DOSING AND ADMINISTRATION
Qbrelis Offers Convenient Dosing and Administration
Ready-to-use lisinopril oral solution requires no additional preparation by the pharmacist or caregiver.
Qbrelis is an oral solution containing lisinopril 1 mg/mL in 150 mL of aqueous solution with a sweet taste; no artificial flavoring or dyes.
Weight-based dosing for pediatric patients 6 years of age and older with hypertension
The recommended starting dose is 0.07 mg/kg (up to 5 mg orally total) once daily.
Dosing for adult hypertension
The recommended starting dosage is 10 mg orally once daily, up to a maximum of 40 mg daily based on blood pressure response.
The usual dosage range is 20 to 40mg per day.
Dosing for adults with cardiac conditions
- Dosage should be adjusted according to blood pressure response.
- Doses above 0.61 mg/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.
Oral solution ensures consistent potency and stability
- For heart failure, initiate with 5 mg orally once daily, when used with diuretics and (usually) digitalis up to a maximum of 40 mg daily.
- For acute myocardial infarction (MI), give 5 mg orally within 24 hours of MI, followed by 5 mg after 24 hours, then 10 mg once daily.
- Same potency from first to last dose.
- Consistent from hospital to home.
- No refrigeration required—Qbrelis can be stored at room temperature (20°C–25°C, 68°F–77°F); in a tightly closed container. Protect from freezing and excessive heat.
- No shaking necessary prior to administration.
IMPORTANT SAFETY INFORMATION✕
IMPORTANT SAFETY INFORMATION
WARNING: FETAL TOXICITY
See full Prescribing Information for complete boxed warning.
- When pregnancy is detected, discontinue QBRELIS as soon as possible.
- Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
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
See full Prescribing Information for further information, including other Adverse Reactions.
- 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 and should not be co-administered with aliskiren 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 sacubitrol/valsartan.
- 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.
- 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 follow-up.
- 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.
- Adverse Reactions (where rate on lisinopril exceeds the rate on placebo by at least
2%) occurring in greater than 1% of patients with:
- Hypertension: headache, dizziness, and cough.
- Systolic heart failure: hypotension and chest pain.
- Acute MI: hypotension and renal dysfunction.
Please see accompanying full Prescribing Information for additional Important Safety Information, including
- 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
- Concomitant administration of Qbrelis and antidiabetic medicines may cause
an increased blood-glucose-lowering effect.
- In patients who are elderly, volume-depleted (as 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 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 coadministratoin 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.
- Concomitant use of Qbrelis with mammalian target of rapamycin (mTOR) inhibitor
therapy may increase the risk for angioedema.
- Because of the potential for severe adverse reactions in the breastfed infant, advise women not to breastfeed while taking Qbrelis.
- 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.
To report SUSPECTED ADVERSE REACTIONS, contact Silvergate Pharmaceuticals at 1-855-379-0383, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch