Pasireotide

SIGNIFOR is an injectable cyclohexapeptide somatostatin analogue. Pasireotide exerts its pharmacological activity via binding to somatostatin receptors (SSTRs).

• SIGNIFOR is a somatostatin analog indicated for the treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative ( 1 ) 1.1 Cushing's Disease SIGNIFOR is indicated for the treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative.

• None.contraindicated

Recommended initial dosage is either 0.6 mg or 0.9 mg by subcutaneous injection twice a day; recommended dosage range is 0.3 mg to 0.9 mg twice a day ( 2.1 ) Titrate dosage based on treatment response [clinically meaningful reduction in 24-hour urinary free cortisol (UFC) and/or improvements in signs and symptoms of disease] and tolerability ( 2.1 ) Testing Prior to Dosing : fasting plasma glucose (FPG), hemoglobin A1c (HbA1c), liver tests, electrocardiogram (ECG), gallbladder ultrasound, and serum potassium and magnesium levels ( 2.2 ) Patients With Hepatic Impairment : Child-Pugh B: Recommended initial dosage is 0.3 mg twice a day and maximum dosage is 0.6 mg twice a day ( 2.3 , 8.6 ) Child-Pugh C: Avoid use in these patients ( 2.3 , 8.6 ) 2.1 Recommended Dosage Range The recommended dosage range of SIGNIFOR is 0.3 mg to 0.9 mg by subcutaneous injection twice a day. The recommended initial dose is either 0.6 mg or 0.9 mg twice a day. Titrate dose based on response and tolerability. Patients should be evaluated for a treatment response [clinically meaningful reduction in 24-hour urinary free cortisol (UFC) levels and/or improvement in signs or symptoms of the disease] and should continue receiving therapy with SIGNIFOR as long as benefit is derived [see Clinical Studies (14)] . Maximum UFC reduction is typically seen by two months of treatment [see Clinical Studies (14)] .

Hypocortisolism : Decreases in circulating levels of cortisol may occur resulting in biochemical and/or clinical hypocortisolism. SIGNIFOR dose reduction or interruption and/or adding a low-dose short-term glucocorticoid may be necessary ( 5.1 ) Hyperglycemia and Diabetes (occurs with initiation) : Intensive glucose monitoring is recommended and may require initiation or adjustment of anti-diabetic treatment per standard of care ( 5.2 ) Bradycardia and QT Prolongation : Use with caution in at-risk patients; ECG testing prior to dosing and on treatment ( 5.3 , 7.1 ) Liver Test Elevations : Evaluate liver tests prior to and during treatment ( 5.4 ) Cholelithiasis and Complications of Cholelithiasis : Monitor periodically. Discontinue if complications of cholelithiasis are suspected ( 5.5 ) 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 ( 5.7 ) 5.1 Hypocortisolism Treatment with SIGNIFOR leads to suppression of adrenocorticotropic hormone (ACTH) secretion in Cushing's disease. Suppression of ACTH may lead to a decrease in circulating levels of cortisol and potentially hypocortisolism. Monitor and instruct patients on the signs and symptoms associated with hypocortisolism (e.g., weakness, fatigue, anorexia, nausea, vomiting, hypotension, hyponatremia, or hypoglycemia).

Clinically significant adverse reactions that appear in other sections of the labeling include: Hypocortisolism [see Warnings and Precautions (5.1)] Hyperglycemia and Diabetes [see Warnings and Precautions (5.2)] Bradycardia and QT prolongation [see Warnings and Precautions (5.3)] Liver Test Elevations [see Warnings and Precautions (5.4)] Cholelithiasis and Complications of Cholelithiasis [see Warnings and Precautions (5.5)] Pituitary Hormone Deficiency [see Warnings and Precautions (5.6)] Steatorrhea and Malabsorption of Dietary Fats [see Warnings and Precautions (5.7) ] Most common adverse reactions occurring in ≥ 20% of patients are diarrhea, nausea, hyperglycemia, cholelithiasis, headache, abdominal pain, fatigue, and diabetes mellitus ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases at 1-888-575-8344 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. A total of 162 Cushing's disease patients were exposed to SIGNIFOR in the Phase III study [see Clinical Studies (14)] . At study entry, patients were randomized to receive twice a day doses of either 0.6 mg or 0.9 mg of SIGNIFOR given subcutaneously. The mean age of patients was approximately 40 years old with a predominance of female patients (78%).

Females and Males of Reproductive Potential : Advise premenopausal females of the potential for an unintended pregnancy ( 8.3 ) Safety and effectiveness of SIGNIFOR in children under 18 years have not been established ( 8.4 ) 8.1 Pregnancy Risk Summary The limited data with SIGNIFOR in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In embryo-fetal development studies in rabbits, findings indicating developmental delay were observed with subcutaneous administration of pasireotide during organogenesis at doses less than the exposure in humans at the highest recommended dose; maternal toxicity was not observed at this dose (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. Data Animal Data In embryo-fetal development studies in rats given 1, 5, and 10 mg/kg/day subcutaneously throughout organogenesis, maternal toxicity was observed at all doses, including the lowest dose tested which had exposures 4 times higher than that at the maximum therapeutic dose based on area under the curve (AUC) comparisons across species.

