Fulphila (pegfilgrastim-jmdb)

Adult Dosing .

Dosage forms:  INJ (pre-filled syringe): 6 mg per 0.6 mL

Special Note

[formulation clarification]

Info: nonproprietary name = pegfilgrastim-jmdb

febrile neutropenia prophylaxis, chemo-induced

[6 mg SC x1]

Start: >24h after chemo; Info: for pts w/ non-myeloid malignancies; do not give w/in 14 days before chemo

hematopoietic subsyndrome of acute radiation syndrome (off-label)

[6 mg SC qwk x2 doses]

Start: ASAP after suspected or confirmed exposure to radiation doses >2 Gy

renal dosing

[see below]

renal impairment: no adjustment

HD/PD: not defined

hepatic dosing

[not defined]

Peds Dosing .

Dosage forms:  INJ (pre-filled syringe): 6 mg per 0.6 mL

Special Note

[formulation clarification]

Info: nonproprietary name = pegfilgrastim-jmdb

febrile neutropenia prophylaxis, chemo-induced

[<10 kg]

Dose: 0.1 mg/kg/dose SC x1; Start: >24h after chemo; Info: for pts w/ non-myeloid malignancies; do not give w/in 14 days before chemo; pre-filled syringe product not recommended for direct admin. of doses <6 mg

[10-20 kg]

Dose: 1.5 mg SC x1; Start: >24h after chemo; Info: for pts w/ non-myeloid malignancies; do not give w/in 14 days before chemo; pre-filled syringe product not recommended for direct admin. of doses <6 mg

[21-30 kg]

Dose: 2.5 mg SC x1; Start: >24h after chemo; Info: for pts w/ non-myeloid malignancies; do not give w/in 14 days before chemo; pre-filled syringe product not recommended for direct admin. of doses <6 mg

[31-44 kg]

Dose: 4 mg SC x1; Start: >24h after chemo; Info: for pts w/ non-myeloid malignancies; do not give w/in 14 days before chemo; pre-filled syringe product not recommended for direct admin. of doses <6 mg

[>45 kg]

Dose: 6 mg SC x1; Start: >24h after chemo; Info: for pts w/ non-myeloid malignancies; do not give w/in 14 days before chemo

hematopoietic subsyndrome of acute radiation syndrome (off-label)

[<10 kg]

Dose: 0.1 mg/kg/dose SC qwk x2 doses; Start: ASAP after suspected or confirmed exposure to radiation doses >2 Gy; Info: pre-filled syringe product not recommended for direct admin. of doses <6 mg

[10-20 kg]

Dose: 1.5 mg SC qwk x2 doses; Start: ASAP after suspected or confirmed exposure to radiation doses >2 Gy; Info: pre-filled syringe product not recommended for direct admin. of doses <6 mg

[21-30 kg]

Dose: 2.5 mg SC qwk x2 doses; Start: ASAP after suspected or confirmed exposure to radiation doses >2 Gy; Info: pre-filled syringe product not recommended for direct admin. of doses <6 mg

[31-44 kg]

Dose: 4 mg SC qwk x2 doses; Start: ASAP after suspected or confirmed exposure to radiation doses >2 Gy; Info: pre-filled syringe product not recommended for direct admin. of doses <6 mg

[>45 kg]

Dose: 6 mg SC qwk x2 doses; Start: ASAP after suspected or confirmed exposure to radiation doses >2 Gy

renal dosing

[see below]

renal impairment: no adjustment

HD/PD: not defined

hepatic dosing

[not defined]