Loading…
ZIEXTENZO 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: Indications have been granted on the basis of similarity between ZIEXTENZO and the reference biologic drug Neulasta. ZIEXTENZO (pegfilgrastim) is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • ZIEXTENZO should be administered no sooner than 24 hours after the administration of cytotoxic Product Monograph Template Date: September 2020 PrZIEXTENZO® (Pegfilgrastim Injection) Page 5 of 31 chemotherapy (see 7 WARNINGS AND PRECAUTIONS).
• Renal impairment, including end-stage renal disease, appears to have no effect on the pharmacokinetics of pegfilgrastim and no dosage adjustment is required. 2 Recommended Dose and Dosage Adjustment The recommended dosage of ZIEXTENZO is a single subcutaneous injection of 6 mg, administered once per cycle of chemotherapy (see 7 WARNINGS AND PRECAUTIONS).
1 PEDIATRICS). No dosage adjustment required in renal impairment. 3 Reconstitution Not applicable. Product does not need to be reconstituted. 4 Administration ZIEXTENZO is intended for subcutaneous injection only and should not be given by any other route of administration.
ZIEXTENZO should not be mixed with any diluents. ZIEXTENZO should not be vigorously shaken. After the medicine has been injected, the needle guard will be activated to cover the needle. The needle guard is intended to protect healthcare professionals, care providers and patients from accidental needle sticks after the injection.
5 Missed Dose If a scheduled dose is missed, ZIEXTENZO should not be administered less than 14 days before subsequent administration of cytotoxic chemotherapy.
). Because of the potential for patients to receive full doses of chemotherapy on the prescribed schedule‚ patients may be at greater risk of thrombocytopenia‚ anemia‚ and non-hematologic consequences of increased chemotherapy doses (please refer to the prescribing information for specific chemotherapy agents).
Regular monitoring of hematocrit value and platelet count is recommended. Furthermore‚ care should be exercised in the administration of ZIEXTENZO in conjunction with drugs known to lower platelet count.
Thrombocytopenia:
Thrombocytopenia, including serious events, has been reported in patients Product Monograph Template Date: September 2020 PrZIEXTENZO® (Pegfilgrastim Injection) Page 8 of 31 receiving pegfilgrastim. Platelet counts should be monitored regularly as clinically indicated.
Immune Hypersensitivity/Allergic Reactions:
Hypersensitivity including serious allergic reactions and anaphylactic reactions, skin rash, urticaria and erythema/flushing occurring on initial or subsequent treatment have been reported both with pegfilgrastim and filgrastim. In some cases, symptoms have recurred with rechallenge, suggesting a causal relationship.
In rare cases, allergic reactions, including anaphylactic reactions, recurred within days after initial anti-allergic treatment was discontinued. If a serious allergic reaction or an anaphylactic reaction occurs, appropriate therapy should be administered and further use of ZIEXTENZO should be discontinued.
Antibodies to filgrastim or pegfilgrastim have been reported, although no neutralizing antibodies have been reported (see 8 ADVERSE REACTIONS, Immunogenicity). Do not administer filgrastim to patients with a history of hypersensitivity to filgrastim or pegfilgrastim.
, Carcinogenesis and Mutagenesis 02/2021 7 WARNINGS AND PRECAUTIONS, Hematologic 02/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .........................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................................. 4 1 INDICATIONS ..........................................................................................................................
4 2 CONTRAINDICATIONS ............................................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................................
4 4 DOSAGE AND ADMINISTRATION ............................................................................................. 5 5 OVERDOSAGE .........................................................................................................................
5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................................. 5 7 WARNINGS AND PRECAUTIONS .............................................................................................. 9 8 ADVERSE REACTIONS ..............................................................................................................
1 Clinical Trial Adverse Reactions: Pediatrics ................................................................ 3 Less Common Clinical Trial Adverse Reactions ................................................................. 5 Post-Market Adverse Reactions ........................................................................................
13 9 DRUG INTERACTIONS............................................................................................................ 2 Drug Interactions Overview ..............................................................................................
ZIEXTENZO (pegfilgrastim) is contraindicated in patients with known hypersensitivity to E. coli-derived products, pegfilgrastim, filgrastim, or any other component of the product, 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 Pegfilgrastim 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.
