MERAVO FILM-COATED TABLETS 50MG [SIN16872P]

Product Info

MERAVO FILM-COATED TABLETS 50MG

[SIN16872P]

Indication

INDICATIONS
Heart Failure
MERAVO 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.

MERAVO is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other ARB.

Hypertension
MERAVO is indicated for the treatment of essential hypertension.

Dosing

DOSAGE AND ADMINISTRATION

Dosage regimen

Heart Failure
The target dose of MERAVO is 200 mg twice daily.

The recommended starting dose of MERAVO 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 CLINICAL STUDIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The dose of MERAVO 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, MERAVO must not be started until 36 hours after discontinuing ACE inhibitor therapy (see section CONTRAINDICATIONS).

MERAVO should not be co-administered with an ARB due to the angiotensin II receptor blocking activity of MERAVO (see sections WARNINGS AND PRECAUTIONS and 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 MERAVO.

Essential hypertension
The recommended starting dose of MERAVO is 200 mg once daily. In patients whose blood pressure could not be adequately controlled with MERAVO 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.

MERAVO may be used alone or in combination with other antihypertensive agents except angiotensin-converting enzyme (ACE) inhibitors (see section Contraindications) and angiotensin II receptor blockers (ARBs) (see section 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 MERAVO in these patients due to limited data (see section CLINICAL PHARMACOLOGY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Safety and efficacy of MERAVO in patients with essential hypertension and with severe renal impairment (eGFR <30 mL/min/1.73 m²) have not been established (see section 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 MERAVO 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 MERAVO in these patients is not recommended (see section 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 MERAVO 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. MERAVO may be administered with or without food (see section CLINICAL PHARMACOLOGY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Contraindications

CONTRAINDICATIONS

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

• Concomitant use with ACE inhibitors (see sections WARNINGS AND PRECAUTIONS, DOSAGE AND ADMINISTRATION, and INTERACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). MERAVO 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 WARNINGS AND PRECAUTIONS and INTERACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Pregnancy (see section 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.