MERAVO FILM-COATED TABLETS 100MG [SIN16873P]

Product Info

MERAVO FILM-COATED TABLETS 100MG

[SIN16873P]

INDICATIONS
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.

DOSAGE AND ADMINISTRATION
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.

Special populations

Renal impairment
A starting dose of 50 mg twice daily is recommended in 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).
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 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

• 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 FEMALES OF CHILD-BEARING POTENTIAL, PREGNANCY, BREAST-FEEDING AND FERTILITY – 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.