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Pegfilgrastim-Cbqv (Udenyca)

Trade Name : UDENYCA

Coherus BioSciences Inc

INJECTION, SOLUTION

Strength 6 mg/.6mL

PEGFILGRASTIM Granulocyte Colony-Stimulating Factor [CS],Granulocyte-Macrophage Colony-Stimulating Factor [CS],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC]

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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 Pegfilgrastim-Cbqv (Udenyca) which is also known as UDENYCA and Manufactured by Coherus BioSciences Inc. It is available in strength of 6 mg/.6mL per ml. Read more

Pegfilgrastim-Cbqv (Udenyca) 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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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.

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  • No data
  • UDENYCA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia .
  • Limitations of Use
  • UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
  • UDENYCA is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with anclinically significant incidence of febrile neutropenia. ()n n
  • Limitations of Use
  • Patients with cancer receiving myelosuppressive chemotherapy
  • 6 mg administered subcutaneously once per chemotherapy cycle. ()
  • Do not administer between 14 days before and 24 hours after administration of cytotoxic chemotherapy. ()
  • Use weight based dosing for pediatric patients weighing less than 45 kg; refer to . ()
  • Injection: 6 mg/0.6 mL clear, colorless, preservative-free solution in a single-dose prefilled syringe for manual use only.
  • Injection: 6 mg/0.6 mL in a single-dose prefilled syringe fornmanual use only. ()
  • UDENYCA is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis .
  • Patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim products. ()
  • No data
  • Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture ()
  • Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue UDENYCA in patients with ARDS. ()
  • Serious allergic reactions, including anaphylaxis: Permanently discontinue UDENYCA in patients with serious allergic reactions. ()
  • Fatal sickle cell crises: Have occurred. ()
  • Glomerulonephritis: Evaluate and consider dose-reduction or interruption of UDENYCA if causality is likely. ()
  • The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
  • Most common adverse reactions (u2265 5% difference in incidence compared to placebo) are bone pain and pain in extremity. ()
  • No data
  • Overdosage of pegfilgrastim products may result in leukocytosis and bone pain. Events of edema, dyspnea, and pleural effusion have been reported in a single patient who administered pegfilgrastim on 8 consecutive days in error. In the event of overdose, the patient should be monitored for adverse reactions .
  • Pegfilgrastim-cbqv is a covalent conjugate of recombinant methionyl human G-CSF andnmonomethoxypolyethylene glycol. Recombinant methionyl human G-CSF is a water-soluble, 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kDa). Recombinant methionyl human G-CSF is obtained from the bacterial fermentation of a strain of transformed with a genetically engineered plasmid containing the human G-CSF gene. During the pegfilgrastim-cbqv manufacturing process, fermentation is carried out in nutrient medium containing the antibiotic kanamycin. However, kanamycin is cleared in the manufacturing process and is not detectable in the final product. To produce pegfilgrastim-cbqv, a 20 kDa monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of recombinant methionyl human G-CSF. The average molecular weight of pegfilgrastim-cbqv is approximately 39 kDa.
  • UDENYCA (pegfilgrastim-cbqv) injection is supplied in 0.6 mL prefilled syringes for manual subcutaneous injection. The prefilled syringe does not bear graduation marks and is designed to deliver the entire contents of the syringe (6 mg/0.6 mL).
  • Each syringe contains 6 mg pegfilgrastim-cbqv (based on protein weight) in a sterile, clear, colorless, preservative-free solution (pH 4.0) containing acetate (0.35 mg), polysorbate 20 (0.02 mg), sodium (0.02 mg), and sorbitol (30 mg) in Water for Injection, USP.
  • No data
  • Carcinogenesis, Mutagenesis, Impairment of Fertility
  • No carcinogenicity or mutagenesis studies have been performed with pegfilgrastim products.
  • Pegfilgrastim did not affect reproductive performance or fertility in male or female rats at cumulative weekly doses approximately 6 to 9 times higher than the recommended human dose (based on body surface area).
  • Patients with Cancer Receiving Myelosuppressive Chemotherapy
  • Pegfilgrastim was evaluated in three randomized, double-blind, controlled studies. Studies 1 and 2 were active-controlled studies that employed doxorubicin 60 mg/m and docetaxel 75 mg/m administered every 21 days for up to 4 cycles for the treatment of metastatic breast cancer. Study 1 investigated the utility of a fixed dose of pegfilgrastim. Study 2 employed a weight-adjusted dose. In the absence of growth factor support, similar chemotherapy regimens have been reported to result in a 100% incidence of severe neutropenia (ANC < 0.5 x 10/L) with a mean duration of 5 to 7 days and a 30% to 40% incidence of febrile neutropenia. Based on the correlation between the duration of severe neutropenia and the incidence of febrile neutropenia found in studies with filgrastim, duration of severe neutropenia was chosen as the primary endpoint in both studies, and the efficacy of pegfilgrastim was demonstrated by establishing comparability to filgrastim-treated patients in the mean days of severe neutropenia.
