Generic
Pegfilgrastim
3 brands available in the market
At a glance
Pegfilgrastim is a leukocyte growth factor used to prevent infections after chemotherapy. It stimulates bone marrow to produce white blood cells that protect the body against infections.
Description
Pegfilgrastim is a Granulocyte Colony-Stimulating Factor (G-CSF) that is a pegylated glycoprotein that regulates the production and release of functional neutrophils from bone marrow. Pegfilgrastim is a covalent conjugate of recombinant methionyl human G-CSF (Filgrastim) and monomethoxy polyethylene glycol.
Indications
- Decrease incidence of infection in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy associated with febrile neutropenia
Therapeutic class
Hematopoietic drug
Pharmacological class
Granulocyte Colony-Stimulating Factor (G-CSF)
Pharmacology
Pegfilgrastim is a Granulocyte Colony-Stimulating Factor (G-CSF) that regulates the production and release of functional neutrophils from bone marrow. It binds to specific cell surface receptors of hematopoietic cells, stimulating proliferation, differentiation, commitment, and end cell functional activation.
Mechanism of action
Stimulates neutrophil production and release by binding to cell surface receptors on hematopoietic cells.
Dosage
Adult Dose (Subcutaneous):
- Chemotherapy-induced neutropenia: 6 mg single dose per chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy
- Maximum safe dose not determined (up to 300 mcg/kg evaluated)
Pediatric Dose (Subcutaneous):
- >45 kg: 6 mg per chemotherapy cycle
- Do not administer in the period 14 days before and 24 hours after cytotoxic chemotherapy
Administration
- Administered by doctor or nurse as subcutaneous injection
- Do not self-administer
- Do not administer between 14 days before and 24 hours after cytotoxic chemotherapy
- Inspect product before administration; do not use if discoloration or particulates are observed
- Needle cover contains latex; do not use if latex allergy
Missed dose
If you miss a dose, consult your doctor.
Side effects
Side Effects:
- Splenic rupture (can be fatal)
- Acute Respiratory Distress Syndrome (ARDS)
- Serious allergic reactions (anaphylaxis)
- Severe sickle cell crises in sickle cell disorders
- Bone pain
- Joint pain
- Headache
- Nausea
- Low blood platelets
- Muscle pain
- Back pain
- Injection site pain
Precautions & warnings
- Fatal splenic rupture can occur; evaluate for splenomegaly or rupture in patients with left upper abdominal or shoulder pain
- ARDS can occur; evaluate for ARDS in patients who develop fever, lung infiltrates, or respiratory distress; discontinue Pegfilgrastim in patients with ARDS
- Serious allergic reactions including anaphylaxis can occur; permanently discontinue for serious allergic reactions
- Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders
- Do not administer with cytotoxic chemotherapy (increased risk of myelosuppression)
- Avoid driving if dizziness occurs
Contraindications
- History of serious allergic reactions to pegfilgrastim or filgrastim
Drug interactions
- Do not administer at the same time as cytotoxic chemotherapy (myelosuppression risk)
- Do not mix with other medicinal products, particularly sodium chloride solutions
Food interactions
It is not known whether it is safe to consume alcohol with Pegfilgrastim; consult your doctor.
Use in pregnancy
Use in Pregnancy: May be unsafe during pregnancy; animal studies have shown harmful effects. Doctor will weigh benefits and risks before prescribing. Pregnancy Category C.
Pregnancy Category: C — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Probably safe; limited human data suggests no significant risk. Other G-CSF products are poorly secreted in breast milk and not orally absorbed by neonates.
Pediatric use
Safety and effectiveness not established in pediatric patients.
Geriatric use
No overall differences in safety or effectiveness observed in elderly patients (≥65 years).
Renal / hepatic impairment
Renal Impairment: Safe in kidney disease; no dose adjustment required.
Hepatic Impairment: Limited information available on use in liver disease; consult your doctor.
Overdose effects
Overdose: Maximum safe dose not determined. Single SC doses of 300 mcg/kg have been administered without serious adverse effects. Maximum ANC observed was 96x10⁹/L. Treatment: symptomatic supportive care.
Storage conditions
Store in a refrigerator at 2-8°C; do not freeze; do not shake; keep away from light.
Chemical structure
Pegfilgrastim