filgrastim

Generic Name: filgrastim (fil GRAS tim)Brand names: 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 other purposes not listed in this medication guide.

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

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.

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

Do not use this medication if you are allergic to filgrastim or to other medicines that contain the E. coli bacteria.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use filgrastim:

• sickle cell disorder;

• a blood cell disorder;

• 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 is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether filgrastim passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use filgrastim?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Filgrastim is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. 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.

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

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

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.

Do not shake the medication vial (bottle) or prefilled syringe. Vigorous shaking can ruin the medicine. Do not draw your filgrastim dose into a syringe until you are ready to give yourself an injection. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

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

A filgrastim vial or prefilled syringe is for one use only. Throw the bottle or syringe away after using, even if there is still some medicine left inside. Do not use filgrastim if the expiration date on the label has passed. Call your doctor for a new prescription.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

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.

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. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a filgrastim overdose are not known.

What should I avoid while using filgrastim?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact 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 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.

Filgrastim Dosing Information

Usual Adult Dose for Neutropenia Associated with Chemotherapy:

Initial dose: 5 mcg/kg subcutaneously or IV once a day for up to 2 weeks, until the absolute neutrophil count reaches 10,000/mm??. Administer no earlier than 24 hours after the administration of cytotoxic chemotherapy. May be increased after 5 to 7 days if the neutrophil response is inadequate by 5 mcg/kg increments with each chemotherapy cycle. Efficacy has been observed at doses of 4-8 mcg/kg/day.

Usual Adult Dose for Myelodysplastic Syndrome:

5 mcg/kg subcutaneously or IV once a day. If after 5 to 7 days the neutrophil count is not adequate, the dose may be increased by 5 mcg/kg.

Usual Adult Dose for Bone Marrow Transplantation:

10 mcg/kg/day by continuous subcutaneous infusion or IV infusion once a day. Therapy is generally started 24 hours after bone marrow transplantation and continued for 2 to 4 weeks. When ANC >1000/mm?? for 3 days, reduce dose to 5 mcg/kg/day. If after 5 to 7 days the neutrophil count is not adequate, the dose may be increased by 5 mcg/kg.

Usual Adult Dose for Neutropenia Associated with AIDS or Zidovudine:

1 to 5 mcg/kg subcutaneously or IV once a day. If after 5 to 7 days the neutrophil count is not adequate, the dose may be increased by 5 mcg/kg.

Usual Adult Dose for Peripheral Progenitor Cell Transplantation:

10 mcg/kg subcutaneously or IV once a day for at least 4 days before the first leukapheresis procedure and continued until the last leukapheresis; 5 to 24 mcg/kg/day, with 5 mcg/kg/day being an effective dose for most patients. Myeloid recovery dosages are continued until a consistent absolute neutrophil count of >500 cells/mm?? is reached. Dose modification should be considered with a white blood cell count >10,000 cells/mm??.

Usual Adult Dose for Neutropenia:

6 mcg/kg subcutaneously twice a day. Chronic administration is required.

Usual Pediatric Dose for Neutropenia:

>3 m:Neonatal: 5 to 10 mcg/kg once daily. Congenital: 6 mcg/kg/dose twice daily.Idiopathic or Cyclic: 5 mcg/kg once daily.

Usual Pediatric Dose for Neutropenia Associated with Chemotherapy:

Initial dose: 5 mcg/kg subcutaneously or IV once a day for up to 2 weeks, until the absolute neutrophil count reaches 10,000/mm??. Administer no earlier than 24 hours after the administration of cytotoxic chemotherapy. May be increased after 5 to 7 days if the neutrophil response is inadequate by 5 mcg/kg increments with each chemotherapy cycle. Efficacy has been observed at doses of 4 to 8 mcg/kg/day.

Usual Pediatric Dose for Aplastic Anemia:

Study (n=4)400 mcg/m?? per day by IV infusion.

Usual Pediatric Dose for Sepsis:

10 mcg/kg daily

What other drugs will affect filgrastim?

Before using filgrastim, tell your doctor if you are also using lithium (Eskalith, Lithobid). You may need a dose adjustment or special tests to safely use filgrastim.

There may be other drugs that can interact with filgrastim. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

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.
• 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 1996-2006 Cerner Multum, Inc. Version: 4.02. Revision Date: 07/20/2009 9:15:23 AM.