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Medicine

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Pediatric Prtfolio

From Azurity Pharmaceuticals, providing safe, high-quality treatments for patients requiring customized formulations for their care.

FDA-Approved Oral Solutions and Suspensions

  • Well-established safety and efficacy for adult and pediatric patients who are unable to swallow tablets:
    • enalapril maleate for adults and children over one month of age, and
    • lisinopril and amlodipine for adult and pediatric patients 6 years of age and older
  • The first FDA-approved oral solutions and suspensions of enalapril maleate, lisinopril, and amlodipine.
  • No compounding, crushing or mixing is necessary
  • Sweet-tasting formulations designed to help improve compliance in pediatric patients1
  • Affordable and accessible —reimbursed by Medicaid in every state and covered by commercial payers.2
    • eVoucher Programs: Eligible commercial insurance patients may pay no more than $30 for a prescription at participating pharmacies (see katerzia.com, epaned.com, or qbrelis.com for eligibility requirements).
    • Dedicated Prior Authorization Hotline: (844) 472-2032

References:
1. JA Mennella, AC Spector, DR Reed, and SE Coldwell. The Bad Taste of Medicines: Overview of Basic Research on Bitter Taste Clin Ther. 2013 August;35(8): 1225–1246.
2. Data on file, Azurity Pharmaceuticals, Inc.

Calcium
Channel Blocker

ACE
Inhibitors

Please visit katerzia.com, epaned.com, qbrelis.com for Full Prescribing Information, including Boxed Warning (Epaned and Qbrelis only) and additional Important Safety Information.

KATERZIA® (amlodipine) Oral Suspension, 1 mg/mL

KATERZIA® (amlodipine) Oral Suspension, 1 mg/mL

INDICATIONS:

KATERZIA is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:

  • Hypertension in adults and children 6 years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
  • Coronary Artery Disease:
    • Chronic stable angina.
    • Vasospastic angina (Prinzmetal’s or Variant Angina).
    • Angiographically documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.
EPANED® (enalapril maleate) Oral Solution, 1 mg/mL

EPANED® (enalapril maleate) Oral Solution, 1 mg/mL

WARNING: FETAL TOXICITY

See Full Prescribing Information for complete boxed warning.

  • When pregnancy is detected, discontinue EPANED 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).

INDICATIONS:

EPANED is an angiotensin-converting enzyme (ACE) inhibitor indicated for:

  • Treatment of hypertension in adults and children older than 1 month, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
  • Treatment of symptomatic heart failure.
  • Treatment of asymptomatic left ventricular dysfunction, to decrease the rate of development of overt heart failure and reduce hospitalization for heart failure.
QBRELIS® (lisinopril) Oral Solution, 1 mg/mL

QBRELIS® (lisinopril) Oral Solution, 1 mg/mL

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).

INDICATIONS:

QBRELIS is an angiotensin-converting enzyme (ACE) inhibitor indicated for:

  • Treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure (BP). Lowering BP decreases the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (MI).
  • Reduction of signs and symptoms of systolic heart failure.
  • Reduction of mortality in treatment of hemodynamically stable patients within 24 hours of acute MI. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin, and beta-blockers.

Calcium
Channel Blocker

KATERZIA® (amlodipine) Oral Suspension, 1 mg/mL

KATERZIA® (amlodipine) Oral Suspension, 1 mg/mL

INDICATIONS:

KATERZIA is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:

  • Hypertension in adults and children 6 years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
  • Coronary Artery Disease:
    • Chronic stable angina.
    • Vasospastic angina (Prinzmetal’s or Variant Angina).
    • Angiographically documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.

ACE
Inhibitors

Please visit katerzia.com, epaned.com, qbrelis.com for Full Prescribing Information, including Boxed Warning (Epaned and Qbrelis only) and additional Important Safety Information.

EPANED® (enalapril maleate) Oral Solution, 1 mg/mL

EPANED® (enalapril maleate) Oral Solution, 1 mg/mL

WARNING: FETAL TOXICITY

See Full Prescribing Information for complete boxed warning.

  • When pregnancy is detected, discontinue EPANED 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).

