Signifor LAR Signifor

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For treatment of Cushing’s disease in adults for whom surgery has not worked well enough or who cannot have surgery.

For treatment of acromegaly in adults for whom surgery has not worked well enough or who cannot have surgery.

INDICATION(S) AND IMPORTANT SAFETY INFORMATION


What is SIGNIFOR LAR?

SIGNIFOR LAR is a prescription medicine used to treat people with:

It is not known if SIGNIFOR LAR is safe and effective for use in children.


IMPORTANT SAFETY INFORMATION

Before starting SIGNIFOR LAR, tell your healthcare provider (HCP) about all your medical conditions, including if you:

INDICATION(S) AND IMPORTANT SAFETY INFORMATION


What is SIGNIFOR LAR?


SIGNIFOR LAR is a prescription medicine used to treat people with:

It is not known if SIGNIFOR LAR is safe and effective for use in children.


IMPORTANT SAFETY INFORMATION


Before starting SIGNIFOR LAR, tell your healthcare provider (HCP) about all your medical conditions, including if you:


Females and Males of Reproductive Potential: Treatment with SIGNIFOR LAR may result in improved fertility and the possibility of unplanned pregnancy in females who have acromegaly or Cushing’s disease and have not gone through menopause. Talk to your healthcare provider about birth control methods that may be right for you during treatment.


Tell your healthcare provider about all the medicines you take, including any prescription and over-the-counter medicines, vitamins, or herbal supplements.


SIGNIFOR LAR and other medicines may affect each other, causing side effects. Your healthcare provider may need to change your dose of SIGNIFOR LAR or your other medicines. Especially tell your healthcare provider if you take medicines to control your heart beat (antiarrhythmics), your blood pressure (beta-blockers or calcium channel blockers), potassium and magnesium (electrolytes) levels in your body, medicines that may affect the way the electrical system of your heart works (QT prolongation), cyclosporine, and bromocriptine.


What are the possible side effects of SIGNIFOR LAR?


SIGNIFOR LAR may cause serious side effects including:


The most common side effects of SIGNIFOR LAR include diarrhea, headache, stomach-area pain, hair loss, stuffy nose and sore throat, low blood sugar, limb swelling, loss of appetite, nausea, increase in level of the creatine phosphokinase (CPK) enzyme in your blood, tiredness, stomach bloating, high blood pressure, back pain.


These are not all the possible side effects of SIGNIFOR LAR. Call your HCP 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 LAR® (pasireotide) for injectable suspension, for intramuscular use, is available as 10 mg, 20 mg, 30 mg, 40 mg, and 60 mg powder in a vial to be reconstituted with the provided 2 mL diluent.


Please see full Prescribing Information and Patient Information.