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{{customText[Do you worry about your patients with acromegaly adhering to treatment? | You want what's best for your patients with acromegaly, and managing GH and IGF-1 levels requires ongoing support.¹ | Are your patients with acromegaly truly controlled on a first-generation somatostatin analog (SSA)? | There are several sources that provide guidance to help you manage GH and IGF-1 levels in your patients with acromegaly. | Is your patient with acromegaly responding optimally to treatment? | You may be concerned about your patient with acromegaly experiencing changes in blood glucose levels. | SIGNIFOR^® LAR (pasireotide) for injectable suspension targets the most relevant somatostatin receptors in GH-secreting pituitary adenomas.¹ | There is a second-generation somatostatin analog monotherapy treatment option that provides once monthly dosing for your patients with acromegaly. | Do you have patients with acromegaly who have had an inadequate response to surgery or for whom surgery is not an option? Maybe you have a patient with acromegaly who is inadequately controlled with a first-generation somatostatin analog (SSA)?]}}

Not achieving biochemical control can leave your patients with acromegaly at high risk of complications and even mortality.¹ On average, 45% of patients do not experience GH or IGF-1 control despite medical treatment with first-generation SSAs.²

SIGNIFOR^® LAR (pasireotide) for injectable suspension was proven effective in the largest randomized head-to-head trial comparing two SSAs. In a Phase III, multicenter, parallel group, three-arm study in patients previously uncontrolled on a first-generation SSA, patients receiving SIGNIFOR LAR were more likely to achieve biochemical control vs an active comparator.³ Biochemical control was achieved by 15% of patients in the 40 mg group and 20% of patients in the 60 mg group vs 0% of patients in the active comparator group.³ Additionally, 81% and 70% of patients treated with SIGNIFOR LAR 40 mg and 60 mg, respectively, had either a reduction or no change in tumor volume at Month 6.⁴

In a Phase III, multicenter, randomized, two-arm study in drug-naïve patients, patients taking SIGNIFOR LAR were 63% more likely to achieve biochemical control at 12 months compared with the active comparator.⁵ Furthermore, 98% of drug-naïve patients had a reduction in or no change in tumor volume from baseline at Month 12.⁴

In addition, patients in both studies receiving SIGNIFOR LAR had reduced headache, fatigue, perspiration, paresthesia, and osteoarthralgia.4,6 Drug-naïve patients receiving SIGNIFOR LAR also had reduced ring size.⁴


Download PDF	TARGETING THE MOST RELEVANT SOMATOSTATIN RECEPTORS Learn what makes SIGNIFOR LAR different from first-generation SSAs.¹ Reference: 1. Signifor LAR [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2014.


Download PDF	PROVEN CONTROL IN 2 PIVOTAL TRIALS Learn about the largest randomized active comparator controlled trials in acromegaly.^1,2 Reference: 1. Colao A, Bronstein MD, Freda P, et al. Pasireotide versus octreotide in acromegaly: a head-to-head superiority study. J Clin Endocrinol Metab. 2014;99(3):791-799. 2. Gadelha MR, Bronstein MD, Brue T, et al. Pasireotide versus continued treatment with octreotide or lanreotide in patients with inadequately controlled acromegaly (PAOLA): a randomized, phase 3 trial. Lancet Diabetes Endocrinol. 2014;2(11):875-884. doi:10.1016/S2213-8587(14)


Download PDF	TREATMENT MANAGEMENT APPROACHES Learn about management strategies for patients on SIGNIFOR LAR.


Download PDF	COMPREHENSIVE PATIENT SUPPORT Your patients may get the support they need with patient support programs offered by Novartis Pharmaceuticals Corporation. Sign up here.


Download PDF	CONVENIENT DOSING SIGNIFOR LAR offers a convenient dosing schedule – once every 4 weeks – to help ensure adherence.¹ Reference: 1. Signifor LAR [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2014..


Download PDF	ACROMEGALY GUIDELINES OVERVIEW Consistent monitoring of GH and IGF-1 levels are crucial to acromegaly treatment.¹ Learn more about managing acromegaly. Reference: 1. Katznelson L, Laws ER Jr, Melmed S, et al. Acromegaly: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2014;99(11):3933-3951. doi:10.1210/jc.2014-2700.

