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Prescribing Information
SIGNIFOR LAR (pasireotide) for injectable suspension
For US Healthcare Professionals Only

SIGNIFOR LAR (pasireotide) for injectable suspension Signifor

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Prevalence and Impact ACROMEGALY IS A RARE DISEASE

Often referred to as somatotroph adenoma or growth hormone excess, acromegaly is a chronic metabolic disorder caused by the presence of too much growth hormone.4

About 25,000 Patients in the U.S.

About 25,000 patients in the U.S.5

3,000 New Cases Per Year

3,000 new cases per year5

Affects Men and Women Equally

Affects men and women equally6

Becomes More Common with Age

Becomes more common with increasing age6

Causes and risk factors

Acromegaly is caused by abnormal production of growth hormone after normal growth of the skeleton and other organs is complete. In children, too much growth hormone causes a condition called gigantism rather than acromegaly.4

The cause of the increased hormone secretion is usually a benign tumor of the pituitary gland. The pituitary gland, which is located just below the brain, controls the production and release of several different hormones including growth hormone.4

There are no known risk factors for acromegaly other than a prior history of a pituitary tumor.4

Symptoms of acromegaly

The most common symptom of acromegaly is abnormal growth of the hands and feet.7

With swelling of the hands and feet being an early symptom of the condition, people with acromegaly might notice that their rings or shoes have become too tight. Over time, as the bones continue to grow, facial features begin to change, with the brow and lower jaw becoming more prominent, the bone of the nose becoming larger, and the teeth developing spaces between them. Acromegaly can also lead to arthritis, carpal tunnel syndrome, and enlargement of the internal organs, including the heart.7

Additional symptoms may include7:

  • Joint aches
  • Headaches
  • Impaired vision
  • Fatigue
  • Weakness
  • Thickening of the skin
  • Oily skin
  • Skin tags
  • Enlargement of the lips, nose, and tongue
  • Deepening of the voice
  • Sleep apnea
  • Excessive sweating
  • Skin odor
  • Abnormal menstrual cycles
  • Breast discharge in women
  • Erectile dysfunction in men
  • Decreased libido
DID YOU KNOW?

The word acromegaly comes from the Greek words “acro,” meaning extremities, and “megaly,” meaning enlargement.

Diagnosing and treating acromegaly

It varies by person and level of severity.

In addition to a full physical exam and a consult around symptoms, a medical evaluation may include the following steps to diagnose acromegaly:

  • An IGF-1 measurement
  • Growth hormone suppression test
  • Imaging

Regarding treatment, the goal is to restore the pituitary gland to normal function, producing normal levels of growth hormone. Surgery to remove the pituitary tumor is the treatment recommended for most patients with acromegaly; but while surgery is successful in many patients, some will see their levels of GH and IGF-1 remain too high even after surgery.

Non-surgical treatments may include radiation therapy, and injection of growth hormone blocking medications. But left untreated, acromegaly can lead to worsening diabetes mellitus and hypertension, among other risks.

Unmet needs in the treatment of acromegaly exist. Learn more

INDICATIONS AND USAGE

SIGNIFOR LAR® (pasireotide) is a somatostatin analog indicated for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option.

IMPORTANT SAFETY INFORMATION

Hyperglycemia, Diabetes, and Ketoacidosis: SIGNIFOR LAR can cause increases in blood glucose levels which are sometimes severe. Monitor glucose levels as clinically appropriate during therapy. There have been postmarketing cases of ketoacidosis with SIGNIFOR LAR in patients with or without history of diabetes. Patients with poor baseline glycemic control are at higher risk of developing severe hyperglycemia. Patients who develop significant hyperglycemia on SIGNIFOR LAR may require initiation of anti-diabetic treatment or adjustment in their current anti-diabetic treatment. The optimal treatment for the management of SIGNIFOR LAR-induced hyperglycemia is not known. If hyperglycemia cannot be controlled despite medical management, reduce the dose or discontinue SIGNIFOR LAR. Patients who present with signs and symptoms consistent with severe metabolic acidosis should be assessed for ketoacidosis regardless of diabetes history. If ketoacidosis is suspected, discontinue SIGNIFOR LAR and promptly evaluate and treat the patient.

INDICATIONS AND USAGE

SIGNIFOR LAR® (pasireotide) is a somatostatin analog indicated for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option.

IMPORTANT SAFETY INFORMATION

Hyperglycemia, Diabetes, and Ketoacidosis: SIGNIFOR LAR can cause increases in blood glucose levels which are sometimes severe. Monitor glucose levels as clinically appropriate during therapy. There have been postmarketing cases of ketoacidosis with SIGNIFOR LAR in patients with or without history of diabetes. Patients with poor baseline glycemic control are at higher risk of developing severe hyperglycemia. Patients who develop significant hyperglycemia on SIGNIFOR LAR may require initiation of anti-diabetic treatment or adjustment in their current anti-diabetic treatment. The optimal treatment for the management of SIGNIFOR LAR-induced hyperglycemia is not known. If hyperglycemia cannot be controlled despite medical management, reduce the dose or discontinue SIGNIFOR LAR. Patients who present with signs and symptoms consistent with severe metabolic acidosis should be assessed for ketoacidosis regardless of diabetes history. If ketoacidosis is suspected, discontinue SIGNIFOR LAR and promptly evaluate and treat the patient.

Bradycardia and QT Prolongation: Bradycardia has been reported with the use of SIGNIFOR LAR. Patients with cardiac disease and/or risk factors for bradycardia, such as history of clinically significant bradycardia, high grade heart block, or concomitant use of drugs associated with bradycardia, should be monitored. Adjustments in the dose of drugs known to slow the heart rate (e.g., beta-blockers, calcium channel blockers) and correction of electrolyte disturbances may be necessary when initiating or during the course of SIGNIFOR LAR treatment. In cardiac electrophysiology studies with pasireotide via subcutaneous route, QT prolongation occurred at therapeutic and supra-therapeutic doses. Use with caution in patients at significant risk; evaluate ECG and electrolytes prior to dosing and periodically while on treatment. Hypokalemia or hypomagnesemia must be corrected prior to initiating SIGNIFOR LAR and should be monitored periodically during therapy.

Liver Test Elevations: Increases in liver enzymes have been observed with SIGNIFOR LAR. Evaluate liver enzyme tests prior to and during treatment.

Cholelithiasis and Complications of Cholelithiasis: There have been reports of cholelithiasis resulting in complications including cholecystitis or cholangitis and requiring cholecystectomy in patients taking SIGNIFOR LAR. Monitor periodically. Discontinue SIGNIFOR LAR if complications of cholelithiasis are suspected and treat appropriately.

Pituitary Hormone Deficiency(ies): Suppression of anterior pituitary hormones may occur on SIGNIFOR LAR. Monitor for occurrence periodically and treat if clinically indicated.

Steatorrhea and Malabsorption of Dietary Fats: New onset steatorrhea, stool discoloration, loose stools, abdominal bloating, and weight loss may occur. If new occurrence or worsening of these symptoms are reported, evaluate for potential pancreatic exocrine insufficiency.

The most common adverse reactions occurring in ≥ 20% of patients with acromegaly were diarrhea, hyperglycemia, cholelithiasis, and diabetes mellitus.

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

Drug Interactions

Females and Males of Reproductive Potential: Advise premenopausal females of the potential for an unintended pregnancy.

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 the accompanying full Prescribing Information and Patient Information.

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