Indicated for:

Hypertension:

• The treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in Black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

QBRELIS may be administered alone or with other antihypertensive agents.

Heart Failure:

• To reduce signs and symptoms of systolic heart failure.

Reduction of Mortality in Acute Myocardial Infarction:

• For the reduction of mortality in treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers.

Doses above 0.61 mg per kg (or in excess of 40 mg) have not been studied in pediatric patients.

QBRELIS is not recommended in pediatric patients less than 6 years of age or in pediatric patients with glomerular filtration rate < 30 mL/min/1.73m².

Patients whose renal function may depend in part on the activity of the renin angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, post-myocardial infarction or volume depletion) may be at particular risk of developing acute renal failure on QBRELIS.

ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice or hepatitis and progresses to fulminant hepatic necrosis and sometimes death.

QBRELIS can cause symptomatic hypotension, sometimes complicated by oliguria, progressive azotemia, acute renal failure or death. Patients at risk of excessive hypotension include those with the following conditions or characteristics: heart failure with systolic blood pressure below 100 mmHg, ischemic heart disease, cerebrovascular disease, hyponatremia, high dose diuretic therapy, renal dialysis, or severe volume and/or salt depletion of any etiology.

Serum potassium should be monitored periodically in patients receiving QBRELIS. Drugs that inhibit the renin-angiotensin system can cause hyperkalemia.

QBRELIS is contraindicated in patients with a history of angioedema or hypersensitivity related to previous treatment with an angiotensin converting enzyme inhibitor and hereditary or idiopathic angioedema.

Angioedema of the face, extremities, lips, tongue, glottis and/or larynx, including some fatal reactions, have occurred in patients treated with angiotensin converting enzyme inhibitors, including lisinopril, at any time during treatment.

Two patients undergoing desensitizing treatment with hymenoptera venom while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions.

Sudden and potentially life threatening anaphylactoid reactions have occurred in some patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor.

Patients receiving coadministration of an ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy or a neprilysin inhibitor may be at increased risk for angioedema.

Do not co-administer aliskiren with QBRELIS in patients with diabetes.

QBRELIS is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer QBRELIS within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor.

Initiation of QBRELIS in patients on diuretics may result in excessive reduction of blood pressure. The possibility of hypotensive effects with QBRELIS can be minimized by either decreasing or discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with QBRELIS.

QBRELIS attenuates potassium loss caused by thiazide-type diuretics. Potassium sparing diuretics (spironolactone, amiloride, triamterene, and others) can increase the risk of hyperkalemia.

Concomitant administration of QBRELIS and antidiabetic medicines (insulins, oral hypoglycemic agents) may cause an increased blood-glucose-lowering effect with risk of hypoglycemia.

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, including lisinopril, may result in deterioration of renal function, including possible acute renal failure.

Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy.

In general, avoid combined use of RAS inhibitors.

Lithium toxicity has been reported in patients receiving lithium concomitantly with drugs, which cause elimination of sodium, including ACE inhibitors.

Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy including lisinopril.

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. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue QBRELIS as soon as possible.

Because of the potential for severe adverse reactions in the breastfed infant, advise women not to breastfeed during treatment with QBRELIS.

GoToSource

• Use in patients under the age of 6. GoToSource

• Scleroderma. GoToSource

• Diabetes type 2. GoToSource

• Migraines. GoToSource

Dizziness, cough and diarrhea. GoToSource

Angioedema (swelling in deep layers of skin). GoToSource

Increased blood urea nitrogen, blood urea, serum creatinine and plasma potassium. GoToSource

Hyperkalemia (elevated blood potassium level). GoToSource

Liver damage. GoToSource

Kidney failure. GoToSource

Neutropenia (low level of neutrophils a type of white blood cell) and skin rash. GoToSource

Hypotension (low blood pressure). GoToSource

Induction of mania. GoToSource

Lawsuits filed for liver failure.