Dosing and uses of Neulasta (pegfilgrastim)
Adult dosage forms and strengths
prefilled syringe
- 6mg/0.6mL
Myelosuppressive Chemotherapy Adjunct
6mg SC once per chemotherapy cycle
Not for administration in the period 14 days before & 24 hours after admin of cytotoxic chemotherapy
Indicated to decrease incidence of infection in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy assoc with febrile neutropenia
Myelosuppression (Orphan)
Orphan designation for treatment of subjects at risk of developing myelosuppression after a radiological or nuclear incident
Orphan sponsor
- Amgen, Inc.; One Amgen Center Drive M/S 17-2-B; Thousand Oaks, CA 91320-1799
Pediatric dosage forms and strengths
prefilled syringe
- 6mg/0.6mL
Prevention of Chemotherapy Induced Neutropenia
<45 kg: 100 mcg/kg per chemotherapy cycle; not to exceed 6 mg/dose; do not administer in the period 14 days before and 24-72 hr after administration of cytotoxic chemotherapy
≥45kg: 6 mg SC once per chemotherapy cycle; do not administer in the period 14 days before and 24 hr after administration of cytotoxic chemotherapy
Neulasta (pegfilgrastim) adverse (side) effects
>10%
Peripheral edema (12%)
Asthenia (13%)
Headache (16%)
Vomiting (13%)
Bone pain (31-57%)
Myalgia (21%)
Weakness (13%)
Alopecia (15-72%)
Pyrexia (23%)
Frequency not defined
Acute respiratory distress syndrome
Sickle cell crisis
Splenic rupture
Hyperuricemia
Elevated lactate dehydrogenase
Elevated alkaline phosphatase
Allergic reaction
Postmarketing Reports
Gastrointestinal disorders: Splenic rupture
Blood and lymphatic system disorder: Sickle cell crisis
Hypersensitivity Reactions: Allergic reactions/hypersensitivity, including anaphylaxis, skin rash, and urticaria, generalized erythema and flushing, cutaneous vasculitis to skin, and subcutaneous tissue disorders
Respiratory, thoracic, and mediastinal disorder: ARDs
General disorders and administration site conditions: Injection site reactions
Skin and subcutaneous tissue disorders: Sweet’s syndrome, cutaneous vasculitis
Warnings
Contraindications
Hypersensitivity to E. coli derived proteins or any component
Cautions
Permanently discontinue therapy if serious allergic reaction occurs
Capillary leak syndrome may occur; may vary in frequency and severity; manage symptoms; delayed treatment may be life-threatening
Glomerulonephritis reported; if suspected, evaluate for cause; if causality likely, consider dose-reduction or interruption of therapy
Monitoring of complete blood count (CBC) during therapy recommended; higher counts reported
Acute respiratory distress syndrome (ARDS) reported; evaluate symptoms including fever, pulmonary infiltrates, or respiratory distress; discontinue if ARDS occurs
Not for use 14 days before or 24 hr after administering cytotoxic chemotherapy, because of potential increase in sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy; effect not studied
The 6 mg fixed dose is not for use in infants, children, and adolescents weighing <45 kg
Not indicated for peripheral blood progenitor cell (PBRC) mobilization for hematopoietic stem cell transplantation
Pegfilgrastim may potentially act as growth factor for any tumor type, including myeloid malignancies and myelodysplasia
Associated with rare cases of splenic rupture; evaluate if patient experiences left upper abdominal &/or shoulder tip pain
May precipitate sickle cell crises in patients with sickle cell anemia
The body Injector uses acrylic adhesive; for patients who have reactions to acrylic adhesives, use of this product may result in a significant reaction
Pregnancy and lactation
Pregnancy category: C
Lactation: not known if excreted in breast milk
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Neulasta (pegfilgrastim)
Mechanism of action
Recombinant PEG-conjugated human G-CSF; acts on hematopoietic cells to stimulate production, maturation & activation of neutrophilsl; increases migration and cytotoxicity of neutrophils.
Pharmacokinetics
Half-Life: 15-80 hr (adults); 20-30 hr (children)
