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Filgrastim

 

Key Terms: Food and Drug Administration, Chemotherapy, Subcutaneous, Intravenous, Reinfusion, Neutropenia, Recovery, Apheresis, Peripheral blood stem cell transplant.

Definition

Filgrastim is a medicine used to increase the white blood cell count in the body, which will help prevent infection. Filgrastim is known by the brand name Neupogen.

Purpose

Filgrastim is a drug approved by the Food and Drug Administration (FDA) to increase white blood cell counts. If a patient has a lower than normal white blood cell count it is referred to as neutropenia.

Filgrastim can be used to treat neutropenia caused by cancer chemotherapy treatment. In these patients the filgrastim increases the recovery of white blood cells after chemotherapy. Filgrastim can also be used to treat patients who have a neutropenia not related to chemotherapy. In both cases, the filgrastim decreases the risk of fever and infection.

Filgrastim is not usually used in leukemia patients. However, in patients with the disease known as acute myelocytic leukemia, it is approved for use after chemotherapy. Filgrastim can increase the recovery of the white blood cell count thereby decreasing the length of time a patient may have a fever associated with a low white count.

Filgrastim can also be used after bone marrow transplantation. Once the new healthy bone marrow has been given back to a patient, filgrastim can be administered to help increase the white blood cell count and decrease the risk of fever and infection.

Filgrastim can be used for patients who will receive a peripheral blood stem cell transplant. Patients will receive the filgrastim before the transplant. The filgrastim in these patients causes young, non-developed blood cells, known as stem or progenitor cells, to move from the bone marrow to the blood where they will then be removed from a patient by the process of apheresis. These blood cells are stored until after the patient receives larges doses of chemotherapy that destroy the bone marrow and the cancer. The patient then receives these stored cells back by an intravenous infusion. The stored cells repopulate the bone marrow and develop into the many types of functioning blood cells.

Description

Filgrastim has been available to cancer patients since the 1990s, and is highly effective at decreasing neutropenia. Filgrastim may be referred to as G-CSF, granulocyte colony stimulating factor, colony stimulating factor. This compound is manufactured by recombinant DNA methods using E. coli as the host organism. Chemotherapy destroys white blood cells temporarily. These white blood cells will grow again, but during the time that the levels are low, patients are at an increased risk of developing fevers and infection. Filgrastim acts to stimulate the bone marrow to make more white blood cells, which can either prevent the white count from dropping below normal or decrease the time that the level is low. By effectively avoiding fevers and infections, patients are able to receive their next doses of chemotherapy without delay.

Recommended Dosage

Filgrastim is a clear colorless liquid that is dosed on body weight in kilograms. It is kept refrigerated until ready to use, and it is administered to patients as a subcutaneous injection (directly underneath the skin) It is usually administered in the back of the arms, upper legs, or stomach area. Filgrastim can also be given to patients as a short intravenous infusion into a vein over 15 to 30 minutes.

Chemotherapy-Caused Neutropenia

The starting dose for patients who have just finished chemotherapy is 5 micrograms per kilogram of body weight per day. This is given as a subcutaneous injection under the skin daily for up to 14 consecutive days, and sometimes longer. The doctor will inform the patient when it is time to stop the filgrastim.

Bone Marrow Transplants

The recommended dose is 10 micrograms per kilogram per day. This can be administered as a 4- to 24-hour infusion intravenously, or as a 24-hour subcutaneous infusion.

Peripheral Blood Stem Cell Transplant

The recommended dose is 10 micrograms per kilogram per day. This can be given either as a under the skin injection, intravenously, or as a continuous infusion over 24 hours. This dosing should begin four days before the first apheresis collection process and continue until the last day of collection.

Other Neutropenia

The dose recommendation is variable based on the reason for neutropenia. The range of filgrastim doses has been from 5 micrograms per kilogram per day up to 100 microgram per kilogram per day. Doctors may increase the filgrastim dose based on how the white blood cell count responds to the treatment. Other factors that play a role in filgrastim dosing include how low the white blood cell count is and the length of time the white blood cell count remains low.