INDICATIONS:

EPANED is an angiotensin-converting enzyme (ACE) inhibitor indicated for:

  • Treatment of hypertension in adults and children older than 1 month, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
  • Treatment of symptomatic heart failure.
  • Treatment of asymptomatic left ventricular dysfunction, to decrease the rate of development of overt heart failure and reduce hospitalization for heart failure.
QBRELIS® (lisinopril) Oral Solution, 1 mg/mL

QBRELIS® (lisinopril) Oral Solution, 1 mg/mL

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).

INDICATIONS:

QBRELIS is an angiotensin-converting enzyme (ACE) inhibitor indicated for:

  • Treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure (BP). Lowering BP decreases the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (MI).
  • Reduction of signs and symptoms of systolic heart failure.
  • Reduction of mortality in treatment of hemodynamically stable patients within 24 hours of acute MI. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin, and beta-blockers.

IMPORTANT SAFETY INFORMATION

KATERZIA® (amlodipine) Oral Solution, 1 mg/mL

INDICATIONS:
KATERZIA is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:

  • Hypertension in adults and children 6 years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
  • Coronary Artery Disease

– Chronic stable angina.
– Vasospastic angina (Prinzmetal’s or Variant Angina).
– Angiographically documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.

 ADDITIONAL IMPORTANT SAFETY INFORMATION:

Contraindications:
KATERZIA is contraindicated in patients with known sensitivity to amlodipine.

Warnings and Precautions:
Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely.

Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of KATERZIA, particularly in patients with severe obstructive coronary artery disease.

Because KATERZIA is extensively metabolized by the liver, and the plasma elimination half-life is 56 hours in patients with impaired hepatic function, titrate slowly when administering KATERZIA to patients with severe hepatic impairment.

Adverse Reactions: See Full Prescribing Information for other Adverse Reactions (6).
The most common dose-related adverse reaction to amlodipine is edema.
Incidents of dose-related dizziness, flushing, and palpitation also have been observed.

For several reported adverse experiences that appear to be drug and dose related (edema, flushing, palpitations), there was a greater incidence in women than in men associated with amlodipine treatment.
Other adverse experiences not dose-related but reported are fatigue, nausea, abdominal pain, and somnolence.

Drug Interactions:

Impact of Other Drugs on Amlodipine
Co-administration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction. Monitor for symptoms of hypotension and edema when amlodipine is co-administered with CYP3A inhibitors to determine the need for dose adjustment. Blood pressure should be closely monitored when amlodipine is co-administered with CYP3A inducers.

Impact of Amlodipine on Other Drugs:
Co-administration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily. 
Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered. Frequent monitoring of trough blood levels of cyclosporine and tacrolimus is recommended and adjust the dose when appropriate.

Use in Specific Populations: See Full Prescribing Information for Additional Information (8).

Pregnancy
Limited data on post-marketing use of amlodipine in pregnant women are not sufficient to inform a drug-associated risk for major birth defects or miscarriages. There are risks to the mother and fetus associated with poorly controlled hypertension during pregnancy.

Lactation
Limited available data from a published clinical lactation study reports that amlodipine is present in human milk. No adverse effects of amlodipine on the breastfed infant have been observed.

Pediatric Use
Amlodipine (2.5 to 5 mg daily) is effective in lowering blood pressure in patients 6 to 17 years. The effect of amlodipine on blood pressure in patients less than 6 years of age is not known.

Geriatric Use
In general, dose selection for elderly patients should be cautious, usually starting with a lower initial dose.

Hepatic Impairment
A lower initial dose may be required for patients with hepatic insufficiency.

This Important Safety Information does not include all the information needed to use KATERZIA safely and effectively. Visit KATERZIA.com for Full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-855-379-0383, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.

 

EPANED® (enalapril maleate) Oral Solution, 1 mg/mL

WARNING: FETAL TOXICITY
See Full Prescribing Information for complete boxed warning.

  • When pregnancy is detected, discontinue EPANED 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).

INDICATIONS:
EPANED is an angiotensin-converting enzyme (ACE) inhibitor indicated for:

  • Treatment of hypertension in adults and children older than 1 month, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
  • Treatment of symptomatic heart failure.
  • Treatment of asymptomatic left ventricular dysfunction, to decrease the rate of development of overt heart failure and reduce hospitalization for heart failure.

