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SIGNIFOR SOLUTION FOR INJECTION 0.3mg/ML

Product Information

Registration Status: Active

SIN14457P

SIGNIFOR SOLUTION FOR INJECTION 0.3mg/ML is approved to be sold in Singapore with effective from 2013-12-13. It is marketed by NOVARTIS (SINGAPORE) PTE LTD, with the registration number of SIN14457P.

This product contains Pasireotide 0.3mg in the form of INJECTION, SOLUTION. It is approved for SUBCUTANEOUS use.

This product is manufactured by Novartis Pharma Stein AG in SWITZERLAND.

It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Product Reference
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Description

Pasireotide is a synthetic long-acting cyclic hexapeptide with somatostatin-like activity. It is marketed as a diaspartate salt called Signifor, which is used in the treatment of Cushing's disease.

Indication

For the treatment of Cushing’s disease, specifically for those patients whom pituitary surgery has not been curative or is not an option.

Mechanism of Action

Pasireotide activates a broad spectrum of somatostatin receptors, exhbiting a much higher binding affinity for somatostatin receptors 1, 3, and 5 than octreotide in vitro, as well as a comparable binding affinity for somatostatin receptor 2. The binding and activation of the somatostatin receptors causes inhibition of ACTH secretion and results in reduced cortisol secretion in Cushing's disease patients. Also this agent is more potent than somatostatin in inhibiting the release of human growth hormone (HGH), glucagon, and insulin.

Pharmacokinetics

Absorption
The peak plasma concentration of pasireotide occurs in 0.25-0.5 hours. After administration of single and multiple doses, there is dose-proportionoal increases in Cmax and AUC.
Distribution
Pasireotide is widely distributed and has a volume of distribution of >100L.
Metabolism
Metabolism is minimal.
Elimination

Clearance

The clearance in healthy patient is ~7.6 L/h and in Cushing’s disease patients is ~3.8 L/h.

Toxicity

The most common toxic effects observed are hyperglycemia, cholelithiasis, diarrhea, nausea, headache, abdominal pain, fatigue, and diabetes mellitus.

Active Ingredient/Synonyms

cyclo((4R)-4-(2-aminoethylcarbamoyloxy)-L-prolyl-L-phenylglycyl-D-tryptophyl-L-lysyl-4-O-benzyl-L-tyrosyl-L- phenylalanyl-) | Pasireotida | Pasiréotide | Pasireotidum | Pasireotide |


Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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