Neupogen

DRUG DESCRIPTION

Filgrastim is a human granulocyte colony-stimulating factor (G-CSF)?? produced by recombinant DNA technology. NEUPOGEN® is the Amgen Inc. trademark for Filgrastim?? which has been selected as the name for recombinant methionyl human granulocyte colony-stimulating factor (r-metHuG-CSF).

NEUPOGEN® (filgrastim) is a 175 amino acid protein manufactured by recombinant DNA technology.1 NEUPOGEN® (filgrastim) is produced by Escherichia coli (E coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. NEUPOGEN® (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 NEUPOGEN® (filgrastim) is produced in E coli?? the product is nonglycosylated and thus differs from G-CSF isolated from a human cell.

NEUPOGEN® (filgrastim) is a sterile?? clear?? colorless?? preservative-free liquid for parenteral administration containing Filgrastim at a specific activity of 1.0 ± 0.6 x 108 U/mg (as measured by a cell mitogenesis assay). The product is available in single use vials and prefilled syringes. The single use vials contain either 300 mcg or 480 mcg Filgrastim at a fill volume of 1.0 mL or 1.6 mL, respectively. The single use prefilled syringes contain either 300 mcg or 480 mcg Filgrastim at a fill volume of 0.5 mL or 0.8 mL, respectively. See table below for product composition of each single use vial or prefilled syringe.

  300 mcg/1.0 mL Vial 480 mcg/1.6 mL Vial 300 mcg/0.5 mL Syringe 480 mcg/0.8 mL Syringe
Filgrastim 300 mcg 480 mcg 300 mcg 480 mcg
Acetate 0.59 mg 0.94 mg 0.295 mg 0.472 mg
Sorbitol 50.0 mg 80.0 mg 25.0 mg 40.0 mg
Polysorbate 80 0.04 mg 0.064 mg 0.02 mg 0.032 mg
Sodium 0.035 mg 0.056 mg 0.0175 mg 0.028 mg
Water for Injection USP q.s. ad 1.0 mL 1.6 mL 0.5 mL 0.8 mL

What are the possible side effects of filgrastim (Neupogen)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using filgrastim and call your doctor at once if you have any of these serious side effects:

  • sudden or severe pain in your left upper stomach spreading up to your shoulder;
  • rapid breathing or feeling short of breath; or
  • signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding...

Read All Potential Side Effects and See Pictures of Neupogen »

What are the precautions when taking filgrastim (Neupogen)?

Before using filgrastim, tell your doctor or pharmacist if you are allergic to it; or to other medications made in a similar manner (biotechnology-produced proteins using E. coli); 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, heart disease, spleen problems, other blood disorders (e.g., myelodysplastic syndrome, congenital neutropenia), certain skin disorders (e.g., psoriasis).

If you are scheduled to have radiation therapy, tell your doctor you...

Read All Potential Precautions of Neupogen »

What are the possible side effects of filgrastim (Neupogen)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using filgrastim and call your doctor at once if you have any of these serious side effects:

  • sudden or severe pain in your left upper stomach spreading up to your shoulder;
  • rapid breathing or feeling short of breath; or
  • signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding...

Read All Potential Side Effects and See Pictures of Neupogen »

What are the precautions when taking filgrastim (Neupogen)?

Before using filgrastim, tell your doctor or pharmacist if you are allergic to it; or to other medications made in a similar manner (biotechnology-produced proteins using E. coli); 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, heart disease, spleen problems, other blood disorders (e.g., myelodysplastic syndrome, congenital neutropenia), certain skin disorders (e.g., psoriasis).

If you are scheduled to have radiation therapy, tell your doctor you...

Read All Potential Precautions of Neupogen »

What are the possible side effects of filgrastim (Neupogen)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using filgrastim and call your doctor at once if you have any of these serious side effects:

  • sudden or severe pain in your left upper stomach spreading up to your shoulder;
  • rapid breathing or feeling short of breath; or
  • signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding...

Read All Potential Side Effects and See Pictures of Neupogen »

What are the precautions when taking filgrastim (Neupogen)?

Before using filgrastim, tell your doctor or pharmacist if you are allergic to it; or to other medications made in a similar manner (biotechnology-produced proteins using E. coli); 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, heart disease, spleen problems, other blood disorders (e.g., myelodysplastic syndrome, congenital neutropenia), certain skin disorders (e.g., psoriasis).

If you are scheduled to have radiation therapy, tell your doctor you...

Read All Potential Precautions of Neupogen »


Neupogen Consumer (continued)

SIDE EFFECTS: Aching in the bones and muscles may occur. Taking a non-aspirin pain reliever such as acetaminophen may help with this pain. Ask your doctor or pharmacist for more details. Nosebleeds or injection site reactions such as redness, swelling, itching, lumps or bruising may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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 immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, bloody urine, bloody vomit, fast/irregular heartbeat, fever, muscle pain, joint pain, fast breathing, trouble breathing.

Rarely, possibly fatal damage to the spleen may occur. Seek immediate medical attention if you experience the following side effects: stomach/abdominal pain, and/or shoulder pain.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using filgrastim, tell your doctor or pharmacist if you are allergic to it; or to other medications made in a similar manner (biotechnology-produced proteins using E. coli); 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, heart disease, spleen problems, other blood disorders (e.g., myelodysplastic syndrome, congenital neutropenia), certain skin disorders (e.g., psoriasis).

If you are scheduled to have radiation therapy, tell your doctor you are taking filgrastim. This medication should not be given during the time you are receiving radiation therapy.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Neupogen Patient Information Including Side Effects

Brand Names: Neupogen

Generic Name: filgrastim (Pronunciation: fil GRAS tim)

  • What is filgrastim (Neupogen)?
  • What are the possible side effects of filgrastim (Neupogen)?
  • What is the most important information I should know about filgrastim (Neupogen)?
  • What should I discuss with my healthcare provider before using filgrastim (Neupogen)?
  • How should I use filgrastim (Neupogen)?
  • What happens if I miss a dose (Neupogen)?
  • What happens if I overdose (Neupogen)?
  • What should I avoid while using filgrastim (Neupogen)?
  • What other drugs will affect filgrastim (Neupogen)?
  • Where can I get more information?

What is filgrastim (Neupogen)?

Filgrastim is a man-made form of a protein that stimulates the growth of white blood cells in your body. White blood cells help your body fight against infection.

Filgrastim is used to treat neutropenia, a lack of certain white blood cells caused by cancer, bone marrow transplant, receiving chemotherapy, or by other conditions.

Filgrastim may also be used for other purposes not listed in this medication guide.

What are the possible side effects of filgrastim (Neupogen)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using filgrastim and call your doctor at once if you have any of these serious side effects:

  • sudden or severe pain in your left upper stomach spreading up to your shoulder;
  • rapid breathing or feeling short of breath; or
  • signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, unusual weakness.

Less serious side effects may include:

  • diarrhea, constipation;
  • bone pain;
  • muscle aches;
  • hair loss;
  • headache, tired feeling;
  • mild skin rash; or
  • itching, swelling, or redness where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about filgrastim (Neupogen)?

Before using filgrastim, tell your doctor if you have sickle cell disorder, a blood cell disorder, chronic myeloid leukemia, myelodysplasia (also called "preleukemia"), or if you are receiving chemotherapy or radiation treatment.

Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

Filgrastim is usually given daily for up to 2 weeks. Follow your doctor's instructions. For best results, use this medication at the same time each day.

To be sure this medication is helping your condition, your blood will need to be tested often. This will help your doctor determine how long to treat you with filgrastim. Your liver function will also need to be tested. Do not miss any scheduled appointments.

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