Metabolism

In healthy volunteers, pasireotide demonstrates approximately linear pharmacokinetics (PK) for a dose range from 0.0025 to 1.5 mg. In Cushing's disease patients, pasireotide demonstrates linear dose-exposure relationship in a dose range from 0.3 mg to 1.2 mg.

No cases of overdosage have been reported in patients with Cushing's disease receiving SIGNIFOR subcutaneously. Doses up to 2.1 mg twice a day have been used in healthy volunteers with adverse reactions of diarrhea being observed at a high frequency. In the event of overdosage, it is recommended that appropriate supportive treatment be initiated, as dictated by the patient's clinical status, until resolution of the symptoms. Up-to-date information about the treatment of overdose can be obtained from a certified Regional Poison Center. Contact Poison Control (1-800-222-1222) for latest recommendations.

• Dec 14, 2012NDANDA200677Recordati Rare
• Dec 15, 2014NDANDA203255Recordati Rare

1. 1Blood Glucose Increased25712%
2. 2Hyperglycaemia24311%
3. 3Diabetes Mellitus24211%
4. 4Nausea22410%
5. 5Diarrhoea2069.4%
6. 6Fatigue1999.1%
7. 7Headache1727.8%
8. 8Off Label Use1647.5%
9. 9Drug Ineffective1567.1%
10. 10Dizziness1255.7%
11. 11Vomiting1225.6%
12. 12Asthenia974.4%
13. 13Weight Decreased944.3%
14. 14Blood Pressure Increased904.1%
15. 15Abdominal Pain833.8%

The 10 most recently updated of 86 ClinicalTrials.gov registrations naming Pasireotide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET
  Recruiting · Phase 3 · Interventional · 240 enrolled · Novartis Pharmaceuticals
  NCT06784752updated 2026-04-30
• A Study of Pasireotide in People With Prolactinoma
  Recruiting · Phase 2 · Interventional · 10 enrolled · Memorial Sloan Kettering Cancer Center
  NCT06295952updated 2026-03-04
• Study in Healthy Subjects to Investigate the Relative Bioavailability and Safety of Pasireotide After Single Subcutaneous Dose Administration Using a Reusable ServoPen With Cartridge as Compared to Administration Using a Syringe Drawn From an Ampule
  Completed · Phase 1 · Interventional · 40 enrolled · RECORDATI GROUP
  NCT07312643updated 2026-02-04
• Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET
  Active not recruiting · Phase 3 · Interventional · 226 enrolled · Advanced Accelerator Applications
  NCT03972488updated 2026-01-21
• Reduction by Pasireotide of the Effluent Volume in High-output Enterostomy in Patients Refractory to Usual Medical Treatment
  Completed · Phase 2 · Interventional · 57 enrolled · Hospices Civils de Lyon
  NCT02713776updated 2025-12-19
• Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia
  Active not recruiting · Phase 2 · Interventional · 93 enrolled · RECORDATI GROUP
  NCT05928390updated 2025-09-22
• Effects of Pasireotide Lar Therapy on Bone Metabolism
  Recruiting · Observational · 120 enrolled · Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  NCT07179926updated 2025-09-18
• Pasireotide (SOM230) With or Without Everolimus in Treating Patients With Hormone Resistant, Chemotherapy Naive Prostate Cancer
  Terminated · Phase 2 · Interventional · 6 enrolled · Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
  NCT01313559updated 2025-04-30
• A Study in Healthy Subjects to Assess the Safety, Tolerability, PK and PD of HTL0030310
  Completed · Phase 1 · Interventional · 42 enrolled · Nxera Pharma UK Limited
  NCT03847207updated 2025-02-19
• Pasireotide as Maintenance Treatment in Synovial Sarcoma and Desmoplastic Small Round Cell Tumor
  Recruiting · Phase 2 · Interventional · 28 enrolled · University Hospital Heidelberg
  NCT06456359updated 2025-01-13

Frequently asked questions

How does Pasireotide work?

SIGNIFOR is an injectable cyclohexapeptide somatostatin analogue. Pasireotide exerts its pharmacological activity via binding to somatostatin receptors (SSTRs).

What is Pasireotide used for?

According to FDA labeling, Pasireotide carries indications including: SIGNIFOR is a somatostatin analog indicated for the treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative ( 1 ) 1.1 Cushing's Disease SIGNIFOR is indicated for the treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Pasireotide?

Pasireotide is classified as Somatostatin and analogues, Somatostatin Analog, Somatostatin Receptor Agonists, Decreased Adrenocorticotropic Hormone Secretion, Decreased Glucocorticoid Secretion.

What are the brand names for Pasireotide?

Pasireotide is marketed under brand names including Signifor.

What are the contraindications for Pasireotide?

Pasireotide labeling lists contraindications including: None.. Always consult the full prescribing information and a clinician.