CORLANOR- ivabradine tablet, film coated CORLANOR- ivabradine solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IVABRADINE HYDROCHLORIDE (UNII: TP19837BZK) (IVABRADINE - UNII:3H48L0LPZQ)

Available from:

Amgen Inc

INN (International Name):

IVABRADINE HYDROCHLORIDE

Composition:

IVABRADINE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Corlanor is indicated to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction ≤ 35%, who are in sinus rhythm with resting heart rate ≥ 70 beats per minute and either are on maximally tolerated doses of beta-blockers or have a contraindication to beta-blocker use.  Corlanor is indicated for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate. Corlanor is contraindicated in patients with: • Acute decompensated heart failure • Clinically significant hypotension • Sick sinus syndrome, sinoatrial block or 3rd degree AV block, unless a functioning demand pacemaker is present • Clinically significant bradycardia [see Warnings and Precautions ( 5.3 )] • Severe hepatic impairment [see Use in Specific Populations ( 8.6 )] • Pacemaker dependence (heart rate maintained exclu

Product summary:

Tablets : Corlanor (ivabradine) 5 mg tablets are formulated as salmon-colored, oval-shaped, film-coated tablets functionally scored on both edges, marked with “5” on one face and bisected on the other face. They are supplied as follows: Corlanor (ivabradine) 7.5 mg tablets are formulated as salmon-colored, triangular-shaped, film-coated tablets debossed with “7.5” on one face and plain on the other face.  They are supplied as follows: Oral Solution: Corlanor (ivabradine) oral solution is a colorless liquid supplied in an opaque, low density polyethylene (LDPE) plastic ampule. Each 5 mL ampule is individually packaged in a child-resistant foil pouch and supplied in cartons containing 28 foil pouches. Corlanor oral solution is supplied as 5 mg/5 mL (1 mg/mL) (NDC 55513-813-01). Storage Store Corlanor tablets and oral solution at 25°C (77°F); excursions permitted to 15°C - 30°C (59°F - 86°F) [see USP Controlled Room Temperature] . Protect Corlanor ampule from light by storing in the foil pouch until use.

Authorization status:

New Drug Application

Patient Information leaflet

CORLANOR- IVABRADINE SOLUTION
Amgen Inc
----------
MEDICATION GUIDE
Corlanor® (core lan ore)
(ivabradine)
tablets and oral solution
What is the most important information I should know about Corlanor?
Corlanor may cause serious side effects in adults and children,
including:
•
Harm to an unborn baby. Females who are able to get pregnant:
○ Must use effective birth control during treatment with Corlanor.
○ Tell your doctor right away if you become pregnant during
treatment with Corlanor.
•
Increased risk of irregular or rapid heartbeat (atrial fibrillation or
heart rhythm
problems). Tell your doctor if you feel any of the following symptoms
of an irregular
or rapid heartbeat:
○ heart is pounding or racing (palpitations).
○ chest pressure.
○ worsened shortness of breath.
○ near fainting or fainting.
•
Slower than normal heart rate (bradycardia). Tell your doctor if you
have:
○ a slowing of heart rate, or
○ symptoms of a slow heart rate such as dizziness, fatigue, lack of
energy. In young
children signs and symptoms of slow heart rate may include: poor
feeding, difficulty
breathing or turning blue.
What is Corlanor?
Corlanor is a prescription medicine used:
•
to treat adults who have chronic (lasting a long time) heart failure,
with symptoms, to
reduce their risk of hospitalization for worsening heart failure.
•
to treat certain children 6 months of age and older who have stable
heart failure, with
symptoms, that is due to an enlarged heart (dilated cardiomyopathy).
Who should not take Corlanor?
Do not take Corlanor if you have:
•
symptoms of heart failure that recently worsened
•
very low blood pressure (hypotension)
•
certain heart conditions: sick sinus syndrome, sinoatrial block, or
3rd degree
atrioventricular block
•
a slow resting heart rate before treatment with Corlanor. Ask your
doctor what a slow
resting heart rate is for you.
•
certain liver problems
•
been prescribed any medicines that can increase the effects of
Corlanor.
Ask your doctor if you are not sure if you

Summary of Product characteristics

CORLANOR- IVABRADINE TABLET, FILM COATED
CORLANOR- IVABRADINE SOLUTION
AMGEN INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CORLANOR SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CORLANOR.
CORLANOR (IVABRADINE) TABLETS, FOR ORAL USE
CORLANOR (IVABRADINE) ORAL SOLUTION
INITIAL U.S. APPROVAL: 2015
INDICATIONS AND USAGE
Corlanor (ivabradine) is a hyperpolarization-activated cyclic
nucleotide-gated channel blocker indicated:
To reduce the risk of hospitalization for worsening heart failure in
adult patients with stable,
symptomatic chronic heart failure with reduced left ventricular
ejection fraction. (1.1)
For the treatment of stable symptomatic heart failure due to dilated
cardiomyopathy in pediatric
patients ages 6 months and older. (1.2)
DOSAGE AND ADMINISTRATION
ADULT AND PEDIATRIC PATIENTS GREATER THAN 40 KG
Starting dose is 2.5 (pediatrics and vulnerable adults) or 5 mg twice
daily with food. After 2 weeks of
treatment, adjust dose based on heart rate. The maximum dose is 7.5 mg
twice daily. (2.1)
PEDIATRIC PATIENTS LESS THAN 40 KG
Starting dose is 0.05 mg/kg twice daily with food. Adjust dose at
two-week intervals by 0.05 mg/kg
based on heart rate. Maximum dose is 0.2 mg/kg (patients 6 months to
less than 1 year old) or
0.3 mg/kg (patients 1 year old and older), up to a total of 7.5 mg
twice daily.
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 7.5 mg (3)
Oral Solution: 5 mg/5 mL (1 mg/mL) (3)
CONTRAINDICATIONS
Acute decompensated heart failure (4)
Clinically significant hypotension (4)
Sick sinus syndrome, sinoatrial block or 3 degree AV block, unless a
functioning demand pacemaker
is present (4)
Clinically significant bradycardia (4)
Severe hepatic impairment (4)
Heart rate maintained exclusively by the pacemaker (4)
In combination with strong cytochrome CYP3A4 inhibitors (4)
WARNINGS AND PRECAUTIONS
Fetal toxicity: Females should use effective contraception. (5.1)
Monitor patients for atrial fibrillation. (5.2)
Monitor heart