• To decrease the incidence of infection (febrile neutropenia) in patients with nonmyeloid malignancies receiving myelosuppressive antineoplastics associated with a high risk of febrile neutropenia.

Neulasta and Udenyca:

• To increase survival in patients acutely exposed to myelosuppressive doses of radiation.

Contraindicated in:

• Hypersensitivity to filgrastim or Escherichia coli–derived proteins.

Use Cautiously in:

• Patients with breast or lung cancer receiving chemotherapy and/or radiotherapy (↑ risk of myelodysplastic syndrome or acute myeloid leukemia)
• Patients with sickle cell disease (↑ risk of sickle cell crisis)
• Malignancy with myeloid characteristics
• OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant.

CV: aortitis.

GI: SPLENIC RUPTURE.

GU: glomerulonephritis.

Hemat: ACUTE MYELOID LEUKEMIA, leukocytosis, MYELODYSPLASTIC SYNDROME, SICKLE CELL CRISIS, thrombocytopenia.

MS: medullary bone pain.

Resp: ADULT RESPIRATORY DISTRESS SYNDROME (ARDS).

Misc: CAPILLARY LEAK SYNDROME, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS).

Drug-Drug:

• Simultaneous use with antineoplastics may have adverse effects on rapidly proliferating neutrophils; avoid use for 24 hr before and 24 hr following chemotherapy.
• Lithium may potentiate the release of neutrophils; concurrent use should be undertaken cautiously.

• Solution for injection (prefilled syringes and autoinjectors): 6 mg/0.6 mL;

Patients with Cancer Receiving Myelosuppressive Chemotherapy

• SC (Adults and Children ≥45 kg): 6 mg per chemotherapy cycle.
• SC (Children 31–44 kg): 4 mg per chemotherapy cycle.
• SC (Children 21–30 kg): 2.5 mg per chemotherapy cycle.
• SC (Children 10–20 kg): 1.5 mg per chemotherapy cycle.
• SC (Children <10 kg): 0.1 mg/kg per chemotherapy cycle.

Patients Acutely Exposed to Myelosuppressive Doses of Radiation

• SC (Adults and Children ≥45 kg): 6 mg as soon as possible after suspected or confirmed exposure to radiation levels >2 gray (Gy), then 6 mg 1 wk later.
• SC (Children 31–44 kg): 4 mg as soon as possible after suspected or confirmed exposure to radiation levels >2 gray (Gy), then 4 mg 1 wk later.
• SC (Children 21–30 kg): 2.5 mg as soon as possible after suspected or confirmed exposure to radiation levels >2 gray (Gy), then 2.5 mg 1 wk later.
• SC (Children 10–20 kg): 1.5 mg as soon as possible after suspected or confirmed exposure to radiation levels >2 gray (Gy), then 1.5 mg 1 wk later.
• SC (Children <10 kg): 0.1 mg/kg as soon as possible after suspected or confirmed exposure to radiation levels >2 gray (Gy), then 0.1 mg/kg 1 wk later.

Fulphila, Fylnetra, Neulasta, Neulasta Onpro, Nyvepria, Stimufend, Udenyca, Ziextenzo

• Filgrastim is a glycoprotein that binds to and stimulates neutrophils to divide and differentiate. Also activates mature neutrophils. Binding to a polyethylene glycol molecule prolongs its effects.

• Decreased incidence of infection in patients who are neutropenic from chemotherapy.
• Improved survival in patients acutely exposed to myelosuppressive doses of radiation.

Therapeutic Classification: colony-stimulating factors

Absorption: Well absorbed following SUBQ administration.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-life: 15–80 hr.

Lapelga

• Instruct patient in technique for injection, care of medication, and disposal of equipment. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
• Advise patient to notify health care professional immediately if signs of allergic reaction (shortness of breath, hives, rash, pruritus, laryngeal edema), ARDS (shortness of breath with or without a fever, trouble breathing, fast rate of breathing), kidney injury (swelling of face or ankles, blood in urine or dark-colored urine, urinate less than usual), capillary leak syndrome (swelling or puffiness and urinating less than usual, trouble breathing, swelling of abdomen and feeling of fullness, dizziness or feeling faint, general feeling of tiredness), myelodysplastic syndrome or acute myeloid leukemia (tiredness, fever, and easy bruising or bleeding), inflammation of the aorta (fever, abdominal pain, feeling tired, back pain), or signs of splenic rupture (left upper abdominal or shoulder tip pain) occur.
• Advise patients with sickle cell disease to maintain hydration and to notify health care professional promptly if symptoms of sickle cell crisis occur.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
• Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected, or if breast feeding.
• Emphasize the importance of adherence with therapy and regular monitoring of blood counts.
• Home Care Issues: Instruct patient on correct disposal technique for home administration. Caution patient not to reuse needle, syringe, or drug product. Provide patient with a puncture-proof container for disposal of prefilled syringe.

peg-fil-GRA-stim

NDC Code^*

• 55513- Amgen Inc
  • 55513-190- Neulasta
    • 55513-190-01- 1 SYRINGE in 1 CARTON (55513-190-01) >.6 mL in 1 SYRINGE

• 55513- Amgen Inc
  • 55513-192- Neulasta
    • 55513-192-01- 1 KIT in 1 CARTON (55513-192-01) *.6 mL in 1 SYRINGE

• 67457- Mylan Institutional LLC
  • 67457-833- Fulphila
    • 67457-833-06- 1 SYRINGE in 1 CARTON (67457-833-06) >.6 mL in 1 SYRINGE