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NYPOZI 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: Indications have been granted on the basis of similarity between Nypozi and the reference biologic drug Neupogen. Nypozi (filgrastim for injection) is indicated for: Cancer Patients Receiving Myelosuppressive Chemotherapy Nypozi (filgrastim) is indicated to decrease the incidence of infection, as manifested by…
Verbatim from this product's HC label. Tap a section to expand.
3 mL (180 mcg). Therefore, patients weighing less than 36 kg cannot be accurately dosed at a dose of 5 mcg/kg/day. Cancer Patients Receiving Myelosuppressive Chemotherapy Nypozi should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy.
Nypozi should not be administered in the period 24 hours before the Nypozi Product Monograph Page 6 of 54 administration of chemotherapy (see WARNINGS AND PRECAUTIONS). Cancer Patients Receiving Myeloablative Chemotherapy Followed by Bone Marrow Transplantation Nypozi 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 Nypozi (filgrastim) 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 Nypozi 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 × 109/L after the ANC nadir has occurred. Nypozi should be administered daily for up to 2 weeks, until the ANC has reached 10 × 10 9/L following the expected chemotherapy-induced neutrophil nadir.
The duration of Nypozi therapy needed to attenuate chemotherapy-induced neutropenia may be dependent on the myelosuppressive potential of the chemotherapy regimen employed. Nypozi therapy should be discontinued if the ANC surpasses 10 × 109/L after the expected chemotherapy-induced neutrophil nadir (see WARNINGS AND PRECAUTIONS).
In phase 3 trials, efficacy was observed at doses of 4 to 8 mcg/kg/day. Cancer Patients Receiving Myeloablative Chemotherapy Followed by Bone Marrow Transplantation The recommended dose of Nypozi 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.
The adverse drug reaction profiles reported in clinical studies that compared Nypozi to the reference biologic drug were comparable. The description of adverse reactio ns in this section is based on clinical experience with the reference biologic drug.
1 Adverse Reaction Overview Dose-dependent musculoskeletal pain, specifically medullary bone pain, was the only consistently reported adverse event across all cancer patient populations. These events were usually mild-to-moderate, and most patients that experienced this effect were symptomatically controlled by non-narcotic analgesia.
Bone pain and pain in extremity occurred at a higher incidence in filgrastim-treated patients as compared with placebo-treated patients across all indications. See WARNINGS AND PRECAUTIONS regarding Splenic Rupture, ARDS, Allergic Reactions and Sickle Cell Crises.
2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Cancer Patients Receiving Myelosuppressive Chemotherapy In clinical trials involving over 350 patients receiving filgrastim following cytotoxic chemotherapy, most adverse experiences were the sequelae of the underlying malignancy or cytotoxic chemotherapy.
In all phase 2 and 3 trials, medullary bone pain, reported in 24% of patients, was the only consistently observed adverse reaction attributed to filgrastim therapy. This bone pain was generally reported to be of mild-to-moderate severity, and could be controlled in most patients with non-narcotic analgesics.
Please see the Serious Warnings and Precautions Box at the beginning of PART I:
HEALTH PROFESSIONAL INFORMATION. General Splenic Rupture Splenic rupture, including fatal cases, has been reported following the administration of filgrastim. Patients receiving Nypozi(filgrastim) who report left upper abdominal and/or shoulder tip pain should be evaluated for an enlarged spleen or splenic rupture.
Simultaneous Use with Chemotherapy The safety and efficacy of filgrastim given simultaneously with cytotoxic chemotherapy have not been established. Studies in adult patients showed that an interaction between concurrent filgrastim and 5-fluorouracil (5-FU) is possible and can result in a paradoxical fall in ANC.
Because of the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy, do not use Nypozi in the period 24 hours before through 24 hours after the administration of cytotoxic chemotherapy (see DOSAGE AND ADMINISTRATION).
, nitrosoureas) or with mitomycin C or with myelosuppressive doses of anti-metabolites such as 5-FU or cytosine arabinoside. The safety and efficacy of filgrastim have not been evaluated in patients receiving concurrent radiation therapy, except for patients with breast or lung cancer.
Simultaneous use of Nypozi with chemotherapy and radiation therapy should be avoided. Carcinogenesis and Mutagenesis The carcinogenic potential of filgrastim has not been studied. Filgrastim failed to induce bacterial gene mutations in either the presence or absence of a drug metabolizing enzyme system.