INDICATION AND IMPORTANT SAFETY INFORMATION

SIGNIFOR^® LAR (pasireotide) for injectable suspension, for intramuscular use

INDICATION
SIGNIFOR LAR 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
Warnings and Precautions:

•	Hyperglycemia and Diabetes: SIGNIFOR LAR can cause increases in blood glucose levels which are sometimes severe. Patients with poor baseline glycemic control are at higher risk of developing severe hyperglycemia. A majority of patients, including those with normal glucose tolerance, pre-diabetes, and diabetes, experienced increased glucose levels within the first 2 to 3 months of treatment with SIGNIFOR LAR. Fasting plasma glucose and hemoglobin A1c should be assessed prior to starting treatment with SIGNIFOR LAR. In patients with poorly controlled diabetes mellitus, anti-diabetic treatment should be optimized before SIGNIFOR LAR treatment is started. Blood glucose monitoring should be done weekly for the first 3 months after initiating SIGNIFOR LAR and the first 4 to 6 weeks after dose increases. Periodic monitoring should continue thereafter, as clinically appropriate. Patients who develop significant hyperglycemia on SIGNIFOR LAR may require initiation of anti-diabetic therapy(ies) or adjustment in the dose or type of anti-diabetic therapy(ies) per standard of care. The optimal treatment for the management of SIGNIFOR LAR-induced hyperglycemia is not known. If hyperglycemia cannot be controlled, despite medical management, the dose of SIGNIFOR LAR should be reduced or discontinued. After treatment discontinuation, fasting plasma glucose and hemoglobin A1c should be assessed if indicated. Patients on anti-diabetic therapy discontinuing SIGNIFOR LAR may require more frequent blood glucose monitoring and anti-diabetic dose adjustment to mitigate the risk of hypoglycemia.

•	Bradycardia and QT Prolongation Bradycardia 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. QT Prolongation SIGNIFOR LAR is associated with QT prolongation and should be used with caution in patients who are at significant risk of developing prolongation of the QT interval. A baseline ECG is recommended prior to initiating therapy with SIGNIFOR LAR 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. ALT or AST elevation greater than 3 times the upper limit of normal (ULN) were observed in 3% of patients and ALT or AST elevation greater than 5 times the upper limit of normal (ULN) were observed in 1% of patients treated with SIGNIFOR LAR. Assessment of liver function is recommended prior to treatment with SIGNIFOR LAR, and after the first 2 to 3 weeks, then monthly for 3 months. Thereafter, liver function should be monitored as clinically indicated. Patients who develop increased transaminase levels should be monitored until values return to pre-treatment levels. Treatment with SIGNIFOR LAR should be discontinued if signs or symptoms suggestive of clinically significant liver impairment develop.

•	Cholelithiasis: Cholelithiasis was reported in up to 33% of patients treated with SIGNIFOR LAR in clinical trials. Patients should be monitored periodically.

•	Pituitary Hormone Deficiency(ies): Suppression of pituitary hormones other than GH/IGF-1, may occur on SIGNIFOR LAR. Monitoring pituitary function (e.g., thyroid, adrenal, gonadal) prior to initiation of therapy with SIGNIFOR LAR, as well as periodically during treatment, as clinically appropriate, is recommended. Patients should be monitored for and instructed on the signs and symptoms of adrenal insufficiency during therapy. If adrenal insufficiency is suspected it should be confirmed and treated per standard of care with exogenous glucocorticoids at replacement doses.

Adverse Reactions
Adverse reactions associated with SIGNIFOR LAR and occurring in ≥20% of patients were diarrhea, cholelithiasis, hyperglycemia, and diabetes mellitus.

Drug Interactions
Caution is advised when co-administering drugs that prolong the QT interval with SIGNIFOR LAR.

The following drugs may require monitoring and possible dose adjustment when used with SIGNIFOR LAR: cyclosporine and bromocriptine.

Contraindications
None

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References: 1. Biermasz NR, Dekker FW, Pereira AM, et al. Determinants of survival in treated acromegaly in a single center: predictive value of serial insulin-like growth factor I measurements. J Clin Endocrinol Metab. 2004;89(6):2789-2796. 2. Carmichael, JD, Bonert VS, Nuño M, Ly D, Melmed S. Acromegaly clinical trial methodology impact on reported biochemical efficacy rates of somatostatin receptor ligand treatments- a meta-analysis. J Clin Endocrinol Metab. 2014;99(5):1825-1833. doi:10.1210/jc.2013-3757. 3. Gadelha MR, Bronstein MD, Brue T, et al. Pasireotide versus continued treatment with octreotide or lanreotide in patients with inadequately controlled acromegaly (PAOLA): a randomized, phase 3 trial. Lancet Diabetes Endocrinol. 2014;2(11):875-884. doi:10.1016/S2213-8587(14)70169-X. 4. SIGNIFOR Lar [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2014. 5. Colao A, Bronstein MD, Freda P, et al. Pasireotide versus octreotide in acromegaly: a head-to-head superiority study. J Clin Endocrinol Metab. 2014;99(3):791-799. 6. Gadelha MR, Bronstein MD, Brue T, et al. Supplementary Appendix. Lancet Diabetes Endocrinol. 2014;2(11):1-9. doi:10.1016/S2213-8587(14)70169-X.

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