Neupogen

Clinical Pharmacology

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Clinical Pharmacology

Neupogen

Type of Malignancy	Regimen	Chemotherapy Dose	No. Pts.	Trial Phase	NEUPOGEN® Daily Dosage^a
Small Cell Lung Cancer	Cyclophosphamide Doxorubicin Etoposide	1 g/m²/day 50 mg/m²/day 120 mg/m²/day x 3 q 21 days	210	3	4 – 8 mcg/kg SC days 4 – 17
Small CellLung Cancer¹¹	Ifosfamide Doxorubicin Etoposide Mesna	5 g/m²/day 50 mg/m²/day 120 mg/m²/day x 3 8 g/m²/day q 21 days	12	1/2	5.75 – 46 mcg/kg IV days 4 – 17
Urothelial Cancer¹²	Methotrexate Vinblastine Doxorubicin Cisplatin	30 mg/m²/day x 2 3 mg/m²/day x 2 30 mg/m²/day 70 mg/m²/day q 28 days	40	1/2	3.45 – 69 mcg/kg IV days 4 – 11
Various Nonmyeloid Malignancies¹³	Cyclophosphamide Etoposide Cisplatin	2.5 g/m²/day x 2 500 mg/m²/day x 3 50 mg/m²/day x 3 q 28 days	18	1/2	23 – 69 mcg/kg^b IV days 8 – 28
Breast/Ovarian Cancer¹⁴	Doxorubicin^c	75 mg/m² 100 mg/m² 125 mg/m² 150 mg/m²q 14 days	21	2	11.5 mcg/kg IV days 2 – 9 5.75 mcg/kg IV days 10 – 12
Neuroblastoma	Cyclophosphamide Doxorubicin Cisplatin	150 mg/m² x 7 35 mg/m² 90 mg/m² q 28 days (cycles 1‚3‚5) ^d	12	2	5.45 – 17.25 mcg/kg SC days 6 – 19
^aNEUPOGEN® doses were those that accelerated neutrophil production. Doses which provided no additional acceleration beyond that achieved at the next lower dose are not reported. ^bLowest dose(s) tested in the study. ^c Patients received doxorubicin at either 75‚ 100‚ 125‚ or 150 mg/m². ^d Cycles 2‚6 = cyclophosphamide 150 mg/m² x 7 and etoposide 280 mg/m² x 3. Cycle 4 = cisplatin 90 mg/m² x 1 and etoposide 280 mg/m² x 3.

Patients With Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy

In a randomized, double-blind‚ placebo-controlled‚ multi-center‚ phase 3 clinical trial‚ 521 patients (median age 54‚ range 16 to 89 years) were treated for de novo acute myeloid leukemia (AML). Following a standard induction chemotherapy regimen comprising daunorubicin, cytosine arabinoside, and etoposide¹⁵ (DAV 3+7+5), patients received either NEUPOGEN® at 5 mcg/kg/day or placebo, SC, from 24 hours after the last dose of chemotherapy until neutrophil recovery (ANC 1000/mm³ for 3 consecutive days or 10,000/mm³ for 1 day) or for a maximum of 35 days.

Brand Name: Neupogen
Generic Name: Filgrastim