Denver, October 26, 2016 — Silvergate Pharmaceuticals, Inc. (www.silvergatepharma.com), leader in the development and commercialization of innovative and safe medicines for children, today announced that Qbrelis™ (lisinopril) oral solution, the first and only FDA-approved lisinopril oral solution, is now available for ordering. Qbrelis™ is indicated for the treatment of hypertension (high blood pressure) in adult patients and pediatric patients 6 years of age and older, adjunct therapy for heart failure, and treatment of acute myocardial infarction (heart attack) in adults.1
Pediatric Hypertension Medication Oral Solution Gets FDA Approval
“We are excited to launch our second product focused on pediatric patients and pediatric hypertension” said Frank Segrave, President & CEO, Silvergate Pharmaceuticals, Inc.“Qbrelis provides a ready-to-use oral solution for these children with the additional assurance of an FDA approved medication. As a company, we continue to focus on pediatric medications that are safe, effective, and readily available.”
Qbrelis enables weight-based dosing for children 6 years of age and older who until now have relied on an adjusted adult dose.Qbrelis will be available through an extensive network of pharmacies and a qualified mail order service.For additional information on how to obtain Qbrelis, please call 1-855-379-0382 or visit www.qbrelis.com.
Qbrelis delivers the trusted efficacy of lisinopril (an ACE inhibitor), the effectiveness of which has been well established in clinical trials.1 As a unique formulation of an oral solution, Qbrelis provides consistent potency and stability in each dose, in addition to the quality of a product made in accordance with FDA regulations and requirements.1 Patients over 6 years of age who have been prescribed lisinopril tablets and have trouble swallowing pills may also benefit from Qbrelis oral solution.
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.Control of high blood pressure should be part of a comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake.
QBRELIS is an angiotensin-converting enzyme (ACE) inhibitor indicated for the:
- treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure.
- reduction of signs and symptoms of systolic heart failure.
- reduction of mortality in treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction.
IMPORTANT SAFETY INFORMATION
BOXED 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.
ADDITIONAL IMPORTANT SAFETY INFORMATION
- 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.
- 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 angioedemahas 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.(See full prescribing information for other adverse reactions.)
- 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 (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 ofaliskiren 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.
- Concomitant use of Qbrelis with mammalian target of rapamycin (mTOR) inhibitor therapy may increase the risk for angioedema.
- 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.
- ACE inhibitors, including Qbrelis, have an effect on blood pressure that is less in Blacks than in non-Blacks.
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
Please see accompanying full Prescribing Information for additional Important Safety Information, including the BOXED WARNING.
About Silvergate Pharmaceuticals, Inc.
Headquartered near Denver, Colorado, Silvergate Pharmaceuticals, Inc., is a privately held pharmaceutical company dedicated to leading the way in the development and commercialization of innovative pediatric medications that are safe, effective, and readily available.
Silvergate Pharmaceuticals is committed to filling the unmet needs of children, developing innovative medications that will help improve the quality of care and outcomes for pediatric patients. For more information, please visit www.silvergatepharma.com.
Reference: 1. Qbrelis [prescribing information]. Greenwood Village, CO: Silvergate Pharmaceuticals, Inc. ; 2016.
Silvergate Pharmaceuticals, Inc.
SOURCE Silvergate Pharmaceuticals, Inc.