Signifor
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SIGNIFOR® LAR (pasireotide) is similar to somatostatin, a hormone that occurs naturally in the body. It works by reducing the excess release of hormones.
SIGNIFOR LAR is given as a monthly injection by a trained healthcare professional.
Cushing’s disease is a rare hormonal condition caused when a noncancerous tumor on the pituitary gland produces too much of a natural hormone called adrenocorticotropic hormone (ACTH).
SIGNIFOR LAR works in the pituitary gland to reduce the amount of ACTH released, which in turn helps stop the overproduction of cortisol.
As with any medication, it is important to familiarize yourself with the benefits and risks so you know what to expect from your treatment and can work closely with your doctor to address any concerns.
Here is some important information for you to know about. Treatment with SIGNIFOR LAR may lead to:
High blood sugar, also known as hyperglycemia, which may cause excessive thirst, high urine output, increased appetite with weight loss, or tiredness
Slow heart rate, also known as bradycardia, or electrical system problem (QT prolongation), both of which may cause weakness, dizziness or fainting
Elevation in liver enzymes, which your doctor may want to test
Gallstones, also known as cholelithiasis, which may require an ultrasound
Low cortisol, also known as hypocortisolism, which may cause weakness, fatigue, loss of appetite, nausea, vomiting, low blood pressure, a low level of sodium in the blood or low blood sugar
Your cortisol may begin to decrease after the first few months of starting SIGNIFOR LAR treatment.
If you experience any of these or other side effects, contact your doctor for guidance before discontinuing SIGNIFOR LAR.
SIGNIFOR LAR is a prescription medicine used to treat people with Cushing’s disease for whom surgery has not worked well enough or who cannot have surgery. It is not known if SIGNIFOR LAR is safe and effective for use in children.
Before starting SIGNIFOR LAR, tell your healthcare provider (HCP) about all your medical conditions, including if you:
SIGNIFOR LAR is a prescription medicine used to treat people with Cushing's disease for whom surgery has not worked well enough or who cannot have surgery.
It is not known if SIGNIFOR LAR is safe and effective for use in children.
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.
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