Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Sacubitril and Valsartan
- Form
- Tablet
- Strength
- Sacubitril 24MG; Valsartan 26MG · Sacubitril 49MG; Valsartan 51MG · Sacubitril 97MG; Valsartan 103MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Torrent
- FDA application
- ANDA213604
- FDA boxed warning
- Yes — see the boxed warning
What is Sacubitril and Valsartan?
From the FDA label:Sacubitril and valsartan is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan contain anionic forms of sacubitril and valsartan, sodium cations in the molar ratio of 1:1:3, respectively. Following oral administration, Sacubitril and valsartan dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The Sacubitril and valsartan is chemically described as Trisodium (4-{[(1 S ,3 R )-1-([1,1'-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)-( N -pentanoyl- N -{[(2'-(1 H -tetrazol-1-id-5-yl)[1,1'-biphenyl]-4-yl]methyl}-L-valinate). Its empirical formula is C 48 H 55 N 6 O 8 Na 3 . Its molecular mass is 912.96 g/mol and its schematic structural formula is: Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are crospovidone, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide and talc. The film-coat inactive ingredients are hypromellose, macrogol/PEG, talc and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet contains iron oxide black and iron oxide red.…
How to use
The recommended starting dosage for adults is 49 mg/51 mg orally twice daily. The target maintenance dose is 97 mg/103mg orally twice daily. (2.2) Adjust adult doses every 2 to 4 weeks to the target maintenance dose, as tolerated by the patient. ( 2.2 ) For pediatric patients, see the Full Prescribing Information for recommended dosage, titrations, preparation and administration instructions. (2.3, 2.4) Reduce starting dose to half the usually recommended starting dosage for: o patients not currently taking an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) or previously taking a low dose of these agents. ( 2.6 ) o patients with severe renal impairment.( 2.7 ) o patients with moderate hepatic impairment. ( 2.8 ) 2.1 General Considerations Sacubitril and valsartan tablets are contraindicated with concomitant use of an angiotensin-converting enzyme (ACE) inhibitor. If switching from an ACE inhibitor to sacubitril and valsartan tablets allow a washout period of 36 hours between administration of the two drugs [see Contraindications ( 4 ) and Drug Interactions ( 7.1 )] . 2.2 Adult Heart Failure The recommended starting dose of sacubitril and valsartan tablet is 49/51 mg orally twice-daily. Double the dose of sacubitril and valsartan tablets after 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the…
Side effects
Clinically significant adverse reactions that appear in other sections of the labeling include: Angioedema [see Warnings and Precautions ( 5.2 )] Hypotension [see Warnings and Precautions ( 5.3 )] Impaired Renal Function [see Warnings and Precautions ( 5.4 )] Hyperkalemia [see Warnings and Precautions ( 5.5 )] Adverse reactions occurring greater than or equal to 5% are hypotension, hyperkalemia, cough, dizziness, and renal failure. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc., at 1-800-912-9561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 6,622 heart failure patients were treated with sacubitril and valsartan in the PARADIGM-HF (vs. enalapril) and PARAGON-HF (vs. valsartan) clinical trials. Of these, 5,085 were exposed for at least 1 year. Adult Heart Failure In PARADIGM-HF, patients were required to complete sequential enalapril and sacubitril and valsartan run-in periods of (median) 15 and 29 days, respectively, prior to entering the randomized double-blind period comparing sacubitril and valsartan and enalapril. During the enalapril run-in…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
When pregnancy is detected, discontinue sacubitril and valsartan tablets as soon as possible ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.1 ) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue sacubitril and valsartan tablets as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 )
Warnings
