INDICATION(S) AND IMPORTANT SAFETY INFORMATION
What is SIGNIFOR?
SIGNIFOR is a prescription medicine used to treat Cushing’s disease in adults who cannot have surgery or have failed surgery. It is not known if SIGNIFOR is safe and effective for use in children.
IMPORTANT SAFETY INFORMATION
Before starting SIGNIFOR, tell your doctor about all your medical conditions, including if you:
- have or have had high blood sugar (hyperglycemia)
- have diabetes
- have or have had heart problems
- have a history of low levels of potassium or magnesium in your blood
- have or have had liver problems
- have or have had gallstones
- have any other medical conditions
- are pregnant or plan to become pregnant. SIGNIFOR may harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if SIGINFOR passes into your breast milk. You and your doctor should decide if you will take SIGNIFOR or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take, including any prescription and over-the-counter medicines, vitamins, or herbal supplements.
SIGNIFOR and other medicines may affect each other, causing side effects. Especially tell your doctor if you take medicines to control your heartbeat (anti-arrhythmics), that can affect the electrical system of your heart (QT prolongation), to control your blood pressure (beta-blockers or calcium channel blockers), to control electrolyte levels in your blood (such as potassium or magnesium), cyclosporine, and/or bromocriptine.
What are the possible side effects of SIGNIFOR?
SIGNIFOR may cause serious side effects including:
- Low cortisol levels in your blood (hypocortisolism). Tell your doctor right away if you have any signs and symptoms of hypocortisolism, which may include weakness, fatigue, loss of appetite, nausea, vomiting, low blood pressure, low level of sodium in your blood, or low blood sugar. If you get hypocortisolism while taking SIGNIFOR, your doctor may change your dose or ask you to stop taking it.
- High blood sugar (hyperglycemia). Your doctor should check your blood sugar level before you start taking SIGNIFOR and while you take it. Signs and symptoms of hyperglycemia may include excessive thirst, high urine output, increased appetite with weight loss, or tiredness. If you get hyperglycemia while taking SIGNIFOR, your doctor may give you another medicine to take to lower your blood sugar. Your doctor may also change your dose of SIGNIFOR or ask you to stop taking it.
- Slow heart rate (bradycardia): SIGNIFOR can cause your heart to beat slower, which may cause you to feel weak, dizzy or even faint. People who have, or have had, heart problems are at higher risk for bradycardia.
- Problems with the electrical system of your heart (QT interval prolongation), which can put you at risk for abnormal heart beats, dizziness, and fainting spells that can be very serious. Call your doctor right away if you experience such spells.
- Elevation of your liver tests: Your doctor should do blood tests to monitor your liver tests while you use SIGNIFOR.
- Gallstones (cholelithiasis) and complications that can happen if you have gallstones: Gallstones are a serious but common side effect of SIGNIFOR. Possible complications of gallstones include inflammation and infection of the gallbladder. Your doctor should do a test (ultrasound) to check for gallstones before you start using SIGNIFOR and while you use it. Tell your healthcare provider if you get any of these symptoms.
- Fatty stool: SIGNIFOR may cause your body to have issues absorbing dietary fats. Tell your doctor if you have any new or worsening symptoms including fatty stools, changes in the color of your stools, loose stools, stomach (abdominal) bloating or weight loss.
- Sudden pain in your upper right stomach area (abdomen), yellowing of your skin and whites of your eyes, nausea, sudden pain in your right shoulder or between your shoulder blades, and fever with chills.
The most common side effects of SIGNIFOR include diarrhea, nausea, high blood sugar, headache, abdominal pain, fatigue, diabetes mellitus, injection-site reactions, common cold, hair loss, weakness, fluid retention, and abnormal blood test result for glycosylated hemoglobin.
These are not all the possible side effects of SIGNIFOR. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
SIGNIFOR (pasireotide) injection, for subcutaneous use, is available as a 0.3 mg/1 mL, 0.6 mg/1 mL, and 0.9 mg/1 mL pasireotide (as diaspartate) glass ampule.
Please see the accompanying full Prescribing Information, including the Medication Guide.