Indications
Patients With Cancer Receiving Myelosuppressive Chemotherapy: Pegfilgrastim is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropeniaPegfilgrastim is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
Patients With Hematopoietic Subsyndrome Of Acute Radiation Syndrome: Pegfilgrastim is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation
Pharmacology
Pegfilgrastim is a covalent conjugate of filgrastim and monomethoxypolyethylene glycol which binds to specific cell surface receptors of haematopoietic cells, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.
Dosage & Administration
Cancer patients receiving Myelosuppressive Chemotherapy: The recommended dosage of Pegfilgrastim is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle in adults. For pediatric patients weight less than 10 kg is 0.1 mg (0.01 ml)/kg, 10-20 kg is 0.15 ml, 21-30 kg is 0.25 ml & 31-44 kg is 0.4 ml. Do not administer Pegfilgrastim between 14 days before and 24 hours after administration of cytotoxic chemotherapy.Hematopoietic Subsyndrome of Acute Radiation Syndrome: The recommended dose of Pegfilgrastim is two doses of 6 mg each, administer the first dose as soon as possible after suspected or confirmed exposure to radiation levels greater than 2 gray (Gy) & the second dose one week after the first dose. For dosing in pediatric patients weighing less than 45 kg, refer to Myelosuppressive Chemotherapy dosing system.
Interaction
No formal drug interaction studies between Pegfilgrastim and other drugs have been performed.
Contraindications
Do not administer Pegfilgrastim to patients with a history of serious allergic reactions to Pegfilgrastim or Filgrastim.
Side Effects
Bone or musculoskeletal pain, hypersensitivity reactions (e.g. urticaria, skin rash, angioedema, erythema, flushing, dyspnoea, hypotension, cutaneous vasculitis, SC tissue disorders), splenomegaly, glomerulonephritis, leukocytosis, pulmonary AR (e.g. interstitial pneumonia; pulmonary oedema, infiltrates and fibrosis).
Pregnancy & Lactation
Pregnancy: Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Therefore, Pegfilgrastim should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.Lactation: It is not known whether Pegfilgrastim is secreted in human milk. Other recombinant G-CSF products are poorly secreted in breast milk and G-CSF is not orally absorbed by neonates. Caution should be exercised when administered to a nursing woman.
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