor may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

AU and UK: Use is contraindicated. US: Use is not recommended. Excreted into human milk: Data not available Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown.