PEG-Filastin prefilled syringe injection: Each pre-filled syringe contains 0.6 ml sterile solution containing pegylated Filgrastim INN 6 mg.
Pegfilgrastim is a covalent conjugate of recombinant methionyl human G-CSF (Filgrastim) and monomethoxypolyethylene glycol. Filgrastim is a water-soluble 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kD). Filgrastim is obtained from the bacterial fermentation of a strain of E. coli transformed with a genetically engineered plasmid containing the human G-CSF gene. To produce Pegfilgrastim, a 20 kD monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of Filgrastim. The average molecular weight of Pegfilgrastim is approximately 39 kD.
Pegfilgrastim is a leukocyte growth factor 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 neutropenia. Pegfilgrastim is also indicated to increase survival in patients acutely exposed to Myelosuppressive doses of radiation.
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 (0.01ml)/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.
Splenic rupture, acute respiratory distress syndrome, serious allergic reactions, sickle cell crises, glomerulonephritis, leukocytosis, capillary leak syndrome and potential for tumor growth stimulatory effects of malignant cells may occur.
Mifepristone & Misoprostol combination should not give to anyone else. Administration must be under the supervision of a qualified physician. The combination of Mifepristone & Misoprostol has been prescribed for the patients specific condition, it may not be the correct treatment for another patients, and may be dangerous to the other women if she is or were to become pregnant. Any intrauterine device (IUD) should be removed before treatment with Mifepristone begins. Menstrual Regulation (MR) by surgery is recommended in cases when combination of Mifepristone & Misoprostol fails to cause Menstrual Regulation. Patients who have an ongoing pregnancy at last visit have a risk of fetal malformation resulting from the treatment. Surgical termination/MVA (Manual vaccum Aspiration) is recommended to manage Menstrual Regulation (MR)/termination of pregnancy failures.
Do not administer Pegfilgrastim to patients with a history of serious allergic reactions to Pegfilgrastim or Filgrastim.
Use in 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.
Use in special population
Pediatric use: The safety and effectiveness of Pegfilgrastim have not been established. Geriatric use: No overall differences in safety or effectiveness were observed in patients with age 65 and older.
No formal drug interaction studies between Pegfilgrastim and other drugs have been performed.
The maximum amount of Pegfilgrastim that can be safely administered has not been determined.
Pegfilgrastim should be stored at 2-8ºC & avoid shaking before injection. Don’t store it at room temperature for more than 48 hours. Do not administer this product if discoloration or particulates are observed.
PEG-Filastin prefilled syringe injection: Each box contains 1 prefilled syringe of 0.6 ml solution.