Loading…
NEUPOGEN is a brand name for Filgrastim, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: NEUPOGEN® (filgrastim injection) is indicated for: • Cancer Patients Receiving Myelosuppressive Chemotherapy NEUPOGEN is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies (see Patients with Acute Myeloid Leukemia) receiving…
Verbatim from this product's HC label. Tap a section to expand.
NEUPOGEN is supplied in either vials or in prefilled syringes (SingleJect) with UltraSafe Needle Guards. Following administration of NEUPOGEN from the prefilled syringe, the UltraSafe Needle Guard should be activated to prevent accidental needle sticks.
To activate the UltraSafe Needle Guard, place your hands behind the needle, grasp the guard with one hand, and slide the guard forward until the needle is completely covered and the guard clicks into place.
NOTE:
If an audible click is not heard, the needle guard may not be completely activated. The prefilled syringe should be disposed of by placing the entire prefilled syringe with guard activated into an approved puncture-proof container. 1 Dosing Considerations • Cancer Patients Receiving Myelosuppressive Chemotherapy NEUPOGEN should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy.
NEUPOGEN should not be administered in the period 24 hours before the administration of chemotherapy (see 7 WARNINGS AND PRECAUTIONS). • Cancer Patients Receiving Myeloablative Chemotherapy Followed by Bone Marrow Transplantation NEUPOGEN should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy and at least 24 hours after bone marrow infusion.
• Cancer Patients Undergoing Peripheral Blood Progenitor Cell (PBPC) Collection and Therapy The first dose should be administered at least 24 hours after cytotoxic chemotherapy and at least 24 hours after PBPC infusion. 2 Recommended Dose and Dosage Adjustment Cancer Patients Receiving Myelosuppressive Chemotherapy The recommended starting dose of NEUPOGEN in adult patients is 5 mcg/kg/day, administered as a single daily injection by subcutaneous bolus injection, by short intravenous infusion (15 to 30 minutes), or by continuous subcutaneous or continuous intravenous infusion.
The recommended dose in pediatric oncology patients is 5 mcg/kg/day administered subcutaneously. A CBC and platelet count should be obtained before instituting NEUPOGEN therapy, and monitored twice weekly during therapy. Doses may be increased in increments of 5 mcg/kg for each chemotherapy cycle, according to the duration and severity of the ANC nadir.
Therapy should be discontinued if the ANC surpasses 10 x 109/L after the ANC nadir has occurred. NEUPOGEN should be administered daily for up to 2 weeks, until the ANC has reached 10 x 109/L following the expected chemotherapy-induced neutrophil nadir.
). As a result of the potential of receiving higher doses of chemotherapy (ie, full doses on the prescribed schedule), the patient may be at greater risk of thrombocytopenia, anemia, and non-haematological consequences of increased chemotherapy doses (please refer to the prescribing information of the specific chemotherapy agents used).
Regular monitoring of the hematocrit and platelet count is recommended. Leukocytosis Cancer Patients Receiving Myelosuppressive Chemotherapy In all studies, including phase 1/2 dose ranging studies, WBC counts of 100 x 109/L or greater were observed in approximately 2% of patients receiving NEUPOGEN at doses above 5 and up to 115 mcg/kg/day.
There were no reports of adverse events associated with this degree of leukocytosis. In order to avoid the potential complications of excessive leukocytosis, a complete blood count (CBC) is recommended twice per week during NEUPOGEN therapy (see Monitoring and Laboratory Tests).
Cancer Patients Undergoing Peripheral Blood Progenitor Cell (PBPC) Collection and Therapy During the period of administration of NEUPOGEN for PBPC mobilization in cancer patients, discontinuation of NEUPOGEN is appropriate if the leukocyte count rises to > 100 x 109/L (see Monitoring and Laboratory Tests).
Thrombocytopenia Thrombocytopenia, including serious events, has been reported in patients receiving NEUPOGEN. Platelet counts should be monitored regularly (see Monitoring and Laboratory Tests). NEUPOGEN (filgrastim injection) Page 14 of 50 Immune As with all therapeutic proteins, there is a potential for immunogenicity.
