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DYRUPEG is a brand name for Pegfilgrastim, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
). The safety and efficacy of DYRUPEG 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 pegfilgrastim with 5-FU or other anti-metabolites has not been evaluated in humans; although it has been studied and shown to potentiate myelosuppression in animal models (see 16 NON- CLINICAL TOXICOLOGY). The safety and efficacy of pegfilgrastim have not been evaluated in patients receiving radiation therapy, except for patients with breast or lung cancer.
Carcinogenesis and Genotoxicity No carcinogenesis or mutagenesis studies were conducted with DYRUPEG. Potential Effect on Malignant Cells DYRUPEG (pegfilgrastim) and filgrastim are growth factors that primarily stimulate the production of neutrophils and neutrophil precursors by binding to the G - CSF receptor.
Overall, the possibility that DYRUPEG can act as a growth factor for any tumour type cannot be excluded. The use of DYRUPEG in chronic myeloid leukemia (CML) and myelodysplastic syndrome (MDS) has not been studied. MDS and AML in Breast Cancer and Lung Cancer Patients In the post-marketing observational study setting, findings showed that pegfilgrastim is associated with an increased risk of MDS and AML in breast and lung cancer patients when used in conjunction with chemotherapy and/or radiotherapy.
Monitor patients for signs and symptoms of MDS/AML in these settings. Cardiovascular Aortitis Aortitis has been reported in patients receiving pegfilgrastim and may present with generalized signs and symptoms such as fever and increased inflammatory markers.
Consider aortitis in patients who develop these signs and symptoms without known etiology. Capillary Leak Syndrome Capillary leak syndrome (CLS) has been reported after the administration of pegfilgrastim or filgrastim. CLS can cause circulatory shock and may be fatal and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration.
Episodes vary in frequency and severity and may be life-threatening if treatment is delayed. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive treatment, which may include a need for intensive care.
PrDYRUPEGTM (pegfilgrastim injection) Page 8 of 33 Hematologic Sickle Cell Crises Severe sickle cell crises have been associated with the use of DYRUPEG 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.
Only physicians qualified by specialized training or experience in the treatment of patients with sickle cell trait and sickle cell disease should prescribe DYRUPEG for such patients, and only after careful consideration of the potential risks and benefits.
). 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 DYRUPEG 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 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 anaphylaxis, 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 DYRUPEG 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 DYRUPEG to patients with a history of hypersensitivity to filgrastim or pegfilgrastim.
Cutaneous Vasculitis PrDYRUPEGTM (pegfilgrastim injection) Page 9 of 33 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 DYRUPEG is unknown.
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).
4. 1. Dosing Considerations • DYRUPEG (pegfilgrastim) should be administered no sooner than 24 hours after the administration PrDYRUPEGTM (pegfilgrastim injection) Page 5 of 33 of cytotoxic chemotherapy (see 7 WARNINGS AND PRECAUTIONS).
• Renal impairment, including end-stage renal disease, appears to have no effect on the pharmacokinetics of DYRUPEG and no dosage adjustment is required. 2. Recommended Dose and Dosage Adjustment The recommended dose of DYRUPEG is a single subcutaneous injection of 6 mg, administered once per cycle of chemotherapy.
DYRUPEG should be administered no sooner than 24 hours after the administration of cytotoxic chemotherapy (see 7 WARNINGS AND PRECAUTIONS). 3. Reconstitution Not applicable. Product does not need to be reconstituted. 4. Administration DYRUPEG is intended for subcutaneous injection only and should not be given by any other route of administration.
DYRUPEG should not be mixed with any diluents. DYRUPEG should not be vigorously shaken. Following administration of DYRUPEG 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, DYRUPEG should not be administered less than 14 days before subsequent administration of cytotoxic chemotherapy.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Leukocytosis In clinical studies with pegfilgrastim, white blood cell counts of 100 x 109/L or greater have been reported in less than 1% of patients with cancer receiving myelosuppressive chemotherapy (n = 930) and were not associated with any reported adverse clinical effects (see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests).
