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.

Fylnetra, Neulasta, Stimufend, Udenyca, and Ziextenzo

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

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.

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed following SUBQ administration.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: 15–80 hr.

Time/Action Profile ⬆ ⬇

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	unknown	unknown

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.

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): Fylnetra, 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): Fylnetra, 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): Fylnetra, 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): Fylnetra, 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): Fylnetra, 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.

Availability ⬆ ⬇

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

Assessment ⬆ ⬇

Assess patient for bone pain during therapy. Pain is usually mild to moderate and usually controllable with nonopioid analgesics, but may require opioid analgesics.
Assess patient periodically for signs of ARDS (fever, lung infiltration, respiratory distress). If ARDS occurs, treat condition and discontinue pegfilgrastim and/or withhold until symptoms resolve.
Monitor for signs/symptoms of splenic rupture (left upper abdominal or shoulder pain) during therapy.
Monitor for signs/symptoms of capillary leak syndrome (hypotension, hypoalbuminemia, edema, hemoconcentration). Treat symptomatically.
Assess for signs/symptoms of aortitis (fever, abdominal pain, malaise, back pain, ↑ inflammatory markers [C-reactive protein, WBC]). If aortitis suspected, discontinue pegfilgrastim.
May cause transient positive nuclear bone-imaging changes.

Lab Test Considerations:

Obtain baseline CBC. Monitor WBCs, hematocrit, and platelets regularly.
- May ↑ LDH, alkaline phosphatase, and uric acid.

Implementation ⬆ ⬇

Do not confuse Neulasta with Lunesta or Nuedexta.
Pegfilgrastim should not be administered between 14 days before and 24 hr after administration of cytotoxic chemotherapy.
- Keep patients with sickle cell disease receiving pegfilgrastim well hydrated and monitor for sickle cell crisis. If sickle cell crisis occurs, discontinue pegfilgrastim.
SC: Administer SUBQ once per chemotherapy cycle. Do not administer solutions that are discolored or contain particulates. Do not shake. Store refrigerated; allow to reach room temperature for ≥30 min and maximum of 48 hr, but protect from light.
- On-body Injector: Small, one-time use, lightweight, battery-powered, and waterproof up to 8 feet for 1 hr. Filled by health care provider with a prefilled syringe before application. The prefilled syringe with Neulasta and the On-body Injector are part of Neulasta Onpro kit. The On-body Injector is applied directly to skin using a self-adhesive backing. The On-body Injector uses sounds and lights to inform its status. The prefilled syringe gray needle cap contains dry natural rubber, derived from latex; do not use if allergic to latex. Apply to intact, nonirritated skin on abdomen or back of arm. Back of arm may only be used if there is a caregiver available to monitor the status of the On-body Injector. Approximately 27 hr after the On-body Injector is applied, Neulasta will be delivered over approximately 45 min. Follow manufacturer's instructions for monitoring and removal. Instruct patients using the On-body Injector to notify health care provider immediately if they suspect the device may not have performed as intended in order to determine need for a replacement dose.

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.
- 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.
Emphasize the importance of adherence with therapy and regular monitoring of blood counts.
Advise patient to notify health care provider 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 provider promptly if symptoms of sickle cell crisis occur.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care provider before taking other medications.
Rep: Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes ⬆ ⬇

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

US Brand Names ⬆ ⬇

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

Canadian Brand Names ⬆ ⬇

Code ⬆

NDC Code

0078- Novartis Pharmaceuticals Corporation
- 0078-1434-
  - 0078-1434-02- 1 kg in 1 BOTTLE (0078-1434-02)

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

70121- Amneal Pharmaceuticals LLC
- 70121-1627- FYLNETRA
  - 70121-1627-1- 1 SYRINGE in 1 CARTON (70121-1627-1) / .6 mL in 1 SYRINGE

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