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Pasireotide (Signifor)

Trade Name : Signifor

Novartis Pharmaceuticals Corporation

INJECTION

Strength 0.3 mg/mL

PASIREOTIDE Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA]

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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) which is also known as Signifor and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 0.3 mg/mL per ml. Read more

Pasireotide (Signifor) 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

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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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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.

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  • No data
  • No data
  • SIGNIFOR is indicated for the treatment of adult patients with Cushingu2019s diseaseu00a0for whom pituitary surgery is not an option or has not been curative.
  • SIGNIFOR is a somatostatin analog indicated for the treatment of adult patients with Cushingu2019s disease for whom pituitary surgery is not an option or has not been curativeu00a0()
  • No data
  • 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 ()nttttttttt
  • 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 ()nttttttttt
  • Testing Prior to Dosing
  • Patients With Hepatic Impairment
  • Injection: 0.3 mg/mL, 0.6 mg/mL, and 0.9 mg/mL in a single-dose, 1 mL colorless glass ampule.
  • Injection:u00a00.3 mg/mL, 0.6 mg/mL, and 0.9 mg/mL in a single-dose ampule ()
  • None.
  • None ()
  • No data
  • Hypocortisolism
  • Hyperglycemia and Diabetesu00a0(occurs with initiation)
  • Bradycardia and QT Prolongation
  • Liver Test Elevations
  • Cholelithiasis and Complications of Cholelithiasis
  • Clinically significant adverse reactions that appear in other sections of the labeling include:
  • Most common adverse reactions occurring in u2265 20% of patients are diarrhea, nausea, hyperglycemia, cholelithiasis, headache,u00a0abdominal pain, fatigue,u00a0and diabetes mellitusu00a0()
  • No data
  • Drugs that Prolong QT
  • Cyclosporine
  • Bromocriptine
  • No data
  • Females and Males of Reproductive Potential
  • Safety and effectiveness of SIGNIFOR in children under 18 years have not been established ()nttttttttt
  • No cases of overdosage have been reported in patients with Cushingu2019s 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 patientu2019s 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.u00a0Contact Poison Control (1-800-222-1222) for latest recommendations.
  • SIGNIFOR (pasireotide) injection is prepared as a sterile solution of pasireotide diaspartate in a tartaric acid buffer for administration by subcutaneous injection. SIGNIFOR is a somatostatin analog. Pasireotide diaspartate, chemically known as (2-Aminoethyl)u00a0carbamic 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, di[(S)-2-aminosuccinic acid] salt, is a cyclohexapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin.
  • The molecular formula of pasireotide diaspartate is CHNO u2022 2 CHNO and the molecular weight is 1313.41 g/mol. The structural formula is:
  • SIGNIFOR is supplied as a sterile solution in a single-dose, 1 mL colorless glass ampule containing pasireotide in 0.3u00a0mg/mL, 0.6 mg/mL, or 0.9 mg/mL strengths for subcutaneous injection.
  • Each glass ampule contains:
  • No data
  • Carcinogenesis
  • A life-time carcinogenicity study was conducted in rats and transgenic mice.u00a0Rats were given daily subcutaneous doses of pasireotide at 0.01, 0.05, 0.3 mg/kg/day for 104 weeks.u00a0There were no drug-related tumors in rats at exposures up to 7-fold higher than the maximum recommended clinical exposure at the 1.8 mg/day dose.u00a0Mice were given subcutaneous doses of pasireotide at 0.5, 1.0, 2.5 mg/kg/day for 26 weeks and did not identify any carcinogenic potential.
  • Mutagenesis
  • Pasireotide was not genotoxic in a battery of in vitro assays (Ames mutation test in and and mutation test in human peripheral lymphocytes). Pasireotide was not genotoxic in an in vivo 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 (5-fold higher than the maximum therapeutic exposure based on surface area, comparisons across species).
  • A Phase III, multicenter, randomized study was conducted to evaluate the safety and efficacy of two dose levels of SIGNIFOR over a 6-month treatment period in Cushingu2019s disease patients with persistent or recurrent disease despite pituitary surgery or patients for whom surgery was not indicated or who had refused surgery.
  • Patients with a baseline 24-hour urine free cortisol (UFC) >1.5 x ULN were randomized to receive a SIGNIFOR dosage of either 0.6 mg subcutaneous twice a day or 0.9u00a0mg subcutaneousu00a0twice a day. After 3 months of treatment, patients with a mean 24-hour UFC u2264 2.0 x ULN and below or equal to their baseline values continued blinded treatment at the randomized dose until Month 6. Patients who did not meet these criteria were unblinded and the dose was increased by 0.3 mg twice a day. After the initial 6 months in the study, patients entered an additional 6-month open-label treatment period. The dosage could be reduced by 0.3u00a0mg twice a day at any time during the study for intolerability.
