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Pasireotide (Signifor Lar)

Trade Name : Signifor LAR

Novartis Pharmaceuticals Corporation

KIT

Strength

Delivery Process

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Pasireotide (Signifor Lar) which is also known as Signifor LAR and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of per ml. Read more

Pasireotide (Signifor Lar) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more
  • No data
  • No data
  • 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 Cushingu2019s disease for whom pituitary surgery is not an option or has not been curative. ()
  • No data
  • Evaluate fasting plasma glucose, hemoglobin A1c (HbA1c), liver enzyme tests, electrocardiogram (ECG), serum magnesium, and serum potassium prior to starting. ()nttttttttt
  • 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:ntttttttttn
  • Adjust dose based on response and tolerability. ()
  • Patients with Hepatic Impairment:ntttttttttn
  • Follow reconstitution and administration instructions. ()
  • SIGNIFOR LAR for injectable suspension: 10 mg, 20 mg, 30 mg, 40 mg, or 60 mg of slightly yellow to yellow powder in a vial and 2 mL diluent.
  • SIGNIFOR LAR for injectable suspension: 10 mg, 20 mg, 30 mg, 40 mg, and 60 mg, powder in a vial to be reconstituted with the provided 2 mL diluent. ()
  • None.
  • None. ()
  • No data
  • Hyperglycemia and Diabetes:
  • Bradycardia and QT Prolongation:
  • Liver Test Elevations:
  • Cholelithiasis and Complications of Cholelithiasis:
  • Pituitary Hormone Deficiency(ies):
  • Clinically significant adverse reactions that appear in other sections of the labeling include:ntttttt
  • Adverse drug reactions associated with SIGNIFOR LAR and occurring in u2265 20% of patients were diarrhea, cholelithiasis, hyperglycemia and diabetes mellitus. ()
  • No data
  • Drugs that Prolong QT:
  • Cyclosporine:
  • Bromocriptine:
  • No data
  • nttttttttttFemales and Males of Reproductive Potential
  • 8.3
  • In the event of overdosage, it is recommended that appropriate supportive treatment be initiated, as dictated by the patientu2019s clinical status, until resolution of the symptoms. ntttttt
  • Up-to-date information about the treatment of overdose can be obtained from a certified Regional Poison Center. In the event of an overdose, contact the National Capital Poison Center at 1-800-222-1222 or www.poison.org.ntttttt
  • SIGNIFOR LAR (pasireotide) for injectable suspension is a long-acting release form of pasireotide pamoate, as powder to be suspended in the provided diluent immediately prior to intramuscular injection. SIGNIFOR LAR contains pasireotide, a somatostatin analog in the form of pasireotide pamoate (pamoic acid salt). Pasireotide is a cyclohexapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin. Pasireotide pamoate has a chemical name of (2-Aminoethyl) carbamic acid (2R,5S,8S,11S,14R,17S,19aS)-11-(4-aminobutyl)-5-benzyl-8-(4-benzyloxybenzyl)-14-(1H-indol-3-ylmethyl)-4,7,10,13,16,19-hexaoxo-17-phenyloctadecahydro-3a,6,9,12,15,18-hexaazacyclopentacyclooctadecen-2-yl ester pamoic acid salt. ntttttt
  • The molecular formula of pasireotide pamoate is CHNO u2022 CHO and the molecular weight is 1435.58 g/mol.
  • The structural formula is:ntttttt
  • The drug product consists of pasireotide pamoate uniformly distributed within microspheres which are made of biodegradable copolymers of poly (D,L-lactide-co-glycolide) acids (PLGA).
  • SIGNIFOR LAR is available in a vial containing the sterile pasireotide pamoate, PLGA microspheres powder, 10 mg, 20 mg, 30 mg, 40 mg, and 60 mg to be reconstituted with the provided 2 mL sterile diluent.
  • Each vial contains:
  • Each diluent prefilled syringe contains: ntttttt
  • No data
  • Carcinogenesis
  • A lifetime carcinogenicity study was conducted in rats and transgenic mice. Rats were given daily subcutaneous doses of pasireotide at 0.01 mg/kg/day, 0.05 mg/kg/day, and 0.3 mg/kg/day for 104 weeks. There were no drug-related tumors in rats at exposures up to 5-times higher than the maximum recommended clinical exposure of the pasireotide LAR 60 mg dose. Mice were given subcutaneous doses of pasireotide at 0.5 mg/kg/day, 1 mg/kg/day, and 2.5 mg/kg/day for 26 weeks and did not identify any carcinogenic potential.
  • Mutagenesis
  • Pasireotide was not genotoxic in a battery of assays (Ames mutation test in and and mutation test in human peripheral lymphocytes). Pasireotide was not genotoxic in an rat bone marrow nucleus test.
  • Impairment of Fertility
  • Subcutaneous dosing at 0.1 mg/kg/day before mating and continuing into gestation in rats at exposures less than the human clinical exposure based on body surface area comparisons across species resulted in statistically significant increased implantation loss and decreased viable fetuses, corpora lutea, and implantation sites. Abnormal cycles or acyclicity were observed at 1 mg/kg/day (4-fold higher than the maximum therapeutic exposure of pasireotide LAR based on surface area, comparisons across species).
  • No data
  • No data
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Hyperglycemia and Diabetes
  • Bradycardia and QT Prolongation
  • Liver Test Elevations
  • Cholelithiasis and Complications of Cholelithiasis
  • Pituitary Hormone Deficiency(ies)
  • Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, NJ 07936ntttttt
  • T2019-53
  • T2019-54
  • PRINCIPAL DISPLAY PANEL
  • Package Label u2013 10 mg
  • Rx Only nttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0748-81
  • Signifor LAR (pasireotide)
  • For Injectable Suspension
  • For Intramuscular Use
  • PRINCIPAL DISPLAY PANEL
  • Package Label u2013 20 mg
  • Rx Only nttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0641-81
  • Signifor LAR (pasireotide)
  • For Injectable Suspension
  • For Intramuscular Use
  • PRINCIPAL DISPLAY PANEL
  • Package Label u2013 30 mg
  • Rx Only nttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0741-81
  • Signifor LAR (pasireotide)
  • For Injectable Suspension
  • For Intramuscular Use
  • PRINCIPAL DISPLAY PANEL
  • Package Label u2013 40 mg
  • Rx Only nttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0642-81
  • Signifor LAR (pasireotide)
  • For Injectable Suspension
  • For Intramuscular Use
  • PRINCIPAL DISPLAY PANEL
  • Package Label u2013 60 mg
  • Rx Only nttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0643-81
  • Signifor LAR (pasireotide)
  • For Injectable Suspension
  • For Intramuscular Use

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