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Sacubitril + Valsartan: Brands, Price & Uses in Bangladesh
Sacubitril + Valsartan is a fixed-dose combination of a neprilysin inhibitor (sacubitril) and an angiotensin II receptor blocker (valsartan) and more.
About Sacubitril + Valsartan
Indications of Sacubitril + Valsartan
Sacubitril + Valsartan is a fixed-dose combination of a neprilysin inhibitor (sacubitril) and an angiotensin II receptor blocker (valsartan), classified as an angiotensin receptor-neprilysin inhibitor (ARNI).
- Established/FDA-approved use (adults): Sacubitril + Valsartan is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure, generally in patients with reduced ejection fraction. It is most beneficial when ejection fraction is below normal.
- Established/FDA-approved use (pediatrics): Sacubitril + Valsartan is indicated for the treatment of symptomatic heart failure due to systemic left ventricular systolic dysfunction in children aged 1 year and older.
- Guideline-supported use: Major heart failure guidelines (e.g., ACC/AHA/HFSA) recommend Sacubitril + Valsartan as a preferred first-line agent (in place of an ACE inhibitor or ARB) in patients with heart failure with reduced ejection fraction who can tolerate it, as part of guideline-directed medical therapy alongside a beta-blocker, mineralocorticoid receptor antagonist, and an SGLT2 inhibitor.
- Combination therapy requirement: Sacubitril + Valsartan is used together with other heart failure therapies (diuretics, beta-blockers, mineralocorticoid receptor antagonists) as clinically indicated; it is not a substitute for comprehensive heart failure management.
Sacubitril + Valsartan is not indicated in patients who are unable to tolerate an ACE inhibitor or ARB due to a history of angioedema, or in patients with severe hepatic impairment.
Dosage & Administration of Sacubitril + Valsartan
| Indication / Population | Dosing |
|---|---|
| Adults with heart failure - ACEI/ARB naive or on a low dose | Starting dose 24/26 mg (sacubitril/valsartan) orally twice daily; double the dose every 2-4 weeks as tolerated to the target maintenance dose of 97/103 mg twice daily. |
| Adults with heart failure - already on an established ACE inhibitor or ARB dose | Starting dose 49/51 mg orally twice daily (after the required washout period from an ACE inhibitor, see below); titrate every 2-4 weeks to the target of 97/103 mg twice daily as tolerated. |
| Switching from an ACE inhibitor | Discontinue the ACE inhibitor and wait at least 36 hours before starting Sacubitril + Valsartan, due to the risk of angioedema. |
| Severe renal impairment (eGFR <30 mL/min/1.73m²) | Starting dose 24/26 mg twice daily; titrate cautiously. |
| Moderate hepatic impairment (Child-Pugh B) | Starting dose 24/26 mg twice daily; titrate cautiously. |
| Pediatric patients (1 year and older) with symptomatic heart failure | Weight-based, individualized starting dose using tablets or oral pellet (sprinkle) formulation, with stepwise titration approximately every 2 weeks as tolerated, up to the maximum recommended dose for body weight, under specialist supervision. |
Sacubitril + Valsartan may be taken with or without food. Tablets should be swallowed whole with water.
Side Effects of Sacubitril + Valsartan
The most commonly reported adverse reactions with Sacubitril + Valsartan (observed in large controlled trials) include:
- Hypotension (very common, especially at treatment initiation and up-titration)
- Hyperkalemia (common)
- Cough (common)
- Dizziness (common)
- Renal impairment / increased serum creatinine (common)
- Fatigue
- Orthostatic hypotension and falls, particularly in elderly patients
Serious but less common: angioedema (potentially life-threatening; discontinue immediately if symptoms of swelling of the face, lips, tongue, glottis, larynx, or airway obstruction occur - see Precautions and Warnings), acute kidney injury, and severe hypotension leading to syncope.
Contraindications of Sacubitril + Valsartan
- Known hypersensitivity to sacubitril, valsartan, or any component of Sacubitril + Valsartan.
- Concomitant use with an ACE inhibitor (must not be co-administered; a 36-hour washout is required when switching, see Interactions).
- History of angioedema related to previous ACE inhibitor or ARB therapy.
- Concomitant use with aliskiren in patients with diabetes mellitus.
Frequently Asked Questions about Sacubitril + Valsartan
What is Sacubitril + Valsartan used for?
Sacubitril + Valsartan is used to treat chronic heart failure in adults, especially those with reduced ejection fraction, to lower the risk of cardiovascular death and hospitalization for heart failure. It is also approved for symptomatic heart failure in children aged 1 year and older.
Can I take Sacubitril + Valsartan together with an ACE inhibitor?
No. Sacubitril + Valsartan must never be taken together with an ACE inhibitor because this combination significantly increases the risk of life-threatening angioedema (severe swelling that can block the airway). If switching from an ACE inhibitor to Sacubitril + Valsartan, a waiting period of at least 36 hours is required between stopping the ACE inhibitor and starting Sacubitril + Valsartan, and vice versa.
Is Sacubitril + Valsartan safe during pregnancy?
No. Sacubitril + Valsartan is contraindicated during pregnancy because it can cause serious harm or death to the developing fetus, particularly in the second and third trimesters. If pregnancy occurs or is suspected while taking Sacubitril + Valsartan, stop the medicine and contact your physician immediately to switch to a safer alternative.
What are the most common side effects of Sacubitril + Valsartan?
The most common side effects include low blood pressure (hypotension), high potassium levels (hyperkalemia), cough, dizziness, and changes in kidney function. Most of these are more likely when starting or increasing the dose and should be reported to your physician, who may adjust your dose.
What should I do if I notice swelling of my face, lips, tongue, or throat while taking Sacubitril + Valsartan?
Swelling of the face, lips, tongue, or throat (angioedema) can be a medical emergency. Stop Sacubitril + Valsartan immediately and seek emergency medical care, as this reaction can be life-threatening if it affects the airway. Do not take Sacubitril + Valsartan again after such a reaction.
Can I take Sacubitril + Valsartan with potassium supplements or salt substitutes?
Caution is needed. Sacubitril + Valsartan can raise blood potassium levels, and combining it with potassium supplements, potassium-sparing diuretics, or potassium-containing salt substitutes can further increase this risk. Your physician should monitor your blood potassium levels periodically and advise you on safe use of these products.
Disclaimer
The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.