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Filgrastim Dosage

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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.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

BMT:
Absolute neutrophil count (ANC) greater than 1000/mm3 for 3 consecutive days: Reduce to 5 mcg/kg/day
If ANC remains 1000/mm3 for 3 more consecutive days: Discontinue filgrastim
If ANC decreases to less than 1000/mm3: Resume at 5 mcg/kg/day
While on 5 mcg/kg/day dose, ANC decreases to less than 1000/mm3: Increase dose to 10 mcg/kg/day

Precautions

Consult WARNINGS section for dosing related precautions.

Dialysis

Data not available

Other Comments

Administration advice: Refer to the manufacturer's product information for additional information.

Storage requirements: Store in refrigerator at 2C to 8C (36F to 46F). Avoid shaking.

Reconstitution/preparation techniques: Refer to the manufacturer's product information for additional information.

IV compatibility: Do not dilute with saline as this may cause precipitation.

General: Filgrastim may act as a growth factor for any tumor with myeloid characteristics.

Monitoring: Clinical monitoring should include a complete blood count (CBC), with white blood cell (WBC) differential and platelet count at least twice weekly during filgrastim therapy. Following marrow transplantation CBC and platelet counts are recommended at least three times per week.

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