Resources | SIGNIFOR® LAR (pasireotide)

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R.A.R.E. Patient Support Program start form

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Patient resources

Cushing’s disease overview brochure

SIGNIFOR LAR patient brochure

Symptom and self-monitoring diary

FAQs

Find answers to frequently asked questions about SIGNIFOR LAR.

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Helpful links

The following websites can provide you with more information about Cushing’s disease.

The Endocrine Society

The Hormone Foundation

Hormone Health Network

National Adrenal Diseases Foundation

National Institute of Diabetes and Digestive and Kidney Diseases

National Institutes of Health

National Organization for Rare Disorders

Pituitary Network Association

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

Patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative

Important Safety Information

Warnings and Precautions

Hyperglycemia and Diabetes: SIGNIFOR LAR (pasireotide) can cause increases in blood glucose levels which are sometimes severe. Patients who develop significant hyperglycemia on SIGNIFOR LAR (pasireotide) may require initiation of anti-diabetic therapy or adjustment in their current anti-diabetic therapy per standard of care. The optimal treatment for the management of SIGNIFOR LAR (pasireotide)-induced hyperglycemia is not known. If hyperglycemia cannot be controlled despite medical management, the dose of SIGNIFOR LAR (pasireotide) should be reduced or SIGNIFOR LAR (pasireotide) should be discontinued

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

Patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative

Important Safety Information

Warnings and Precautions

Bradycardia and QT Prolongation: Bradycardia has been reported with the use of SIGNIFOR LAR (pasireotide). 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 (pasireotide) treatment. Use with caution in at-risk patients; evaluate ECG and electrolytes prior to dosing and periodically while on treatment

Liver Test Elevations: Evaluate liver enzyme tests prior to and during treatment. Please see sections 2.1, 5.3 in full Prescribing Information

Cholelithiasis and Complications of Cholelithiasis: Monitor periodically. Discontinue if complications of cholelithiasis are suspected. Please see section 5.4 in full Prescribing Information

Pituitary Hormone Deficiency(ies): Monitor for occurrence periodically and treat if clinically indicated. Please see section 5.5 in full Prescribing Information

Adverse Reactions

Adverse drug reactions associated with SIGNIFOR LAR (pasireotide) and occurring in ≥20% of patients were diarrhea, cholelithiasis, hyperglycemia 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

Drugs that Prolong QT: Use with caution in patients who are at significant risk of developing QTc prolongation

Cyclosporine: Consider additional monitoring

Bromocriptine: Consider bromocriptine dose reduction

Females and Males of Reproductive Potential

Advise premenopausal females of the potential for an unintended pregnancy

Signifor

Help settle the storm

Find valuable resources to help you support your patients during their treatment

R.A.R.E. Patient Support Program start form

Patient resources

FAQs

Helpful links

Indications and Usage

Important Safety Information

Warnings and Precautions

Indications and Usage

Important Safety Information

Warnings and Precautions

Adverse Reactions

Drug Interactions

Females and Males of Reproductive Potential

Help settle the storm

Find valuable resources to help you support your patients during their treatment

R.A.R.E. Patient Support Program start form

Patient resources

FAQs

Helpful links

Indications and Usage

Important Safety Information

Warnings and Precautions

Indications and Usage

Important Safety Information

Warnings and Precautions

Adverse Reactions

Drug Interactions

Females and Males of Reproductive Potential

Contact a Recordati Rare Diseases Representative

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