The incidence of antibody development in patients receiving NEUPOGEN has not been adequately determined. While available data suggest that a small proportion of patients developed binding antibodies to filgrastim, the nature and specificity of these antibodies has not been adequately studied.
, General). • Severe sickle cell crises, in some cases resulting in death, have been associated with the use of NEUPOGEN in patients with sickle cell trait or sickle cell disease (see 7 WARNINGS AND PRECAUTIONS, Hematologic). 4 DOSAGE AND ADMINISTRATION NEUPOGEN is supplied in either vials or in prefilled syringes (SingleJect) with UltraSafe Needle Guards.
Following administration of NEUPOGEN from the prefilled syringe, the UltraSafe Needle Guard should be activated to prevent accidental needle sticks. To activate the UltraSafe Needle Guard, place your hands behind the needle, grasp the guard with one hand, and slide the guard forward until the needle is completely covered and the guard clicks into place.
NOTE:
If an audible click is not heard, the needle guard may not be completely activated. The prefilled syringe should be disposed of by placing the entire prefilled syringe with guard activated into an approved puncture-proof container. 1 Dosing Considerations • Cancer Patients Receiving Myelosuppressive Chemotherapy NEUPOGEN should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy.
NEUPOGEN should not be administered in the period 24 hours before the administration of chemotherapy (see 7 WARNINGS AND PRECAUTIONS). • Cancer Patients Receiving Myeloablative Chemotherapy Followed by Bone Marrow Transplantation NEUPOGEN should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy and at least 24 hours after bone marrow infusion.
• Cancer Patients Undergoing Peripheral Blood Progenitor Cell (PBPC) Collection and Therapy The first dose should be administered at least 24 hours after cytotoxic chemotherapy and at least 24 hours after PBPC infusion. 2 Recommended Dose and Dosage Adjustment Cancer Patients Receiving Myelosuppressive Chemotherapy The recommended starting dose of NEUPOGEN in adult patients is 5 mcg/kg/day, administered as a single daily injection by subcutaneous bolus injection, by short intravenous infusion (15 to 30 minutes), or by continuous subcutaneous or continuous intravenous infusion.
NEUPOGEN is contraindicated in patients with known hypersensitivity to E. coli-derived products, filgrastim, pegfilgrastim, or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Filgrastim in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
The duration of NEUPOGEN therapy needed to attenuate chemotherapy-induced neutropenia may be dependent on the myelosuppressive potential of the chemotherapy regimen employed. NEUPOGEN therapy should be discontinued if the ANC surpasses 10 x 109/L after the expected chemotherapy-induced neutrophil nadir (see 7 WARNINGS AND PRECAUTIONS).
In phase 3 trials, efficacy was observed at doses of 4 to 8 mcg/kg/day. NEUPOGEN (filgrastim injection) Page 7 of 50 Cancer Patients Receiving Myeloablative Chemotherapy Followed by Bone Marrow Transplantation The recommended dose of NEUPOGEN following bone marrow transplant is 10 mcg/kg/day given as an intravenous infusion of 4 or 24 hours, or as a continuous 24-hour subcutaneous infusion.
During the period of neutrophil recovery, the daily dose of NEUPOGEN should be titrated against the neutrophil response as follows: Table 1. 0 x 109/L at any time during the 5 mcg/kg/day administration, NEUPOGEN should be increased to 10 mcg/kg/day, and the above steps should then be followed.
Cancer Patients Undergoing Peripheral Blood Progenitor Cell (PBPC) Collection and Therapy The recommended dose of NEUPOGEN for PBPC mobilization is 10 mcg/kg/day given as a single daily subcutaneous injection or a continuous 24-hour infusion.
NEUPOGEN therapy should be given for at least 4 days before the first leukapheresis procedure, and should be continued through to the day of the last leukapheresis procedure. Collections should be commenced on day 5 and continued on consecutive days until the desired yield of haematopoietic progenitor cells is obtained.
For peripheral blood progenitor cells mobilized with NEUPOGEN, a schedule of leukapheresis collections on days 5, 6, and 7 of a 7-day treatment regimen has been found to be effective. The target number of progenitor cells to be collected and reinfused is to be determined by the treating physician.
