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Signifor LAR Signifor

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HOW SIGNIFOR LAR works

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Watch to learn more

Acromegaly is usually caused by a noncancerous pituitary tumor. This tumor causes too much growth hormone to be made. SIGNIFOR® LAR (pasireotide) binds most strongly to the hormone receptors that are most commonly found on the pituitary tumor.

This video can tell you more about what this means. It also describes what happens when you have acromegaly, and how SIGNIFOR LAR works in your body.

SIGNIFOR LAR binds to key receptors on the pituitary tumor to help lower levels of growth hormone (GH) and insulin-like growth factor 1 (IGF-1) in the body

What SIGNIFOR LAR does

SIGNIFOR LAR was shown in clinical studies to reduce GH and normalize IGF-1 levels in some patients with acromegaly.

In a 12-month study

  • Patients who had not been previously treated with any acromegaly drug were given either SIGNIFOR LAR or another standard acromegaly treatment
  • The goal of this study was to show if SIGNIFOR LAR could help patients achieve biochemical control—defined as reduced GH and IGF-1 levels at the 12-month mark—compared with the other standard treatment
  • SIGNIFOR LAR helped significantly more patients achieve biochemical control at 12 months (31% vs 19%)
  • This study also showed that, after 12 months of treatment, some patients who received SIGNIFOR LAR achieveda:
    • Reduction in tumor size
    • Reduction in ring size
    • Improvements in other symptoms of acromegaly, such as headache, fatigue, sweating, skin tingling or numbness, and bone and joint pain
Ring
Headache
Sweating
Bone pain

aThese were secondary end points. This means that these findings were not the main focus of the study.



In a 24-week study

  • Patients who had tried other standard treatments previously and whose acromegaly was still not well controlled either continued their treatment or were given SIGNIFOR LAR (40-mg or 60-mg dose)
  • The goal of this study was to see how many patients achieved biochemical control (defined as reduced GH and IGF-1 levels at the 24-week mark)
  • A greater number of patients who received either dose of SIGNIFOR LAR achieved biochemical control (defined as reduced GH and normalized IGF-1) compared to patients who continued to receive their previous treatment

SIGNIFOR LAR dosing

for patients with acromegaly

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 (pasireotide), 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 acromegaly 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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What should I know about SIGNIFOR LAR?

As with any medicine, 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 healthcare provider to address any concerns.

SIGNIFOR LAR may cause serious side effects, including

  • High blood sugara (also known as hyperglycemia), diabetesa, or increased ketones in your urine or blood (ketoacidosis)
  • Slow heart rate (also known as bradycardia)
  • Changes in the electrical system of your heart (also known as QT interval prolongation)
  • Higher than normal liver function tests
  • Gallstonesa (also known as cholelithiasis) and complications that can happen when you have gallstones
  • Low levels of pituitary hormones (also known as pituitary insufficiency)

aThese are serious but common side effects of SIGNIFOR LAR.

More information about side effects can be found in the Patient Information section of the full Prescribing Information.

Read more about side effects.

The 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

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of SIGNIFOR LAR. For more information about side effects, ask your healthcare provider or pharmacist or refer to the Patient Information section of the 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.

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What is SIGNIFOR LAR?

SIGNIFOR LAR is a prescription medicine used to treat people with acromegaly for whom surgery has not worked well enough or who cannot have surgery. It is not known if SIGNIFOR LAR is safe and effective for use in children.


IMPORTANT SAFETY INFORMATION

Before starting SIGNIFOR LAR, tell your healthcare provider (HCP) about all your medical conditions, including if you:

INDICATION(S) AND IMPORTANT SAFETY INFORMATION


What is SIGNIFOR LAR?


SIGNIFOR LAR is a prescription medicine used to treat people with acromegaly for whom surgery has not worked well enough or who cannot have surgery.


It is not known if SIGNIFOR LAR is safe and effective for use in children.


IMPORTANT SAFETY INFORMATION


Before starting SIGNIFOR LAR, tell your healthcare provider (HCP) about all your medical conditions, including if you:


Females and Males of Reproductive Potential: Treatment with SIGNIFOR LAR may result in improved fertility and the possibility of unplanned pregnancy in females who have acromegaly or 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.


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


SIGNIFOR LAR and other medicines may affect each other, causing side effects. 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), your blood pressure (beta-blockers or calcium channel blockers), 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.


What are the possible side effects of SIGNIFOR LAR?


SIGNIFOR LAR may cause serious side effects including:


The 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 level of the creatine phosphokinase (CPK) enzyme in your blood, tiredness, stomach bloating, high blood pressure, back pain.


These are not all the possible side effects of SIGNIFOR LAR. Call your HCP 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 LAR® (pasireotide) for injectable suspension, for intramuscular use, is available as 10 mg, 20 mg, 30 mg, 40 mg, and 60 mg powder in a vial to be reconstituted with the provided 2 mL diluent.


Please see full Prescribing Information and Patient Information.