Home | SIGNIFOR® (pasireotide)

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

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.

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.

Dosing

LEARN MORE ABOUT DOSING WITH SIGNIFOR

What to expect on treatment

TREATMENT WITH SIGNIFOR MAY ALSO LEAD TO REDUCTIONS IN:

Blood pressure

Body mass index

Weight

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.

LEARN MORE ABOUT the Safety of SIGNIFOR

IMPORTANT SAFETY INFORMATION

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

have or have had high blood sugar (hyperglycemia)

have diabetes

have or have had heart problems

have a history of low levels of potassium or magnesium in your blood

have or have had liver problems

have or have had gallstones

have any other medical conditions

are pregnant or plan to become pregnant. SIGNIFOR may harm your unborn baby.

are breastfeeding or plan to breastfeed. It is not known if SIGINFOR passes into your breast milk. You and your doctor should decide if you will take SIGNIFOR or breastfeed. You should not do both.

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:

Low cortisol levels in your blood (hypocortisolism). Tell your doctor right away if you have any signs and symptoms of hypocortisolism, which may include weakness, fatigue, loss of appetite, nausea, vomiting, low blood pressure, low level of sodium in your blood, or low blood sugar. If you get hypocortisolism while taking SIGNIFOR, your doctor may change your dose or ask you to stop taking it.

High blood sugar (hyperglycemia). Your doctor should check your blood sugar level before you start taking SIGNIFOR and while you take it. Signs and symptoms of hyperglycemia may include excessive thirst, high urine output, increased appetite with weight loss, or tiredness. If you get hyperglycemia while taking SIGNIFOR, your doctor may give you another medicine to take to lower your blood sugar. Your doctor may also change your dose of SIGNIFOR or ask you to stop taking it.

Slow heart rate (bradycardia): SIGNIFOR can cause your heart to beat slower, which may cause you to feel weak, dizzy or even faint. People who have, or have had, heart problems are at higher risk for bradycardia.

Problems with the electrical system of your heart (QT interval prolongation), which can put you at risk for abnormal heart beats, dizziness, and fainting spells that can be very serious. Call your doctor right away if you experience such spells.

Elevation of your liver tests: Your doctor should do blood tests to monitor your liver tests while you use SIGNIFOR.

Gallstones (cholelithiasis) and complications that can happen if you have gallstones: Gallstones are a serious but common side effect of SIGNIFOR. Possible complications of gallstones include inflammation and infection of the gallbladder. Your doctor should do a test (ultrasound) to check for gallstones before you start using SIGNIFOR and while you use it. Tell your healthcare provider if you get any of these symptoms.

Fatty stool: SIGNIFOR may cause your body to have issues absorbing dietary fats. Tell your doctor 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.

Sudden pain in your upper right stomach area (abdomen), yellowing of your skin and whites of your eyes, nausea, sudden pain in your right shoulder or between your shoulder blades, and fever with chills.

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.

SIGNIFOR

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

Cushing’s disease at a glance

Dosing

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

What to expect on treatment