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Important Safety Information:

This information does not take the place of talking to your doctor about your medical condition or treatment.

Warnings and Precautions:

  • Treatment with Signifor may cause symptoms associated with low lev

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Approved Use:

Signifor is indicated for the treatment of adult patients with Cushing’s disease who cannot have pituitary surgery or who have failed surgery. It is not known if Signifor is safe and effective in children.

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Signifor® (pasireotide) Injection

Learn more about how Signifor can help you reduce your hormone levels to help you manage your disease.

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Cushing’s Disease

Cushing’s disease is a rare hormonal condition caused when a benign (noncancerous) tumor (called a pituitary adenoma) on the pituitary gland makes too much adrenocorticotropic hormone (ACTH). Large amounts of ACTH cause the body to create too much cortisol. When your cortisol level is too high for too long, you have hypercortisolism. This can cause the signs and symptoms of Cushing’s disease.

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Important Safety Information

This information does not take the place of talking to your doctor about your medical condition or treatment.

Warnings and Precautions:

  • Treatment with Signifor may cause symptoms associated with low levels of cortisol in your blood. Signs and symptoms of low levels of cortisol may include: weakness, fatigue, loss of appetite, nausea, vomiting, low blood pressure, low levels of sodium in your blood, and low blood sugar. Call your doctor right away if you experience any of these signs and symptoms. If you get hypocortisolism while taking Signifor, your doctor may change your dose or ask you to stop taking it.
  • Treatment with Signifor causes high blood sugar levels (hyperglycemia). Signs and symptoms of hyperglycemia may include: excessive thirst, high urine output, increased appetite with weight loss, and tiredness. Call your doctor right away if you experience any of these signs and symptoms. If you get hyperglycemia, your doctor may give you medicine to lower your blood sugar. Your doctor may also change your dose of Signifor or ask you to stop taking it.
  • Treatment with Signifor may cause your heart to beat slower (bradycardia) or cause problems with the electrical system of your heart (QT interval prolongation). Signs and symptoms may include: weakness, dizziness, and fainting. Call your doctor right away if you experience dizziness or fainting spells. Your doctor may do an ECG to check your heart’s electrical system before and during Signifor treatment.
  • Treatment with Signifor may cause elevations in liver tests; therefore, your doctor may do blood tests to monitor your liver.
  • Treatment with Signifor may affect your gallbladder. Your doctor may do an ultrasound to check for gallstones before and during treatment with Signifor.
  • Treatment with Signifor may affect your pituitary hormones. Your doctor may do a blood test to check your pituitary hormones before starting Signifor and during treatment.

Common Side Effects: Most patients experience side effects at some time. Some common side effects you may experience include: diarrhea, nausea, high blood sugar, gallstones, headache, abdominal pain, fatigue, and diabetes mellitus. These are not all the possible side effects of Signifor. For more information, ask your doctor or pharmacist.

Before Taking Signifor: Tell your doctor if you take drugs to control your heart beat (anti-arrhythmics), medicines that affect the electrical system in your heart, medicines to control your blood pressure (beta-blockers or calcium channel blockers), medicines to control the electrolyte levels in your blood, cyclosporine (Gengraf®, Neoral®, Restasis®, Sandimmune®), and bromocriptine (Cycloset®, Parlodel®).

Tell your doctor if you have any side effect that bothers you or does not go away.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information.

The brands listed are the trademarks or registered trademarks of their respective owners and are not trademarks or registered trademarks of Novartis.

Approved Use

Signifor is indicated for the treatment of adult patients with Cushing’s disease who cannot have pituitary surgery or who have failed surgery. It is not known if Signifor is safe and effective in children.