In studies of pegfilgrastim administration after chemotherapy‚ most reported side effects were consistent with those usually seen as a result of cytotoxic chemotherapy (see 8 ADVERSE REACTIONS). 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 DYRUPEG 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 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 anaphylaxis, 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 DYRUPEG 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 DYRUPEG to patients with a history of hypersensitivity to filgrastim or pegfilgrastim.
Cutaneous Vasculitis PrDYRUPEGTM (pegfilgrastim injection) Page 9 of 33 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 DYRUPEG 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 […]
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 • Fertility No studies evaluating sexual function or reproduction in humans were conducted with pegfilgrastim.
• Function No studies evaluating sexual function or reproduction in humans were conducted with pegfilgrastim. 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 DYRUPEG who develop fever, lung infiltrates, or respiratory distress should be evaluated for the possibility of ARDS. In the event that ARDS occurs, DYRUPEG should be discontinued and/or withheld until the ARDS is resolved, and patients should receive appropriate medical management for this condition.
1. 1. Pregnancy There were no pregnant women exposed to pegfilgrastim in clinical trials. DYRUPEG should be used during pregnancy only if the potential benefit outweighs the risk to the fetus (see 16 NON- CLINICAL TOXICOLOGY). 2. Breastfeeding It is not known whether pegfilgrastim is excreted in human milk.
Because many drugs are excreted in human milk‚ DYRUPEG is not recommended for women who are breast-feeding. DYRUPEG should only be administered to a nursing woman if the potential benefit outweighs the risk. 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 experiences had 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. 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 clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Safety data are based on 7 randomized clinical trials involving 932 patients with […]
5. Overdose The maximum tolerated dose of DYRUPEG (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.
For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764- 7669). 6. Dosage Forms, Strengths, Composition, and Packaging To help ensure the traceability of biologic products health professionals should record 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.
PrDYRUPEGTM (pegfilgrastim injection) Page 6 of 33 Table 1 Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Subcutaneous (SC) Injection Sterile Solution for Injection / 6 mg (10 mg/mL) Acetate polysorbate 20 sorbitol water for injection DYRUPEG (pegfilgrastim) is a sterile‚ clear‚ colourless‚ preservative-free liquid for SC administration.
6 mL of DYRUPEG contains 6 mg of pegfilgrastim (based on protein mass only). 004% polysorbate 20 and water for injection. 6 mL) of pegfilgrastim (10mg/mL) in asingle-use pre-filled syringe with a 27 gauge, ½ inch needle, witha BD UltraSafe PLUS™ Passive™ Needle Guard.
The DYRUPEG syringe plunger stopper and needle cover are not made with natural rubber latex. To reduce the risk of accidental needle sticks to users, each single-use prefilled syringe is equipped with an UltraSafe® Needle Guard that is manually activated to cover the needle during disposal.
DYRUPEG is provided in a carton containing one blister packaged pre-filled syringe along with the package insert. 7. Warnings and Precautions General DYRUPEG (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 DYRUPEG 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 DYRUPEG administered concurrently with cytotoxic chemotherapy have not been established. Because of the potential for an increase in sensitivity of rapidly dividing myeloid cells PrDYRUPEGTM (pegfilgrastim injection) Page 7 of 33 to cytotoxic chemotherapy‚ DYRUPEG 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 DYRUPEG 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 pegfilgrastim with 5-FU or other anti-metabolites has not been evaluated in humans; although it has been studied and shown to potentiate myelosuppression in animal models (see 16 NON- CLINICAL TOXICOLOGY). The safety and efficacy of pegfilgrastim have not been evaluated in patients receiving radiation therapy, except for patients with breast or lung cancer.
Carcinogenesis and Genotoxicity No carcinogenesis or mutagenesis studies were conducted with DYRUPEG. Potential Effect on Malignant Cells DYRUPEG (pegfilgrastim) and filgrastim are growth factors that primarily stimulate the production of neutrophils and neutrophil precursors by binding to the G - CSF receptor.
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