WARNING: FETAL TOXICITY
See Full Prescribing Information for complete boxed warning.
- When pregnancy is detected, discontinue QBRELIS 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).
ADDITIONAL IMPORTANT SAFETY INFORMATION:
CONTRAINDICATIONS:
QBRELIS is contraindicated in patients with:
- a history of angioedema or hypersensitivity related to previous treatment with an angiotensin converting enzyme inhibitor
- hereditary or idiopathic 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.
WARNINGS AND PRECAUTIONS:
Fetal Toxicity. 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.
Angioedema and Anaphylactoid Reactions.
Head and Neck Angioedema
Angioedema of the face, extremities, lips, tongue, glottis and/or larynx, including some fatal reactions, have occurred in patients treated with ACE inhibitors, including lisinopril, at any time during treatment. Patients with involvement of the tongue, glottis or larynx are likely to experience airway obstruction, especially those with a history of airway surgery. QBRELIS should be promptly discontinued and appropriate therapy and monitoring should be provided until complete and sustained resolution of signs and symptoms of angioedema has occurred. Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor. ACE inhibitors have been associated with a higher rate of angioedema in Black than in non-Black patients.
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.
Intestinal Angioedema
Intestinal angioedema has occurred in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior history of facial angioedema and C-1 esterase levels were normal. In some cases, the angioedema was diagnosed by procedures including abdominal CT scan or ultrasound, or at surgery, and symptoms resolved after stopping the ACE inhibitor.
Anaphylactoid Reactions
Anaphylactoid Reactions During Desensitization
Two patients undergoing desensitizing treatment with hymenoptera venom while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions.
Anaphylactoid Reactions During Dialysis
Sudden and potentially life threatening anaphylactoid reactions have occurred in some patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor. In such patients, dialysis must be stopped immediately, and aggressive therapy for anaphylactoid reactions must be initiated. Symptoms have not been relieved by antihistamines in these situations. In these patients, consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive agent. Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption.
Impaired Renal Function. Monitor renal function periodically in patients treated with QBRELIS. Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system. 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. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on QBRELIS.
Hypotension. 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.
In these patients, QBRELIS should be started under very close medical supervision and such patients should be followed closely for the first two weeks of treatment and whenever the dose of QBRELIS and/or diuretic is increased. Avoid use of QBRELIS in patients who are hemodynamically unstable after acute MI. Symptomatic hypotension is also possible in patients with severe aortic stenosis or hypertrophic cardiomyopathy.
Surgery/Anesthesia
In patients undergoing major surgery or during anesthesia with agents that produce hypotension, QBRELIS may block angiotensin II formation secondary to compensatory renin release. If hypotension occurs and is considered to be due to this mechanism, it can be corrected by volume expansion.
Hyperkalemia. Serum potassium should be monitored periodically in patients receiving QBRELIS. Drugs that inhibit the renin-angiotensin system can cause hyperkalemia. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus, and the concomitant use of potassium-sparing diuretics, potassium supplements and/or potassium-containing salt substitutes.
Hepatic Failure. ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice or hepatitis and progresses to fulminant hepatic necrosis and sometimes death. The mechanism of this syndrome is not understood. Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical treatment.
ADVERSE REACTIONS
The most common adverse reactions (events 2% greater than placebo) by use are:
- Hypertension: headache, dizziness, and cough.
- Systolic heart failure: hypotension and chest pain.
- Acute MI: hypotension and renal dysfunction.
These are not all the possible side effects of QBRELIS. Please see Full Prescribing Information for a full list.
DRUG INTERACTIONS
Diuretics: Excessive drop in blood pressure.
NSAIDS: Increased risk of renal impairment and loss of antihypertensive efficacy.
Dual inhibition of the renin angiotensin system: Increased risk of renal impairment, hypotension and hyperkalemia.
Lithium: Symptoms of lithium toxicity.
Gold: Nitritoid reactions have been reported.
See Full Prescribing Information for Specific Drugs and Interactions.
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed.
Race: Less antihypertensive effect in Blacks than non-Black
The Important Safety Information does not include all the information needed to use QBRELIS safely and effectively. Please see accompanying Full Prescribing Information for QBRELIS.
To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
QBRELIS® is a trademark of Azurity Pharmaceuticals, Inc.
©2025 Azurity Pharmaceuticals, Inc.
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