ADDITIONAL IMPORTANT SAFETY INFORMATION:

Contraindications:
EPANED is contraindicated in patients with a history of hypersensitivity related to previous treatment with an ACE inhibitor.

EPANED is contraindicated in patients with hereditary or idiopathic angioedema.

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

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

Warnings and Precautions:
Head and Neck Angioedema: Angioedema of the face, extremities, lips, tongue, glottis, and/or larynx, including some fatal reactions, have been reported in patients treated with ACE inhibitors, including EPANED, at any time during treatment. EPANED should be promptly discontinued and appropriate therapy and monitoring provided until complete and sustained resolution of signs and symptoms of angioedema has occurred. Patients with a history of angioedema 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.

Intestinal Angioedema has been reported in patients treated with ACE inhibitors.

Anaphylactoid Reactions: Sudden and potentially life-threatening anaphylactoid reactions have occurred in some patients dialyzed with high-flux membranes treated concomitantly with an ACE inhibitor. In such patients, dialysis must be stopped immediately, and aggressive therapy for anaphylactoid reactions must be initiated. 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. Life-threatening anaphylactoid reactions have been reported with concomitant ACE inhibitor and desensitizing treatment with hymenoptera venom.

Hypotension: EPANED 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. These patients should be started under close medical supervision and closely followed for the first 2 weeks of treatment with EPANED and whenever the dose of EPANED and/or a diuretic is increased. 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, EPANED may block angiotensin II formation secondary to compensatory renin release.

Hepatic Failure: Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death. Patients who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up.

Impaired Renal Function: Monitor renal function in patients treated with EPANED. Changes in renal function, including acute renal failure, can be caused by drugs that inhibit the renin-angiotensin system. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on EPANED.

Hyperkalemia: Serum potassium should be monitored in patients receiving EPANED. 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.

Adverse Reactions: See Full Prescribing Information for other Adverse Reactions (6).

Adverse Reactions (where rate on enalapril exceeds the rate on placebo by at least 0.2%) occurring in greater than 1% of patients with hypertension treated with enalapril in controlled trials include: fatigue, orthostatic effects, asthenia, cough, and rash. Adverse reactions reported in clinical trials of heart failure were similar to those seen in clinical trials for hypertension. In patients treated for heart failure, there was an increased incidence of hypotension and dizziness.

Drug Interactions:
In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, use of non-steroidal anti-inflammatory agents (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors, with ACE inhibitors, including enalapril, may result in deterioration of renal function, including possible acute renal failure. Monitor renal function periodically in patients receiving enalapril and NSAID therapy.

Dual Inhibition of the Renin-Angiotensin System (RAS): 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. Closely monitor BP, renal function and electrolytes.

Avoid use of aliskiren with EPANED in patients with renal impairment.

EPANED attenuates potassium loss caused by thiazide-type diuretics. Potassium-sparing diuretics, potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium.

Lithium toxicity has been reported in patients receiving enalapril and lithium concomitantly. Monitor serum lithium levels frequently if lithium is concomitantly administered with EPANED.

Nitritoid reactions have been reported rarely in patients with injectable gold (sodium aurothiomalate) and concomitant enalapril therapy.

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

Use in Specific Populations: See Full Prescribing Information for Additional Information (8).

Pregnancy
EPANED can cause fetal harm. See Full Prescribing Information for Additional Information (5.1, 8.1).

Lactation
Women should not breastfeed during treatment with EPANED.

Pediatric Use
EPANED is not recommended in neonates (i.e., infants 1 month of age or less), preterm infants who have not reached a post-conceptual age of 44 weeks, and in pediatric patients with glomerular filtration rate < 30 mL/min/1.73 m2.

This Important Safety Information does not include all the information needed to use EPANED safely and effectively. Visit EPANED.com for Full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-855-379-0383, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.

 

QBRELIS® (lisinopril) Oral Solution, 1 mg/mL

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).

