NYVEPRIA (PEGFILGRASTIN-APGF) 6MG/0.6ML SOLUTION IN A SINGLE-DOSE PRE-FILLED SYRINGE FOR SUBCUTANEOUS USE

Indications

• Febrile neutropenia prevention in patients undergoing chemotherapy
• Bone marrow suppression due to chemotherapy
• Neutropenia associated with certain malignancies

Dosage

Children: Refer to the BNF for Children for specific dosing recommendations for paediatric patients.

Adults: Refer to the specific dosing guidelines in the BNF or local protocols for adult patients, typically given as a single subcutaneous injection per chemotherapy cycle.

Mechanism of action

Pegfilgrastim binds to the G-CSF receptor on hematopoietic cells, promoting proliferation, differentiation, and survival of neutrophil precursors in the bone marrow. This action leads to increased neutrophil production and release into the bloodstream, enhancing the immune response against infections.

Pharmacodynamics

The pharmacodynamics of pegfilgrastim is characterized by its ability to increase absolute neutrophil counts (ANC) in patients receiving chemotherapy. The effects typically begin within 24 hours of administration, with peak neutrophil counts occurring around 1 to 2 weeks post-injection. The duration of action is prolonged due to the pegylation, allowing for less frequent dosing compared to non-pegylated G-CSF.

Pharmacokinetics

Pegfilgrastim exhibits a prolonged half-life due to its pegylated structure, which decreases renal clearance and increases systemic circulation time. The drug is administered subcutaneously, with an absorption half-life ranging from approximately 15 to 80 hours. Peak plasma concentrations are reached within 24 to 48 hours after dosing. Elimination occurs primarily through the reticuloendothelial system, with minimal excretion through urine.

Contra-indications

• Hypersensitivity to pegfilgrastim or any component of the formulation
• History of serious allergic reactions to filgrastim

Adverse effects

• Bone pain
• Splenic rupture
• Leukocytosis
• Fatigue
• Nausea
• Vomiting
• Headache
• Peripheral edema
• Increased uric acid levels

Interactions

• Concomitant use with cytotoxic chemotherapy should be evaluated due to potential for increased white blood cell counts affecting treatment response

Precautions

• Use with caution in patients with sickle cell disease
• Monitor for signs of splenic rupture
• Evaluate patients for prior allergic reactions to filgrastim
• Caution in patients with respiratory disease

Pregnancy

Pegfilgrastim is categorized as a pregnancy category C drug. Animal studies have shown adverse effects, but there are no well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

It is not known whether pegfilgrastim is excreted in human milk. Caution should be exercised when administering to a nursing mother.

Storage

Store in a refrigerator (2 to 8 degrees Celsius). Do not freeze. Keep the prefilled syringe in its carton to protect from light.

Formulations

• Pegfilgrastim injection in prefilled syringes