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Frequently Asked Questions

Signifor® LAR (pasireotide) for injectable suspension

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:

  • 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)
  • have any other medical conditions
  • are pregnant or planning to become pregnant. Signifor LAR may harm your unborn baby
  • are breastfeeding or planning to breastfeed. It is not known if Signifor LAR passes into your breast milk. You and your health care provider should decide if you will receive Signifor LAR or breastfeed. You should not do both.

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:

  • medicines to control your heart beat (antiarrhythmics)
  • medicines to control your blood pressure (such as beta-blockers or calcium channel blockers)
  • medicines to control the potassium and magnesium (electrolytes) levels in your body
  • medicines that may affect the way the electrical system of your heart works (QT prolongation)
  • cyclosporine
  • bromocriptine

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.

  • Signifor LAR must be given by a trained health care provider as an injection into the muscle of your buttocks (intramuscularly).
  • Your health care provider will tell you how much Signifor LAR you will receive and when you will receive it.
  • Your health care provider may change your dose of Signifor LAR or the length of time between your injections. Your health care provider will tell you how long you need to receive Signifor LAR.
  • Before you receive Signifor for the first time, your health care provider should do a blood test to check your fasting blood sugar level, electrolyte levels, and your liver function.

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:

    • feel very thirsty
    • experience tiredness
    • urinate more than usual
    • have increased appetite with weight loss

    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:

    • weakness
    • dizziness
    • fainting or near fainting spells
  • changes in the electrical system of your heart (QT interval prolongation). Tell your health care provider if you get any of these symptoms:

    • weakness
    • dizziness
    • fainting or near fainting spells
  • 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:

    • 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 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:

    • nausea and vomiting
    • tiredness
    • dizziness
    • diarrhea
    • low blood glucose levels
    • loss of appetite
    • weight loss

The most common side effects of Signifor LAR include:

  • diarrhea
  • gallstones (cholelithiasis)
  • high blood sugar (hyperglycemia)
  • diabetes mellitus

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.

  • Store Signifor LAR in the refrigerator between 36°F to 46°F (2°C to 8°C)
  • Take Signifor LAR out of the refrigerator at least 30 minutes before you will receive it to allow it to come to room temperature
  • Do not use Signifor LAR if it has been out of the refrigerator and at room temperature for more than 24 hours
  • Your health care provider should give you Signifor LAR right away after it is mixed

Keep Signifor LAR and all medicines out of the reach of children.

Active ingredient: Pasireotide

Inactive ingredients:

Vial: Poly(D, L-lactide-co-glycolide)

Prefilled Syringe: Mannitol, carboxymethylcellulose sodium, poloxamer 188, water for injections