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FULPHILA 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: The indication has been granted on the basis of similarity between Fulphila and the reference biologic drug Neulasta (pegfilgrastim). Fulphila (pegfilgrastim) is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Fulphila (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 Fulphila is a single subcutaneous injection of 6 mg, administered once per cycle of chemotherapy. Fulphila should be administered no sooner than 24 hours after the administration of cytotoxic chemotherapy (see 7 WARNINGS AND PRECAUTIONS).
Health Canada has not authorized an indication for pediatric use. (see 1 INDICATIONS: Pediatrics). 3 Reconstitution Not applicable; Fulphila is administered from a prefilled syringe and should not be mixed with any diluents. 4 Administration Fulphila is intended for subcutaneous injection only and should not be given by any other route of administration.
Fulphila should not be mixed with any diluents. Fulphila should not be vigorously shaken. Following administration of Fulphila from the single-use prefilled syringe, the patient should activate the UltraSafe™ Plus Passive Needle Guard by releasing the plunger and allowing the syringe to move up until the needle is covered by needle guard.
Note:
The needle guard will not activate unless the entire dose is injected. 5 Missed Dose If a scheduled dose is missed, Fulphila 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 Fulphila 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. Immune Hyersensitivity/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 re- challenge, 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 Fulphila 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. 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.
, Carcinogenesis and Mutagenesis [09/2022] 7 WARNINGS AND PRECAUTIONS, Hematologic [09/2022] TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ......................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ................................................................
4 1 INDICATIONS .................................................................................................................. 1 Pediatrics .................................................................................................................
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 ......................... 6 7 WARNINGS AND PRECAUTIONS ..................................................................................
1 Special Populations ............................................................................................... 1 Pregnant Women ..................................................................................................
Fulphila (pegfilgrastim) is contraindicated in patients with known hypersensitivity to E. coli- derived proteins‚ pegfilgrastim‚ filgrastim, or 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.
Other brands of Pegfilgrastim in Canada.
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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 sterile solution for injection and is postulated to be secondary to an influx of neutrophils to sites of inflammation in the lungs.
Neutropenic patients receiving Fulphila who Fulphila Page 10 of 41 develop fever, lung infiltrates, or respiratory distress should be evaluated for the possibility of ARDS. In the event that ARDS occurs, Fulphila should be discontinued and/or withheld until resolution of ARDS and patients should receive appropriate medical management for this condition.
Sexual Health Reproduction No studies evaluating reproduction in humans were conducted with Fulphila. Function No studies evaluating sexual function in humans were conducted with Fulphila. 1 Pregnant Women There were no pregnant women exposed to Fulphila in clinical trials.
Fulphila should be used during pregnancy only if the potential benefit outweighs the risk to the fetus (see 16 NONCLINICAL TOXICOLOGY). 2 Breast-feeding It is not known whether Fulphila is excreted in human milk. Because many drugs are excreted in human milk‚ Fulphila is not recommended for women who are breast feeding.
Fulphila 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 Fulphila in pediatric patients have not been established.
4 Geriatrics Geriatrics (>65 years of age): Of the total number of patients with cancer who received pegfilgrastim in clinical studies (n = 930), 139 patients (15%) were 65 years or older and 18 patients (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 patients, small but clinically relevant differences cannot be excluded.
8 ADVERSE REACTIONS The adverse drug reaction profiles reported in clinical studies that compared Fulphila 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 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 tumors (breast and thoracic) who received pegfilgrastim after […]
2 Breast-feeding ...................................................................................................... 3 Pediatrics .............................................................................................................
4 Geriatrics ............................................................................................................. 10 8 ADVERSE REACTIONS .................................................................................................
1 Adverse Reaction Overview .................................................................................. 2 Clinical Trial Adverse Reactions ............................................................................ 1 Clinical Trial Adverse Reactions (Pediatrics) ..........................................................
3 Less Common Clinical Trial Adverse Reactions (<1%) ......................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ............................................................................................................
13 Immunogenicity ............................................................................................................... 5 Post-Market Adverse Reactions ............................................................................
14 9 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 ............................................................................
15 Fulphila Page 3 of 41 10 CLINICAL PHARMACOLOGY ..................................................................................... 1 Mechanism of Action .........................................................................................
2 Pharmacodynamic ............................................................................................. 3 Pharmacokinetics .............................................................................................. 16 11 STORAGE, STABILITY AND DISPOSAL ......................................................................
17 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................ 17 PART II: SCIENTIFIC INFORMATION .................................................................................... 18 13 PHARMACEUTICAL INFORMATION .........................................................................
18 14 CLINICAL TRIALS ........................................................................................................ 1 Trial Design and Study Demographics .............................................................. 2 Study Results .....................................................................................................
3 Comparative Bioavailability Studies ................................................................... 1 Pharmacokinetics ................................................................................................. 2 Pharmacodynamics […]