  • A total of 162 patients were enrolled in this study. The majority of patients were female (78%) and had persistent or recurrent Cushingu2019s disease despite pituitary surgery (83%) with a mean age of 40 years. A few patients (4%) in either treatment group received previous pituitary irradiation. The median value of the baseline 24-hour UFC for all patients was 565 nmol/24 hours (normal range 30 to 145 nmol/24 hours). About two-thirdsu00a0of all randomized patients completed 6 months of treatment.
  • The primary efficacy endpoint was the proportion of patients who achieved normalization of mean 24-hour UFC levels after 6 months of treatment and did not dose increase during this period.
  • 24-Hour Urinary Free Cortisol Results
  • At Month 6, the percentages of responders for the primary endpoint were 15% and 26% in the 0.6 mg twice a day and 0.9 mg twice a day groups, respectively (Table 3).u00a0The percentages of patients with mUFC u2264 ULN or u2265 50% reduction from baseline, a less stringent endpoint than the primary endpoint, were 34% in the 0.6 mg twice a day and 41% in the 0.9 mg twice a day groups.u00a0Dose increases appeared to have minimal effect on 24-hour UFC response. Mean and median percentage changes in UFC from baseline are presented in Table 3.
  • SIGNIFOR resulted in a decrease in the mean 24-hour UFC after 1 month of treatment (Figure 1).u00a0For patients (n = 78) who stayed in the trial, similar UFC lowering was observed at Month 12.
  • Note: Only patients who completed 6 months of treatment are included in this analysis (n = 110). The reference line is the ULN for UFC, which is 145 nmol/24hour; +/-Standard errors are displayed.
  • Other Endpoints
  • Decreases from baseline for blood pressure were observed at Month 6, including patients who did not receive any anti-hypertensive medication. However, due to the fact that the study allowed initiation of anti-hypertensive medication and dose increases in patients already receiving such medications, the individual contribution of SIGNIFOR or of anti-hypertensive medication adjustments cannot be clearly established.
  • The mean decreases from baseline at Month 6 for weight, body mass index, and waist circumference were 4.4 kg, 1.6 kg/m and 2.6 cm, respectively.u00a0Individual patients showed varying degrees of improvement in Cushing's disease manifestations, but because of the variability in response and the absence of a control group in this trial, it is uncertain whether these changes could be ascribed to the effects of SIGNIFOR.
  • SIGNIFOR is supplied as a single dose, colorlessu00a0glass ampule packaged in a box of 60 ampules, arranged in 10 packs of 6 ampules each. The following packaging configurations are available.
  • 0.3 mg/1 mL pasireotide (as diaspartate)
  • Box of 60 ampulesnttu00a0u00a0u00a0u00a0u00a0ntNDC# 0078-0633-20
  • 0.6 mg/1 mL pasireotide (as diaspartate)n- u00a0
  • Box of 60 ampulesnttu00a0u00a0u00a0u00a0u00a0ntNDC# 0078-0634-20
  • 0.9 mg/1 mL pasireotide (as diaspartate)n- u00a0
  • Box of 60 ampulesnttu00a0u00a0u00a0u00a0u00a0ntNDC# 0078-0635-20
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0C-30u00b0C (59u00b0F-86u00b0F), protect from light.
  • See FDA approved patient labeling (Medication Guide and Instructions for Use).
  • Counsel patients on the following possible significant adverse reactions:
  • Instruct the patients
  • For instructions on the use of SIGNIFOR glass ampules, refer to the Medication Guide that follows.
  • **Trademark of Thomson Healthcare, Inc.
  • Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, NJ 07936
  • T2020-01
  • T2020-02
  • Instructions for Use
  • SIGNIFORn- Arrayn- [sig-na-for]
  • (pasireotide)
  • Injection
  • Supplies you will need to give your SIGNIFOR injection:
  • Getting started:
  • Step 1:
  • Step 2:
  • Step 3:
  • Do not
  • Ampules should be opened just prior to administration and any unused portion discarded.
  • Step 4:
  • nttu00a0u00a0u00a0u00a0u00a0ntttttttn
  • Injecting your SIGNIFOR dose:
  • After injecting your SIGNIFOR dose:
  • This Instructions for Use has been approved by the U.S. Food and Drug Administration.u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Revised: January 2019
  • Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, NJ 07936
  • T2019-25
  • PRINCIPAL DISPLAY PANEL
  • Package Label u2013 n- 0.3 mg/mL
  • Rx Onlynttu00a0u00a0u00a0u00a0u00a0nnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0633-20Signiforu00ae (pasireotide)u00a0Injection0.3 mg/mLFor subcutaneous use onlyDispense with enclosed Medication Guide.60 ampules (10 packs of 6 ampules)
  • PRINCIPAL DISPLAY PANEL
  • Package Label u2013 n- 0.6 mg/mL
  • Rx Onlynttu00a0u00a0u00a0u00a0u00a0nnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0634-20Signiforu00ae (pasireotide)u00a0Injection0.6 mg/mLFor subcutaneous use onlyDispense with enclosed Medication Guide.60 ampules (10 packs of 6 ampules)
  • PRINCIPAL DISPLAY PANEL
  • Package Label u2013 n- 0.9 mg/mL
  • Rx Onlynttu00a0u00a0u00a0u00a0u00a0nnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0635-20Signiforu00ae (pasireotide)u00a0Injection0.9 mg/mLFor subcutaneous use onlyDispense with enclosed Medication Guide.60u00a0ampules (10 packs of 6 ampules)

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