INDICATIONS:
QBRELIS is an angiotensin-converting enzyme (ACE) inhibitor indicated for:

  • Treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure (BP). Lowering BP decreases the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (MI).
  • Reduction of signs and symptoms of systolic heart failure.
  • Reduction of mortality in treatment of hemodynamically stable patients within 24 hours of acute MI. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin, and beta-blockers.

ADDITIONAL IMPORTANT SAFETY INFORMATION:

Contraindications:
QBRELIS is contraindicated in patients who are hypersensitive to lisinopril or any component of QBRELIS, or in patients with a history of hypersensitivity related to previous ACE inhibitor treatment.

QBRELIS is contraindicated in patients with 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.

Warnings and Precautions:
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 QBRELIS, at any time during treatment. 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 non-Black patients.

Intestinal angioedema has been reported with ACE inhibitors. Discontinue QBRELIS and obtain appropriate therapy.

Anaphylactoid Reactions: Sudden and potentially life-threatening anaphylactoid reactions have occurred in some patients dialyzed with high-flux membranes 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 and in patients undergoing desensitizing treatment with hymenoptera venom.

Impaired Renal Function: Monitor renal function in patients treated with QBRELIS. Changes in renal function, including acute renal failure, can be caused by drugs that inhibit the renin-angiotensin system (RAS). Patients whose renal function may depend in part on the activity of the RAS (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, post-MI 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. QBRELIS should be started under close medical supervision and followed closely for the first 2 weeks of treatment and whenever the dose of QBRELIS and/or a diuretic is increased. Avoid the use of QBRELIS in hemodynamically unstable patients after acute MI.

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 it is considered to be due to this mechanism, it can be corrected by volume expansion.

Hyperkalemia: Serum potassium should be monitored 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 and progresses to fulminant hepatic necrosis and sometimes death. If jaundice or marked elevations of hepatic enzymes develop, discontinue the ACE inhibitor and receive appropriate medical treatment.

Adverse Reactions: See Full Prescribing Information for other Adverse Reactions (6).
Common adverse reactions where rate on lisinopril exceeds the rate on placebo by at least 2% by use are:

  • Hypertension: headache, dizziness, and cough.
  • Systolic heart failure: hypotension and chest pain.
  • Acute MI: hypotension and renal dysfunction.

Drug Interactions:
Initiation of QBRELIS in patients on diuretics may result in excessive reduction of blood pressure. This can be minimized by either decreasing or discontinuing the diuretic or increasing salt intake prior to initiating QBRELIS treatment.

QBRELIS attenuates potassium loss caused by thiazide-type diuretics. If concomitant use of such agents is indicated, monitor the patient’s serum potassium frequently.

Concomitant administration of QBRELIS and antidiabetic medicines may cause an increased blood-glucose-lowering effect.

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, use of non-steroidal anti-inflammatory agents (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors, with ACE inhibitors, including lisinopril, may result in deterioration of renal function, including possible acute renal failure. Monitor renal function periodically in patients receiving lisinopril and NSAID therapy.

Dual Inhibition of the Renin-Angiotensin System (RAS): 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. Closely monitor BP, renal function and electrolytes in patients receiving QBRELIS and agents that effect the RAS.

Avoid use of aliskiren with QBRELIS in patients with renal impairment.

Lithium toxicity has been reported in patients receiving lithium concomitantly with drugs that cause elimination of sodium, including ACE inhibitors. It is usually reversible upon discontinuation of lithium and the ACE inhibitor. Monitor serum lithium levels during concurrent use.

Nitritoid reactions have been reported rarely in patients with injectable gold (sodium aurothiomalate) and concomitant lisinopril therapy.

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

Use in Specific Populations: See Full Prescribing Information for Additional Information (8).

Pregnancy
QBRELIS can cause fetal harm. See Full Prescribing Information for Additional Information (5.1, 8.1).

Lactation
Because of the potential for severe adverse reactions in the breastfed infant, advise women not to breastfeed while taking QBRELIS.

Pediatric Use
QBRELIS is not recommended in children under the age of 6 years or in pediatric patients with glomerular filtration rate < 30 mL/min/1.73m2.

This Important Safety Information does not include all the information needed to use QBRELIS safely and effectively. Visit QBRELIS.com for Full Prescribing Information

To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-855-379-0383, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.