Neupogen

What is Neupogen?

Neupogen is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body. It stimulates the growth of neutrophils, a type of white blood cell important in the body’s fight against infection.

Acute Radiation Syndrome: The effectiveness of Neupogen for this use was only studied in animals, because it could not be studied in people.

Description

Filgrastim is a 175 amino acid human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. Filgrastim is produced by Escherichia coli (E coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. Filgrastim 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 filgrastim is produced in E coli‚ the product is non-glycosylated and thus differs from G-CSF isolated from a human cell.

NEUPOGEN injection is a sterile‚ clear‚ colorless‚ preservative-free liquid containing filgrastim at a specific activity of 1.0 ± 0.6 × 108 U/mg (as measured by a cell mitogenesis assay). The product is available in single-dose vials and prefilled syringes. The single-dose vials contain either 300 mcg/mL or 480 mcg/1.6 mL of filgrastim. The single-dose prefilled syringes contain either 300 mcg/0.5 mL or 480 mcg/0.8 mL of filgrastim. See table below for product composition of each single-dose vial or prefilled syringe.

Who should not take Neupogen?

Do not take Neupogen if you have had a serious allergic reaction to human G-CSFs such as filgrastim or pegfilgrastim products.

What should I tell my healthcare provider before taking Neupogen?

Before you take Neupogen, tell your healthcare provider about all of your medical conditions, including if you:

• have a sickle cell disorder.
• have kidney problems.
• are receiving radiation therapy.
• are allergic to latex. The needle cap on the prefilled syringe contains dry natural rubber (derived from latex). You should not give Neupogen using the prefilled syringe if you have latex allergies. Ask your healthcare provider about using the vial if you have latex allergies.
• are pregnant or plan to become pregnant. It is not known if Neupogen will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Neupogen passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take Neupogen?

• Neupogen injections can be given by a healthcare provider by intravenous (IV) infusion or under your skin (subcutaneous injection). Your healthcare provider may decide subcutaneous injections can be given at home by you or your caregiver. If Neupogen is given at home, see the detailed “Instructions for Use” that comes with your Neupogen for information on how to prepare and inject a dose of Neupogen.
• You and your caregiver should be shown how to prepare and inject Neupogen before you use it, by your healthcare provider.
• Your healthcare provider will tell you how much Neupogen to inject and when to inject it. Do not change your dose or stop Neupogen unless your healthcare provider tells you to.
• If you are receiving Neupogen because you are also receiving chemotherapy, your dose of Neupogen should be injected at least 24 hours before or 24 hours after your dose of chemotherapy. Your healthcare provider will do blood tests to monitor your white blood cell count, and if necessary, adjust your Neupogen dose.
• If you are receiving Neupogen because you have been suddenly (acutely) exposed to an amount of radiation that can affect your bone marrow (Acute Radiation Syndrome), you will need to have blood tests about every 3 days during treatment with Neupogen to check your white blood cell count.
• If you miss a dose of Neupogen, talk to your healthcare provider about when you should give your next dose.

What are the possible side effects of Neupogen?

Neupogen may cause serious side effects, including:

• Spleen rupture. Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in the left upper stomach (abdomen) area or your left shoulder.
• A serious lung problem called acute respiratory distress syndrome (ARDS). Call your healthcare provider or get emergency medical help right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing.
• Serious allergic reactions. Neupogen can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating. If you have any of these symptoms, stop using Neupogen and call your healthcare provider or get emergency medical help right away.
• Sickle cell crises. You may have a serious sickle cell crisis, which could lead to death, if you have a sickle cell disorder and receive Neupogen. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.
• Kidney injury (glomerulonephritis). Neupogen can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms:
  • swelling of your face or ankles
  • blood in your urine or dark colored urine
  • you urinate less than usual
• Capillary leak syndrome. Neupogen can cause fluid to leak from blood vessels into your body’s tissues. This condition is called “Capillary Leak Syndrome” (CLS). CLS can quickly cause you to have symptoms that may become life-threatening. Get emergency medical help right away if you develop any of the following symptoms:
  • swelling or puffiness and are urinating less than usual
  • trouble breathing
  • swelling of your stomach area (abdomen) and feeling of fullness
  • dizziness or feeling faint
  • a general feeling of tiredness
• Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatment with Neupogen. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with Neupogen. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot.
• Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood during treatment with Neupogen.
• Inflammation of your blood vessels (cutaneous vasculitis). Tell your healthcare provider right away if you develop purple spots or redness of your skin.
• Inflammation of the aorta (aortitis). Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported in patients who received Neupogen. Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms.

