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ARMLUPEG 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 Armlupeg and the reference biologic drug Neulasta. Armlupeg (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 Armlupeg (pegfilgrastim) should be administered no sooner than 24 hours after the administration of cytotoxic 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 Armlupeg is a single subcutaneous injection of 6 mg, administered once per cycle of chemotherapy. Armlupeg should be administered no sooner than 24 hours after the administration of cytotoxic chemotherapy (see 7 WARNINGS AND PRECAUTIONS).
Pediatrics (<18 years of age):
No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 1 Pediatrics). 3 Reconstitution Not applicable. Product does not need to be reconstituted. 4 Administration Armlupeg is intended for subcutaneous injection only and should not be given by any other route of administration.
Armlupeg should not be mixed with any diluents. Armlupeg should not be vigorously shaken. Following administration of Armlupeg from the single-use prefilled syringe, the patient should activate the UltraSafe® Plus Passive 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, Armlupeg 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 Armlupeg in conjunction with drugs known to lower platelet count. Thrombocytopenia Thrombocytopenia, including serious events, has been reported in patients receiving pegfilgrastim.
Platelet counts should be monitored regularly as clinically indicated. 10 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 Armlupeg 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. 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 pegfilgrastim 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.
General). • Severe sickle cell crises have been associated with the use of pegfilgrastim in patients with sickle cell trait or sickle cell disease. Severe sickle cell crises, in some cases resulting in death, have also been associated with filgrastim, the parent compound of pegfilgrastim (see 7 WARNINGS AND PRECAUTIONS: Hematologic).
1 Dosing Considerations Armlupeg (pegfilgrastim) should be administered no sooner than 24 hours after the administration of cytotoxic 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 Armlupeg is a single subcutaneous injection of 6 mg, administered once per cycle of chemotherapy. Armlupeg should be administered no sooner than 24 hours after the administration of cytotoxic chemotherapy (see 7 WARNINGS AND PRECAUTIONS).
Pediatrics (<18 years of age):
No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 1 Pediatrics). 3 Reconstitution Not applicable. Product does not need to be reconstituted. 4 Administration Armlupeg is intended for subcutaneous injection only and should not be given by any other route of administration.
Armlupeg should not be mixed with any diluents. Armlupeg should not be vigorously shaken. Following administration of Armlupeg from the single-use prefilled syringe, the patient should activate the UltraSafe® Plus Passive 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, Armlupeg should not be administered less than 14 days before subsequent administration of cytotoxic chemotherapy.
Armlupeg (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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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. Respiratory Acute Respiratory Distress Syndrome (ARDS) 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 Armlupeg who develop fever, lung infiltrates, or respiratory distress should be evaluated for the possibility of ARDS. In the event that ARDS occurs, Armlupeg should be discontinued and/or withheld until resolution of ARDS and patients should receive appropriate medical management for this condition.
11 Sexual Function/Reproduction No studies evaluating sexual function or reproduction in humans were conducted with Armlupeg. 1 Pregnant Women There were no pregnant women exposed to pegfilgrastim in clinical trials. Armlupeg 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 not known whether pegfilgrastim is excreted in human milk. Because many drugs are excreted in human milk‚ Armlupeg is not recommended for women who are breast feeding. Armlupeg should only be administered to a nursing woman if the potential benefit outweighs the risk.
3 Pediatrics Pediatrics (< 18 years of age): The safety and effectiveness of Armlupeg in pediatric patients have not been established. 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 Armlupeg 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, 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 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 […]
5 OVERDOSAGE The maximum tolerated dose of Armlupeg (pegfilgrastim) has not been determined in humans. Pegfilgrastim administered at a dose of 300 mcg/kg (n = 12), approximately three times the recommended dose, exhibited an adverse event profile similar to that observed at the recommended dose.
7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING To help ensure the traceability of biologic products, including biosimilars, health professionals should recognize the importance of recording both the brand name and the non-proprietary (active ingredient) name as well as other product-specific identifiers such as the Drug Identification Number (DIN) and the batch/lot number of the product supplied.
Table 1. 6 mL solution for injection. 20. 6 mL) containing 6 mg of pegfilgrastim (10 mg/mL) in a single-dose syringe with a 27 gauge, ½ inch needle, with an UltraSafe® Plus Passive Needle Guard. The needle cover on the single-use prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions and should not be handled by individuals who are sensitive to latex.
To reduce the risk of accidental needle sticks to users, each single-use prefilled syringe is equipped with an UltraSafe® Plus Passive Needle Guard that is manually activated to cover the needle during disposal. Armlupeg is provided in a dispensing pack containing one syringe.
Description Armlupeg (pegfilgrastim) is a biosimilar biological drug that is a long-acting form of recombinant human granulocyte colony-stimulating factor (r-metHuG-CSF) or filgrastim. Armlupeg is composed of filgrastim with a 20,000 dalton polyethylene glycol (PEG) molecule covalently bound to the N- terminal methionine residue.
Filgrastim is a 175 amino acid protein with a molecular weight of 18,800 daltons; Armlupeg has a total molecular weight of 39,000 daltons. For management of a suspected drug overdose, contact your regional poison control centre. 8 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX.
General Armlupeg (pegfilgrastim) has not been evaluated for PBPC (peripheral blood progenitor cell) mobilization. Therefore, it should not be used in that setting. Splenic Rupture Splenic rupture, including fatal cases, has been reported following the administration of pegfilgrastim and its parent compound, filgrastim.
Patients receiving Armlupeg who report left upper abdominal and/or shoulder tip pain should be evaluated for an enlarged spleen or splenic rupture. Simultaneous Use with Chemotherapy and Radiation Therapy The safety and efficacy of Armlupeg administered concurrently with cytotoxic chemotherapy have not been established.
Because of the potential for an increase in sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy‚ Armlupeg should not be administered in the period between 14 days before and 24 hours after administration of cytotoxic chemotherapy (see 4 DOSAGE AND ADMINISTRATION).
The safety and efficacy of Armlupeg have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression (eg, nitrosoureas), mitomycin C, or myelosuppressive doses of anti-metabolites such as 5-fluorouracil (5-FU).
Concomitant use of Armlupeg with 5-FU or other anti-metabolites has not been evaluated in […]