Sacuva 50

✔️ Sacuva is indicated for:

• Reducing the risk of cardiovascular death and hospitalization in adults with chronic heart failure (NYHA Class II–IV) and reduced ejection fraction
• Treating symptomatic heart failure with left ventricular systolic dysfunction in children aged 1 year and older

✔️ Dosage & Administration

Adults

• Recommended starting dose: 49/51 mg twice daily
• Increase the dose after 2–4 weeks to the target maintenance dose of 97/103 mg twice daily, if tolerated.

Start with 24/26 mg twice daily in patients who:

• Are not currently taking an ACE inhibitor or ARB
• Previously received low doses of ACE inhibitors or ARBs
• Have severe renal impairment
• Have moderate hepatic impairment

✔️ Dosage & Administration

Pediatric Patients (≥1 year)

Less than 40 kg

• Starting: 1.6 mg/kg twice daily
• Second: 2.3 mg/kg twice daily
• Final: 3.1 mg/kg twice daily

40 kg to <50 kg

• Starting: 24/26 mg twice daily
• Second: 49/51 mg twice daily
• Final: 49/51 mg twice daily

≥50 kg

• Starting: 49/51 mg twice daily
• Second: 72/78 mg twice daily
• Final: 97/103 mg twice daily

Dose adjustments are usually made every 2 weeks according to tolerability.

✔️ Side Effects

Common side effects

• Low blood pressure (hypotension)
• Dizziness
• Cough
• High potassium levels (hyperkalemia)
• Impaired kidney function

Serious side effect

• Angioedema (swelling of the face, lips, tongue, or throat), which may be life-threatening and requires immediate medical attention

✔️ Avoid or use with caution with:

• ACE inhibitors
• Other ARBs
• Aliskiren (especially in diabetes)
• Potassium-sparing diuretics and potassium supplements (may increase potassium levels)
• NSAIDs (may increase the risk of kidney impairment)
• Lithium (may increase lithium toxicity)

✔️ Sacuva should not be used in:

• Patients allergic to sacubitril, valsartan, or any ingredient in the formulation
• Patients with a history of angioedema related to ACE inhibitors or ARBs
• Patients receiving ACE inhibitors (a 36-hour washout period is required when switching)
• Patients with diabetes who are taking aliskiren

✔️ Safety Information:

• Monitor blood pressure regularly, as Sacuva can cause symptomatic hypotension.
• Kidney function should be assessed periodically, especially in patients with renal artery stenosis or existing kidney disease.
• Monitor serum potassium levels, particularly in patients with renal impairment, diabetes, hypoaldosteronism, or those consuming a high-potassium diet.
• Discontinue and seek medical care immediately if signs of angioedema occur.

✔️ Storage:

• Store below 30°C in a dry place.
• Protect from moisture.
• Keep out of the reach of children.