The following should be considered: • A minimum or optimal number of progenitor cells in the leukapheresis product, needed for adequate haematopoietic reconstitution, have not been determined. However, studies indicate that the infusion of higher numbers of progenitor cells appears to be associated with a shorter time to neutrophil and platelet recovery, • Tests for quantifying the number of progenitor cells, measured as CD34+ or GM-CFU, are not standardized and variations may exist between laboratories, and • Factors other than NEUPOGEN dosage, such as prior cytotoxic chemo- or radio-therapy, may affect the number and quality of progenitor cells mobilized and collected by leukapheresis.
The recommended dose of NEUPOGEN following PBPC transplant is 5 mcg/kg/day given either subcutaneously or as an intravenous infusion. The daily dose of NEUPOGEN should be titrated according to the schedule provided in Table 1 (Cancer Patients Receiving Myeloablative Chemotherapy Followed by Bone Marrow Transplantation).
NEUPOGEN (filgrastim injection) Page 8 of 50 Patients with HIV Infection The recommended starting dose of NEUPOGEN is 1 mcg/kg/day or 300 mcg 3 times per week by subcutaneous injection until a normal […]
In clinical studies comparing NEUPOGEN and Neulasta, the incidence of antibodies binding to NEUPOGEN was 3% (11/333). In these 11 patients, no evidence of a neutralizing response was observed using a cell-based bioassay. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay, and the observed incidence of antibody positivity in an assay may be influenced by several factors including timing of sampling, sample handling, concomitant medications, and underlying disease.
Therefore, comparison of the incidence of antibodies to NEUPOGEN with the incidence of antibodies to other products may be misleading. Cytopenias resulting from an antibody response to exogenous growth factors have been reported on rare occasions in patients treated with other recombinant growth factors.
There is a theoretical possibility that an antibody directed against filgrastim may cross react with endogenous G-CSF, resulting in immune-mediated neutropenia; however, this has not been reported in clinical studies or in post-marketing experience.
coli- derived proteins. Hypersensitivity / Allergic Reactions Hypersensitivity, including serious allergic reactions and anaphylactic reactions occurring on initial or subsequent treatment have been reported in < 1 in 4,000 patients treated with NEUPOGEN.
These have generally been characterized by systemic symptoms involving at least 2 body systems, most often skin (rash, urticaria, facial edema), respiratory (wheezing, dyspnea), and cardiovascular (hypotension, tachycardia). Some reactions occurred on initial exposure.
Reactions tended to occur within the first 30 minutes after administration and appeared to occur more frequently in patients receiving NEUPOGEN intravenously. Rapid resolution of symptoms occurred in most cases after administration of antihistamines, steroids, bronchodilators, and/or epinephrine.
Symptoms recurred in more than half the patients who were rechallenged. Do not administer NEUPOGEN to patients with a history of allergic reactions to filgrastim or pegfilgrastim (see 2 CONTRAINDICATIONS). If a serious allergic reaction or anaphylactic reaction occurs, appropriate therapy should be administered and NEUPOGEN should be permanently discontinued.
Cutaneous Vasculitis Cutaneous vasculitis has been reported in patients treated with NEUPOGEN. In most cases‚ the severity of cutaneous vasculitis was moderate or severe. Most of the reports involved patients with SCN receiving long-term NEUPOGEN therapy.
Symptoms of vasculitis generally developed simultaneously with an increase in the ANC and abated when the ANC decreased. Many patients were able to continue NEUPOGEN at a reduced dose. NEUPOGEN (filgrastim injection) Page 15 of 50 Monitoring and Laboratory Tests Cancer Patients Receiving Myelosuppressive Chemotherapy A complete blood count (CBC) and platelet count should be obtained prior to chemotherapy, and at regular intervals (twice per week) during NEUPOGEN therapy.
Following cytotoxic chemotherapy, the neutrophil nadir occurred earlier during cycles when NEUPOGEN was administered, and white blood cell (WBC) differentials demonstrated a left shift, including the appearance of promyelocytes and myeloblasts.
