Quality and Consistency of an FDA-Approved Oral SolutionThe FDA is reinforcing the importance of prescribing an FDA-approved product such as Qbrelis.
According to the FDA:
“When a drug is FDA-approved, patients are assured that the FDA has reviewed the safety and efficacy of the drug and the adequacy of the manufacturing process to produce a quality product….compounded drugs do not provide such assurance and, therefore, should only be used when an FDA-approved product is not available to meet the medical needs of an individual patient.”1The FDA approval process helps ensure safety and effectiveness for your pediatric patients 6 years of age and older.
FDA-Approved Medications Differ From Extemporaneously Compounded Drugs1
|QBRELIS Oral Solution||Compounded lisinopril suspension|
|Meets FDA standards for potency and purity||Unknown2|
|Required compliance with FDA’s CGMPs*||Unconfirmed3|
|Sourcing of active ingredient approved by FDA||Unknown2|
|Shelf life/stability||24 months5||Unknown2|
|Refrigeration required||NO 5||Unknown 2|
|Available at retail pharmacies||YES||Unknown|
|Covered by Medicaid||YES||Unknown|
Trusted efficacy delivered with consistent potency when stored at controlled room temperature (20°C–25°C, 68°F–77°F) in a tightly closed container. Protect from freezing and excessive heat.
Well established efficacy: The efficacy of lisinopril is well established for the treatment of hypertension in pediatric patients who are 6 years of age and older. Qbrelis is also indicated for adjunct therapy for heart failure and treatment of acute myocardial infarction.1
Weight-based dosing: With Qbrelis (lisnopril) oral solution 1 mg/mL, you can provide weight-based dosing for the treatment of hypertension in children 6 years of age and older who have previously needed to rely on a manually prepared suspension.
Consistent potency: When you choose to prescribe or dispense Qbrelis, it provides consistent potency from first to last dose in every prescription, and helps ensure consistency from hospital to home.
References: 1. Hamberg MA. Department of Health and Human Services. Letter to: Colleague. January 8, 2014. 2. Sellers S, Utian WH. Pharmacy compounding primer for physicians. Drugs. 2012;72:2043-2050. 3. FDA/CDER. Guidance for Industry: Compounded drug products that are essentially copies of commercially available drug product under section 503A of the FFDCA. (DRAFT) July 2016. 4. Qbrelis [prescribing information]. Greenwood Village, CO: Silvergate Pharmaceuticals, Inc.; 2016. 5. Data on file, Silvergate Pharmaceuticals, Inc.; 2016.