Filgrastim

Filgrastim
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

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Overview

Filgrastim is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the {{{indicationType}}} of Cancer Patients Receiving Myelosuppressive Chemotherapy， Patients With Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy， Cancer Patients Receiving Bone Marrow Transplant， Patients Undergoing Peripheral Blood Progenitor Cell Collection and Therapy， Patients With Severe Chronic Neutropenia. Common adverse reactions include Bone pain.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Cancer Patients Receiving Myelosuppressive Chemotherapy

• Dosing information

• Recommended starting dosage: 5 mcg/kg/day‚ administered as a single daily injection by SC bolus injection‚ by short IV infusion (15 to 30 minutes)‚ or by continuous SC or continuous IV infusion.

• A CBC and platelet count should be obtained before instituting NEUPOGEN® therapy and monitored twice weekly during therapy.
• Doses may be increased in increments of 5 mcg/kg for each chemotherapy cycle‚ according to the duration and severity of the ANC nadir.

• NEUPOGEN® should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy.
• NEUPOGEN® should not be administered in the period 24 hours before the administration of chemotherapy.
• NEUPOGEN® should be administered daily for up to 2 weeks‚ until the ANC has reached 10‚000/mm3 following the expected chemotherapy-induced neutrophil nadir.
• The duration of NEUPOGEN® therapy needed to attenuate chemotherapy-induced neutropenia may be dependent on the myelosuppressive potential of the chemotherapy regimen employed.
• NEUPOGEN® therapy should be discontinued if the ANC surpasses 10‚000/mm3 after the expected chemotherapy-induced neutrophil nadir.

Cancer Patients Receiving Bone Marrow Transplant

• Dosing information

• Recommended dosage following BMT: 10 mcg/kg/day given as an IV infusion of 4 or 24 hours‚ or as a continuous 24-hour SC infusion. For patients receiving BMT‚ the first dose of NEUPOGEN® should be administered at least 24 hours after cytotoxic chemotherapy and at least 24 hours after bone marrow infusion.

During the period of neutrophil recovery‚ the daily dose of NEUPOGEN® should be titrated against the neutrophil response as follows:

File:Filgrastim administration 01,png

This image is provided by the National Library of Medicine.

Peripheral Blood Progenitor Cell Collection and Therapy in Cancer Patients

• Dosing information

• Recommended dosage for the mobilization of PBPC: 10 mcg/kg/day SC‚ either as a bolus or a continuous infusion. It is recommended that NEUPOGEN® be given for at least 4 days before the first leukapheresis procedure and continued until the last leukapheresis. Although the optimal duration of NEUPOGEN® administration and leukapheresis schedule have not been established‚ administration of NEUPOGEN® for 6 to 7 days with leukaphereses on days 5‚ 6‚ and 7 was found to be safe and effective. Neutrophil counts should be monitored after 4 days of NEUPOGEN®, and NEUPOGEN® dose modification should be considered for those patients who develop a WBC count > 100‚000/mm3.

In all clinical trials of NEUPOGEN® for the mobilization of PBPC‚ NEUPOGEN® was also administered after reinfusion of the collected cells.

Patients With Severe Chronic Neutropenia

• Dosing information

• NEUPOGEN® should be administered to those patients in whom a diagnosis of congenital‚ cyclic‚ or idiopathic neutropenia has been definitively confirmed. Other diseases associated with neutropenia should be ruled out.

• Starting Dose:

• Congenital Neutropenia: The recommended daily starting dose is 6 mcg/kg BID SC every day.
• Idiopathic or Cyclic Neutropenia: The recommended daily starting dose is 5 mcg/kg injection SC qd.

• Dose Adjustments:

• Chronic daily administration is required to maintain clinical benefit. Absolute neutrophil count should not be used as the sole indication of efficacy. The dose should be individually adjusted based on the patient's clinical course as well as ANC. In the SCN postmarketing surveillance study, the reported median daily doses of NEUPOGEN® were: 6.0 mcg/kg (congenital neutropenia), 2.1 mcg/kg (cyclic neutropenia), and 1.2 mcg/kg (idiopathic neutropenia). In rare instances, patients with congenital neutropenia have required doses of NEUPOGEN® ≥ 100 mcg/kg/day.

Dilution

If required‚ NEUPOGEN® may be diluted in 5% dextrose. NEUPOGEN® diluted to concentrations between 5 and 15 mcg/mL should be protected from adsorption to plastic materials by the addition of Albumin (Human) to a final concentration of 2 mg/mL. When diluted in 5% dextrose or 5% dextrose plus Albumin (Human)‚ NEUPOGEN® is compatible with glass bottles‚ PVC and polyolefin IV bags‚ and polypropylene syringes. Dilution of NEUPOGEN® to a final concentration of less than 5 mcg/mL is not recommended at any time. Do not dilute with saline at any time; product may precipitate.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Filgrastim in adult patients.

Non–Guideline-Supported Use

Agranulocytosis

• Dosing information

• 350 micrograms/day 7507240
• 5 micrograms/kg/day subcutaneously for 7 days 7512460
• 300 micrograms/day subcutaneously7525175

Aplastic anemia

• Dosing information

• 20 milligrams/kilogram/day (mg/kg/day)

Disorder related to renal transplantation - Neutropenic disorder

• Dosing information

• 6 micrograms/kilogram/day subcutaneously 12803133

Febrile neutropenia

• Dosing information

• 100mcg/m(2) to 400 mcg/m(2) 10071455

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Filgrastim FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Filgrastim in pediatric patients.

Non–Guideline-Supported Use

Aplastic anemia

• Dosing information

• Not applicable 10979946

Contraindications

There is limited information regarding Filgrastim Contraindications in the drug label.

Warnings

There is limited information regarding Filgrastim Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Filgrastim Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Filgrastim Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Filgrastim Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Filgrastim in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Filgrastim in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Filgrastim during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Filgrastim in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Filgrastim in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Filgrastim in geriatric settings.

Gender

There is no FDA guidance on the use of Filgrastim with respect to specific gender populations.

Race

There is no FDA guidance on the use of Filgrastim with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Filgrastim in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Filgrastim in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Filgrastim in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Filgrastim in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Filgrastim Administration in the drug label.

Monitoring

There is limited information regarding Filgrastim Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Filgrastim and IV administrations.

Overdosage

There is limited information regarding Filgrastim overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Filgrastim Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Filgrastim Mechanism of Action in the drug label.

Structure

There is limited information regarding Filgrastim Structure in the drug label.

Pharmacodynamics

There is limited information regarding Filgrastim Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Filgrastim Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Filgrastim Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Filgrastim Clinical Studies in the drug label.

How Supplied

There is limited information regarding Filgrastim How Supplied in the drug label.

Storage

There is limited information regarding Filgrastim Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Filgrastim Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Filgrastim interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Filgrastim Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Filgrastim Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.