The pivotal trial leading to approval showed filgrastim administration decreased FN incidence; reduced grade 4 neutropenia incidence, duration, and severity; and decreased infection rates, duration of antibiotic treatment, and hospitalization in patients with small cell lung cancer (SCLC) receiving myelosuppressive chemotherapy [ 4 ].
Full Answer
Does filgrastim improve hospital outcomes?
Six RCTs [4, 23, 26–29], 1 NCT [30], and 1 observational study [31] reported hospitalizations, with statistical comparisons provided in 6 RCTs and the observational study [31]. Four RCTs [23, 27–29] demonstrated significantly improved hospital outcomes with filgrastim vs placebo or no filgrastim.
Does filgrastim reduce the risk of Grade 3 or 4 neutropenia?
The risk of developing grade 3 or 4 neutropenia was significantly lower with filgrastim vs placebo or no filgrastim (RR 0.50, 95% CI 0.37–0.68). Table 2 Incidence of grade 3 or 4 neutropenia in CIN
Are there any English-language reports of clinical trials evaluating filgrastim?
A literature search of electronic databases, congress abstracts, and bibliographies of recent reviews was conducted to identify English-language reports of clinical trials and observational studies evaluating filgrastim in its US-approved indications up to February 2015.
Is there medical literature on originator filgrastim in the US?
This systematic review examined medical literature on originator filgrastim in all its US-approved indications based on pre-specified criteria and identified 1194 unique reports published in a period spanning > 29 years (1987–2015).
Which symptom is most likely a side effect to the Filgrastim the patient is receiving?
Filgrastim injection products may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away: redness, swelling, bruising, itching or a lump in the place where the medication was injected. bone, joint, back, arm, leg, mouth, throat, or muscle pain.
Which factor increases when a patient is taking filgrastim Neupogen )?
Filgrastim is a growth factor that stimulates the production, maturation, and activation of neutrophils (a type of white blood cell).
How does Neupogen work?
Neupogen works by stimulating the bone marrow to increase the production of white blood cells. After chemotherapy administration, the medication is given as a subcutaneous injection (in the tissue under the skin).
When is Neupogen indicated?
NEUPOGEN® is indicated for chronic administration to reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia.