AMBIGRAST Filgrastim 300mcg / 0.5mL Solution for IV/SC Injection 0.5mL 1's
RXDRUG-BRP-051
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Treatment or prevention of neutropenia in patients receiving myelosuppressive cancer chemotherapy & period reduction of neutropenia in patients undergoing bone marrow transplantation. Mobilization of peripheral blood progenitor cells for use as an alternative to bone marrow transplantation, in the management of chronic neutropenia (congenital, cyclic, or idiopathic), & persistent neutropenia in patients w/ advanced HIV infection.
Dosage/Direction for Use
Adult & childn Adjunct to antineoplastic therapy 5 mcg/kg daily starting not <24 hr after last dose of antineoplastic, may be given as single daily SC inj, as continuous IV/SC infusion or as daily IV infusion over 15-30 min. Continue until neutrophil count has stabilized w/in normal range, may take up to ≥14 days. Bone marrow transplantation Initially 10 mcg/kg daily, adjusted according to response, may be given by IV infusion over 30 min or 4 hr, or by continuous IV/SC infusion over 24 hr. Mobilization of peripheral blood progenitor cells 10 mcg/kg daily may be given as single daily SC inj or by continuous infusion for 4-7 days until leukapheresis. Dose is halved to 5 mcg/kg daily by SC inj if given after myelosuppressive chemotherapy. Patients w/ congenital neutropenia Initially 12 mcg/kg daily given SC in single or divided doses & adjusted according to response. Patients w/ idiopathic or cyclic neutropenia Initially 5 mcg/kg daily given SC in single or divided doses & adjusted according to response. Patients w/ HIV infection & persistent neutropenia Initially 1 mcg/kg daily by SC inj, may be titrated up to max of 4 mcg/kg daily until a normal neutrophil count is achieved, then adjusted for maintenance according to response. Maintenance dose: 300 mcg daily on 1-7 days a wk.
Overdosage
Filgrastim therapy should be discontinued if the ANC surpasses 10,000/mm3 after the chemotherapy induced ANC nadir has occurred. Doses of filgrastim that increase the ANC beyond 10,000/mm3 may not result in any additional clinical benefit and should be avoided. The maximum tolerated dose of Filgrastim (Ambigrast) has not been determined.
Contraindications
Filgrastim (Ambigrast) should not be administered to patients with known hypersensitivity to Filgrastim or to any of the excipients in the preparation.
Special Precautions
Avoid simultaneous use w/ chemotherapy & radiation therapy, & in patients receiving cytotoxic drugs, for 24 hr prior to & 24 hr after chemotherapy. May act as a growth factor for any tumor type. Monitor patients who have history of gout or malignancies regularly. Pregnancy & lactation. Not to be used in childn or adolescents weighing <45 kg. Neonates & autoimmune neutropenia of infancy.
Use In Pregnancy & Lactation
Pregnancy: Pregnancy Category C: Rhg-CSF has been shown to have adverse effects in pregnant rabbits when given in doses 2 to 10 times the human dose. In rabbits, increased abortion and embryolethality were observed in animals treated with rhG-CSF at 80 mcg/kg body weight/day. RhG-CSF administered to pregnant rabbits at doses of 80 mcg/kg body weight/day during the period of organogenesis was associated with increased fetal resorption, genitourinary bleeding, developmental abnormalities, decreased body weight, live births and food consumption. External abnormalities were not observed in the fetuses of dams treated at 80 mcg/kg body weight/day. Reproductive studies in pregnant rats have shown that rhG-CSF was not associated with lethal, teratogenic, or behavioral effects on fetuses when administered by daily IV injections during the period of organogenesis at dose levels up to 575 mcg/kg body weight/day. In rats, offspring of dams treated at >20 mcg/kg body weight/day exhibited a delay in external differentiation (detachment of auricles and descent of testes) and slight growth retardation, possibly due to lower body weight of females during rearing and nursing. Offspring of dams treated at 100 mcg/kg body weight/day exhibited decreased body weights at birth, and a slightly reduced 4-day survival rate.
Use in Lactation: it is not known whether rhG-CSF is excreted in human milk. Because many drugs are excreted in human milk, rhG-CSF is not recommended for use in breastfeeding women.
Use in Lactation: it is not known whether rhG-CSF is excreted in human milk. Because many drugs are excreted in human milk, rhG-CSF is not recommended for use in breastfeeding women.
