SIGNIFOR SIGNIFOR

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Target the source

SIGNIFOR is the first and only subcutaneously administered,
pituitary-targeted therapy clinically proven to treat Cushing’s disease.


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SIGNIFOR® (pasireotide) is similar to somatostatin, a hormone that occurs naturally in the body. It works by reducing the excess release of hormones by targeting the receptors in the tumor most responsible for causing that excess.

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SIGNIFOR is given as a self-administered injection, or injection by a caregiver, twice daily.

Cushing’s disease at a glance

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).

  • The extra ACTH then leads to overproduction of another natural hormone called cortisol
  • The overproduction of cortisol causes the symptoms of Cushing’s disease

SIGNIFOR works in the pituitary gland to reduce the amount of ACTH released, which in turn helps stop the overproduction of cortisol from the adrenal gland.

Piuitary gland diagram

Dosing

SIGNIFOR is a twice-daily self-administered
injection, or injection by a caregiver.

LEARN MORE ABOUT DOSING WITH SIGNIFOR

What to expect on treatment

While on treatment with SIGNIFOR, improvements in cortisol levels may be experienced.

Cortisol may begin to decrease after starting SIGNIFOR treatment.

TREATMENT WITH SIGNIFOR MAY ALSO LEAD TO REDUCTIONS IN:

Blood pressure

Blood pressure

Body mass index

Body mass index

Weight

Weight

Waist circumference

Waist circumference

In studies, individual patients showed different amounts of improvement in the symptoms of Cushing's disease. Because there was not a group who didn't receive the medication, there were different rates of reductions (lowering) of these symptoms, and blood pressure medications were allowed during this trial, it is not known if these changes were from taking SIGNIFOR or not.

Treatment with SIGNIFOR 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. Your doctor should be monitoring your blood sugar before starting treatment, as well as for the first several weeks and regularly with dose changes.

Gallstones, also known as cholelithiasis, which may cause sudden pain in your abdomen or shoulder area, jaundice (yellowing of the skin or whites of the eyes), nausea, or fever with chills. Your doctor might order an ultrasound to see if this is the cause of these symptoms.

Elevation in liver enzymes, which your doctor may want to test 1-2 weeks after starting treatment, then monthly for 3 months, and eventually every 6 months.

Slow heart rate, also known as bradycardia, or electrical system problem (QT prolongation), both of which may cause weakness, dizziness, or fainting. You should tell your doctor if you have any of these symptoms or if you take any medications for either of these conditions. Your doctor will monitor your heart with an ECG and blood work. Tell your doctor if you have had or have heart problems.

Low cortisol, also known as hypocortisolism, which may cause weakness, fatigue, loss of appetite, nausea, vomiting, low blood pressure, low level of sodium in the blood, or low blood sugar.

If you experience any of these or other side effects, contact your doctor for guidance before discontinuing SIGNIFOR. Learn more about side effects in the Prescribing Information.

SEE MORE

What is SIGNIFOR?

SIGNIFOR is a prescription medicine used to treat Cushing’s disease in adults who cannot have surgery or have failed surgery. It is not known if SIGNIFOR is safe and effective for use in children.

IMPORTANT SAFETY INFORMATION

Before starting SIGNIFOR, tell your doctor about all your medical conditions, including if you:

INDICATION(S) AND IMPORTANT SAFETY INFORMATION

What is SIGNIFOR?

SIGNIFOR is a prescription medicine used to treat Cushing’s disease in adults who cannot have surgery or have failed surgery. It is not known if SIGNIFOR is safe and effective for use in children.

IMPORTANT SAFETY INFORMATION

Before starting SIGNIFOR, tell your doctor about all your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including any prescription and over-the-counter medicines, vitamins, or herbal supplements.

SIGNIFOR and other medicines may affect each other, causing side effects. Especially tell your doctor if you take medicines to control your heartbeat (anti-arrhythmics), that can affect the electrical system of your heart (QT prolongation), to control your blood pressure (beta-blockers or calcium channel blockers), to control electrolyte levels in your blood (such as potassium or magnesium), cyclosporine, and/or bromocriptine.

What are the possible side effects of SIGNIFOR?

SIGNIFOR may cause serious side effects including:

The most common side effects of SIGNIFOR include diarrhea, nausea, high blood sugar, headache, abdominal pain, fatigue, diabetes mellitus, injection-site reactions, common cold, hair loss, weakness, fluid retention, and abnormal blood test result for glycosylated hemoglobin.

These are not all the possible side effects of SIGNIFOR. Call your doctor 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 (pasireotide) injection, for subcutaneous use, is available as a 0.3 mg/1 mL, 0.6 mg/1 mL, and 0.9 mg/1 mL pasireotide (as diaspartate) glass ampule.

Please see the accompanying full Prescribing Information, including the Medication Guide.