Important safety information
Observe for signs and symptoms of angioedema and hypotension. ( 5.2 , 5.3 ) Monitor renal function and potassium in susceptible patients. ( 5.4 , 5.5 ) 5.1 Fetal Toxicity Sacubitril and valsartan can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. When pregnancy is detected, consider alternative drug treatment and discontinue sacubitril and valsartan tablets. However, if there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system, and if the drug is considered lifesaving for the mother, advise a pregnant woman of the potential risk to the fetus [see Use in Specific Populations ( 8.1 )]. 5.2 Angioedema Sacubitril and valsartan may cause angioedema [see Adverse Reactions ( 6.1 )] . If angioedema occurs, discontinue sacubitril and valsartan tablets immediately, provide appropriate therapy, and monitor for airway compromise. Sacubitril and valsartan must not be re-administered. In cases of confirmed angioedema where swelling has been confined to the face and lips, the condition has generally resolved without treatment, although antihistamines have been useful in relieving symptoms. Angioedema associated with laryngeal edema may be fatal. Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, administer appropriate therapy, e.g., subcutaneous epinephrine/adrenaline solution 1:1,000 (0.3 mL to 0.5 mL) and take measures necessary to ensure maintenance of a patent airway. Sacubitril and valsartan has been associated with a higher rate of angioedema in Black than in non-Black patients. Patients with a prior history of angioedema may be at increased risk of angioedema with sacubitril and valsartan [see Adverse Reactions ( 6.1 )] . Sacubitril and valsartan must not be used in patients with a known history of angioedema related to previous ACE inhibitor or ARB therapy [see Contraindications ( 4 )] . Sacubitril and valsartan should not be used in patients with hereditary angioedema. 5.3 Hypotension Sacubitril and valsartan lowers blood pressure and may cause symptomatic hypotension [see Adverse Reactions ( 6.1 )] . Patients with an activated renin-angiotensin system, such as volume-and/or salt-depleted patients (e.g., those being treated with high doses of diuretics), are at greater risk. Correct volume or salt depletion prior to administration of sacubitril and valsartan or start at a lower dose. If hypotension occurs, consider dose adjustment of diuretics, concomitant antihypertensive drugs, and treatment of other causes of hypotension (e.g., hypovolemia). If hypotension persists despite such measures, reduce the dosage or temporarily discontinue sacubitril and valsartan tablets. Permanent discontinuation of therapy is usually not required. 5.4 Impaired Renal Function As a consequence of inhibiting the renin-angiotensin-aldosterone system (RAAS), decreases in renal function may be anticipated in susceptible individuals treated with sacubitril and valsartan [see Adverse Reactions ( 6.1 )]. In patients whose renal function depends upon the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure), treatment with ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria, progressive azotemia and, rarely, acute renal failure and death. Closely monitor serum creatinine, and down-titrate or interrupt sacubitril and valsartan in patients who develop a clinically significant decrease in renal function [see Use in Specific Populations ( 8.7 ) and Clinical Pharmacology ( 12.3 )]. As with all drugs that affect the RAAS, sacubitril and valsartan may increase blood urea and serum creatinine levels in patients with bilateral or unilateral renal artery stenosis. In patients with renal artery stenosis, monitor renal function. 5.5 Hyperkalemia Through its actions on the RAAS, hyperkalemia may occur with sacubitril and valsartan [see Adverse Reactions ( 6.1 )] . Monitor serum potassium periodically and treat appropriately, especially in patients with risk factors for hyperkalemia such as severe renal impairment, diabetes, hypoaldosteronism, or a high potassium diet. Dosage reduction or interruption of sacubitril and valsartan may be required [see Dosage and Administration ( 2. 7)].
