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ZARXIO 300MCG/0.5ML SYR 1/EA

  • Manufacturer Name : Sandoz
  • MFG # : 61314031801
  • NDC : 61314031801
  • Distributor Name : AmeriSource Bergen
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Product Information

NDC Package Code61314-318-01
Proprietary NameZarxio
Non-Proprietary NameFilgrastim-sndz
Package1 BLISTER PACK in 1 CARTON (61314-318-01) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE
Dosage FormINJECTION, SOLUTION
RouteINTRAVENOUS; SUBCUTANEOUS
Active Ingredient Strength300
Active Ingredient Unitsug/.5mL
Substance NameFILGRASTIM

Description

ZARXIO is a leukocyte growth factor indicated to: 1 Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever (1.1), 2 Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) (1.2), 3 Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) (1.3), 4 Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis (1.4), 5 Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia (1.5).

Filgrastim-sndz is a 175 amino acid human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. ZARXIO is produced by Escherichia coli (E coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. ZARXIO has a molecular weight of 18‚800 daltons. The protein has an amino acid sequence that is identical to the natural sequence predicted from human DNA sequence analysis‚ except for the addition of an N-terminal methionine necessary for expression in E coli. Because ZARXIO is produced in E coli‚ the product is non-glycosylated and thus differs from G-CSF isolated from a human cell. ZARXIO injection is a sterile‚ clear‚ colorless to slightly yellowish‚ preservative-free liquid containing filgrastim-sndz at a specific activity of 1.0 x 108 U/mg (as measured by a cell mitogenesis assay). The product is available in single-dose prefilled syringes. The single-dose prefilled syringes contain either 300 mcg/0.5 mL or 480 mcg/0.8 mL of filgrastim-sndz. See Table 4 below for product composition of each single-dose prefilled syringe. *quantity sufficient to make.

Product Properties:

Description Zarxio inj, 1 MCG
DESI Drug Ind -
DESI2 Drug Ind -
Drug Category S
Drug Type Code 1
FDA Approval Date 03/06/2015
FDA Therap Equiv NR
HCPCS Q5101
Market Entry Date 09/04/2015
Medical Coverage COVERED WITH SPECIAL INSTRUCTIONS
Termination Date -
Unit ML
Units Per Pkg -
Active Ingredients 15943 filgrastim-sndz
AHFS Class 20160000 HEMATOPOIETIC AGENTS
DEA Class NC
Dose Form SYRINGE (ML)
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 73646 filgrastim-sndz INJECTION SYRINGE 300MCG/0.5
Inactive Ingredients 2551 polysorbates 9005645; 2599 sorbitol 50704; 8921 latex
OMP Family -
Product Category RX Pharmaceuticals
Strength 300MCG
Common Brand Name COMMON BRAND NAME(S): Granix, Neupogen, Nivestym, Releuko, Zarxio
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. Filgrastim is very similar to pegfilgrastim. Do not use a pegfilgrastim product while using a filgrastim product. This medication may interfere with certain lab tests (such as bone imaging tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.
Allocation Period -
Case Quantity 144
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 0.5
How to Use HOW TO USE: Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using filgrastim and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Depending on your filgrastim product, this medication is injected under the skin or into a vein. Use as directed by your doctor, usually once a day. The dosage and length of treatment are based on your medical condition, weight, lab tests, and response to treatment. If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package. Take the medication out of the refrigerator at least 30 minutes before you inject it to allow it to reach room temperature. Do not shake the medication. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. If you are injecting this drug under the skin, first clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject filgrastim into skin that is bruised, tender, red, hard, or that has scars or stretch marks. Learn how to store and discard medical supplies safely. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. If you are receiving cancer chemotherapy, you should not use this medication within 24 hours before or 24 hours after chemotherapy. Ask your doctor for specific directions about when to use this medication.
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 (fil-GRA-stim)
Precautions PRECAUTIONS: Before using filgrastim, tell your doctor or pharmacist if you are allergic to it; or to any filgrastim or pegfilgrastim 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: kidney disease, sickle cell disease, spleen problems, radiation treatment. This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). 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 passes into breast milk. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Dizziness, headache, and aching or pain in the bones, joints, 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: easy bleeding/bruising, pink/bloody urine, bloody vomit, coughing up blood, fast heartbeat, fever, 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, fast breathing, shortness of breath), 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 congenital neutropenia or in people with breast or lung cancer who are receiving chemotherapy/radiation. Ask your doctor for more details. Filgrastim can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash. 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 in the refrigerator. If kept at room temperature, use or discard it within the time directed in your product package. Keep the medication in the original package to protect it from light. Do not freeze or shake. 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: Filgrastim 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. Filgrastim is given to people whose ability to make white blood cells is reduced (for instance, due to chemotherapy, chronic neutropenia, or exposure to large amounts of radiation). It is also used in certain treatment procedures (such as bone marrow/stem cell transplant). This monograph is about the following filgrastim products: filgrastim, tbo-filgrastim, filgrastim-sndz, filgrastim-aafi, and filgrastim-ayow.

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ZARXIO 300MCG/0.5ML SYR 1/EA is manufactured by Sandoz.
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