Pegfilgrastim

Indications
 Subcutaneous
Chemotherapy-induced neutropenia
Adult: To reduce incidence of infection in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy that is associated with a clinically significant risk of febrile neutropenia: ≥18 yr: 6 mg once per chemotherapy cycle. Do not administer between 14 days before and 24 hr after admin of cytotoxic chemotherapy.
Contraindications
 Hypersensitivity to Pegfilgrastim or filgrastim; or to any ingredients in the formulation.
Warnings / Precautions
 Splenic rupture (including fatal cases) or enlarged spleen have been reported following admin of Pegfilgrastim; patients who reported left upper abdominal or shoulder tip pain should be evaluated for development of splenomegaly or splenic rupture. Acute respiratory distress syndrome (ARDS) may occur; monitor patients for pulmonary symptoms e.g. cough, fever, lung infiltrates, or respiratory distress. Discontinue or withhold Pegfilgrastim in patients with confirmed ARDS. Caution in patients with existing sickle cell disorders; as severe sickle cell crisis may occur. Possibility of Pegfilgrastim acting as a growth factor for any tumor type cannot be excluded. Not approved for myeloid malignancies and myelodysplasia. Monitor platelet count and haematocrit regularly. Do not administer Pegfilgrastim during the 14 days before and 24 hr after chemotherapy admin due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy. Safety and efficacy in paediatric patients have not been established. Pregnancy and lactation.
Adverse Reactions
 Bone pain, pain in extremity, myalgia, arthralgia, headache, nausea, vomiting , constipation, peripheral oedema, inj site reactions, skin rash, urticaria, erythema, flushing, splenomegaly, splenic rupture, sickle cell crises, ARDS, thrombocytopenia, leukocytosis, antibody formation, Sweet's syndrome; elevations in uric acid, alkaline phosphatase, lactate dehydrogenase, ALT and AST.
Potentially Fatal: Anaphylaxis.
Overdose Reactions
 No experience of Pegfilgrastim overdose in humans. Maximum amount that can be safely administered has not been determined.
Drug Interactions
 Colony-stimulating factors such as Pegfilgrastim should not be given at the same time as cytotoxic chemotherapy due to the increased risk of myelosuppression.
See Below for More pegfilgrastim Drug Interactions
Lab Interactions
 May produce transiently positive bone-imaging changes due to increased haematopoietic activity of the bone marrow in response to growth factor therapy.
Mechanism of Actions
 Pegfilgrastim is a covalent conjugate of filgrastim and monomethoxypolyethyleneglycol (PEG). It is a colony-stimulating factor which binds to specific cell surface receptors of haematopoietic cells, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation. Pegfilgrastim has delayed renal clearance and prolonged half-life relative to filgrastim as a result of conjugation with PEG.
Excretion: Half-life: About 15-80 hr after SC inj. Clearance decreases with increasing dose. Mainly eliminated by neutrophil mediated clearance; serum concentration of Pegfilgrastim declines with resolution of neutropenia.
Storage Conditions
 Subcutaneous: Prior to use, refrigerate at 2-8°C (36-46°F). Keep in its carton to protect from light. Do not shake. Do not freeze. If frozen, thaw in the refrigerator before use and discard if frozen more than once. Allow to reach room temperature prior to injection. Discard syringes if stored at room temperature for more than 48 hr.
ATC Classification
 L03AA13 - pegfilgrastim ; Belongs to the class of colony stimulating factors. Used as immunostimulants.
Storage
 Subcutaneous: Prior to use, refrigerate at 2-8°C (36-46°F). Keep in its carton to protect from light. Do not shake. Do not freeze. If frozen, thaw in the refrigerator before use and discard if frozen more than once. Allow to reach room temperature prior to injection. Discard syringes if stored at room temperature for more than 48 hr.
Available As
  • Pegfilgrastim 6 mg

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