SIGNIFOR

Generic Name/API: pasireotide

Manufacturer: Recordati

Dosage Forms & Strength & Pack Size:
Injection: 0.3 mg/mL, 0.6 mg/mL, and 0.9 mg/mL in a single-dose ampule

Storage:
SIGNIFOR is supplied as a single dose, colorless glass ampule packaged in a box
of 60 ampules, arranged in 10 packs of 6 ampules each. The following packaging
configurations are available.
0.3 mg/1 mL pasireotide (as diaspartate)
Box of 60 ampules
0.6 mg/1 mL pasireotide (as diaspartate)
Box of 60 ampules
0.9 mg/1 mL pasireotide (as diaspartate)

Box of 60 ampules Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F), protect from
light.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

Indications

SIGNIFOR is a prescription medicine used to treat Cushing’s disease in adults who cannot have surgery or have failed surgery.

Important Safety Information:

  • Low cortisol levels in your blood (hypocortisolism): Treatment with SIGNIFOR may cause symptoms associated with low levels of cortisol in your blood which may include: weakness, fatigue, loss of appetite, nausea, vomiting, low blood pressure, low levels of sodium in your blood, and low blood sugar. Tell your doctor right away if you experience any of these signs and symptoms. If you get hypocortisolism while taking SIGNIFOR, your doctor may change your dose or ask you to stop taking it.
  • High blood sugar (hyperglycemia): Treatment with SIGNIFOR may cause high blood sugar levels. Signs and symptoms of hyperglycemia may include: excessive thirst, high urine output, increased appetite with weight loss, and tiredness. Tell your doctor right away if you experience any of these signs and symptoms. If you get hyperglycemia, your doctor may give you medicine 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) and problems with the electrical system of your heart (QT prolongation): SIGNIFOR can cause your heart to beat slower, which can cause you to feel weak, dizzy, or even faint. People who have, or have had, heart problems, are at greater risk for bradycardia. Abnormal heart beats, dizziness, and fainting spells may occur due to problems with the electrical system of the heart and can be serious. Tell your doctor right away if you experience such spells.
  • Liver Test Elevations: Treatment with SIGNIFOR may cause elevations in liver tests; therefore, your doctor may do blood tests to monitor your liver.
  • Gallstones (cholelithiasis) and complications that can happen if you have gallstones: Gallstones are a serious 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: 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; fever with chills.
  • Most common side effects include: diarrhea; nausea; high blood sugar; headache; abdominal pain; fatigue; diabetes mellitus; injection-site reactions; common cold; hair loss; weakness; fluid retention; abnormal blood test result for glycosylated hemoglobin (HbA1c). These are not all the possible side effects of SIGNIFOR. For more information, ask your doctor or pharmacist.
  • To report SUSPECTED SIDE EFFECTS, contact Recordati Rare Diseases Inc. at 1-888-575-8344, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Taking SIGNIFOR with other medications: Tell your doctor about all of the medicines you take. SIGNIFOR may affect the way other medicines work and other medicines may affect how SIGNIFOR works. Especially tell your doctor if you take medicines to control your heart beat (anti-arrhythmics), medicines that affect the electrical system in your heart (QT prolongation), medicines to control your blood pressure (beta-blockers or calcium channel blockers), medicines to control the electrolyte levels (potassium and magnesium) in your blood, cyclosporine and bromocriptine.
  • Use in Specific Populations:
    Females of Reproductive Potential: Before you take SIGNIFOR, tell your doctor if you are pregnant or plan to become pregnant. SIGNIFOR may harm your unborn baby.
    It is not known if SIGNIFOR is safe and effective in children.
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