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Molecule

Pasireotide

Somatostatin Analog
Available on requestOrphanCold chainEndocrinology
Presentations
4
Brands
2
Manufacturers
1
Available from stock
0

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, among other approved uses. MedsAcross supplies Pasireotide for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Somatostatin Analog, Somatostatin Receptor Agonists
ATC classification
H01CB05 Pasireotide · Hypothalamic hormones, subgroup H01CB
US FDA first approval
15 December 2014
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Subcutaneous
Dosage forms
Kit, Injection
Identifiers
UNII 98H1T17066RxCUI 1364105CAS 396091-73-9DrugBank DB06663Q3896970

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

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

Source: US FDA prescribing information

How it works

SIGNIFOR LAR is an injectable cyclohexapeptide, somatostatin analog. Pasireotide exerts its pharmacological activity via binding to somatostatin receptors (SSTR). There are 5 known human somatostatin receptor subtypes: SSTR 1, 2, 3, 4, and 5. These receptor subtypes are expressed in different tissues under normal physiological conditions. Somatostatin analogs bind to SSTRs with different potencies. Pasireotide binds with high affinity to 4 of the 5 SSTRs. Table 4 – Binding Affinities of Somatostatin (SRIF-14) and Pasireotide to the Five Human SSTR Subtypes (SSTR 1-5) Results are the mean + SEM of IC 50 values expressed as nmol/l (nM). Compound SSTR1 SSTR2 SSTR3 SSTR4 SSTR5 Somatostatin (SRIF-14) 0.93 ± 0.12 0.15 ± 0.02 0.56 ± 0.17 1.5 ± 0.4 0.29 ± Pasireotide 9.3 ± 0.1 1.0 ± 0.1 1.5 ± 0.3 > 100 0.16 ± 0.01

Source: US FDA prescribing information

Dosing overview

Evaluate fasting plasma glucose (FPG), hemoglobin A1c (HbA1c), liver enzyme tests, electrocardiogram (ECG), serum magnesium, and serum potassium prior to starting. Optimize glucose control in patients with poorly controlled diabetes mellitus prior to starting. Must be administered by a health care professional only by intramuscular injection in the right or left gluteus immediately after reconstitution. Initial Dose: Acromegaly: The initial dose is 40 mg by intramuscular injection once every 4 weeks (every 28 days). Cushing's Disease: The initial dose is 10 mg by intramuscular injection once every 4 weeks (every 28 days). Adjust dose based on response and tolerability. Patients with Hepatic Impairment: Child-Pugh B: Acromegaly: Recommended initial dose is 20 mg once every 4 weeks and maximum dose is 40 mg once every 4 weeks.

Source: US FDA prescribing information

Warnings and precautions

Hyperglycemia, Diabetes, and Ketoacidosis: Sometimes severe. Monitor glucose levels as clinically appropriate during therapy. Monitor glucose levels more frequently in the months that follow initiation or discontinuation of SIGNIFOR LAR therapy and following SIGNIFOR LAR dose adjustment. Use anti-diabetic treatment if indicated.If ketoacidosis is suspected, discontinue SIGNIFOR LAR and promptly evaluate and treat the patient. Bradycardia and QT Prolongation: 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. Cholelithiasis and Complications of Cholelithiasis: Monitor periodically. Discontinue if complications of cholelithiasis are suspected.

Source: US FDA prescribing information

Side effects

Clinically significant adverse reactions that appear in other sections of the labeling include: Hyperglycemia, Diabetes, and Ketoacidosis Bradycardia and QT Prolongation Liver Test Elevations Cholelithiasis and Complications of Cholelithiasis Pituitary Hormone Deficiency(ies) Steatorrhea and Malabsorption of Dietary Fats Adverse drug reactions associated with SIGNIFOR LAR and occurring in ≥ 20% of patients were diarrhea, cholelithiasis, hyperglycemia, and diabetes mellitus.

Source: US FDA prescribing information

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.

Source: US FDA prescribing information

Storage

Store at 2°C to 8°C (36°F-46°F). Do not freeze. SIGNIFOR LAR should be stored at refrigerated temperatures between 2°C to 8°C (36°F-46°F) until the time of use. Do not freeze. SIGNIFOR LAR drug product kit should remain at room temperature for a minimum of 30 minutes before reconstitution, but should not exceed 24 hours at room temperature.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

4 presentations of Pasireotide, sorted by availability.

MedicineManufacturerRegisterAvailability
Signifor LAR kit Cold chainRecordati Rare DiseasesUS FDAAvailable on request
Signifor 0.3 mg/1 mL injectionSubcutaneousRecordati Rare DiseasesUS FDAAvailable on request
Signifor 0.6 mg/1 mL injectionSubcutaneousRecordati Rare DiseasesUS FDAAvailable on request
Signifor 0.9 mg/1 mL injectionSubcutaneousRecordati Rare DiseasesUS FDAAvailable on request

Brands by market

2 brand names across 1 markets.

Brand names by country

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 15 December 2014Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Pasireotide in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Pasireotide available for export from India?

Yes, on request. MedsAcross lists 4 presentations of Pasireotide and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Pasireotide have?

The catalogue lists 2 brand names for Pasireotide, including Signifor, Signifor LAR.

Is Pasireotide approved by the US FDA?

Yes. The US FDA first approved Pasireotide on 15 December 2014, according to Drugs@FDA.

Is Pasireotide authorised in the European Union?

Yes. Pasireotide has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Pasireotide need cold chain shipping?

At least one listed presentation of Pasireotide must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

Which ATC class is Pasireotide in?

Pasireotide is classified under ATC code H01CB05 (Pasireotide).

References

  1. Signifor LAR prescribing information (Recordati Rare Diseases). U.S. National Library of Medicine, DailyMed. Retrieved 16 July 2024
  2. Signifor: European public assessment report (EPAR). European Medicines Agency. Retrieved 5 August 2026

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