Description
Neulasta (pegfilgrastim) is a long-acting granulocyte colony-stimulating factor (G-CSF) analog used to reduce the incidence of infection, as manifested by febrile neutropenia, in patients receiving myelosuppressive chemotherapy associated with a clinically significant risk of neutropenia. Pegfilgrastim is a pegylated form of filgrastim, which prolongs its half-life and allows for once-per-chemotherapy-cycle administration. It acts by stimulating the production and differentiation of neutrophils from hematopoietic stem cells in the bone marrow.
| Fact Table |
| Formula | C845H1343N223O243S9 (pegylated filgrastim) |
| License | US FDA (2002), EMA |
| Bioavailability | ~70% (subcutaneous) |
| Legal status | Rx-only |
| Chemical Name | Pegfilgrastim |
| Elimination half-life | 15–80 hours (self-regulating) |
| Dosage (Strength) | 6 mg/0.6 mL prefilled syringe, once per chemotherapy cycle |
| Pregnancy | Category C – use only if clearly needed |
| Brands | Neulasta, biosimilars (Fulphila, Ziextenzo, Udenyca, Fylnetra, Stimufend) |
| Protein binding | Low; cleared by neutrophil receptor binding |
| PubChem CID | 16131129 |
| MedlinePlus | a607010 |
| ChEBI | 75357 |
| ATC code | L03AA13 |
| DrugBank | DB00019 |
| KEGG | D08367 |
| Routes of administration | Subcutaneous injection |
Directions
Neulasta is administered subcutaneously at a dose of 6 mg once per chemotherapy cycle, typically 24 to 72 hours after cytotoxic chemotherapy completion.
- It should not be given within 14 days before or within 24 hours after chemotherapy.
- Neulasta is available as a prefilled syringe or as part of the Onpro® on-body injector system, which is applied on the day of chemotherapy and delivers the dose approximately 27 hours later.
- Administration should be under the guidance of healthcare professionals trained in oncology supportive care.
Ingredients
Each 0.6 mL prefilled syringe contains:
- Pegfilgrastim 6 mg (injection solution)
The solution is preservative-free and intended for single-dose use only.
Contraindications
Neulasta is contraindicated in patients with:
- History of serious allergic reactions to pegfilgrastim or filgrastim
- Known hypersensitivity to E. coli–derived proteins (used in manufacturing)
Cautions
- Splenic rupture has been reported, including fatal cases; patients with left upper abdominal or shoulder pain should be evaluated immediately.
- Acute respiratory distress syndrome (ARDS) may occur in patients with sepsis or pulmonary inflammation.
- Use with caution in patients with sickle cell disease due to risk of sickle cell crisis.
- Rare cases of serious allergic reactions, including anaphylaxis, may occur; discontinue permanently if suspected.
- Monitor for leukocytosis (WBC count >100,000/mm³), which may occur but rarely results in complications.
- Myeloid malignancies (e.g., AML, MDS): Use only when potential benefit outweighs risk due to stimulation of myeloid cells.
Side Effects
Common side effects include:
Serious adverse effects may include:
- Acute respiratory distress syndrome
- Allergic reactions (anaphylaxis, angioedema)
IMPORTANT NOTE:
The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.
Product Code : 10752
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