Cutaneous Vasculitis:
Uncommon (≥1/1,000 to <1/100) events of cutaneous vasculitis have been reported in patients treated with pegfilgrastim. The mechanism of vasculitis in patients receiving ZIEXTENZO is unknown. Monitoring and Laboratory Tests To assess a patient's hematologic status and ability to tolerate myelosuppressive chemotherapy, a complete blood count (CBC) and platelet count should be obtained before chemotherapy is administered.
Pegfilgrastim produced ANC (absolute neutrophil count) profiles similar to daily filgrastim, including earlier ANC nadir, shorter duration of severe neutropenia, and accelerated ANC recovery, compared with ANC profiles observed without growth factor support.
Regular monitoring of hematocrit value, white blood cell count and platelet count, as clinically indicated, is recommended.
Renal Glomerulonephritis:
Glomerulonephritis has been reported in patients receiving filgrastim and pegfilgrastim. Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and pegfilgrastim. Urinalysis monitoring is recommended.
Reproductive Health:
Female and Male Potential No studies evaluating sexual function or reproduction in humans were conducted with ZIEXTENZO. Respiratory Acute respiratory distress syndrome (ARDS) has been reported following administration of pegfilgrastim, and is postulated to be secondary to an influx of neutrophils to sites of inflammation in the lungs.
Neutropenic patients receiving ZIEXTENZO who develop fever, lung infiltrates, or respiratory distress should be evaluated for the possibility of ARDS. In the event that ARDS occurs, ZIEXTENZO should be discontinued and/or withheld until resolution of ARDS and patients should receive appropriate medical management for this condition.
1 Pregnant Women There were no pregnant women exposed to pegfilgrastim in clinical trials. ZIEXTENZO should be used during pregnancy only if the potential benefit outweighs the risk to the fetus (see 16 NON-CLINICAL TOXICOLOGY). 2 Breast-feeding It is unknown if ZIEXTENZO (pegfilgrastim) is excreted in human milk.
Precaution should be exercised because many drugs can be excreted in human milk. Where an assessment of the risk to benefit ratio suggests the use of this product in nursing mothers, feeding formula should be substituted for breast feeding.
3 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 4 Geriatrics Geriatrics (> 65 years of age): Of the total number of subjects with cancer who received pegfilgrastim in clinical studies (n = 930), 139 subjects (15%) were 65 years or older and 18 subjects (2%) were 75 years or older.
No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients; however, due to the small number of elderly subjects, small but clinically relevant differences cannot be excluded.
8 ADVERSE REACTIONS The adverse drug reaction profiles reported in clinical studies that compared ZIEXTENZO to the reference biologic drug were comparable. The description of adverse reactions in this section is based on clinical experience with the reference biologic drug.
1 Adverse Reaction Overview The most frequently reported study drug-related adverse event was bone pain, for which the incidence in patients treated with pegfilgrastim was similar to that in patients treated with filgrastim. Bone pain was generally reported as mild-to-moderate and could be controlled in most patients with non-narcotic analgesia.
See 7 WARNINGS AND PRECAUTIONS regarding Splenic Rupture, ARDS, Hypersensitivity/Allergic Reactions, and Sickle Cell Crises. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the […]
3 Drug-Behavioural Interactions .......................................................................................... 4 Drug-Drug Interactions .....................................................................................................
5 Drug-Food Interactions ..................................................................................................... 6 Drug-Herb Interactions .....................................................................................................
7 Drug-Laboratory Test Interactions .................................................................................... 14 10 CLINICAL PHARMACOLOGY ...................................................................................................
1 Mechanism of Action .................................................................................................. 2 Pharmacodynamics ....................................................................................................
3 Pharmacokinetics ....................................................................................................... 14 11 STORAGE, STABILITY AND DISPOSAL .....................................................................................
15 12 SPECIAL HANDLING INSTRUCTIONS....................................................................................... 15 PART II: SCIENTIFIC INFORMATION ...................................................................................................
16 13 PHARMACEUTICAL INFORMATION........................................................................................ 16 14 CLINICAL TRIALS....................................................................................................................
1 Clinical Trials by […]