Filgrastim had no observed effect on the fertility of male or female rats, or on gestation at doses up to 500 mcg/kg. Growth Factor Potential Nypoziis a growth factor that primarily stimulates production of neutrophils. However, the possibility that Nypozi can act as a growth factor for certain tumor types cannot be excluded.
Nypozi (filgrastim) is contraindicated in patients who are hypersensitive to E. coli derived products, filgrastim, pegfilgrastim, including any non-medicinal ingredient, or component of the container. For a complete listing, see DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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0 × 109/L at any time during the 5 mcg/kg/day administration, Nypozi 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 Nypozi for PBPC mobilization is 10 mcg/kg/day given as a single daily subcutaneous injection or a continuous 24-hour infusion.
Nypozi 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 filgrastim, 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 healthcare professional.
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 Nypozi 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 Nypozi following PBPC transplant is 5 mcg/kg/day given either subcutaneously or as an intravenous infusion. The daily dose of Nypozi should be titrated according to the schedule provided above (Cancer Patients Receiving Myeloablative Chemotherapy Followed by Bone Marrow Transplantation).
Patients with HIV Infection The recommended starting dose of Nypozi is 1 mcg/kg/day or 300 mcg 3 times per week by subcutaneous injection until a normal neutrophil count is reached and can be maintained (ANC ≥ 2 × 109/L). Dose adjustments may be necessary as determined by the patient’s ANC to maintain the ANC between 2 × 109 and 10 × 109/L.
When reversal of neutropenia has been achieved, the minimal effective dose to maintain a normal neutrophil count should be established. An initial dose of 300 mcg 3 times per week by subcutaneous injection is recommended. A further dose adjustment may be necessary to maintain the […]
Infrequently, bone pain was severe enough to require narcotic analgesics. Bone pain was reported more frequently in patients treated with higher doses (20 to 100 mcg/kg/day) administered intravenously, and less frequently in patients treated with lower subcutaneous doses of filgrastim (3 to 10 mcg/kg/day).
Nypozi Product Monograph Page 20 of 54 In the randomized, double-blind, placebo-controlled trial of filgrastim therapy following combination chemotherapy in patients (n = 207) with small cell lung cancer, the following adverse events were reported during blinded cycles of study medication (placebo or filgrastim at 4 to 8 mcg/kg/day).
Events are reported as exposure adjusted since patients r emained on double-blind filgrastim a median of 3 cycles versus 1 cycle for placebo.
Table 3:
Adverse Events in the randomized, double-blind, placebo-controlled trial (n=207) Event % of Blinded Cycles with Events Filgrastim Patient Cycles N = 384 Placebo Patient Cycles N = 257 Nausea/Vomiting 57 64 Skeletal Pain 22 11 Alopecia 18 27 Diarrhea 14 23 Neutropenic Fever 13 35 Mucositis 12 20 Fever 12 11 Fatigue 11 16 Anorexia 9 11 Dyspnea 9 11 Headache 7 9 Cough 6 8 Skin Rash 6 9 Chest Pain 5 6 Generalized Weakness 4 7 Sore Throat 4 9 Stomatitis 5 10 Constipation 5 10 Pain (Unspecified) 2 7 In this study, there were no serious, life-threatening, or fatal adverse reactions attributed to filgrastim therapy.
Specifically, there were no reports of flu-like symptoms, pleuritis, pericarditis, or other major systemic reactions to filgrastim. Spontaneously reversible elevations in uric acid, lactate dehydrogenase, and alkaline phosphatase occurred in 27% to 58% of 98 patients receiving blinded filgrastim therapy following cytotoxic chemotherapy.
Increases were generally mild-to-moderate. Transient decreases in blood pressure (< 90/60 mmHg) which did not require clinical treatment, were reported in 7 of 176 patients in phase 3 clinical studies following administration of filgrastim.
No evidence of interaction of filgrastim with other drugs was observed in the course of clinical trials (see WARNINGS AND PRECAUTIONS, Simultaneous Use with Chemotherapy). The safety profile of filgrastim in the pediatric population is comparable to that seen in adult cancer patients receiving cytotoxic chemotherapy.
Adverse events considered related to filgrastim administration by the investigators of 3 non-blinded studies included application site disorders, haematologic disorders (including thrombocytopenia), musculoskeletal disorders, and a single case of vasculitis.
