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Udenyca- Pegfilgrastim-Cbqv Injection, Solution 6Mg/0.6Ml

  • Manufacturer Name : COHERUS BIOSCIENCES INC
  • MFG # : 70114010101
  • NDC : 70114010101
  • Distributor Name : AmeriSource Bergen
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Product Information

NDC Package Code70114-101-01
Proprietary NameUdenyca
Non-Proprietary NamePegfilgrastim-cbqv
Package1 SYRINGE in 1 CARTON (70114-101-01) / .6 mL in 1 SYRINGE
Dosage FormINJECTION, SOLUTION
RouteSUBCUTANEOUS
Active Ingredient Strength6
Active Ingredient Unitsmg/.6mL
Substance NamePEGFILGRASTIM

Description

UDENYCA is a leukocyte growth factor indicated to : 1 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. (1.1), 2 Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). (1.2).

Pegfilgrastim-cbqv is a covalent conjugate of recombinant methionyl human G-CSF and monomethoxypolyethylene 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 E coli 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 as a 0.6 mL prefilled single-dose autoinjector or a 0.6 mL prefilled single-dose syringe 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). The UDENYCA prefilled autoinjector delivers the entire contents (6mg in 0.6mL) in a single injection and is not adjustable. Each single-dose prefilled syringe or prefilled autoinjector 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.

Product Properties:

Description -
DESI Drug Ind -
DESI2 Drug Ind NR
Drug Category -
Drug Type Code S
FDA Approval Date 01/03/2019
FDA Therap Equiv ML
HCPCS Udenyca inj, 0.5 mg
Market Entry Date -
Medical Coverage Q5111
Termination Date 1
Unit -
Units Per Pkg 11/02/2018
Active Ingredients 17832 pegfilgrastim-cbqv
AHFS Class 20160000 HEMATOPOIETIC AGENTS
DEA Class NC
Dose Form SYRINGE (ML)
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 79223 pegfilgrastim-cbqv SUBCUT SYRINGE 6 MG/0.6ML
Inactive Ingredients 2551 polysorbates 9005645; 2599 sorbitol 50704
OMP Family -
Product Category RX Pharmaceuticals
Strength 6MG
Common Brand Name COMMON BRAND NAME(S): Fulphila, Fylnetra, Neulasta, Nyvepria, Stimufend, Udenyca, Ziextenzo
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Pegfilgrastim is very similar to filgrastim. Do not use a filgrastim product while using a pegfilgrastim product. This medication may interfere with certain lab tests (such as bone imaging tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
Allocation Period -
Case Quantity 35
Drug Form Pack Size -
Form PRE-FILLED SYRINGE
Hazard Code -
Listed Chemical -
NIOSH Code -
Orange Book ZB Particular pharmaceutical entity was not evaluated.
Retail Pack Quantity 1
Returnable Status Returnable
Special Storage Cond 00 None
Temp Zone 30 Refrige./DoNot Freez
Unit EA
Unit Size 0.6
How to Use HOW TO USE: Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using pegfilgrastim and each time you get a refill. If you have any questions, ask your doctor or pharmacist. This medication is given by injection under the skin as directed by your doctor. For use during chemotherapy, it is usually given once during each chemotherapy cycle. However, it should not be given within 14 days before or 24 hours after chemotherapy. Ask your doctor for specific directions about when to use this medication. For use after radiation exposure, pegfilgrastim is usually given for 2 doses, one week apart. The dosage and schedule are based on your medical condition and response to treatment. Children's dosage is also based on weight. If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package. Before use, take the medication out of the refrigerator. Let it warm up to room temperature, usually for at least 30 minutes. Do not heat this medication any other way, such as by heating in the microwave or placing in hot water. Do not shake this medication. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the injection site with rubbing alcohol. Change where you inject each time to lessen injury under the skin. Do not inject pegfilgrastim into skin that is bruised, tender, red, hard, or that has scars, moles, or stretch marks. Learn how to store and discard medical supplies safely.
Missed Dose MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.
Notes NOTES: Do not share this medication with others. Lab and/or medical tests (such as complete blood count, kidney function) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Phonetic Pronunciation (PEG-fil-GRA-stim)
Precautions PRECAUTIONS: Before using pegfilgrastim, tell your doctor or pharmacist if you are allergic to it; or to any pegfilgrastim or filgrastim products; or to eflapegrastim; or if you have any other allergies. This product may contain inactive ingredients (such as dry natural rubber/latex in the needle cover on the prefilled syringe), which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: sickle cell disease, spleen problems. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. This medication may pass into breast milk. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Aching or pain in the bones and muscles may occur. Taking a non-aspirin pain reliever such as acetaminophen may help relieve pain. Ask your doctor or pharmacist for more details. Redness, swelling, itching, or bruising at the injection site may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: pink/bloody urine, easy bleeding/bruising, fever, fast heartbeat, purple/red spots on your skin, back pain. Get medical help right away if you have any very serious side effects, including: breathing problems (such as trouble breathing, shortness of breath, fast breathing), unusual decrease in urination, unusual tiredness, swelling/puffiness of the body. Rarely, serious (possibly fatal) damage to the spleen may occur. Get medical help right away if you develop stomach/abdominal pain or shoulder pain. Rarely, this medication may increase the risk of developing a certain bone marrow disorder (myelodysplastic syndrome-MDS) or blood cancer (acute myeloid leukemia-AML) in people with breast or lung cancer who are receiving chemotherapy/radiation. Ask your doctor for more details. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage STORAGE: Store this medication in the refrigerator. Keep the medication in the original package to protect from light. Do not freeze or shake. If this medication is taken out of the refrigerator, use or discard it within the time directed in your product package. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Uses USES: Pegfilgrastim is a man-made version of a certain natural substance made by your body. It is used to help your body make more white blood cells. White blood cells are important to help you fight off infections. Pegfilgrastim is given to people whose ability to make white blood cells is reduced due to chemotherapy. Some brands may also be used to increase white blood cells after exposure to large amounts of radiation. This monograph is about the following pegfilgrastim products: pegfilgrastim, pegfilgrastim-apgf, pegfilgrastim-cbqv, pegfilgrastim-jmdb, pegfilgrastim-bmez, pegfilgrastim-fpgk, and pegfilgrastim-pbbk.

Frequently Asked Questions(FAQs)

The cost of Udenyca- Pegfilgrastim-Cbqv Injection, Solution 6Mg/0.6Ml is available for registerd members only .
Udenyca- Pegfilgrastim-Cbqv Injection, Solution 6Mg/0.6Ml is manufactured by COHERUS BIOSCIENCES INC.
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