LIPEGFILGRASTIM 6 mg Prefilled Syringe (PFS)

Long-Acting Recombinant G-CSF – Neutropenia Prophylaxis

ATC Code: L03AA14 | Prescription Only

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Product Description:

Lipegfilgrastim is a long-acting glycoPEGylated recombinant human granulocyte colony-stimulating factor (G-CSF) used to reduce the incidence and duration of chemotherapy-induced neutropenia. It is derived from filgrastim and modified with a PEG moiety via a glyco-linkage to extend its half-life, allowing for once-per-cycle dosing. Lipegfilgrastim promotes the proliferation and differentiation of neutrophil precursors and supports immune recovery in oncology patients undergoing myelosuppressive chemotherapy.

Available Presentation:

• Strength: 6 mg (equivalent to 105 mcg/kg for patients ≥60 kg)
• Formulation: Prefilled syringe with clear, colorless solution
• Volume: 0.6 mL solution for subcutaneous injection
• Packaging: Single-use syringe with safety needle in carton box
• Route of Administration: Subcutaneous (SC)
• Storage: Refrigerate at 2°C–8°C; do not freeze; protect from light

Uses:

• Prevention of chemotherapy-induced neutropenia (CIN) in adult cancer patients
• Reduction of febrile neutropenia, hospitalization, and infection rates
• Once-per-cycle alternative to daily filgrastim injections
• Indicated for solid tumors and hematologic malignancies

Indications:

• Prophylaxis of neutropenia: In patients receiving chemotherapy with a high risk of febrile neutropenia (e.g., breast cancer, lung cancer, lymphoma)
• Enhancement of neutrophil recovery: Following chemotherapy-induced myelosuppression

Regulatory and Safety Profile:

• ATC Code: L03AA14
• Dosing Frequency: Once per chemotherapy cycle
• Common Adverse Effects: Bone pain, back pain, headache, fatigue, injection site reactions
• Serious Risks (rare): Splenic rupture, ARDS, allergic reactions, capillary leak syndrome
• Contraindications: Hypersensitivity to lipegfilgrastim, PEGylated proteins, or E. coli-derived proteins
• Monitoring: CBC with differential, signs of splenic enlargement, pulmonary function if symptomatic

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For institutional procurement, biosimilar options, and regulatory documentation, please contact info@panamfarma.com.