Adverse Reactions
Filgrastim generally is well tolerated, and very rarely produces severe adverse effects that discontinuation is required. The adverse effect reported most frequently is mild to moderate (occasionally severe) medullary bone pain. The bone pain appears to be dependent on the dose and/or route of administration (lower incidence with subcutaneous injection, and higher with intravenous). The safety profile reveals Filgrastim (Ambigrast) to be well tolerated with no significant adverse reactions observed. The most common adverse events were pyrexia, vomiting, diarrhea, asthenia, generalized pain, cough, abdominal pain, anemia, pain in extremity, nausea, anorexia, hypoaesthesia, paraesthesia, mucosal inflammation and dysuria, all of these being chemotherapy emergent and not treatment related. Most adverse events were of mild severity requiring no hospitalization or medication. The incidence of bone pain was also low, with only two patients complaining of severe bone pain.
Drug Interactions
Drug interactions between Filgrastim and other drugs have not been fully evaluated. Drugs which may potentiate the release of neutrophils, such as lithium, should be used with caution.
Storage
Store at temperatures between 2°C - 8°C. Do not freeze. Avoid shaking. Prior to injection, Filgrastim may be allowed to attain room temperature.
Shelf-Life: The shelf-life of the single dose pre-filled syringe is two years from the date of manufacturing.
Shelf-Life: The shelf-life of the single dose pre-filled syringe is two years from the date of manufacturing.
Action
Pharmacology: Pharmacodynamics: Colony-stimulating factors are glycoproteins which act on hematopoietic cells by binding to specific cell surface receptors. Endogenous G-CSF is a lineage specific colony-stimulating factor which is produced by monocytes, fibroblasts, and endothelial cells. G-CSF regulates the production of neutrophils within the bone marrow and affects neutrophil progenitor proliferation, differentiation, and selected end-cell functional activation (including enhanced phagocytic ability, priming of the cellular metabolism associated with respiratory burst, antibody dependent killing, and the increased expression of some functions associated with cell surface antigens). G-CSF is not species specific and has been shown to have minimal direct in vivo or in vitro effects on the production of hematopoietic cell types other than the neutrophil lineage.
Pharmacokinetics: There is a positive linear correlation between the dose and the serum concentration of Filgrastim, whether administered intravenously or subcutaneously. Peak serum concentrations following subcutaneous injection are generally attained within 4-5 hours. The volume of distribution averaged 150 mL/kg. Clearance of Filgrastim has been shown to follow first-order pharmacokinetics after both subcutaneous and intravenous administration. The mean serum elimination half-life of Filgrastim is approximately 3.5 hours, with a clearance rate of approximately 0.6 mL/min/kg.
Toxicology: As with other therapeutic proteins, Filgrastim also has a potential for immunogenicity. However, the incidence and effect of this has not been adequately determined. The carcinogenic and mutagenic potential of Filgrastim has not been studied. Single dose of acute and chronic toxicity studies were conducted for Filgrastim (Ambigrast) with intramuscular and subcutaneous dosing in Swiss Albino mice (1000 mcg/kg body weight) and Sprague Dawley rats (500 mcg/kg body weight). The studies revealed no apparent toxicity in the test animals. Filgrastim (Ambigrast) did not cause any skin sensitization in test animals. It did not induce mutations in the mutagenecity model of Salmonella typhimurium.
Pharmacokinetics: There is a positive linear correlation between the dose and the serum concentration of Filgrastim, whether administered intravenously or subcutaneously. Peak serum concentrations following subcutaneous injection are generally attained within 4-5 hours. The volume of distribution averaged 150 mL/kg. Clearance of Filgrastim has been shown to follow first-order pharmacokinetics after both subcutaneous and intravenous administration. The mean serum elimination half-life of Filgrastim is approximately 3.5 hours, with a clearance rate of approximately 0.6 mL/min/kg.
Toxicology: As with other therapeutic proteins, Filgrastim also has a potential for immunogenicity. However, the incidence and effect of this has not been adequately determined. The carcinogenic and mutagenic potential of Filgrastim has not been studied. Single dose of acute and chronic toxicity studies were conducted for Filgrastim (Ambigrast) with intramuscular and subcutaneous dosing in Swiss Albino mice (1000 mcg/kg body weight) and Sprague Dawley rats (500 mcg/kg body weight). The studies revealed no apparent toxicity in the test animals. Filgrastim (Ambigrast) did not cause any skin sensitization in test animals. It did not induce mutations in the mutagenecity model of Salmonella typhimurium.
MedsGo Class
Haematopoietic Agents / Supportive Care Therapy
Features
Brand
Ambigrast
Full Details
Dosage Strength
300 mcg / 0.5 ml
Drug Ingredients
- Filgrastim
Drug Packaging
Solution for IV/SC Injection 0.5mL 1's
Generic Name
Filgrastim
Dosage Form
Solution for IV/SC Injection
Registration Number
BRP-051
Drug Classification
Prescription Drug (RX)
Please sign in so that we can notify you about a reply