Signifor® LAR (pasireotide) for injectable suspension
IMPORTANT SAFETY INFORMATION
Warnings and Precautions:
- Treatment with Signifor LAR may cause high blood sugar levels (hyperglycemia) and diabetes. Your health care provider should check your blood sugar level before you start receiving Signifor LAR and while you receive it. Tell your health care provider if you have any of these symptoms:
If you get hyperglycemia, your health care provider may give you medicine to lower your blood sugar. Your health care provider may also change your dose of Signifor LAR or ask you to stop receiving it.
- excessive thirst
- urinate more than usual
- increased appetite with weight loss
- Treatment with Signifor LAR may cause your heart to beat slower (bradycardia) or cause changes in the electrical system of your heart (QT interval prolongation). Your health care provider should check your heart’s electrical system with an ECG test prior to starting Signifor LAR and after 3 weeks in patients who may be at risk for electrical system problems. call your health care provider right away if you experience any signs and symptoms such as:
- Treatment with Signifor LAR may cause elevations in liver function tests; therefore, your health care provider may do blood tests to monitor your liver.
- Treatment with Signifor LAR may affect your gallbladder (gallstones, cholilethiasis). Tell your health care provider right away if you experience any of the following signs and symptoms:
- sudden pain in the upper right stomach area (abdomen)
- sudden pain in the right shoulder or between your shoulder blades
- yellowing of the skin and whites of your eyes
- fever and chills
- Treatment with Signifor LAR may affect your pituitary hormone levels (pituitary insufficiency). Signifor LAR may reduce the pituitary hormones in your body. Your health care provider should do a blood test to check your pituitary hormone levels before starting Signifor LAR and during treatment. Tell your health care provider if you experience any of these symptoms:
- nausea and vomiting
- low blood glucose levels
- loss of appetite
- weight loss
Common Side Effects: Most patients experience side effects at some time. Some common side effects you may experience include: diarrhea, gallstones, high blood sugar, and diabetes mellitus. Tell your health care provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Signifor LAR. For more information and to get advice about side effects, ask your health care provider or pharmacist.
Before taking Signifor LAR: Tell your health care provider about all the medicines you take including over-the-counter medicines, vitamins and herbal supplements. Especially tell your health care provider if you take medicine
- to control your heart beat (antiarrhythmics)
- to control your blood pressure (such as beta-blockers or calcium channel blockers)
- to control potassium and magnesium (electrolytes) levels in your body
- that affect the electrical system in your heart (QT prolongation)
This information does not take the place of talking to your health care provider about your medical condition or your treatment.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Signifor LAR is indicated for the treatment of patients with acromegaly for whom surgery has not worked well enough or who cannot have surgery. It is not known if Signifor LAR is safe and effective in children.