Drug updated on 9/4/2024
Dosage Form | Injection (subcutaneous; 0.3 mg/mL, 0.6 mg/mL, 0.9 mg/mL) |
Drug Class | Somatostatin 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
- 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 Title | Year | Source |
---|---|---|
Signifor (pasireotide) Prescribing Information. | 2020 | Recordati Rare Diseases Inc., Lebanon, NJ |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
A systematic literature review to evaluate extended dosing intervals in the pharmacological management of acromegaly. | 2023 | Pituitary |
Meningiomas and somatostatin analogs: a systematic scoping review on current insights and future perspectives. | 2023 | International Journal of Molecular Sciences |
Pasireotide-induced shrinkage in GH and ACTH secreting pituitary adenoma: a systematic review and meta-analysis | 2022 | Frontiers in Endocrinology |
Effectiveness of medical treatment of Cushing’s disease: a systematic review and meta-analysis. | 2021 | Frontiers in Endocrinology |
Target therapies plus somatostatin analogs in NETs: a network meta-analysis. | 2021 | Endocrine-Related Cancer |
Do somatostatin-analogues have the same impact on postoperative morbidity and pancreatic fistula in patients after pancreaticoduodenectomy and distal pancreatectomy? - A systematic review with meta-analysis of randomized-controlled trials. | 2020 | Pancreatology |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Second line treatment of acromegaly: pasireotide or pegvisomant? | 2022 | Best Practice & Research Clinical Endocrinology & Metabolism |
A pituitary society update to acromegaly management guidelines. | 2021 | Pituitary |
How to position pasireotide LAR Treatment in acromegaly | 2019 | The Journal of Clinical Endocrinology & Metabolism |
Diagnostics and treatment of acromegaly — updated recommendations of the Polish Society of Endocrinology. | 2019 | Endokrynoligia Polska |