filgrastim

Pronunciation

Generic Name: filgrastim (fil GRAS tim)
Brand Name: Neupogen, Neupogen SingleJect

What is filgrastim?

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 purposes not listed in this medication guide.

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

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

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What should I discuss with my healthcare provider before using filgrastim?

You should not use this medicine if you are allergic to filgrastim or to other medicines that contain the E. coli bacteria.

To make sure filgrastim is safe for you, tell your doctor if you have:

  • a blood cell disorder, such as sickle cell anemia;

  • chronic myeloid leukemia;

  • myelodysplasia (also called "preleukemia"); or

  • if you are receiving chemotherapy or radiation treatment.

FDA pregnancy category C. It is not known whether filgrastim will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether filgrastim passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I use filgrastim?

Filgrastim should not be given within the 24-hour period before or after you receive chemotherapy.

Filgrastim is injected into a vein or under the skin. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, syringes, IV tubing, and other items used to inject the medicine.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

This medicine comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Do not shake the medication bottle or you may ruin the medicine. Prepare your dose only when you are ready to give an injection. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Use a different place on your arms, stomach, hips, or legs each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row.

Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose. Do not use filgrastim if the expiration date on the label has passed. Call your pharmacist for a new prescription.

Use a disposable needle only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

You may need frequent medical tests to help your doctor determine how long to treat you with filgrastim. Your liver function will also need to be tested, and you may need bone density scans.

Store this medication in the refrigerator and do not allow it to freeze. You may allow the medication to reach room temperature for 24 hours before measuring your dose in a syringe. Then place the vial back in the refrigerator. Throw away any filgrastim that has been left out at room temperature for longer than 24 hours.

What happens if I miss a dose?

Use the missed dose as soon as you remember, but not within the 24-hour period before or after you receive chemotherapy treatment. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using filgrastim?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Filgrastim side effects

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:

  • 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.

Common side effects may include:

  • nausea, vomiting;

  • muscle or joint pain;

  • bone pain; or

  • headache.

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.

See also: Side effects (in more detail)

Filgrastim dosing information

Usual Adult Dose for Neutropenia Associated with Chemotherapy:

Initial dose: 5 mcg/kg/day as a single daily subcutaneous bolus injection, or short intravenous infusion (15 to 30 minutes) or by continuous subcutaneous or intravenous infusion.

Maintenance dose: In phase 3 trials, efficacy was observed at doses of 4 to 8 mcg/kg/day.

Duration of therapy: Up to 2 weeks, until the absolute neutrophil count reaches 10,000/mm3.

Comments:
-Administer no earlier than 24 hours after the administration of cytotoxic chemotherapy.
-Doses may be increased in increments of 5 mcg/kg for each chemotherapy cycle according to the duration and severity of the ANC nadir.
-A CBC and platelet count should be obtained before instituting therapy and monitored twice weekly during therapy.

Usual Adult Dose for Bone Marrow Transplantation:

Initial dose: 10 mcg/kg/day given as an intravenous infusion of 4 or 24 hours, or as a continuous 24 hour subcutaneous infusion.

Comments:
-First dose should be given at least 24 hours after cytotoxic chemotherapy and at least 24 hours after bone marrow infusion.
-Frequent CBCs and platelet counts are recommended (at least 3 times per week) following marrow transplantation.

Usual Adult Dose for Peripheral Progenitor Cell Transplantation:

Initial dose: 10 mcg/kg/day subcutaneously, either as a bolus or a continuous infusion, for at least 4 days before the first leukapheresis procedure and continued until the last leukapheresis.

Duration of therapy: Although the optimal duration of administration and leukapheresis schedule have not been established, administration for 6 to 7 days with leukaphereses on days 5, 6, and 7 was found to be safe and effective.

Comments:
-In clinical trials, filgrastim was also administered after the reinfusion of the collected cells.
-Neutrophil counts should be monitored after 4 days of therapy and dose modification should be considered for those patients who develop a WBC count greater than 100,000/mm3.

Usual Adult Dose for Neutropenia:

Congenital Neutropenia:
Initial dose: 6 mcg/kg subcutaneously twice a day
Median dose: 6 mcg/kg/day
Maximum dose: In rare instances, patients have required doses greater than 100 mcg/kg/day.

Idiopathic or Cyclic Neutropenia:
Initial dose: 5 mcg/kg subcutaneously once a day
Median dose:
-Cyclic neutropenia: 2.1 mcg/kg/day
-Idiopathic neutropenia: 1.2 mcg/kg/day

Comments:
-Chronic daily administration is required to maintain clinical benefit.
-The dose should be individually adjusted based on the patient's clinical course as well as ANC.
-During the initial 4 weeks of therapy and during the 2 weeks following any dose adjustment, a CBC with differential and platelet count should be performed twice weekly.
-Once a patient is clinically stable, a CBC with differential and platelet count should be performed monthly for the first year of treatment. Thereafter, if clinically stable, routine monitoring with regular CBCs (i.e., as clinically indicated but at least quarterly) is recommended.
-Additionally, for those patients with congenital neutropenia, annual bone marrow and cytogenetic evaluations should be performed throughout the duration of treatment.

Usual Pediatric Dose for Neutropenia:

Congenital Neutropenia:
Initial dose: 6 mcg/kg subcutaneously twice a day
Median dose: 6.0 mcg/kg/day

Idiopathic or Cyclic Neutropenia:
Initial dose: 5 mcg/kg subcutaneously once a day
Median dose:
-Cyclic neutropenia: 2.1 mcg/kg/day
-Idiopathic neutropenia: 1.2 mcg/kg/day

Comments:
-Chronic daily administration is required to maintain clinical benefit.
-The dose should be individually adjusted based on the patient's clinical course as well as ANC.
-During the initial 4 weeks of therapy and during the 2 weeks following any dose adjustment, a CBC with differential and platelet count should be performed twice weekly.
-Once a patient is clinically stable, a CBC with differential and platelet count should be performed monthly for the first year of treatment. Thereafter, if clinically stable, routine monitoring with regular CBCs (i.e., as clinically indicated but at least quarterly) is recommended.
-Additionally, for those patients with congenital neutropenia, annual bone marrow and cytogenetic evaluations should be performed throughout the duration of treatment.

Usual Pediatric Dose for Neutropenia Associated with Chemotherapy:

Initial dose: 5 mcg/kg/day as a single daily subcutaneous bolus injection, or short intravenous infusion (15 to 30 minutes) or by continuous subcutaneous or intravenous infusion.

Maintenance dose: In phase 3 trials, efficacy was observed at doses of 4 to 8 mcg/kg/day.

Duration of therapy: Up to 2 weeks, until the absolute neutrophil count reaches 10,000/mm3.

Comments:
-Administer no earlier than 24 hours after the administration of cytotoxic chemotherapy.
-Doses may be increased in increments of 5 mcg/kg for each chemotherapy cycle according to the duration and severity of the ANC nadir.
-A CBC and platelet count should be obtained before instituting therapy and monitored twice weekly during therapy.

What other drugs will affect filgrastim?

Other drugs may interact with filgrastim, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about filgrastim.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 7.01. Revision Date: 2014-02-18, 9:18:29 AM.

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