pegfilgrastim

REMS

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, Stimufend, Udenyca, and Ziextenzo

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

Contraind./Precautions ⬆ ⬇

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.

Adv. Reactions/Side Effects ⬆ ⬇

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)

Interactions ⬆ ⬇

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.

Availability ⬆ ⬇

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

Route/Dosage ⬆ ⬇

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): Neulasta, Stimufend, Udenyca, or Ziextenzo: 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): Neulasta, Stimufend, Udenyca, or Ziextenzo: 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): Neulasta, Stimufend, Udenyca, or Ziextenzo: 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): Neulasta, Stimufend, Udenyca, or Ziextenzo: 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): Neulasta, Stimufend, Udenyca, or Ziextenzo: 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.

US Brand Names ⬆ ⬇

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

Action ⬆ ⬇

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.

Therapeutic effects:

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

Classifications ⬆ ⬇

Therapeutic Classification: colony-stimulating factors

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed following SUBQ administration.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: 15–80 hr.

Canadian Brand Names ⬆ ⬇

Time/Action Profile ⬆ ⬇

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	unknown	unknown

Patient/Family Teaching ⬆ ⬇

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, urinating less than usual), capillary leak syndrome (swelling or puffiness, urinating less than usual, trouble breathing, swelling of abdomen, feeling of fullness, dizziness or feeling faint, general feeling of tiredness), myelodysplastic syndrome or acute myeloid leukemia (tiredness, fever, 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 breastfeeding.
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 a puncture-proof container for disposal of prefilled syringe.

Pronunciation ⬆ ⬇

Code ⬆

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

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Indications ⬇