Precautions

Filgrastim should not be received by a patient in the 24-hour time frame before or after receiving chemotherapy or reinfusion of bone marrow or stem cells.

Blood counts will be monitored while on the drug filgrastim. This allows the doctor to determine if the drug is working and when to stop the drug.

It is not recommended to give filgrastim to patients who have certain types of leukemias.

Patients with a known previous allergic reaction to filgrastim or to any other substance derived from the bacteria E. coli should not take filgrastim.

Patients who may be pregnant, or trying to become pregnant, should tell their doctor before receiving filgrastim.

Side Effects

The most common side effect from filgrastim is bone pain. The filgrastim causes the bone marrow to produce more white blood cells, and, as a result, patients may experience pain in their bones. Tylenol, an over-the-counter pain reliever, can usually control mild to moderate pain that occurs with standard dosed filgrastim. Larger doses of filgrastim, like those given for bone marrow transplant patients, can cause severe bone pain that may need a prescription pain reliever to ease the pain.

Another common side effect due to filgrastim administration is pain or burning at the site of the injection. This can be decreased by bringing the filgrastim to room temperature before administering the injection, icing the area of injection to numb it before receiving the injection, and moving the site of the injection with each dose.

Patients who have received filgrastim after cancer chemotherapy have reported fever, nausea and vomiting, muscle pain, diarrhea, hair loss (alopecia), mouth sores, fatigue, shortness of breath, weakness, headache, cough, rash, constipation, and pain. These side effects may be due to the chemotherapy administration.

Interactions

Filgrastim should not be given at the same time as chemotherapy or radiation therapy. Dosing should begin at least 24 hours after the last dose of treatment.

Patients on the drug lithium should tell their doctor before starting filgrastim therapy.

Filgrastim use for delayed myelosuppression has not been studied after the use of the chemotherapy agents mitomycin-C, and nitrosoureas, or after the drug fluorouracil.

—Nancy J. Beaulieu, RPh., BCOP

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Drug Info:

Filgrastim, G-CSF

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Brand names: Neupogen®



Filgrastim (E. coli) Solution for injection

What is this medicine?

FILGRASTIM, G-CSF (fil GRA stim) stimulates the formation of white blood cells. This medicine is given to patients with conditions that may cause a decrease in white blood cells, like those receiving certain types of chemotherapy or bone marrow transplant. It helps the bone marrow recover its ability to produce white blood cells. Increasing the amount of white blood cells helps to decrease the risk of infection and fever.
 
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
•currently receiving radiation therapy
•sickle cell disease
•an unusual or allergic reaction to filgrastim, E. coli protein, other medicines, foods, dyes, or preservatives
•pregnant or trying to get pregnant
•breast-feeding

How should I use this medicine?

This medicine is for injection into a vein or injection under the skin. It is usually given by a health care professional in a hospital or clinic setting.

If you get this medicine at home, you will be taught how to prepare and give this medicine. Always change the site for the injection under the skin. Let the solution warm to room temperature before you use it. Do not shake the solution before you withdraw a dose. Throw away any unused portion. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

Talk to your pediatrician regarding the use of this medicine in children. While this medicine may be prescribed for children for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What may interact with this medicine?

•lithium
•medicines for cancer chemotherapy

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress.

If you get a fever or any sign of infection while you are using this medicine, do not treat yourself. Check with your doctor or health care professional.

Bone pain can usually be relieved by mild pain relievers such as acetaminophen or ibuprofen. Check with your doctor or health care professional before taking these medicines as they may hide a fever. Call your doctor or health care professional if the aches and pains are severe or do not go away.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
•allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
•difficulty breathing, wheezing
•fever
•pain, redness, or swelling at the injection site
•stomach or side pain, or pain at the shoulder

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
•bone pain (ribs, lower back, breast bone)
•headache
•skin rash

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze or leave in direct sunlight. If vials or syringes are left out of the refrigerator for more than 24 hours, they must be thrown away. Throw away unused vials after the expiration date on the carton.