In addition, the duration of severe neutropenia was reduced, and was followed by an accelerated recovery in the neutrophil counts. Therefore, regular monitoring of WBC counts, particularly at the time of the recovery from the post chemotherapy nadir, is recommended in order to avoid excessive leukocytosis.
Cancer Patients Receiving Myeloablative Chemotherapy Followed by Bone Marrow Transplantation A CBC and platelet count should be obtained at regular intervals (3 times per week during NEUPOGEN therapy) following marrow infusion. Cancer Patients Undergoing Peripheral Blood Progenitor Cell (PBPC) Collection and Therapy After 4 days of NEUPOGEN treatment for PBPC mobilization, neutrophil counts should be monitored.
Monitoring of platelet and red blood […]
The recommended dose in pediatric oncology patients is 5 mcg/kg/day administered subcutaneously. A CBC and platelet count should be obtained before instituting NEUPOGEN therapy, and monitored twice weekly during therapy. Doses may be increased in increments of 5 mcg/kg for each chemotherapy cycle, according to the duration and severity of the ANC nadir.
Therapy should be discontinued if the ANC surpasses 10 x 109/L after the ANC nadir has occurred. NEUPOGEN should be administered daily for up to 2 weeks, until the ANC has reached 10 x 109/L following the expected chemotherapy-induced neutrophil nadir.
The duration of NEUPOGEN therapy needed to attenuate chemotherapy-induced neutropenia may be dependent on the myelosuppressive potential of the chemotherapy regimen employed. NEUPOGEN therapy should be discontinued if the ANC surpasses 10 x 109/L after the expected chemotherapy-induced neutrophil nadir (see 7 WARNINGS AND PRECAUTIONS).
In phase 3 trials, efficacy was observed at doses of 4 to 8 mcg/kg/day. NEUPOGEN (filgrastim injection) Page 7 of 50 Cancer Patients Receiving Myeloablative Chemotherapy Followed by Bone Marrow Transplantation The recommended dose of NEUPOGEN following bone marrow transplant is 10 mcg/kg/day given as an intravenous infusion of 4 or 24 hours, or as a continuous 24-hour subcutaneous infusion.
During the period of neutrophil recovery, the daily dose of NEUPOGEN should be titrated against the neutrophil response as follows: Table 1. 0 x 109/L at any time during the 5 mcg/kg/day administration, NEUPOGEN should be increased to 10 mcg/kg/day, and the above steps should then be followed.
Cancer Patients Undergoing Peripheral Blood Progenitor Cell (PBPC) Collection and Therapy The recommended dose of NEUPOGEN for PBPC mobilization is 10 mcg/kg/day given as a single daily subcutaneous injection or a continuous 24-hour infusion.
NEUPOGEN therapy should be given for at least 4 days before the first leukapheresis procedure, and should be continued through to the day of the last leukapheresis procedure. Collections should be commenced on day 5 and continued on consecutive days until the desired yield of haematopoietic progenitor cells is obtained.
For peripheral blood progenitor cells mobilized with NEUPOGEN, a schedule of leukapheresis collections on days 5, 6, and 7 of a 7-day treatment regimen has been found to be effective. The target number of progenitor cells to be collected and reinfused is to be determined by the treating physician.
The following should be considered: • A minimum or optimal number of progenitor cells in the leukapheresis product, needed for adequate haematopoietic reconstitution, have not been determined. However, studies indicate that the infusion of higher numbers of progenitor cells appears to be associated with a shorter time to neutrophil and platelet recovery, • Tests for quantifying the number of progenitor cells, measured as CD34+ or GM-CFU, are not standardized and variations may exist between laboratories, and • Factors other than NEUPOGEN dosage, such as prior cytotoxic chemo- or radio-therapy, may affect the number and quality of progenitor cells mobilized and collected by leukapheresis.
The recommended dose of NEUPOGEN following PBPC transplant is 5 mcg/kg/day given either subcutaneously or as an intravenous infusion. The daily dose of NEUPOGEN should be titrated according to the schedule provided in Table 1 (Cancer Patients Receiving Myeloablative […]