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NEULASTA is a brand name for Pegfilgrastim, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Neulasta® (pegfilgrastim) is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs. 1.1 Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Neulasta (pegfilgrastim) should be administered no sooner than 24 hours after the administration of cytotoxic chemotherapy (see WARNINGS AND PRECAUTIONS). Renal impairment, including end-stage renal disease, appears to have no effect on the pharmacokinetics of Neulasta and no dosage adjustment is required.
2 Recommended Dose and Dosage Adjustment The recommended dosage of Neulasta is a single subcutaneous injection of 6 mg, administered once per cycle of chemotherapy. Neulasta should be administered no sooner than 24 hours after the administration of cytotoxic chemotherapy (see WARNINGS AND PRECAUTIONS).
3 Reconstitution Not applicable. Product does not need to be reconstituted. 4 Administration Neulasta is intended for subcutaneous injection only and should not be given by any other route of administration. Neulasta should not be mixed with any diluents.
Neulasta should not be vigorously shaken. Following administration of Neulasta from the single-use prefilled syringe, the patient should activate the UltraSafe® Needle Guard by placing their hands behind the needle, grasping the guard with one hand, and sliding 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. 5 Missed Dose If a scheduled dose is missed, Neulasta should not be administered less than 14 days before subsequent administration of cytotoxic chemotherapy.
1 Adverse Reaction Overview The most frequently reported study drug-related adverse event was bone pain, for which the incidence in patients treated with Neulasta was similar to that in patients treated with filgrastim. Bone pain was generally reported as mild-to-moderate, could be controlled in most patients with non-narcotic analgesia.
See WARNINGS AND PRECAUTIONS regarding Splenic Rupture, ARDS, Hypersensitivity/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. Safety data are based on 7 randomized clinical trials involving 932 patients with lymphoma and solid tumours (breast and thoracic) who received Neulasta (pegfilgrastim) after non- myeloablative cytotoxic chemotherapy.
Common adverse events occurred at similar rates between the treatment arms in both the filgrastim-controlled trials (Neulasta, n = 465; filgrastim, n = 331) and the placebo-controlled trial (Neulasta, n = 467; placebo, n = 461). Most adverse experiences were attributed by the investigator as the sequelae of the underlying malignancy or cytotoxic chemotherapy.
In the filgrastim-controlled trials, these adverse experiences occurred at rates between 15% and 72% and included: nausea, fatigue, alopecia, diarrhea, vomiting, constipation, fever, anorexia, skeletal pain, headache, taste perversion, dyspepsia, myalgia, insomnia, abdominal pain, arthralgia, generalized weakness, peripheral edema, dizziness, granulocytopenia, stomatitis, mucositis and neutropenic fever.
, Carcinogenesis and Mutagenesis XX/2021 8 WARNINGS AND PRECAUTIONS, Hematologic XX/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
PART I:
HEALTH PROFESSIONAL INFORMATION ............................................................... 4 1 INDICATIONS ................................................................................................................... 1 Pediatrics (< 18 years of age): ..............................................................................
4 2 CONTRAINDICATIONS .................................................................................................... 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .......................................................... 4 4 DOSAGE AND ADMINISTRATION ...................................................................................
1 Dosing Considerations .......................................................................................... 2 Recommended Dose and Dosage Adjustment...................................................... 3 Reconstitution .......................................................................................................
4 Administration ....................................................................................................... 5 Missed Dose .........................................................................................................
5 5 OVERDOSAGE ................................................................................................................ 5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ........................... 5 7 WARNINGS AND PRECAUTIONS ...................................................................................
1 Special Populations .............................................................................................. 2 Breast-feeding ...................................................................................................
Neulasta (pegfilgrastim) is contraindicated in patients with known hypersensitivity to E. coli- derived products, pegfilgrastim, filgrastim, 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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A summary of the most frequently reported adverse reactions in these randomized clinical trials can be found in Table 1 and 2. In clinical trials comparing Neulasta to filgrastim, medullary bone pain was reported in 26% of Neulasta-treated patients, which was comparable to the incidence in filgrastim-treated patients.
In the study comparing Neulasta to placebo, the incidence of bone pain was 23% vs. 16%, respectively. This bone pain was generally reported to be of mild-to-moderate severity. Approximately 17% (for all bone pain type AEs; 10% for specifically “bone pain”) of all subjects NEULASTA Product Monograph Page 11 of 30 utilized non-narcotic analgesics and less than 6% utilized narcotic analgesics in association with bone pain.