Last updated: 7/1/2002

Important Disclaimer: The drug information provided here is for educational purposes only. It is intended to supplement, not substitute for, the diagnosis, treatment and advice of a medical professional. This drug information does not cover all possible uses, precautions, side effects and interactions. It should not be construed to indicate that this or any drug is safe for you. Consult your medical professional for guidance before using any prescription or over the counter drugs.

Wikipedia:

Filgrastim

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Filgrastim
Systematic (IUPAC) name
Human granulocyte colony stimulating factor
Identifiers
CAS number 143011-72-7
ATC code L03AA02
PubChem  ?
DrugBank BTD00072
Chemical data
Formula C845H1343N223O243S9 
Mol. mass 18802.8 g/mol
Pharmacokinetic data
Bioavailability  ?
Metabolism  ?
Half life  ?
Excretion  ?
Therapeutic considerations
Pregnancy cat.  ?
Legal status
Routes  ?


Filgrastim is a granulocyte colony-stimulating factor (G-CSF) analog used to stimulate the proliferation and differentiation of granulocytes.[1] It is produced by recombinant DNA technology. The gene for human granulocyte colony-stimulating factor is inserted into the genetic material of Escherichia coli. The G-CSF then produced by E. coli is only slightly different from G-CSF naturally made in humans.

It is marketed by Amgen with the brand name Neupogen, Reliance Biopharmaceuticals with the brand name Religrast,Zenotech Laboratories Limited with the brand name Nugrafand also by Raichem lifesciences with the brand name Shilgrast

Contents

Therapeutic uses

Filgrastim is used to treat neutropenia[2] (a low number of neutrophils), stimulating the bone marrow to increase production of neutrophils. Causes of neutropenia include chemotherapy and bone marrow transplantation.

Filgrastim is also used to increase the number of hematopoietic stem cells in the blood before collection by leukapheresis for use in hematopoietic stem cell transplantation.

It is produced by many companies world wide.

Contraindications

Filgrastim should not be used in patients with known hypersensitivity to E. coli-derived proteins.[citation needed]

Adverse effects

The most commonly observed adverse effect is mild-to-moderate bone pain after repeated administration and local skin reactions at the site of injection. [3] Other adverse effects include splenic rupture, alveolar hemorrhage, acute respiratory distress syndrome (ARDS), and hemoptysis. [3]

References

  1. ^ Beveridge RA, Miller JA, Kales AN, et al. (1998). "A comparison of efficacy of sargramostim (yeast-derived RhuGM-CSF) and filgrastim (bacteria-derived RhuG-CSF) in the therapeutic setting of chemotherapy-induced myelosuppression". Cancer Invest. 16 (6): 366–73. doi:10.3109/07357909809115775. PMID 9679526. 
  2. ^ Crawford J, Glaspy JA, Stoller RG, et al. (October 2005). "Final results of a placebo-controlled study of filgrastim in small-cell lung cancer: exploration of risk factors for febrile neutropenia". Support Cancer Ther 3 (1): 36–46. doi:10.3816/SCT.2005.n.023. PMID 18632435. http://cigjournals.metapress.com/openurl.asp?genre=article&id=doi:10.3816/SCT.2005.n.023. 
  3. ^ a b Neupogen Prescription information provided by Amgen http://pi.amgen.com/united_states/neupogen/neupogen_pi_hcp_english.pdf
  • Budiono Santoso; Chris J. van Boxtel; Boxtel, Christoffel Jos van (2001). Drug benefits and risks: international textbook of clinical pharmacology. New York: Wiley. ISBN 0-471-89927-5. 
  • "Neupogen Prescribing Information." http://www.neupogen.com/pi.html. Accessed 10/20/05.

 
 
Learn More
Granulocyte colony-stimulating factor (in medicine)
Filgrastim (E. coli) Solution for injection
Immunologic Therapies

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Oncology Encyclopedia. Gale Encyclopedia of Cancer. Copyright © 2006 by The Gale Group, Inc. All rights reserved.  Read more
Drug Info. Gold Standard. Copyright © 2008 by Gold Standard. All rights reserved.  Read more
Wikipedia. This article is licensed under the Creative Commons Attribution/Share-Alike License. It uses material from the Wikipedia article "Filgrastim" Read more