  • In Study 1, 157 patients were randomized to receive a single subcutaneous injection of pegfilgrastim (6 mg) on day 2 of each chemotherapy cycle or daily subcutaneous filgrastim (5 mcg/kg/day) beginning on day 2 of each chemotherapy cycle. In Study 2, 310 patients were randomized to receive a single subcutaneous injection of pegfilgrastim (100 mcg/kg) on day 2 or daily subcutaneous filgrastim (5 mcg/kg/day) beginning on day 2 of each chemotherapy cycle.
  • Both studies met the major efficacy outcome measure of demonstrating that the mean days of severe neutropenia ofnpegfilgrastim-treated patients did not exceed that of filgrastim-treated patients by more than 1 day in cycle 1 of chemotherapy. The mean days of cycle 1 severe neutropenia in Study 1 were 1.8 days in the pegfilgrastim arm compared to 1.6 days in the filgrastim arm [difference in means 0.2 (95% CI -0.2, 0.6)] and in Study 2 were 1.7 days in the pegfilgrastim arm compared to 1.6 days in the filgrastim arm [difference in means 0.1 (95% CI -0.2, 0.4)].
  • A secondary endpoint in both studies was days of severe neutropenia in cycles 2 through 4 with results similar to those for cycle 1.
  • Study 3 was a randomized, double-blind, placebo-controlled study that employed docetaxel 100 mg/m administered every 21 days for up to 4 cycles for the treatment of metastatic or non-metastatic breast cancer. In this study, 928 patients were randomized to receive a single subcutaneous injection of pegfilgrastim (6 mg) or placebo on day 2 of each chemotherapy cycle. Study 3 met the major trial outcome measure of demonstrating that the incidence of febrile neutropenia (defined as temperature u2265 38.2u00b0C and ANC u2264 0.5 x10/L) was lower for pegfilgrastim-treated patients as compared to placebo-treated patients (1% versus 17%, respectively, p < 0.001). The incidence of hospitalizations (1% versus 14%) and IV anti-infective use (2% versus 10%) for the treatment of febrile neutropenia was also lower in the pegfilgrastim-treated patients compared to the placebo-treated patients.
  • Study 4 was a multicenter, randomized, open-label study to evaluate the efficacy, safety, and pharmacokinetics of pegfilgrastim in pediatric and young adult patients with sarcoma. Patients with sarcoma receiving chemotherapy age 0 to 21 years were eligible. Patients were randomized to receive subcutaneous pegfilgrastim as a single dose of 100 mcg/kg (n= 37) or subcutaneous filgrastim at a dose 5 mcg/kg/day (n=6) following myelosuppressive chemotherapy. Recovery of neutrophil counts was similar in the pegfilgrastim and filgrastim groups. The most common adverse reaction reported was bone pain.
  • UDENYCA (pegfilgrastim-cbqv) injection is a clear, colorless, preservative-free solution supplied in a prefilled single-dose syringe with an UltraSafe Passive Needle Guard, containing 6mg of pegfilgrastim-cbqv.
  • The needle cap of the prefilled syringe is not made with natural rubber latex.
  • UDENYCA is provided in a dispensing pack containing one 6 mg/0.6 mL prefilled syringe (NDC 70114-101-01).
  • UDENYCA prefilled syringe does not bear graduation marks and is intended only to deliver the entire contents of the syringe (6 mg/0.6 mL) for direct administration. Use of the prefilled syringe is not recommended for direct administration for pediatric patients weighing less than 45 kg who require doses that are less than the full contents of the syringe.
  • Store refrigerated between 2u00b0 to 8u00b0C (36u00b0 to 46u00b0F) in the carton to protect from light. Do not shake. Discardnsyringes stored at room temperature for more than 48 hours. Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard syringe if frozen more than once.
  • Advise the patient to read the FDA-approved patient labeling ( and )
  • Advise patients of the following risks :
  • Instruct patients who self-administer UDENYCA using the single-dose prefilled syringe of the:
  • CoherusBioSciences
  • UDENYCA (pegfilgrastim-cbqv)
  • Manufactured by:
  • u00a9 2019 Coherus BioSciences Inc. All rights reserved.
  • For more information, go to or call 1-800-4UDENYCA (1-800-483-3692)
  • PMD-0004, Rev. 03
  • CoherusBioSciences
  • UDENYCA (pegfilgrastim-cbqv)n Coherus BioSciences, Inc., Redwood City, California 94065-1442U.S. License No. 2023u00a9 2019 Coherus BioSciences Inc. All rights reserved.
  • For more Information go to or call 1-800-4UDENYCA (1-800-483-3692)
  • PMD-0005, Rev. 02
  • u00a0
  • No data
  • Carton Label - One 6 mg/0.6 mL Single-Dose Prefilled Syringe - UDENYCA
  • PRINCIPAL DISPLAY PANEL
  • CoherusBioSciences
  • 6 mg/0.6 mL
  • NDC 70114-101-01n
  • UDENYCAn pegfilgrastim-cbqvInjection
  • Rx Only
  • 6 mg in 0.6 mL Single-Dose PrefilledSyringeFor Subcutaneous UseSterile Solution - No Preservative
  • Pegylated RecombinantMethionyl Human GranulocyteColony-Stimulating Factor (PEG-r-metHuG-CSF) derivedfrom n
  • One 6 mg/0.6 mL single-dosePrefilled Syringe

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