The most common side effects experienced in patients receiving Neupogen include:

• Patients with cancer receiving chemotherapy: fever, pain, rash, cough, and shortness of breath
• Patients with acute myeloid leukemia receiving chemotherapy: pain, nose bleed, and rash
• Patients with cancer receiving chemotherapy followed by bone marrow transplant: rash
• Patients who are having their own blood cells collected: bone pain, fever, and headache
• Patients with severe chronic neutropenia: pain, decreased red blood cells, nose bleed, diarrhea, reduced sensation, and hair loss

These are not all the possible side effects of Neupogen. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Neupogen

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Neupogen for a condition for which it was not prescribed. Do not give Neupogen to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Neupogen that is written for healthcare professionals.

How should I store Neupogen?

• Store Neupogen in the refrigerator between 36˚F to 46˚F (2˚C to 8˚C).
• Do not freeze.
• Keep Neupogen in the original carton to protect from light or physical damage. Do not leave Neupogen in direct sunlight.
• Do not shake Neupogen.
• Take Neupogen out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection.
• Throw away (dispose of) any Neupogen that has been left at room temperature for longer than 24 hours.
• After you inject your dose, throw away (dispose of) any unused Neupogen left in the vials or prefilled syringes. Do not save unused Neupogen in the vials or prefilled syringes for later use.

Keep Neupogen out of the reach of children.

What are the ingredients in Neupogen?

Active ingredient: filgrastim

Inactive ingredients: acetate, polysorbate 80, sodium, sorbitol, and water for Injection.

Label

PRINCIPAL DISPLAY PANEL – 300 MCG/1 ML VIAL PACKAGE

• AMGEN®
• 300
  mcg
• 10 – 1 mL Single Dose Vials
  NDC 55513-530-10
• NEUPOGEN®
  (filgrastim) for injection
• A Recombinant Granulocyte Colony Stimulating
  Factor (rG-CSF) derived from E Coli
• 300 mcg/1 mL
  (3 x 107 Units/1 mL)
• For Subcutaneous or Intravenous Use Only
  Sterile Solution – No Preservative
• Refrigerate at 2°C to 8°C (36°F to 46°F). Avoid Shaking.
• Amgen Inc. Thousand Oaks, CA 91320 U.S.A.
• U.S. License No. 1080

PRINCIPAL DISPLAY PANEL – 300 MCG/0.5 ML SYRINGE BOX – 924-91

• 300
  mcg
• 1 x 300 mcg/0.5 mL Single Dose Prefilled Syringe with 27 Gauge Needle
  NDC 55513-924-91
• NEUPOGEN® SingleJect®
  (filgrastim) injection
• A Recombinant Granulocyte Colony Stimulating Factor (rG-CSF) derived from E Coli
• Single Dose Prefilled Syringe with 27 Gauge Needle
• 300 mcg/0.5 mL
• For Subcutaneous Use Only
  This Product Contains Dry Natural Rubber
  Sterile Solution – No Preservative
• Refrigerate at 2°C to 8°C (36°F to 46°F).
  Avoid Shaking.
• Rx Only
• Manufactured by Amgen Inc.
  Thousand Oaks, CA 91320 U.S.A.

PRINCIPAL DISPLAY PANEL – 480 MCG/0.8 ML SYRINGE BOX – 209-10

• 480
  mcg
• 10 x 480 mcg/0.8 mL Single Dose Prefilled Syringes with 27 Gauge Needles
  NDC 55513-209-10
• NEUPOGEN® SingleJect®
  (filgrastim) injection
• A Recombinant Granulocyte Colony Stimulating Factor (rG-CSF) derived from E Coli
• Single Dose Prefilled Syringes with 27 Gauge Needles
• 480 mcg/0.8 mL
• For Subcutaneous Use Only
  This Product Contains Dry Natural Rubber
  Sterile Solution – No Preservative
• Refrigerate at 2°C to 8°C (36°F to 46°F). Avoid Shaking.
• Rx Only
• Manufactured by Amgen Inc.
  Thousand Oaks, CA 91320 U.S.A.
  U.S. License No. 1080

SRC: NLM .