ENTRESTO FILM COATED TABLET 50MG [SIN14947P]

Product Info

ENTRESTO FILM COATED TABLET 50MG

[SIN14947P]

3 Indications

Heart Failure

Entresto is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II–IV) and reduced ejection fraction.

Entresto is usually administered in conjunction with other heart failure therapies, in place of an angiotensin converting enzyme (ACE) inhibitor or other angiotensin receptor blocker (ARB).

Hypertension

Entresto is indicated for the treatment of essential hypertension.

4 Dosage regimen and administration

Dosage regimen

Heart Failure

The target dose of Entresto is 200 mg twice daily.

The recommended starting dose of Entresto is 100 mg twice daily. A starting dose of 50 mg twice daily is recommended for patients not currently taking an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), and should be considered for patients previously taking low doses of these agents (see section 12 Clinical studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The dose of Entresto should be doubled every 2–4 weeks to the target dose of 200 mg twice daily, as tolerated by the patient.

Due to the potential risk of angioedema when used concomitantly with an ACE inhibitor, Entresto must not be started until 36 hours after discontinuing ACE inhibitor therapy (see section 5 Contraindications).

Entresto should not be co-administered with an ARB due to the angiotensin II receptor blocking activity of Entresto (see sections 6 Warnings and precautions, and 8 Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

If patients experience tolerability issues (symptomatic hypotension, hyperkalemia, renal dysfunction), consideration should be given to adjustment of concomitant medications, or to temporary down–titration of Entresto.

Essential hypertension

The recommended starting dose of Entresto is 200 mg once daily. In patients whose blood pressure could not be adequately controlled with Entresto 200 mg once daily, the dose can be increased to 400 mg once daily. In hypertensive patients with heart failure, the heart failure dosing is recommended.

Entresto may be used alone or in combination with other antihypertensive agents except angiotensin-converting enzyme (ACE) inhibitors (see section 5 Contraindications) and angiotensin II receptor blockers (ARBs) (see section 6 Warnings and precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Special populations

Renal impairment

A starting dose of 50 mg twice daily is recommended in heart failure patients with severe renal impairment (eGFR <30 mL/min/1.73 m²). Caution is recommended when using Entresto in these patients due to limited data (see section 11 Clinical pharmacology – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Safety and efficacy of Entresto in patients with essential hypertension and with severe renal impairment (eGFR <30 mL/min/1.73 m²) have not been established (see section 11 Clinical pharmacology – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

No dose adjustment is required in patients with mild (eGFR 60–90 mL/min/1.73 m²) to moderate (eGFR 30–60 mL/min/1.73 m²) renal impairment.

Hepatic impairment

A starting dose of 50 mg twice daily is recommended for heart failure patients with moderate hepatic impairment (Child-Pugh B classification).

A starting dose of 100 mg once daily is recommended for essential hypertensive patients with moderate hepatic impairment (Child-Pugh B classification).

No dose adjustment is required when administering Entresto to patients with mild hepatic impairment (Child-Pugh A classification).

No studies have been conducted in patients with severe hepatic impairment (Child-Pugh C classification). Therefore, use of Entresto in these patients is not recommended (see section 11 Clinical pharmacology – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pediatric patients (below 18 years of age)

The safety and efficacy of Entresto in pediatric patients aged below 18 years has not been established.

Geriatric patients (65 years of age and above)

No dosage adjustment is required in patients 65 years of age and above.

Method of administration

For oral use. Entresto may be administered with or without food (see section 11 Clinical pharmacology – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

5 Contraindications

• Hypersensitivity to the active substance, sacubitril, valsartan, or to any of the excipients.

• Concomitant use with ACE inhibitors (see sections 6 Warnings and precautions, 4 Dosage regimen and administration, and 8 Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Entresto must not be administered until 36 hours after discontinuing ACE inhibitor therapy.

• Known history of angioedema related to previous ACE inhibitor or ARB therapy.

• Hereditary angioedema.

• Concomitant use with aliskiren-containing products in patients with diabetes mellitus or renal impairment (eGFR < 60ml/min/1.73 m²) (see sections 6 Warnings and precautions and 8 Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Pregnancy (see section 9 Pregnancy, lactation, females and males of reproductive potential – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Severe renal impairment with eGFR <10 ml/min/1.73 m² and patients undergoing dialysis due to lack of data.