Adults
The recommended starting dose of Corlanor is 5 mg twice daily with food. Assess patient after two weeks and adjust dose to achieve a resting heart rate between 50 and 60 beats per minute (bpm) as shown in Table 1. Thereafter, adjust dose as needed based on resting heart rate and tolerability. The maximum dose is 7.5 mg twice daily. In adult patients unable to swallow tablets, Corlanor oral solution can be used [see Clinical Pharmacology (12.3)].
In patients with a history of conduction defects or other patients in whom bradycardia could lead to hemodynamic compromise, initiate therapy at 2.5 mg twice daily before increasing the dose based on heart rate [see Warnings and Precautions (5.3)].
Table 1. Dose Adjustment for Adults
| Heart Rate |
Dose Adjustment |
| > 60 bpm |
Increase dose by 2.5 mg (given twice daily) up to a maximum dose of 7.5 mg twice daily |
| 50-60 bpm |
Maintain dose |
| < 50 bpm or signs and symptoms of bradycardia |
Decrease dose by 2.5 mg (given twice daily); if current dose is 2.5 mg twice daily, discontinue therapy* |
*[see Warnings and Precautions (5.3)]
Pediatric Patients
Recommended Dosage
Pediatric Patients 6 Months of Age and Older Weighing Less than 40 kg (Oral Solution)
The recommended starting dose of Corlanor oral solution in pediatric patients 6 months of age and older and weighing less than 40 kg is 0.05 mg/kg twice daily with food. Assess patient at two-week intervals and adjust dose by 0.05 mg/kg to target a heart rate (HR) reduction of at least 20%, based on tolerability. The maximum dose is 0.2 mg/kg twice daily for patients 6 months to less than 1 year old, and 0.3 mg/kg twice daily for patients 1 year old and older, up to a total of 7.5 mg twice daily.
If a dose of Corlanor is missed or spit out, do not give another dose to make up for the missed or spit out dose. Give the next dose at the usual time.
Pediatric Patients Weighing 40 kg and Greater (Tablets)
The recommended starting dose of Corlanor tablets in pediatric patients weighing more than 40 kg is 2.5 mg twice daily with food. Assess patient at two-week intervals and adjust dose by 2.5 mg to target a heart rate (HR) reduction of at least 20%, based on tolerability. The maximum dose is 7.5 mg twice daily. In patients unable to swallow tablets, Corlanor oral solution can be used.
Dose Reduction for Bradycardia
If bradycardia develops, reduce the dose to the previous titration step. In patients who develop bradycardia at the recommended initial dosage, consider reducing the dosage to 0.02 mg/kg twice daily.
Oral Solution Preparation and Administration
To administer Corlanor oral solution, empty the entire contents of the ampule(s) into a medication cup. With a calibrated oral syringe, measure the prescribed dose of Corlanor from the medication cup and administer the drug orally.
Corlanor oral solution is sterile and preservative-free. Discard the unused oral solution. Do not store or reuse any oral solution left in either the medication cup or an ampule.
