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Signifor LAR Signifor

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How SIGNIFOR LAR works

SIGNIFOR® LAR (pasireotide) is the first and only proven long-acting treatment that works in the pituitary gland to help reduce cortisol and calm the signs and symptoms of Cushing’s disease.

  • Cushing’s disease is caused by a benign tumor in the pituitary gland, called a pituitary adenoma, that can throw off the balance of hormone production
  • The pituitary gland is an organ of the endocrine system that releases hormones that regulate the functions of other endocrine glands
  • In people who develop this type of tumor, their bodies make too much of a certain hormone called cortisol
  • Excess cortisol causes the biological problems associated with Cushing’s disease
Piuitary gland diagram

SIGNIFOR LAR directly targets the pituitary gland tumor

by activating key receptors that are most responsible for excess cortisol to help reduce the amount produced.

Signifor LAR for Cushing’s disease

SIGNIFOR LAR is the first and only long-acting treatment that works directly in the pituitary gland, where the hormone that causes the excess cortisol is produced. SIGNIFOR LAR is a treatment for adult patients with Cushing’s disease for whom pituitary surgery has not worked well enough or who cannot have surgery.

What SIGNIFOR LAR does

~40% achieved normal cortisol levels

Approximately 40% of patients receiving SIGNIFOR LAR in a clinical study had their levels of the hormone cortisol return to normal. Although some patients did not return to normal, there were also patients who had their cortisol levels drop by at least 50%.

SIGNIFOR LAR has also been shown to help improve the signs and symptoms of Cushing’s disease, including decreases in weight, waist circumference, body mass index, and blood pressure.

Decreases in weight
Waist circumference
Body mass index
Blood pressure

SIGNIFOR LAR dosing

for patients with Cushing’s disease

1 INJECTION EVERY 4 WEEKS (28 DAYS)

SIGNIFOR LAR must be given by a trained healthcare provider as an injection into the left or right muscle of your buttocks (intramuscularly).

Your healthcare provider will tell you:

  • How much SIGNIFOR LAR will be administered and when you will receive it
  • If and when a change of dose is needed or if a change is needed in the amount of time between your scheduled injections
  • How long you need to receive SIGNIFOR LAR
Calendar

1 INJECTION EVERY 4 WEEKS (28 DAYS)

What should I tell my healthcare provider before receiving SIGNIFOR LAR?

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Before you receive SIGNIFOR LAR, tell your healthcare provider about all of your medical conditions, including if you:

  • Have high blood sugar (hyperglycemia)
  • Have diabetes
  • Have or have had heart problems, including an abnormal heart rate or rhythm or problems with the electrical system of your heart (QT prolongation)
  • Have a low level of potassium or magnesium in your blood
  • Have liver problems
  • Have gallstones (cholelithiasis)
  • Are pregnant or plan to become pregnant. It is not known if SIGNIFOR LAR will harm your unborn baby
  • Are breastfeeding or plan to breastfeed. It is not known if SIGNIFOR LAR passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take SIGNIFOR LAR

Treatment with SIGNIFOR LAR may result in improved fertility and the possibility of unplanned pregnancy in women who have Cushing’s disease and have not gone through menopause. Talk to your healthcare provider about birth control methods that may be right for you during treatment with SIGNIFOR LAR.

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

SIGNIFOR LAR and other medicines may affect each other, causing side effects. SIGNIFOR LAR may affect the way other medicines work, and other medicines may affect how SIGNIFOR LAR works. Your healthcare provider may need to change your dose of SIGNIFOR LAR or your other medicines. Especially tell your healthcare provider if you take:

  • Medicines to control your heart beat (antiarrhythmics)
  • Medicines to control your blood pressure (such as 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
  • Bromocriptine

Ask your healthcare provider for a list of these medicines if you are not sure.

Know the medicines you take, and keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Diagram
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How will I receive SIGNIFOR LAR?

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  • SIGNIFOR LAR must be given by a trained healthcare provider as an injection into the muscle of your buttocks (intramuscularly)
  • Your healthcare provider will tell you how much SIGNIFOR LAR you will receive and when you will receive it
  • Your healthcare provider may change your dose of SIGNIFOR LAR or the length of time between your injections. Your healthcare provider will tell you how long you need to receive SIGNIFOR LAR
  • Before you receive SIGNIFOR LAR for the first time, your healthcare provider should do a blood test to check your fasting blood sugar level, hemoglobin A1c level, electrolyte levels, and your liver function
  • You will need to check your blood sugar levels during treatment with SIGNIFOR LAR, especially after you start treatment with SIGNIFOR LAR and after your dose is increased. Your healthcare provider will tell you how often you should check your blood sugar levels
  • Before you receive SIGNIFOR LAR for the first time and during your treatment, your healthcare provider should do a test to check your heart (electrocardiogram)
  • If you miss a dose of SIGNIFOR LAR, you may receive your missed dose up to 14 days before your next dose
  • It is important that you keep your scheduled appointments with your healthcare provider during treatment with SIGNIFOR LAR
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Most common side effects
of SIGNIFOR LAR 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 an 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. 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.

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Indications and Usage

SIGNIFOR LAR (pasireotide) is used to help treat:

Important Safety Information:

Indications and Usage

SIGNIFOR LAR® (pasireotide) is used to help treat:

Important Safety Information:


Please see full Prescribing Information.

Please report negative 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.