ISI Patient

ISI Patient

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.

INDICATIONS

QBRELIS is an angiotensin-converting enzyme (ACE) inhibitor indicated for:
  • treatment of high blood pressure in adults and children 6 years of age and older, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (heart attacks).
  • reducing signs and symptoms of systolic heart failure.
  • reducing the risk of death for those who have experienced a heart attack within 24 hours. Patients should receive, as appropriate, the standard recommended treatments, such as thrombolytics, aspirin, and beta blockers.
Control of high blood pressure should be part of a complete cardiovascular risk management program. This program may also include lipid (cholesterol) control, diabetes management, antithrombotic (anti-stroke) therapy, exercise, quitting smoking, and limiting salt in the diet. Many patients will require more than one drug to achieve blood pressure goals.

ADDITIONAL IMPORTANT SAFETY INFORMATION

Qbrelis (lisinopril) Oral Solution should not be used during pregnancy or if breastfeeding. Taking Qbrelis during pregnancy can harm the unborn child. Stop taking Qbrelis as soon as possible if pregnancy is detected. Before you or your patient takes Qbrelis, tell the doctor if you or your patient has kidney, liver or heart disease, diabetes, or is on dialysis. If you or your patient has diabetes or kidney disease, Qbrelis should not be taken with aliskiren (Amturnide®, Tekamlo®, Tekturna®, Valturna®). Do not use this medication if allergic to lisinopril (Zestril®, Prinivil®) or similar medicines such as: benazepril (Lotensin®), captopril (Capoten®, Capozide®), fosinoprll (Monopril®), enalapril (Epaned®, Vasotec®, Vaseretic®), moexipril (Univasc®, Uniretic®), perindopril (Aceon®), quinapril (Accupril®), ramipril (Altace®), trandolapril (Mavik®, Tarka®), and others, or if allergic to any ingredients in Qbrelis. Do not take or give your patient Qbrelis if there is a history of swelling of the face, extremities, lips, tongue, throat, glottis, and/or larynx (angioedema). Angioedema may occur at any time during treatment with angiotensin-converting enzyme inhibitors, including Qbrelis. If this occurs, discontinue Qbrelis and call the doctor or get emergency medical help right away. Call the doctor right away if you or your patient has any of the following serious side effects at any time during treatment:
  • swelling of face, extremities, lips, tongue, throat, glottis, and/or larynx;
  • difficulty swallowing or breathing; or
  • yellowing of the skin or eyes.
Qbrelis may cause other side effects. The most common side effects are headache, dizziness, cough, and low blood pressure. Call your doctor if you or your patient shows any of these symptoms: headache, dizziness, cough, low blood pressure, chest pain, or kidney dysfunction. If you or your patient faints or feels lightheaded, especially during the first few days of treatment, discontinue Qbrelis until you have talked with the doctor. Qbrelis can cause symptomatic low blood pressure (hypotension). Conditions that may cause very low blood pressure include: vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking diuretics (water pills). If you or your patient has a prolonged illness that causes diarrhea or vomiting, tell the doctor. If you or your patient needs surgery, tell the surgeon ahead of time that you or your patient is taking Qbrelis. The surgeon may recommend that Qbrelis be discontinued for a short time. Tell the doctor about all other medicines you or your patient uses, including potassium supplements and/or potassium-containing salt substitutes, all prescription drugs, over-the-counter medicines, vitamins, and supplements. See full Prescribing Information (Section 7) for drug interactions. If you or your patient is currently taking a non-steroidal anti-inflammatory drug (NSAID), such as aspirin, ibuprofen (Advil®, Motrin®), or naproxen (Aleve®), talk to the doctor before taking or giving Qbrelis. Changes in kidney (renal) function, including acute renal failure, can be caused by Qbrelis. Your kidney function or your patient’s kidney function should be monitored by the doctor. Qbrelis is not recommended for use with pediatric patients under 6 years of age. Qbrelis should not be used in children with kidney problems (i.e., a glomerular filtration rate < 30 mL/min/1.73m2). These are not all the possible side effects of Qbrelis. Your doctor or your patient’s doctor is the best source of advice about side effects. Call the doctor immediately if you or your patient has any side effects that concern you or do not go away. Your blood pressure or your patient’s blood pressure will need to be checked often. In addition, serum potassium levels and renal function will need to be monitored. Make sure you or your patient visits the doctor regularly. See full Prescribing Information for further information, including other Adverse Reactions. 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.