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Nypozi (filgrastim-txid)
filgrastim (G-CSF)
Adult Dosing .
Dosage forms: INJ (pre-filled syringe): 300 mcg per 0.5 mL, 480 mcg per 0.8 mL
Special Note
- [drug name clarification]
- Info: nonproprietary name = filgrastim-txid
febrile neutropenia prophylaxis, chemo-induced
- [5 mcg/kg/dose SC/IV qd]
- Start: >24h after chemo, may incr. dose by 5 mcg/kg/dose per chemo cycle; Info: for patients with non-myeloid malignancies or patients with AML receiving induction or consolidation chemo; SC route preferred; product not recommended for direct administration of doses <180 mcg; continue until ANC >10,000 or for up to 2wk; do not give within 24h before chemo
neutropenia, post-BMT
- [10 mcg/kg/dose IV qd]
- Start: >24h after chemo, >24h after BMT; Info: for patients with non-myeloid malignancies; product not recommended for direct administration of doses <180 mcg; decr. dose by 50% if ANC >1000 x3 consecutive days, then D/C if ANC >1000 x3 more consecutive days; incr. dose back to 10 mcg/kg/day if ANC <1000 during 50% dose reduction; restart 5 mcg/kg/day if ANC <1000 after tx D/C
autologous peripheral blood progenitor cell mobilization
- [10 mcg/kg/dose SC qd x6-7 days]
- Start: at least 4 days before 1st leukapheresis, continue through last leukapheresis; Info: product not recommended for direct administration of doses <180 mcg; D/C if WBC >100,000
neutropenia, severe chronic
- [congenital]
- Start: 6 mcg/kg/dose SC bid; Info: product not recommended for direct administration of doses <180 mcg; individualize dose based on ANC and clinical course
- [idiopathic or cyclic]
- Start: 5 mcg/kg/dose SC qd; Info: product not recommended for direct administration of doses <180 mcg; individualize dose based on ANC and clinical course
hematopoietic syndrome of acute radiation syndrome
- [10 mcg/kg/dose SC qd]
- Start: ASAP after suspected or confirmed exposure to radiation doses >2 Gy; Info: product not recommended for direct administration of doses <180 mcg; continue until ANC >1000 x3 consecutive CBCs or ANC >10,000 after radiation-induced nadir
neutropenia, AIDS-associated (off-label)
- [1-10 mcg/kg/dose SC qd]
- Info: product not recommended for direct administration of doses <180 mcg; refer to literature for dosing protocols
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [no adjustment]
Peds Dosing .
- Dosage forms: INJ (pre-filled syringe): 300 mcg per 0.5 mL, 480 mcg per 0.8 mL
Special Note
- [drug name clarification]
- Info: nonproprietary name = filgrastim-txid
febrile neutropenia prophylaxis, chemo-induced
- [7 mo and older]
- Dose: 5 mcg/kg/dose SC/IV qd; Start: >24h after chemo, may incr. dose by 5 mcg/kg/dose per chemo cycle; Info: for patients with non-myeloid malignancies or patients with AML receiving induction or consolidation chemo; SC route preferred; product not recommended for direct administration of doses <180 mcg; continue until ANC >10,000 or for up to 2wk; do not give within 24h before chemo
neutropenia, post-BMT
- [7 mo and older]
- Dose: 10 mcg/kg/dose IV qd; Start: >24h after chemo, >24h after BMT; Info: for patients with non-myeloid malignancies; product not recommended for direct administration of doses <180 mcg; decr. dose by 50% if ANC >1000 x3 consecutive days, then D/C if ANC >1000 x3 more consecutive days; incr. dose back to 10 mcg/kg/day if ANC <1000 during 50% dose reduction; restart 5 mcg/kg/day if ANC <1000 after tx D/C
autologous peripheral blood progenitor cell mobilization
- [7 mo and older]
- Dose: 10 mcg/kg/dose SC qd x6-7 days; Start: at least 4 days before 1st leukapheresis, continue through last leukapheresis; Info: product not recommended for direct administration of doses <180 mcg; D/C if WBC >100,000
neutropenia, severe chronic
- [congenital, 7 mo and older]
- Start: 6 mcg/kg/dose SC bid; Info: product not recommended for direct administration of doses <180 mcg; individualize dose based on ANC and clinical course
- [idiopathic or cyclic, 7 mo and older]
- Start: 5 mcg/kg/dose SC qd; Info: product not recommended for direct administration of doses <180 mcg; individualize dose based on ANC and clinical course
hematopoietic syndrome of acute radiation syndrome
- [7 mo and older]
- Dose: 10 mcg/kg/dose SC qd; Start: ASAP after suspected or confirmed exposure to radiation doses >2 Gy; Info: product not recommended for direct administration of doses <180 mcg; continue until ANC >1000 x3 consecutive CBCs or ANC >10,000 after radiation-induced nadir
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [no adjustment]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- hypersensitivity to granulocyte stimulating factors, serious
- hypersensitivity to E. coli protein
- XRT use, concurrent
- chemotherapy use within prior 24h
- avoid: chemotherapy use x24h after tx
- caution: sickle cell disease
- caution: myelodysplasia
- caution: myeloid malignancy
- caution: neutropenia, congenital
- caution: breast CA
- caution: lung CA
Drug Interactions .
