For US residents only.
Signifor LAR is a prescription medicine used to treat people 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 for use in children.
Before you receive Signifor LAR, tell your health care provider if you:
Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Signifor LAR and other medicines may affect each other, causing side effects. Signifor LAR may affect the way other medicines work, and other medicines may affect how Signifor LAR works. Your health care provider may need to change your dose of Signifor LAR. Especially tell your health care provider if you take:
Ask your health care provider for a list of these medicines if you are not sure.
Know the medicines you take. Keep a list of them to show to your health care provider and pharmacist when you get a new medicine.
Signifor LAR is administered once a month. Signifor LAR comes as an injection in 3 dosages (20 mg, 40 mg, and 60 mg), and can only be given to you by a trained health care provider.
Before you receive Signifor LAR for the first time and during your treatment, your health care provider should do a test to check your heart (electrocardiogram).
Signifor LAR may cause serious side effects, including:
high blood sugar (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 while receiving Signifor LAR, your health care provider may give you another medicine to lower your blood sugar. Your health care provider may also 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. People who have, or have had heart problems, or take certain medicines used to treat slow heart rate or that may cause a slow heart rate, are at higher risk for bradycardia. Tell your health care provider if you get any of these symptoms:
changes in the electrical system of your heart (QT interval prolongation). Tell your health care provider if you get any of these symptoms:
higher than normal liver function tests. Your health care provider should do blood tests to check your liver while you receive Signifor LAR.
gallstones (cholelithiasis). Tell your health care provider if you get any of these symptoms:
low levels of pituitary hormones (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 you start receiving Signifor LAR and while you receive it. Tell your health care provider if you get any of these symptoms:
The most common side effects of Signifor LAR include:
Tell your health care provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Signifor LAR. For more information, ask your health care provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Keep Signifor LAR and all medicines out of the reach of children.
Active ingredient: Pasireotide
Vial: Poly(D, L-lactide-co-glycolide)
Prefilled Syringe: Mannitol, carboxymethylcellulose sodium, poloxamer 188, water for injections