peg-fil-GRA-stim

Therapeutic Classification: colony-stimulating factors

• 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.

• 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.

Absorption: Well absorbed following SUBQ administration.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-life: 15–80 hr.

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.

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.

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

• 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 and symptoms of splenic rupture (left upper abdominal or shoulder pain) during therapy.
• Monitor for signs and symptoms of capillary leak syndrome (hypotension, hypoalbuminemia, edema, hemoconcentration). Treat symptomatically.
• Assess for signs and symptoms of aortitis (fever, abdominal pain, malaise, back pain, increased inflammatory markers [C-reactive protein, white blood cell count]). Discontinue pegfilgrastim if aortitis is suspected.
• May cause transient positive nuclear bone imaging changes.

• Obtain CBC and platelet count before chemotherapy. Monitor hematocrit, WBC, and platelet count regularly. May cause thrombocytopenia.
  • May cause elevated LDH, alkaline phosphatase, and uric acid.

• Do not confuse Neulasta with Lunesta or Nuedexta.
• Pegfilgrastim should not be administered between 14 days before and 24 hrs after administration of cytotoxic chemotherapy.
  • Keep patients with sickle cell disease receiving pegfilgrastim well hydrated and monitor for sickle cell crisis. Discontinue therapy if sickle cell crisis occurs.
• SC: Administer SUBQ once per chemotherapy cycle. Do not administer solutions that are discolored or contain particulate matter. Do not shake. Store refrigerated; allow to reach room temperature for at least 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 professional 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, non-irritated 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 hrs 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 professional immediately if they suspect the device may not have performed as intended in order to determine need for a replacement dose.

• 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.

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

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

Lapelga

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