INDICATION(S) AND IMPORTANT SAFETY INFORMATION
What is 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.
IMPORTANT SAFETY INFORMATION
Before starting SIGNIFOR LAR, tell your healthcare provider (HCP) about all your medical conditions, including if you:
- have high blood sugar (hyperglycemia)
- have diabetes
- have or have had heart problems, including an abnormal heart rate or rhythm or problems with the electrical system of your heart (QT prolongation)
- have a low level of potassium or magnesium in your blood
- have liver problems
- have gallstones (cholelithiasis)
- are pregnant or plan to become pregnant. It is not known if SIGNIFOR LAR will harm your unborn baby
- are breastfeeding or plan to breastfeed. It is not known if SIGINFOR LAR passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take SIGNIFOR LAR
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:
- High blood sugar (hyperglycemia), diabetes, and increased ketones in your urine or blood (ketoacidosis): Your healthcare provider should check your blood sugar level before you start receiving SIGNIFOR LAR and while you receive it. Tell your healthcare provider right away if you have any of these symptoms: feel very thirsty, urinate more than usual, nausea, vomiting, abdominal pain, increased appetite with weight loss, tiredness, fruity scented breath, trouble breathing, and confusion. If you get hyperglycemia, your healthcare provider may give you another medicine to lower your blood sugar and/or change your dose of SIGNIFOR LAR or advise you to stop receiving it.
- Slow heart rate (bradycardia): SIGNIFOR LAR 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. Call your doctor right away if you experience any of these symptoms.
- Changes in the electrical system of your heart (QT interval prolongation): Abnormal heart beats, weakness, dizziness, and fainting spells may occur due to problems with the electrical system of the heart and can be serious. Call your doctor right away if you experience any of these symptoms.
- Higher than normal liver function tests: Your healthcare provider should do blood tests to check your liver while you receive SIGNIFOR LAR.
- Gallstones (cholelithiasis) and complications that can happen if you have gallstones: Gallstones are a serious but common side effect of SIGNIFOR LAR. Your healthcare provider should do a test (ultrasound) to check your gall bladder before and during your treatment. Tell your healthcare provider if you get any of these symptoms: sudden pain in your upper right stomach area (abdomen), sudden pain in your right shoulder or between your shoulder blades, yellowing of your skin and whites of your eyes, fever with chills, nausea.
- Low levels of pituitary hormones (pituitary insufficiency): SIGNIFOR LAR may reduce pituitary hormones in your body. Your healthcare provider should do a blood test to check your pituitary hormone levels before you start receiving SIGNIFOR LAR and while you receive it. Tell your healthcare provider if you get any of these symptoms: nausea and vomiting, tiredness, dizziness, diarrhea, low blood sugar levels, loss of appetite, weight loss.
- Fatty stool: SIGNIFOR LAR may cause your body to have issues absorbing dietary fats. Tell your healthcare provider 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.
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.
