Signifor LAR Signifor

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


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  • SIGNIFOR® LAR (pasireotide) is similar to a hormone your body makes, called somatostatin
  • Like somatostatin, SIGNIFOR LAR reduces the amount of growth hormone your body makes
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  • SIGNIFOR LAR is a long-acting–release treatment. This means that it continues to work in your body in the weeks after it is injected. It is given as a monthly injection by a trained healthcare provider

Acromegaly at a glance

Acromegaly is usually caused by a noncancerous pituitary tumor. The pituitary gland is a small, pea-sized gland at the base of your brain.

  • This tumor causes too much growth hormone (GH) to be made.
  • Too much GH causes your body to produce too much insulin-like growth factor 1 (IGF-1), which supports growth of bones and tissues
  • This overproduction of hormones over a long period of time causes the symptoms of acromegaly

SIGNIFOR LAR works by reducing the amount of GH and IGF-1 your body makes to help restore hormonal balance.

Piuitary gland diagram

Dosing

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

LEARN MORE ABOUT INJECTION WITH SIGNIFOR LAR

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.

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.