Pasireotide

(Signifor®)

Pasireotide

Drug updated on 9/4/2024

Dosage FormInjection (subcutaneous; 0.3 mg/mL, 0.6 mg/mL, 0.9 mg/mL)
Drug ClassSomatostatin analogs
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • 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.
  • Indicated for the treatment of patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative.

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Summary
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  • Signifor (pasireotide) is 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, and for the treatment of patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative.
  • This summary is based on the review of six systematic review(s)/meta-analysis(es). [1-6]
  • Maintenance of Normal IGF-I in Acromegaly: Normal IGF-I levels were maintained in ≥70% of patients using lanreotide autogel/depot, octreotide long-acting release, and pegvisomant monotherapy. Normal IGF-I was achieved in ≥70% of patients using LAN and pegvisomant combined with SRLs.
  • Tumor Shrinkage in Acromegaly and Cushing’s Disease (CD): Significant tumor shrinkage was observed with pasireotide in 37.7% (95% CI: [18.7%; 61.5%]) of acromegalic patients and 41.2% (95% CI: [22.9%; 62.3%]) of CD patients.
  • Proportion of CD Control: CD control was achieved in 44% of patients with pasireotide (95% CI: 25-35%, eight studies, 522 participants), lower than metyrapone (66%) and osilodrostat (66.4%), but higher than cabergoline (35%) and similar to ketoconazole (41%).
  • Safety profiles in adults with acromegaly were similar between extended dosing intervals and standard regimens, with no significant differences observed.
  • Adverse effects of somatostatin analogs in patients with inoperable or recurrent meningioma were sparse and not detailed.
  • Safety data for acromegaly and Cushing’s Disease patients were not detailed in the studies.
  • In patients with Cushing’s Disease, the most frequent adverse event with pasireotide was hyperglycemia, while cabergoline and metyrapone commonly caused dizziness and nausea, and ketoconazole was associated with elevated transaminases.
  • In patients undergoing pancreatic surgery, somatostatin analogs reduced morbidity and postoperative pancreatic fistula after distal pancreatectomy but did not affect mortality or intra-abdominal abscesses.
  • Population types include adults with acromegaly, patients with inoperable or recurrent meningioma (severely ill as potential last-option treatment), patients with acromegaly and Cushing’s Disease, patients with Cushing’s Disease, patients with gastro-entero-pancreatic neuroendocrine tumors (stratified by functioning and non-functioning NETs), and patients undergoing pancreatic resection (stratified by type of resection: PD and DP).

Product Monograph / Prescribing Information

Document TitleYearSource
Signifor (pasireotide) Prescribing Information.2020Recordati Rare Diseases Inc., Lebanon, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines