Pegfilgrastim

Reviewed on 6/2/2022

What Is Pegfilgrastim and How Does It Work?

Pegfilgrastim is a prescription medication used to prevent neutropenia associated with chemotherapy

  • Pegfilgrastim is available under the following different brand names Neulasta, Fulphila, pegfilgrastim-jmdb, Udenyca, pegfilgrastim-cbqv, Ziextenzo, pegfilgrastim-bmez, pegfilgrastim-apgf, Nyvepria 

What Are Dosages of Pegfilgrastim?

Adult and pediatric dosage

  • Prefilled syringe, single-dose
    • 6mg/0.6mL (Neulasta, Fulphila, Udenyca, Ziextenzo)
  • Prefilled syringe, single-dose co-packaged with the on-body injector (OBI)
    • 6mg/0.6mL (Neulasta Onpro kit)

Prevention of Chemotherapy-induced Neutropenia

Adult dosage

  • 6mg subcutaneous once per chemotherapy cycle

Pediatric dosage

  • Weight above 45 kg: 6 mg subcutaneous once per chemotherapy cycle
  • Weight below 45 kg
  • Below 10 kg: 0.1 mg/kg (0.01 mL/kg) subcutaneous once per chemotherapy cycle
  • 10-20 kg: 1.5 mg (0.15 mL) subcutaneous once per chemotherapy cycle
  • 21-30 kg: 2.5 mg (0.25 mL) subcutaneous once per chemotherapy cycle
  • 31-44 kg: 4 mg (0.4 mL) subcutaneous once per chemotherapy cycle

Hematopoietic Subsyndrome of Acute Radiation Syndrome

Adult dosage

  • 2 doses (6 mg each) subcutaneous 1 week apart

Pediatric dosage

  • Administer the second dose Subcutaneous 1 week after the first dose
  • Weight above 45 kg: 6 mg Subcutaneous once per chemotherapy cycle
  • Weight below 45 kg
  • 2 doses (6 mg each) Subcutaneous 1 week apart
  • Below 10 kg: 0.1 mg/kg (0.01 mL/kg)
  • 10-20 kg: 1.5 mg (0.15 mL)
  • 21-30 kg: 2.5 mg (0.25 mL)
  • 31-44 kg: 4 mg (0.4 mL)

Dosage Considerations – Should be Given as Follows: 

  • See “Dosages”

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What Are Side Effects Associated with Using Pegfilgrastim?

Common side effects of Pegfilgrastim include:

  • bone pain,
  • pain in the arms or legs, or
  • injection site reactions (bruising, swelling, pain, redness, or a hard lump).

Serious side effects of Pegfilgrastim include:

  • breathing problems (e.g., trouble breathing, shortness of breath, fast breathing).
  • Rare side effects of Pegfilgrastim include:

none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

What Other Drugs Interact with Pegfilgrastim?

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

  • Pegfilgrastim has no noted severe interactions with any other drugs 
  • Pegfilgrastim has no noted serious interactions with any other drugs 
  • Pegfilgrastim has no noted moderate interactions with any other drugs 
  • Pegfilgrastim has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

What Are Warnings and Precautions for Pegfilgrastim?

Contraindications

  • History of serious allergic reactions to pegfilgrastim or filgrastim 

Effects of drug abuse

  • None

Short-Term Effects

  • See “What Are Side Effects Associated with Using Pegfilgrastim?”

Long-Term Effects

  • See “What Are Side Effects Associated with Using Pegfilgrastim?”

Cautions

  • Rare cases of splenic rupture may occur; evaluate if the patient experiences left upper abdominal and/or shoulder tip pain
  • ARDS reported; evaluate symptoms, including fever, pulmonary infiltrates, or respiratory distress; discontinue if ARDS occurs
  • Serious allergic reactions (e.g., anaphylaxis) can occur; the majority of reported events occurred upon initial exposure; allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial antiallergic treatment; permanently discontinue treatment in patients with serious allergic reactions (see Contraindications)
  • Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders; discontinue therapy if a sickle cell crisis occurs
  • Capillary leak syndrome may occur; may vary in frequency and severity; closely monitor patients who develop symptoms and provide standard symptomatic treatment, which may include a need for intensive care
  • Glomerulonephritis reported; if suspected, evaluate for a cause; if causality likely, consider dose reduction or interruption of therapy
  • Leukocytosis observed; monitoring CBC count during therapy recommended; higher counts reported
  • Pegfilgrastim may potentially act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia
  • Missed or partial doses were reported in patients receiving drugs via OBI due to the device not performing as intended; in event of missed or partial dose, patients may be at increased risk of events such as neutropenia, febrile neutropenia, and/or infection than if the dose had been correctly delivered; instruct patients using OBI to notify their healthcare professional immediately to determine the need for a replacement dose if they suspect that device may not have performed as intended
  • Aortitis is reported; it may occur as early as the first week after the start of therapy; manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., C-reactive protein and white blood cell count); consider aortitis in patients who develop these signs and symptoms without known etiology; discontinue if aortitis is suspected
  • The increased hematopoietic activity of bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes; this should be considered when interpreting bone imaging results
  • Thrombocytopenia was reported; monitor platelet counts
  • Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) are associated with the use of pegfilgrastim products in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer; monitor patients for signs and symptoms of MDS/AML in these settings

Pregnancy and Lactation

  • Insufficient data available on use in pregnant women to establish whether there is a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
  • Data from published studies in pregnant women exposed to filgrastim products have not established an association of filgrastim product use during pregnancy with major birth defects, miscarriage, or adverse maternal or fetal outcomes
  • Lactation
    • Unknown whether pegfilgrastim is secreted in human milk
    • Other recombinant G-CSF products are poorly secreted in breast milk, and G-CSF is not orally absorbed by neonates
    • Caution should be exercised when administered to a nursing female
References
https://reference.medscape.com/drug/neulasta-fulphila-pegfilgrastim-342167#0

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