Entresto
Generic Name
Sacubitril / Valsartan (97 mg / 103 mg)
Manufacturer
Novartis
Country
Switzerland
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
entresto 97 mg tablet | ৳ 134.00 | ৳ 1,340.00 |
Description
Overview of the medicine
Entresto is a combination medication of sacubitril and valsartan used to treat chronic heart failure with reduced ejection fraction (HFrEF) and symptomatic chronic heart failure in pediatric patients aged one year and older. It works by reducing the strain on the heart, improving blood flow, and decreasing the risk of cardiovascular death and hospitalization.
Uses & Indications
Dosage
Adults
The usual starting dose is 49 mg sacubitril/51 mg valsartan orally twice daily. The dose should be doubled every 2-4 weeks to the target maintenance dose of 97 mg sacubitril/103 mg valsartan twice daily, as tolerated. For patients not currently taking an ACE inhibitor or ARB, or those with severe renal impairment, a lower starting dose (24 mg sacubitril/26 mg valsartan twice daily) may be considered.
Elderly
No specific dose adjustment is required for elderly patients, but dose titration should be gradual and based on individual patient tolerability.
Renal_impairment
For patients with severe renal impairment (eGFR <30 mL/min/1.73m²), consider a starting dose of 24 mg sacubitril/26 mg valsartan twice daily. Careful monitoring of renal function and serum potassium is recommended.
How to Take
Entresto tablets are for oral administration and can be taken with or without food, typically twice daily.
Mechanism of Action
Sacubitril is a prodrug that inhibits neprilysin, an enzyme that degrades natriuretic peptides, leading to increased levels of these peptides. This results in vasodilation, natriuresis, and diuresis. Valsartan is an angiotensin II receptor blocker (ARB) that blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II.
Pharmacokinetics
Onset
Blood pressure lowering effects can be observed within a few hours; clinical benefits in heart failure are typically observed over weeks to months of treatment.
Excretion
Approximately 52-68% of sacubitril (as LBQ657) and 13% of valsartan are excreted in the urine, while 37-48% of sacubitril and 86% of valsartan are excreted in the feces.
Half life
The elimination half-life of LBQ657 is approximately 10-13 hours, and for valsartan, it's about 9-10 hours.
Absorption
Sacubitril is rapidly absorbed and converted to its active metabolite, LBQ657. Valsartan is also rapidly absorbed. Peak plasma concentrations of LBQ657 and valsartan are reached in 2 hours and 1.5 hours, respectively.
Metabolism
Sacubitril is metabolized by esterases to its active metabolite LBQ657. Valsartan is minimally metabolized.
Side Effects
Contraindications
- History of angioedema related to previous ACE inhibitor or ARB therapy.
- Concomitant use with an ACE inhibitor (a 36-hour washout period is required between stopping an ACE inhibitor and starting Entresto).
- Concomitant use with aliskiren in patients with diabetes or renal impairment (eGFR <60 mL/min/1.73m²).
- Severe hepatic impairment, biliary cirrhosis, or cholestasis.
- Pregnancy.
Drug Interactions
Lithium
Increased serum lithium concentrations and lithium toxicity have been reported. Monitor lithium levels.
Aliskiren
Contraindicated in patients with diabetes or renal impairment due to increased risk of hyperkalemia, hypotension, and renal impairment.
ACE Inhibitors
Contraindicated due to increased risk of angioedema. A 36-hour washout period is required.
Other Hypotensive Agents
Increased risk of symptomatic hypotension.
NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
May reduce the antihypertensive effect and worsen renal function.
Potassium-sparing diuretics/Potassium supplements
May lead to increased serum potassium and risk of hyperkalemia.
Storage
Store below 30°C (86°F). Keep in the original package to protect from moisture. Keep out of the reach and sight of children.
Overdose
Limited data are available regarding overdose. The most likely symptom of overdose is hypotension. Treatment should be symptomatic and supportive. Entresto is unlikely to be removed by hemodialysis due to high protein binding.
Pregnancy & Lactation
Pregnancy: Contraindicated due to risk of fetal injury and death. Lactation: Not recommended. It is unknown if sacubitril/valsartan is excreted in human milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture, specific details available on packaging.
Availability
Globally available in hospitals and pharmacies
Approval Status
FDA Approved
Patent Status
Patented by Novartis
WHO Essential Medicine
YesClinical Trials
Key clinical trials include PARADIGM-HF (for HFrEF in adults), PIVOTAL-HF (for acute decompensated HF), PARAGON-HF (for HFpEF, though not a primary indication), and various pediatric studies.
Lab Monitoring
- Serum potassium levels (especially during dose titration and in patients with renal impairment).
- Renal function (eGFR, serum creatinine) at baseline and periodically during treatment.
- Blood pressure monitoring regularly.
Doctor Notes
- Entresto is a cornerstone therapy for HFrEF; ensure proper patient selection and initiation.
- Crucial 36-hour washout period for patients transitioning from an ACE inhibitor to Entresto to minimize angioedema risk.
- Monitor blood pressure, renal function, and serum potassium regularly, especially during dose escalation.
- Educate patients on symptoms of hypotension and angioedema.
Patient Guidelines
- Take Entresto exactly as prescribed by your doctor, usually twice daily.
- Do not stop taking Entresto abruptly without consulting your doctor, as this may worsen your heart failure.
- Report any signs of swelling in the face, lips, tongue, or throat (angioedema) immediately to your doctor.
- Monitor your blood pressure regularly as advised by your healthcare provider.
- Avoid using potassium supplements or salt substitutes containing potassium unless directed by your doctor.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Entresto may cause dizziness or lightheadedness, especially when starting treatment or increasing the dose. Patients should be cautioned about driving or operating machinery until they know how the medication affects them.
Lifestyle Advice
- Adhere to a heart-healthy diet, which typically involves limiting sodium intake and reducing saturated/trans fats.
- Engage in regular physical activity as recommended by your doctor.
- Maintain a healthy weight and manage other conditions like diabetes or high blood pressure.
- Avoid excessive alcohol consumption and smoking.
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