Covista^®

Covista is a combination of a neprilysin inhibitor, sacubitril and an angiotensin receptor blocker,valsartan. Covista ® inhibits neprilysin (neutral endopeptidase; NEP) via LBQ657, the active metabolite of the prodrug sacubitril and blocks the angiotensin II type-1 (AT1) receptor via valsartan. Valsartan also inhibits angiotensin II-dependent aldosterone release.

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Covista ® is indicated in-
• Adult heart failure
It is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal.
• Pediatric heart failure
It is indicated for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.

Route of administration: Covista ® should be taken in oral route.

Adult heart failure: The recommended starting dose is 100 mg twice daily. Double the dose after 2 to 4 weeks to the target maintenance dose of 200 mg twice daily, as tolerated by the patient.

Pediatric heart failure: Recommended dose for pediatric patients aged one year and older is given below. Take the recommended dose twice daily. Adjust doses every 2 weeks, as tolerated
by the patient.

Doses of 72/78 mg can be achieved usin three 24/26 mg tablets.

Dose adjustment for patients not taking an ACE inhibitor or ARB or previously taking low doses of these agents: In patients not currently taking an ACE inhibitor or an angiotensin II receptor blocker (ARB) and for patients previously taking low doses of these agents, start this drug at half the usually recommended starting dose. After initiation, increase the dose every 2 to 4 weeks in adults and every 2 weeks in pediatric patients to follow the recommended dose escalation thereafter.

Renal and hepatic impairment
In adults and pediatric patients with severe renal impairment (eGFR < 30 mL/min/1.73 m²) and with moderate hepatic impairment (Child-Pugh B classification), start at half the usually recommended starting dose. After initiation, increase the dose to follow the recommended dose escalation thereafter. Use in patients with severe hepatic impairment is not recommended

Pregnancy:

This combination can cause fetal harm when administered to a pregnant woman.
When pregnancy is detected, consider alternative drug treatment and discontinue it. However, if
there is no appropriate alternative to it and if the drug is considered life saving for the mother,
advise a pregnant woman of the potential risk to the fetus.

Lactation:

There is no information regarding the presence of sacubitril and valsartan in human
milk, the effects on the breastfed infant or the effects on milk production. Breastfeeding is not
recommended during treatment with this combination.

Use in children and adolescents
Safety and effectiveness have not been established in pediatric patients less than 1 year of age

This combination may cause angioedema. If angioedema occurs, discontinue it immediately, provide appropriate therapy and monitor for airway compromise. 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 of hypotension. Correct volume or salt depletion prior to administration of this drug or start at a lower dose. If hypotension occurs, consider dose adjustment of diuretics, concomitant antihypertensive drugs and treatment of other causes of hypotension. If hypotension persists despite such measures, reduce the dosage or temporarily discontinue it. Closely monitor serum creatinine and down-titrate or interrupt this combination in patients who develop a clinically significant decrease in renal function. Renal function should be monitored patients with renal artery stenosis. Through its actions on the RAAS, hyperkalemia may occur. Monitor serum potassium periodically and treat appropriately in patients with risk factors for hyperkalemia. Dosage reduction or interruption may be required

The most common side effects are hypotension, hyperkalemia, cough and dizziness.

This combination is contraindicated in patients with known hypersensitivity to sacubitril and valsartan or any other components of this product. It is also contraindicated in patients with a history of angioedema related to previous ACE inhibitor or ARB therapy

Drug interaction with medication:

Concomitant use with an ACE inhibitor is contraindicated
because of the increased risk of angioedema. Avoid use with an ARB, because it contains the
angiotensin II receptor blocker valsartan. The concomitant use with aliskiren is contraindicated in
patients with diabetes and renal impairment (eGFR < 60 mL/min/1.73 m²). 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. 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 this combination may result
in worsening of renal function, including possible acute renal failure. Increase in serum lithium
concentrations and lithium toxicity can occur during concomitant administration of lithium with
angiotensin II receptor antagonists.

Drug interaction with food and others: Not applicable

Limited data are available with regard to overdose. In cases of overdose hypotension can occur. Symptomatic treatment should be provided. It is unlikely to be removed by hemodialysis because of high protein binding.

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Covista 50 tablet: Each coated tablet contains Sacubitril Valsartan Sodium Complex equivalent to Sacubitril INN 24 mg and Valsartan USP 26 mg.

Covista 100 tablet: Each coated tablet contains Sacubitril Valsartan Sodium Complex equivalent to Sacubitril INN 49 mg and Valsartan USP 51 mg.

Covista 200 tablet: Each coated tablet contains Sacubitril Valsartan Sodium Complex equivalent to Sacubitril INN 97 mg and Valsartan USP 103 mg

Storage
Store below 30°C in a dry place, protected from light. Keep away from the reach of children.

Packing
Covista 50 tablet: Each box contains 20 tablets in blister pack.
Covista 100 tablet: Each box contains 10 tablets in blister pack.
Covista 200 tablet: Each box contains 10 tablets in blister pack