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FILRA is a brand name for Filgrastim, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
). Filgrastim therapy was titrated to maintain ANCs between 2 x 109 and 10 x 109/L. In the randomized controlled trial, there was a 12% increase in the number of days patients were able to receive full or high-dose myelosuppressive medications.
In a multicenter, noncomparative study of 200 patients, filgrastim allowed more than 80% of patients to increase or maintain dosing of ganciclovir, zidovudine, trimethoprim/sulfamethoxazole and pyrimethamine, or to add 1 or more medications to their therapy.
The number of these 4 medications received per patient increased by approximately 20% during filgrastim therapy. In an open-label study to evaluate neutrophil function by in vitro chemiluminescence measurement, filgrastim-treated patients had increased oxidase-myeloperoxidase activity and potentially greater microbial killing capacity.
In the randomized controlled study, 13 deaths (5%) were reported on study. There were 13 additional deaths within 30 days of study completion. The leading causes of death were HIV-associated complications and AIDS progression. There were no other patterns observed for cause of death.
In 3 uncontrolled studies, 16 of the 32 deaths were reported as AIDS progression, the other 16 deaths were attributed to HIV-associated complications. In these clinical studies, all deaths were reported by the investigator as not related or unlikely to be related to filgrastim.
In clinical trials, changes in HIV viral load were evaluated by a quantitative HIV-1 RNA RT-Polymerase Chain Reaction (PCR) analyses and by measurement of HIV-1 p24 antigen levels. These studies did not show any evidence of increased HIV replication associated with filgrastim administration.
Filra (filgrastim injection) Page 31 of 45 16. Non-Clinical Toxicology General Toxicity Recombinant human granulocyte colony stimulating factor (r-metHuG-CSF) was administered to monkeys, dogs, hamsters, rats and mice as part of a comprehensive pre-clinical toxicology program which included both single-dose acute, repeated dose subacute and chronic studies.
5 mcg/kg based on group mean pre-study body weights). The increased leukocyte counts observed in monkeys on day 7 was an expected result of the pharmacological activity of r-metHuG-CSF and this had returned to control values by day 14.
Consequently, the single-dose LD50 of r-metHuG-CSF in these species is in excess of 3,450 mcg/kg, which is at least 50- to 600-fold greater than the highest anticipated human clinical dose. In the subacute, repeated-dose studies, the changes observed with r-metHuG-CSF can be attributed to the anticipated pharmacological actions of the protein.
In rats, hamsters, dogs and monkeys, increased granulopoiesis was evidenced by dose-dependent increases in total white blood cell counts, an increased proportion of segmented neutrophils in the circulation, and an increase in the myeloid to erythroid ratio in the bone marrow.
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In the 14-day monkey study and 13-week rat study, platelet counts were reduced in the 2 high dose groups. In all species, histopathologic examinations of the liver and spleen revealed evidence of ongoing extramedullary granulopoiesis.
Increased spleen weights were seen in all species and appeared to be dose-related. Few significant changes in blood biochemistry values were observed in rats, hamsters, dogs, or monkeys. However, a dose-dependent increase in serum alkaline phosphatase was observed in rats.
This increase may be reflective of increased activity of osteoblasts and osteoclasts, as published evidence indicates that osteoclasts are derived from haematopoietic precursors. The stimulatory effect of r-metHuG-CSF on granulopoiesis may, therefore, produce an imbalance in the normal equilibrium between osteoclasts and osteoblasts.
The finding of increased osteoclasis and osteoanagenesis in the hind legs (which account for 30% of haematopoiesis in rats) is consistent with this hypothesis. Changes noted in serum chemistry values were readily reversible upon discontinuation of treatment and do not appear to be of serious toxicological consequence.
Whereas rats survived 13 weeks of daily administration of r-metHuG-CSF at dose levels up to 575 mcg/kg, 5 of 8 (4 males and 1 female) monkeys given r-metHuG-CSF at 1,150 mcg/kg died within 18 days. Death was preceded by signs of neurological toxicity and was associated with 15- to 28-fold increases in peripheral leukocyte counts and neutrophil-infiltrated hemorrhagic foci in both the cerebrum and cerebellum.
In contrast, no monkeys died following 13 weeks of daily intravenous administration of r-metHuG-CSF at a dose level of 115 mcg/kg. 9 mcg/kg based on group mean pre-study body weights) and 345 mcg/kg, respectively. One monkey in the control group died in the 14-day study.
Consequently, the lethal dose of r-metHuG-CSF is greater than 115 mcg/kg/day and death was associated with a gross exaggeration of granulopoietic activity. 17. Supporting Product Monographs Neupogen (Filgrastim Injection, Sterile Solution, 300 mcg/mL and 600 mcg/mL), submission control Filra (filgrastim injection) Page 32 of 45 270479, Product Monograph, Amgen Canada Inc.
(MAY 05, 2023) Filra (filgrastim injection) Page 33 of 45 Patient Medication Information READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE PrFilra Filgrastim injection This Patient Medication Information is written for the person who will be taking Filra.
This may be you or a person you are caring for. Read this information carefully. Keep it as you may need to read it again. This Patient Medication Information is a summary. It will not tell you everything about this medication. If you have questions or […]