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Rx Item-UDENYCA pegfilgrastim-cbqv 6 MG PFS 0.6 ML by COHERUS BIOSCIENCES

RX815100Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Rx Item-UDENYCA pegfilgrastim-cbqv 6 MG PFS 0.6 ML by COHERUS BIOSCIENCES

$6784.38$4499.00

UDENYCA pegfilgrastim-cbqv 6 MG PFS 0.6 ML by COHERUS BIOSCIENCES BIOSIMILAR TO NEULASTA. NDC No.n70114-0101-01 70114-101-01 7011410101 70114010101 UPC/GTIN No. 3-70114-10101-7 370114-101017 370114-101017 MPN No.010101 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist,& Pharmacist, PA, Physical Therapist, Podiatrist, Research Co., Uni., VA, Vet & Wholesalers In Scope Of their Practice Can Order Rx Item.

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For: Neutropenia Associated with Chemotherapy

Udenyca (pegfilgrastim-cbqv) is a PEGylated growth colony-stimulating factor biosimilar to Neulasta (pegfilgrastim) indicated to reduce the duration of febrile neutropenia in patients treated with chemotherapy.

FDA Approves Udenyca (pegfilgrastim-cbqv), a Biosimilar to Neulasta.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. These highlights do not include all the information needed to use UDENYCA safely and effectively. See full prescribing information for UDENYCA.

UDENYCA® (pegfilgrastim-cbqv) injection, for subcutaneous use

INITIAL U.S. APPROVAL: 2018

UDENYCA (pegfilgrastim-cbqv) is biosimilar* to Neulasta (pegfilgrastim) for the indications listed. (1)

* Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of UDENYCA has been demonstrated for the condition(s) of use (e.g. indication(s), dosing regimen(s), strength(s), dosage form(s), and route(s) of administration) described in its Full Prescribing Information.
INDICATIONS AND USAGE

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 a clinically significant incidence of febrile neutropenia. (1)

Limitations of Use
UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
DOSAGE AND ADMINISTRATION

Patients with cancer receiving myelosuppressive chemotherapy

6 mg administered subcutaneously once per chemotherapy cycle. (2.1)
Do not administer between 14 days before and 24 hours after administration of cytotoxic chemotherapy. (2.1)
Use weight based dosing for pediatric patients weighing less than 45 kg; refer to Table 1. (2.2)

DOSAGE FORMS AND STRENGTHS

Injection: 6 mg/0.6 mL in a single-dose prefilled syringe for manual use only. (3)
CONTRAINDICATIONS

Patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim products. (4)
WARNINGS AND PRECAUTIONS

Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture (5.1)
Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue UDENYCA in patients with ARDS. (5.2)
Serious allergic reactions, including anaphylaxis: Permanently discontinue UDENYCA in patients with serious allergic reactions. (5.3)
Fatal sickle cell crises: Have occurred. (5.4)
Glomerulonephritis: Evaluate and consider dose-reduction or interruption of UDENYCA if causality is likely. (5.5)

ADVERSE REACTIONS

Most common adverse reactions (? 5% difference in incidence compared to placebo) are bone pain and pain in extremity. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Coherus BioSciences at 1-800-4UDENYCA (1-800-483-3692) or FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 9/2019

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 2° to 8°C (36° to 46°F) in the carton to protect from light. Do not shake. Discard syringes 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.

RX815100
Rx Item-UDENYCA pegfilgrastim-cbqv 6 MG
RX815100

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
Rx Item-UDENYCA pegfilgrastim-cbqv 6 MG
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
AmericanPharmaWholesale.com
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop