For US Audiences Only
For Healthcare Professionals

For adults with Cushing's disease (CD) for whom surgery is not an option or has not been curative

Target the source

SIGNIFOR directly targets the pituitary gland tumor by binding to key receptors that are most responsible for excess cortisol.

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For patient support, call:
1-888-855-7273
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Connect with Patient Liaison

Why SIGNIFOR?

FDA icon

SIGNIFOR has been FDA-approved for
10+ yearsa, helping patients when pituitary
surgery isn’t an option or has been ineffective.

long acting icon

SIGNIFOR is the first and only long-acting,
pituitary-targeted therapy clinically proven
to treat CD.

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

somatostatin icon

SIGNIFOR is similar to somatostatin,
a hormone that occurs naturally
in the body.

aSIGNIFOR was FDA approved in December 2012.

How SIGNIFOR works

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 targets key somatostatin receptors (SSTRs) on the pituitary tumor to reduce ACTH release, helping stop the overproduction of cortisol from the adrenal gland.

  • SIGNIFOR targets 4 of the 5 SST receptors, and works primarily at SSTR5 and SSTR2
  • SSTR5 is known to be the most common SSTR in Cushing’s disease tumors
pituitary gland

SIGNIFOR is proven effective

In a clinical study, up to 26% of people taking SIGNIFOR achieved normal cortisol levels.

About the study

SIGNIFOR 0.6 mg and 0.9 mg were evaluated over a 6-month period in a randomized study in 162 patients with persistent or recurrent Cushing’s disease despite pituitary surgery or for whom surgery was not indicated or who had refused surgery.

mg, milligram

Cortisol levels are measured by your doctor using a urinary cortisol test, which assesses the amount of cortisol in your urine over a period of time, usually 24 hours.

Mean urinary free cortisol is the measurement of the cortisol in the urine that is not connected to other factors that can affect cortisol levels such as some medications and tobacco products.

  • 15%
    of patients who took the 0.6 mg dose twice daily had cortisol levels return to normal.
  • 26%
    of patients who took the 0.9 mg dose twice daily had cortisol levels return to normal.

SIGNIFOR reduced cortisol levels in both treatment groups. Cortisol decreases of approximately 20%-40% were seen in patients even though some did not return to normal.

Secondary Endpoints

Symptom relief with SIGNIFOR

SIGNIFOR may help improve the signs and symptoms of Cushing’s disease, including:

Weight
Waist circumference
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Body mass index
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Blood pressure

In the study, 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

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

High blood sugar, also known as hyperglycemia, symptoms of which may include 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 while you take it and regularly with dose changes.

Slow heart rate, also known as bradycardia, may cause your heart to beat slower, feeling of weakness, dizziness, or fainting. People who have, or have had, heart problems are at higher risk for bradycardia.

Electrical system problems of your heart (QT prolongation), 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.

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 should order an ultrasound to check for gallstones before you start SIGNIFOR, while you use it, and to see if gallstones are 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.

Fatty stool, as 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.

Please report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also contact Recordati Rare Diseases Inc. at 1-888-575-8344 to report side effects.

See additional Important Safety Information below.

How to take SIGNIFOR

Dosing and administration

SIGNIFOR is a twice-daily, self-administered injection, or it can be injected by a caregiver. When starting SIGNIFOR twice a day at 0.6 mg or 0.9 mg, a dose increase or decrease may be considered based on how treatment works and tolerability of the starting dose.

For more detailed instructions on how to take SIGNIFOR, including what to discuss with your healthcare provider before taking SIGNIFOR and how SIGNIFOR is used, see the Medication Guide.

Packaging

4 things to know about taking SIGNIFOR

SIGNIFOR is a self-administered injection. You’re not required to visit a healthcare professional’s office to receive treatment.

Your healthcare professional will train you or your caregiver on how to inject SIGNIFOR into your thigh or abdomen.

Refer to the SIGNIFOR Instructions for Use for detailed administration instructions.

If you have difficulty administering the injection(s), a nurse from the R.A.R.E.® Patient Support Program can provide extra training.

R.A.R.E.® Patient Support Program

Support along the way

The R.A.R.E. Patient Support Program is designed to make it easier for you to get and stay on your treatment. The steps to treatment success include:

Support for any Prior Authorization and Appeal requirement

Investigate patient insurance benefits

Coordinate co-pay assistance for eligible insured patients and help patients identify other financial assistance opportunities

Connect with a Patient Liaison (PL) from Recordati Rare Diseases once you opt-in, to help you on your treatment journeyb

Patient assistance is available for eligible patients who lack insurance and meet certain financial requirementsc

A dedicated R.A.R.E. Nurse Educator to answer your questions and support you in meeting your treatment goalsb

R.A.R.E. Patient Support

This program is administered in partnership with our specialty pharmacy. For assistance, contact R.A.R.E. Monday-Friday, 8:00 am-8:00 pm ET at 1-888-855-RARE (7273). A pharmacist is always available.

$20 copay

Co-pay program

Recordati Rare Diseases offers a $20 co-pay for qualified patients with commercial insurance.d

  • bThese services are provided at no additional cost to you by Recordati Rare Diseases. Information provided is for educational purposes only and is not intended to replace the care and advice of your healthcare providers.
  • cRestrictions, limitations, and/or eligibility requirements apply.
  • dEligibility requirements, restrictions and limitations apply.

A Patient Liaison is ready to help

Your health journey is uniquely your own, but you’re not alone. As part of the R.A.R.E Patient Support Program, you have access to a Recordati Rare Diseases Patient Liaison to help you with your treatment along the way.

Once you opt in, your Patient Liaisone will be there to:

  • Provide additional disease education
  • Answer questions about your medicine
  • Connect to additional resources regarding the disease
  • Listen with an empathetic ear

To enroll, complete the Patient Liaison Program Enrollment Opt-In Form.

Get Started

  • eThese services are provided at no additional cost to you by Recordati Rare Diseases. Information provided by the PL program is for educational purposes only and is not intended to replace the care and advice of your healthcare providers.

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:

  • have or have had high blood sugar (hyperglycemia)
  • have diabetes
  • have or have had heart problems

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:

  • 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.

Please see full Prescribing Information, including the Medication Guide.