Overview
filgrastim (G-CSF)
colony-stimulating factor
- immunomodulatory effects (colony stimulating factor)
Avoid/Use Alternative
- betibeglogene autotemcel
- lovotibeglogene autotemcel
Monitor/Modify Tx
- abemaciclib
- acalabrutinib
- ado-trastuzumab emtansine
- afamitresgene autoleucel
- aldesleukin
- alemtuzumab
- arsenic trioxide
- asciminib
- azacitidine
- belantamab mafodotin
- belinostat
- bendamustine
- bevacizumab
- bexarotene
- blinatumomab
- bortezomib
- bosutinib
- brentuximab vedotin
- brexucabtagene autoleucel
- busulfan
- cabazitaxel
- capecitabine
- carboplatin
- carfilzomib
- carmustine
- chlorambucil
- ciltacabtagene autoleucel
- cisplatin
- cladribine injection
- clofarabine
- copanlisib
- crizotinib
- cyclophosphamide
- cytarabine
- dacarbazine
- dactinomycin
- daratumumab
- dasatinib
- daunorubicin
- decitabine
- docetaxel
- dostarlimab
- doxorubicin
- duvelisib
- eflornithine
- elranatamab
- enfortumab vedotin
- entrectinib
- epcoritamab
- epirubicin
- eribulin
- etoposide
- everolimus
- fam-trastuzumab deruxtecan
- fedratinib
- floxuridine
- fludarabine
- fluorouracil
- gemcitabine
- gemtuzumab ozogamicin
- glasdegib
- glofitamab
- hydroxyurea
- ibritumomab tiuxetan
- ibrutinib
- idarubicin
- idecabtagene vicleucel
- idelalisib
- ifosfamide
- imatinib
- imetelstat
- inotuzumab ozogamicin
- irinotecan
- isatuximab
- ivosidenib
- ixabepilone
- lenalidomide
- lifileucel
- linvoseltamab
- lisocabtagene maraleucel
- lomustine
- loncastuximab tesirine
- lurbinectedin
- lutetium Lu 177 dotatate
- lutetium Lu 177 vipivotide tetraxetan
- melphalan
- mercaptopurine
- methotrexate
- midostaurin
- mitomycin
- mitotane
- mitoxantrone
- mogamulizumab
- momelotinib
- mosunetuzumab
- nelarabine
- nilotinib
- niraparib
- obecabtagene autoleucel
- obinutuzumab
- ofatumumab
- olaparib
- oxaliplatin
- paclitaxel
- pacritinib
- palbociclib
- pemetrexed
- pentostatin
- pirtobrutinib
- polatuzumab vedotin
- pomalidomide
- ponatinib
- pralatrexate
- procarbazine
- quizartinib
- ribociclib
- rituximab
- romidepsin
- rucaparib
- ruxolitinib
- sacituzumab govitecan
- selinexor
- sirolimus albumin-bound
- streptozocin
- tafasitamab
- tagraxofusp
- talazoparib
- talquetamab
- tarlatamab
- tazemetostat
- teclistamab
- temozolomide
- temsirolimus
- thalidomide
- thioguanine
- thiotepa
- tisagenlecleucel
- topotecan
- trabectedin
- trastuzumab
- treosulfan
- trifluridine
- venetoclax
- vinblastine
- vincristine
- vinorelbine
- zanubrutinib
- ziv-aflibercept
Caution Advised
- bleomycin
Adverse Reactions .
Serious Reactions
- splenic rupture
- ARDS
- anaphylaxis
- hypersensitivity reaction
- sickle cell crisis
- myelodysplastic syndrome
- AML
- thrombocytopenia
- glomerulonephritis
- capillary leak syndrome
- aortitis
- alveolar hemorrhage
- cutaneous vasculitis
- acute febrile neutrophilic dermatosis
- osteoporosis (chronic use in peds patients)
- leukocytosis
Common Reactions
- fever
- nausea
- thrombocytopenia
- bone pain
- fatigue
- back pain
- rash
- headache
- chest pain
- dizziness
- cough
- dyspnea
- alk phos incr.
- arthralgia
- extremity pain
Safety/Monitoring .
Monitoring Parameters
Post-Chemo Neutropenia: CBC with diff before chemo, then 2x/wk
Post-BMT Neutropenia: CBC with diff frequently
Autologous Peripheral Blood Progenitor Cell Mobilization: CBC with diff after 4 days of tx
Severe Chronic Neutropenia: CBC with diff during 1st 4wk of tx and for 2wk after dose change, then qmo during 1st year of tx if stable, then routinely thereafter
Hematopoietic Syndrome of Acute Radiation Syndrome: CBC with diff at baseline, then q3 days
Look/Sound-Alike Drug Names
filgrastim confused with: sargramostim
Pregnancy/Lactation .
Pregnancy
Clinical Summary
benefits outweigh risks during pregnancy; risk of fetal harm low based on human data
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no known risk of infant harm based on limited human data and drug properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for filgrastim: other; CYP450: unknown
Excretion: for filgrastim: other; Half-life: 3.5h
Subclass: Colony Stimulating Factors (CSFs) ; Supportive Care: Myelosuppression
Mechanism of Action
for filgrastim: binds to receptors on hematopoietic cells, increasing neutrophil production and activation
Formulary .
No Formulary Selected
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