Who should not take Sacubitril and Valsartan
Sacubitril and valsartan tablets are contraindicated: in patients with hypersensitivity to any component in patients with a history of angioedema related to previous ACE inhibitor or ARB therapy [see Warnings and Precautions ( 5.2 )] with concomitant use of ACE inhibitors. Do not administer within 36 hours of switching from or to an ACE inhibitor [see Drug Interactions ( 7.1 )] with concomitant use of aliskiren in patients with diabetes [see Drug Interactions ( 7.1 )] Hypersensitivity to any component. (4 ) History of angioedema related to previous ACEi or ARB therapy. ( 4 ) Concomitant use with ACE inhibitors. ( 4 , 7.1 ) Concomitant use with aliskiren in patients with diabetes. ( 4 , 7.1 )
Overdose — what happens if you take too much
Limited data are available with regard to overdosage in human subjects with sacubitril and valsartan. In healthy volunteers, a single dose of sacubitril and valsartan 583 mg sacubitril/617 mg valsartan, and multiple doses of 437 mg sacubitril/463 mg valsartan (14 days) have been studied and were well tolerated. Hypotension is the most likely result of overdosage due to the blood pressure lowering effects of sacubitril and valsartan. Symptomatic treatment should be provided. Sacubitril and valsartan is unlikely to be removed by hemodialysis because of high protein binding.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Avoid concomitant use with aliskiren in patients with estimated glomerular filtration rate (eGFR) less than 60. ( 7.1 ) Potassium-sparing diuretics: May lead to increased serum potassium. ( 7.2 ) Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): May lead to increased risk of renal impairment. ( 7.3 ) Lithium: Increased risk of lithium toxicity. ( 7.4 ) 7.1 Dual Blockade of the Renin-Angiotensin-Aldosterone System Concomitant use of sacubitril and valsartan with an ACE inhibitor is contraindicated because of the increased risk of angioedema [see Contraindications ( 4 )] . Avoid use of sacubitril and valsartan with an ARB, because sacubitril and valsartan contains the angiotensin II receptor blocker valsartan . The concomitant use of sacubitril and valsartan with aliskiren is contraindicated in patients with diabetes [see Contraindications ( 4 )] . Avoid use with aliskiren in patients with renal impairment (eGFR less than 60 mL/min/1.73 m 2 ). 7.2 Potassium-Sparing Diuretics As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium [see Warnings and Precautions ( 5.5 )] . 7.3 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, concomitant use of NSAIDs, including COX-2 inhibitors, with sacubitril and valsartan may result in worsening of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically. 7.4 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists. Monitor serum lithium levels during concomitant use with sacubitril and valsartan.
Dosage forms
Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- How is Sacubitril and Valsartan rated?
- pharmaranks gives Sacubitril and Valsartan a composite score of 3.3 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Sacubitril and Valsartan?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Sacubitril and Valsartan. To pay less, Sacubitril and Valsartan is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Sacubitril and Valsartan?
- Sacubitril and Valsartan is marketed by Torrent. You can see Torrent's full profile, rating, and other products on pharmaranks.
- Is Sacubitril and Valsartan a brand-name or generic drug?
- Sacubitril and Valsartan is a generic medication; its active ingredient is Sacubitril and Valsartan. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Sacubitril and Valsartan available over the counter?
- No. Sacubitril and Valsartan is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Sacubitril and Valsartan come in?
- Sacubitril and Valsartan is currently marketed as tablet, per the FDA's National Drug Code Directory.
- Is Sacubitril and Valsartan FDA-registered?
- Sacubitril and Valsartan is on record with the U.S. FDA under application number ANDA213604. You can verify this on its official FDA label.
- Has Sacubitril and Valsartan been recalled by the FDA?
- Sacubitril and Valsartan has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Sacubitril and Valsartan safe?
- There's no single safe-or-not verdict. pharmaranks gives Sacubitril and Valsartan a recall-safety score of 66/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Sacubitril and Valsartan?
- Sacubitril and Valsartan's side effects are taken directly from its FDA label. From the label: Clinically significant adverse reactions that appear in other sections of the labeling include: Angioedema [see Warnings and Precautions ( 5.2 )] Hypotension [see Warnings and Precautions ( 5.3 )] Impaired Renal Function [see Warnings and Precautions ( 5.4 )] Hyperkalemia [see Warnings and Precautio… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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sacubitril and valsartan
66/100