Cushing’s Disease | SIGNIFOR® LAR (pasireotide)

SIGNIFOR LAR is the first and only long-acting, pituitary-targeted therapy clinically proven to treat Cushing’s disease.
It is also the only pituitary-targeted therapy approved to treat Cushing’s disease.

SIGNIFOR^® LAR (pasireotide) is similar to somatostatin, a hormone that occurs naturally in the body. It works by reducing the excess release of hormones.

SIGNIFOR LAR is given as a monthly injection by a trained healthcare professional.

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

Dosing

LEARN MORE ABOUT INJECTION WITH SIGNIFOR LAR

What to expect on treatment

As with any medication, it is important to familiarize yourself with the benefits and risks so you know what to expect from your treatment and can work closely with your doctor to address any concerns.

Here is some important information for you to know about. Treatment with SIGNIFOR LAR 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

Slow heart rate, also known as bradycardia, or electrical system problem (QT prolongation), both of which may cause weakness, dizziness or fainting

Elevation in liver enzymes, which your doctor may want to test

Gallstones, also known as cholelithiasis, which may require an ultrasound

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

Treatment with SIGNIFOR LAR may also lead to reductions in your:

Blood pressure
Body mass index
Weight
Waist circumference

You may also experience side effects, such as:

Nausea and vomiting
Diarrhea
Weight loss
Tiredness
Low blood sugar levels
Dizziness
Loss of appetite

If you experience any of these or other side effects, contact your doctor for guidance before discontinuing SIGNIFOR LAR.

LEARN MORE ABOUT the Safety of Signifor LAR

Important Safety Information

High blood sugar (hyperglycemia), diabetes, and increased ketones in your urine or blood (ketoacidosis): SIGNIFOR LAR can cause serious side effects such as high blood sugar (hyperglycemia), diabetes, and ketoacidosis. Your healthcare provider should check your blood sugar level before you start receiving SIGNIFOR LAR and while you receive it. Tell your healthcare provider right away if you have any of these symptoms: feel very thirsty, urinate more than usual, nausea, vomiting, abdominal pain, increased appetite with weight loss, tiredness, fruity scented breath, trouble breathing, and/or confusion. If you get hyperglycemia, your healthcare provider may give you medicine to lower your blood sugar and/or change your dose of SIGNIFOR LAR or advise you to stop receiving it.

Important Safety Information

Slow heart rate (bradycardia) and changes in the electrical system of your heart (QT Prolongation): SIGNIFOR LAR (pasireotide) can cause your heart to beat slower, which can cause you to feel weak, dizzy, or even faint. People who have, or have had, heart problems, are at greater risk for bradycardia. Abnormal heart beats, weakness, dizziness, and fainting spells may occur due to problems with the electrical system of the heart and can be serious. Call your doctor right away if you experience such spells.

Liver Test Elevations: SIGNIFOR LAR (pasireotide) can cause higher than normal liver function tests. Your healthcare provider should do blood tests to check your liver while you receive SIGNIFOR LAR (pasireotide).

Gallstones (cholelithiasis) and complications that can happen if you have gallstones: Gallstones are a serious but common side effect of SIGNIFOR LAR (pasireotide). Your healthcare provider should do a test (ultrasound) to check your gall bladder before and during your treatment.

Low levels of pituitary hormones (pituitary insufficiency): SIGNIFOR LAR (pasireotide) reduces the pituitary hormones in your body. Your healthcare provider should do a blood test to check your pituitary hormone levels before you start receiving SIGNIFOR LAR (pasireotide) and while you receive it.

Most common side effects of SIGNIFOR LAR (pasireotide) include: diarrhea; headache; stomach-area pain; hair loss; stuffy nose and sore throat; low blood sugar; limb swelling; loss of appetite; nausea; increase in the level of the enzyme in your blood called creatine phosphokinase (CPK); tiredness; stomach bloating, high blood pressure; back pain. These are not all the possible side effects of SIGNIFOR LAR (pasireotide). For more information, ask your healthcare provider.

To report SUSPECTED SIDE EFFECTS, contact Recordati Rare Diseases Inc. at 1-888-575-8344, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before Taking SIGNIFOR LAR (pasireotide) patients should tell their doctor about all of their medications. SIGNIFOR LAR (pasireotide) may affect the way other medicines work, and other medicines may affect how SIGNIFOR LAR (pasireotide) works. Especially tell your healthcare provider if you take medicines to control your heart beat (antiarrhythmics), medicines to control your blood pressure (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, and bromocriptine.

Use in Specific Populations:

Females and Males of Reproductive Potential: Treatment with SIGNIFOR LAR (pasireotide) may result in improved fertility and the possibility of unplanned pregnancy in females who have not gone through menopause. Talk to your healthcare provider about birth control methods that may be right for you during treatment.
It is not known if SIGNIFOR LAR (pasireotide) is safe and effective for use in children.

Signifor

SIGNIFOR LAR is the first and only long-acting, pituitary-targeted therapy clinically proven to treat Cushing’s disease.
It is also the only pituitary-targeted therapy approved to treat Cushing’s disease.

Cushing’s disease at a glance

Dosing

SIGNIFOR LAR: 1 INJECTION EVERY
4 WEEKS (28 DAYS) by a trained healthcare provider.

What to expect on treatment

While on treatment with SIGNIFOR LAR, you may experience improvements in your cortisol levels.

Treatment with SIGNIFOR LAR may also lead to reductions in your:

You may also experience side effects, such as:

Indications and Usage

Important Safety Information

Indications and Usage

Important Safety Information

SIGNIFOR LAR is the first and only long-acting, pituitary-targeted therapy clinically proven to treat Cushing’s disease. It is also the only pituitary-targeted therapy approved to treat Cushing’s disease.

Cushing’s disease at a glance

Dosing

SIGNIFOR LAR: 1 INJECTION EVERY 4 WEEKS (28 DAYS) by a trained healthcare provider.

What to expect on treatment

While on treatment with SIGNIFOR LAR, you may experience improvements in your cortisol levels.

Treatment with SIGNIFOR LAR may also lead to reductions in your:

You may also experience side effects, such as:

Indications and Usage

Important Safety Information

Indications and Usage

Important Safety Information

Are you a Healthcare Professional?

SIGNIFOR LAR is the first and only long-acting, pituitary-targeted therapy clinically proven to treat Cushing’s disease.
It is also the only pituitary-targeted therapy approved to treat Cushing’s disease.

SIGNIFOR LAR: 1 INJECTION EVERY
4 WEEKS (28 DAYS) by a trained healthcare provider.