No patient withdrew from study due to bone pain. Across all studies, no life-threatening or fatal adverse events were attributed to Neulasta. There was only one serious adverse event (dyspnea) reported as possibly related to Neulasta in a single patient.
No events of pleuritis, pericarditis, or other major systemic reactions to Neulasta were reported. No clinically significant changes in vital signs were observed. No evidence of interaction of Neulasta with other drugs was observed in the course of clinical trials (see WARNINGS AND PRECAUTIONS).
Table 2. Most Frequently* Reported Adverse Reactions in Randomized Clinical Trials with Filgrastim as Comparator Body System and Preferred Term Neulasta (pegfilgrastim) (n = 465) Filgrastim (n = 331) Application Site Injection Site Pain 16 (3%) 9 (3%) Body as a whole Pain 8 (2%) 4 (1%) Chest Pain (Non-Cardiac) 4 (1%) 3 (1%) Edema Periorbital 3 (1%) 0 (0%) Fever 3 (1%) 4 (1%) CNS/PNS Headache 20 (4%) 12 (4%) Musculoskeletal Skeletal Pain 96 (21%) 89 (27%) Myalgia 32 (7%) 25 (8%) Arthralgia 27 (6%) 19 (6%) Back Pain 19 (4%) 26 (8%) Limb Pain 12 (3%) 7 (2%) Musculo-skeletal Pain 5 (1%) 4 (1%) Neck Pain 4 (1%) 3 (1%) * Most frequently reported events were considered to be those events reported in 1% of the patients in the Neulasta group.
NEULASTA Product Monograph Page 12 of 30 Table 3. Most Frequently* Reported Adverse Reactions in Randomized Clinical Trials with Placebo Control Body System and Preferred Term Neulasta (pegfilgrastim) (n = 467) Placebo (n = 461) Blood and Lymphatic System Disorders Leukocytosis 5 (1%) 1 (0%) Gastrointestinal Disorders Diarrhea 9 (2%) 10 (2%) General Disorders and Administration Site Conditions Pyrexia 8 (2%) 9 (2%) Fatigue 3 (1%) 5 (1%) Infections and Infestations Influenza 6 (1%) 5 (1%) Musculoskeletal and Connective Tissue Disorders Bone Pain 62 (13%) 41 (9%) Myalgia 26 (6%) 23 (5%) Arthralgia 32 (7%) 19 (4%) Polymyalgia 8 (2%) 7 (2%) Musculoskeletal Pain 14 (3%) 5 (1%) Pain in Limb 11 (2%) 5 (1%) Back Pain 8 (2%) 4 (1%) Polyarthralgia 5 (1%) 0 (0%) Nervous System Disorders Headache 6 (1%) 2 (0%) Skin and Subcutaneous Tissue Disorders Alopecia 8 (2%) 9 (2%) * Most frequently reported events were considered to be those events reported in 1% of the patients in the Neulasta group.
3 Less Common Clinical Trial Adverse Reactions The following adverse drug reactions were reported at an incidence of < 1% in controlled clinical studies (occurring in more than 1 patient, with higher frequency than filgrastim): General Disorders and Administration Site Conditions: injection site bruising; Infections and Infestations: rhinitis; Nervous System Disorders: hypertonia; Skin and Subcutaneous Tissue Disorders: periorbital edema.
The following adverse drug reactions were reported at an incidence of < 1% in controlled clinical studies (occurring in more than 1 patient, with higher frequency than placebo): General Disorders and Administration Site Conditions: chest pain, pain.
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Spontaneously reversible elevations in LDH, alkaline phosphatase, and uric acid of mild-to- moderate severity were observed. Most changes have been attributed to post-cytokine bone marrow expansion as well as to chemotherapy and metastatic […]
3 Pediatrics .......................................................................................................... 22 NEULASTA Product Monograph Page 4 of 30 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Neulasta® (pegfilgrastim) is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs.
1 Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 CONTRAINDICATIONS Neulasta (pegfilgrastim) is contraindicated in patients with known hypersensitivity to E.
coli- derived products, pegfilgrastim, filgrastim, 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, […]