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NIVESTYM 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 Nivestym and the reference biologic drug Neupogen. Nivestym (filgrastim injection) is indicated for: • Cancer Patients Receiving Myelosuppressive Chemotherapy Nivestym (filgrastim) is indicated to decrease the incidence of infection, as manifested by…
Verbatim from this product's HC label. Tap a section to expand.
Nivestym is supplied in either vials or in graduated prefilled syringes with BD UltraSafe Plus™ Passive Needle Guard. Following administration of Nivestym from the prefilled syringe, the Needle Guard is automatically activated to cover the needle after the injection is given.
The Needle Guard will help prevent stick injuries to anyone who handles the prefilled syringe. The prefilled syringe should be disposed of by placing the entire prefilled syringe with activated Needle Guard into an approved puncture-proof container.
1 Dosing Considerations Serious Warnings and Precautions • Splenic rupture, including fatal cases, has been reported following the administration of filgrastim (see 7 WARNINGS AND PRECAUTIONS: General). • 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 (see 7 WARNINGS AND PRECAUTIONS: Hematologic).
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 Nivestym should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy.
Nivestym 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 Nivestym 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 Nivestym (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. 1 Dosing Considerations). A CBC and platelet count should be obtained before instituting Nivestym therapy, and monitored twice weekly during therapy.
). 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-hematological 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 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 Nivestym therapy (see 7 WARNINGS AND PRECAUTIONS: Monitoring and Laboratory Tests).
Cancer Patients Undergoing Peripheral Blood Progenitor Cell (PBPC) Collection and Therapy During the period of administration of Nivestym for PBPC mobilization in cancer patients, discontinuation of Nivestym is appropriate if the leukocyte count rises to > 100 x 109/L (see 7 Nivestym® Product Monograph Page 14 of 64 WARNINGS AND PRECAUTIONS: Monitoring and Laboratory Tests).
Thrombocytopenia Thrombocytopenia, including serious events, has been reported in patients receiving filgrastim.
Platelet counts should be monitored closely (see 7 WARNINGS AND PRECAUTIONS:
Monitoring and Laboratory Tests). Immune As with all therapeutic proteins, there is a potential for immunogenicity. The incidence of antibody development in patients receiving filgrastim 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.
, Carcinogenesis and Mutagenesis 09/2023 7 WARNINGS AND PRECAUTIONS, Hematologic 09/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................
2 TABLE OF CONTENTS.................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................... 4 1 INDICATIONS ......................................................................................................
4 2 CONTRAINDICATIONS ....................................................................................... 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................ 5 4 DOSAGE AND ADMINISTRATION .....................................................................
1 Dosing Considerations ................................................................................... 2 Recommended Dose and Dosage Adjustment ............................................... 3 Reconstitution .................................................................................................
4 Administration ................................................................................................. 5 Missed Dose ................................................................................................... 9 5 OVERDOSAGE ....................................................................................................
9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............. 9 7 WARNINGS AND PRECAUTIONS .................................................................... 1 Special Populations ......................................................................................
1 Pregnant Women ................................................................................... 2 Breast-feeding ........................................................................................ 3 Pediatrics ...............................................................................................
Nivestym (filgrastim) 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.
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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. Nivestym 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 Nivestym therapy needed to attenuate chemotherapy-induced neutropenia may be dependent on the myelosuppressive potential of the chemotherapy regimen employed. Nivestym 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 with filgrastim, 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 Nivestym 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.
0 x 109/L at any time during the 5 mcg/kg/day administration, Nivestym 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 Nivestym for PBPC mobilization is 10 mcg/kg/day given as a single daily subcutaneous injection or a continuous 24-hour infusion.
Nivestym 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 hematopoietic progenitor cells is obtained.
For peripheral blood progenitor cells mobilized with Nivestym, 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 hematopoietic 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 Nivestym dosage, such as prior […]
In clinical studies comparing filgrastim and pegfilgrastim, the incidence of antibodies binding to filgrastim 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 filgrastim 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 crossreact with endogenous G-CSF, resulting in immune-mediated neutropenia; however, this has not been reported in clinical studies or in post-marketing experience with filgrastim.
coli-derived proteins. Hypersensitivity/Allergic Reactions Hypersensitivity, including serious allergic reactions and anaphylactic reactions occurring on initial or subsequent treatment has been reported in < 1 in 4,000 patients treated with filgrastim.
These reactions 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 filgrastim 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 Nivestym 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 Nivestym should be permanently discontinued.
Cutaneous Vasculitis Cutaneous vasculitis has been reported in patients treated with filgrastim. In most cases‚ the severity of cutaneous vasculitis was moderate or severe. Most of the reports involved patients with SCN receiving long-term filgrastim 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 filgrastim at a reduced dose. Nivestym® Product Monograph Page 15 of 64 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 Nivestym therapy.
Following cytotoxic chemotherapy, the neutrophil nadir occurred earlier during cycles when filgrastim was administered, and 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 Nivestym therapy) following marrow infusion.
Cancer Patients Undergoing Peripheral Blood Progenitor Cell (PBPC) Collection and Therapy After 4 days of Nivestym […]
18 8 ADVERSE REACTIONS .................................................................................... 1 Adverse Reaction Overview ......................................................................... 2 Clinical Trial Adverse Reactions ...................................................................
5 Post-Market Adverse Reactions ................................................................... 25 9 DRUG INTERACTIONS ..................................................................................... 1 Serious Drug Interactions .............................................................................
2 Drug Interactions Overview .......................................................................... 3 Drug-Behavioural Interactions ...................................................................... 4 Drug-Drug Interactions .................................................................................
5 Drug-Food Interactions ................................................................................. 6 Drug-Herb Interactions ................................................................................. 7 Drug-Laboratory Test Interactions ................................................................
26 Nivestym® Product Monograph Page 3 of 64 10 CLINICAL PHARMACOLOGY........................................................................... 1 Mechanism of Action ..................................................................................
2 Pharmacodynamics .................................................................................... 3 Pharmacokinetics ....................................................................................... 27 11 STORAGE, STABILITY AND DISPOSAL .........................................................
28 12 SPECIAL HANDLING INSTRUCTIONS ............................................................ 28 PART II: SCIENTIFIC INFORMATION ......................................................................... 29 13 PHARMACEUTICAL INFORMATION ...............................................................
29 14 CLINICAL TRIALS ............................................................................................. 1 Clinical Trials by Indication ......................................................................... 29 15 MICROBIOLOGY ...............................................................................................
34 16 NON-CLINCAL TOXICOLOGY .......................................................................... 34 17 SUPPORTING PRODUCT MONOGRAPHS ...................................................... 35 PATIENT MEDICATION INFORMATION .....................................................................
36 Nivestym® Product Monograph Page 4 of 64 Nivestym® (filgrastim injection) is a biosimilar to Neupogen®. A biosimilar is a biologic drug that was granted authorization based on a demonstration of similarity to a version previously authorized in Canada, known as the reference biologic drug.
PART I:
HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Indications have been granted on the basis of similarity between Nivestym and the reference biologic drug Neupogen. Nivestym (filgrastim injection) is indicated for: • Cancer Patients Receiving Myelosuppressive Chemotherapy Nivestym (filgrastim) 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 myelosuppressive anti-neoplastic drugs.
Nivestym is indicated in adult and pediatric patients with cancer receiving myelosuppressive chemotherapy. A complete blood […]