Of these, musculoskeletal disorders are the most consistent adverse events seen in other filgrastim studies. Nypozi Product Monograph Page 21 of 54 Patients with Acute Myeloid Leukemia In a randomized phase 3 clinical trial involving 521 patients with de novo AML, 259 patients received filgrastim post-chemotherapy and 262 patients received placebo.
Filgrastim was generally well tolerated, and most adverse experiences were considered to be the sequelae of the underlying malignancy or cytotoxic chemotherapy. The most frequently reported events were diarrhea, rash, and petechiae, and there were no significant difference s between the treatment groups.
Cancer Patients Receiving Myeloablative Chemotherapy Followed by Bone Marrow Transplantation In clinical trials, the reported adverse effects were those typically seen in patients receiving intensive chemotherapy followed by bone marrow transplantation.
The most common events reported in both control and treatment groups included stomatitis, nausea and vomiting, generally of mild-to-moderate severity and were considered unrelated to filgrastim. In the randomized studies of BMT involving 167 patients who received study drug, the following events occurred more frequently in patients treated with filgrastim than in controls: nausea (10% vs.
4%), vomiting (7% vs. 3%), hypertension (4% vs. 0%), rash (12% vs. 10%), and peritonitis (2% vs. 0%). None of these events were reported by the investigator to be related to filgrastim. One event of erythema nodosum was reported moderate in severity and possibly related […]
Randomized studies have demonstrated that treatment with filgrastim following chemotherapy for acute myeloid leukemia (AML) does not adversely influence the outcome of treatment. The use of filgrastim in chronic myeloid leukemia (CML) and myelodysplastic syndrome (MDS) has not been fully investigated, and caution should be exercised in using this drug in patients with CML or MDS.
Tumor cells may be collected in the leukapheresis product, following PBPC mobilization by filgrastim. The clinical significance and the effect of reinfusion of tumor cells with the leukapheresis product are still unknown and the possible contribution of clonogenic tumor cells to an eventual relapse has not been determined.
Nypozi Product Monograph Page 12 of 54 MDS and AML in Breast and Lung Cancer Patients In the post-marketing observational study setting, findings showed that filgrastim is associated with an increased risk of MDS and AML in breast and lung cancer patients when used in conjunction with chemotherapy and/or radiotherapy.
Monitor patients for signs and symptoms of MDS/AML in these settings. Cardiovascular Cardiac events (myocardial infarctions, arrhythmias) have been reported in 11 of 375 cancer patients receiving filgrastim in clinical studies; the relationship to filgrastim therapy is unknown.
However, patients with pre-existing cardiac conditions receiving Nypozi should be monitored closely. Aortitis Aortitis has been reported in patients receiving filgrastim and may present with generalized signs and symptoms such as fever and increased inflammatory markers.
Consider aortitis in patients who develop these signs and symptoms without known etiology. Capillary Leak Syndrome Capillary leak syndrome (CLS) has been reported after the administration of filgrastim or pegfilgrastim. CLS can cause circulatory shock and may be fatal, and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration.
Episodes vary in frequency, severity, and may be life-threatening if treatment is delayed. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive treatment, which may include a need for intensive care.
Hematologic Sickle Cell Crises Severe sickle cell crises, in some cases resulting in death, have been associated with the use of filgrastim in patients with sickle cell trait or sickle cell disease. Only healthcare professionals qualified by specialized training or experience in the treatment of patients with sickle cell trait and sickle cell disease should prescribe Nypozi for such patients, and only after careful consideration of the potential risks and benefits.
The response to Nypozi may be diminished in patients with reduced neutrophil precursors such as those previously treated with extensive dose chemotherapy or radiotherapy. In studies of filgrastim administration following chemotherapy, most reported side effects were consistent with those usually seen as a result of cytotoxic chemotherapy (see ADVERSE REACTIONS).
, full doses on the prescribed schedule), the patient may be at greater risk of thrombocytope nia, 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. Nypozi Product Monograph Page 13 of 54 Leukocytosis Cancer Patients Receiving Myelosuppressive Chemotherapy In all studies, including phase 1/2 dose ranging studies, WBC counts of 100 × 10 9/L or greater were observed in approximately 2% of patients receiving filgrastim 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 Nypozi therapy (see […]