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VEPESID is a brand name for Etoposide, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: VEPESID (etoposide) is indicated for: Small Cell Carcinoma of the Lung • first-line therapy in combination with other established antineoplastic agents. • second-line combination or single agent therapy in patients who have not responded or relapsed on other chemotherapeutic regimens. Malignant Lymphoma (histiocytic…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations The bioavailability varies from patient to patient following any oral dose. This should be taken into consideration when prescribing this medication. 2 Recommended Dose and Dosage Adjustment Oral: 100 – 200 mg/m2 daily for 5 days Daily doses greater than 200 mg should be divided and given twice daily.
In view of significant intra-patient variability, dose adjustment may be required to achieve the desired therapeutic effect. Dosage should be modified to take into account the myelosuppressive effects of other drugs in the combination or the effects of prior X-ray therapy or chemotherapy which may have compromised bone marrow reserve.
Renal Impairment:
In patients with impaired renal function, the following initial dose modification should be considered based on measured creatinine clearance.
Product Monograph February 2024 VEPESID, etoposide Page 6 of 37 Table1:
Dosage in Patients with Renal Impairment Measured Creatinine Clearance Dose of Etoposide > 50 mL/min 100 % of dose 15 – 50 mL/min 75 % of dose Subsequent dosing should be based on patient tolerance and clinical effect. Data are not available in patients with creatinine clearance <15 mL/min and further dose reduction should be considered in those patients.
Health Canada has not authorized an indication for pediatric use. 3 Administration Capsules should be taken on an empty stomach. 4 Missed dose Missed doses should not be replaced by double doses and medication should be resumed at the usual time.
). Treatment is symptomatic. The administration of VEPESID should be terminated immediately, followed by the administration of pressor agents, corticosteroids, antihistamines, or volume expanders at the discretion of the physician. Renal Renal function should be regularly monitored.
Reproductive Health:
Female and Male Potential • Fertility Given the mutagenic potential of VEPESID, an effective contraception is required for both male and female patients during treatment and up to 6 months after ending treatment. Genetic consultation is recommended if the patient wishes to have children after ending the treatment.
VEPESID may decrease fertility. As VEPESID may decrease male fertility, Product Monograph February 2024 VEPESID, etoposide Page 10 of 37 preservation of sperm may be considered for the purpose of later fatherhood. VEPESID has caused reduced or absent spermatogenesis and reduced testes weights at autopsy in rats and dogs, as well as reduced weight of ovaries in female rats.
Chronic toxicity studies in rats have shown etoposide to have an oncogenic potential (see 16 NON-CLINICAL TOXICOLOGY Error! Error! ). • Teratogenic Risk VEPESID can cause fetal harm when administered to pregnant women. 1 Pregnant Women).
1 Pregnant Women VEPESID can cause fetal harm when administered to pregnant women. VEPESID has been shown to be embryotoxic in rats and teratogenic in mice and rats. There are no adequate and well-controlled studies in pregnant women.
If the drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.
2 Breast-feeding There has been evidence of VEPESID being excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from etoposide, breast feeding should be discontinued. As with any potent antineoplastic drug, the benefit to patient versus the risk of toxicity must be carefully weighed.
). Severe myelosuppression with resulting infection or bleeding may occur. Blood counts as well as renal and hepatic function tests should be taken regularly. Discontinue the drug if abnormal depression of bone marrow or abnormal renal or hepatic function is seen.
Tumour lysis syndrome (sometimes fatal) has been reported following the use of etoposide in association with other chemotherapeutic drugs. 1 Dosing Considerations The bioavailability varies from patient to patient following any oral dose.
This should be taken into consideration when prescribing this medication. 2 Recommended Dose and Dosage Adjustment Oral: 100 – 200 mg/m2 daily for 5 days Daily doses greater than 200 mg should be divided and given twice daily. In view of significant intra-patient variability, dose adjustment may be required to achieve the desired therapeutic effect.
Dosage should be modified to take into account the myelosuppressive effects of other drugs in the combination or the effects of prior X-ray therapy or chemotherapy which may have compromised bone marrow reserve.
Renal Impairment:
In patients with impaired renal function, the following initial dose modification should be considered based on measured creatinine clearance.
Product Monograph February 2024 VEPESID, etoposide Page 6 of 37 Table1:
Dosage in Patients with Renal Impairment Measured Creatinine Clearance Dose of Etoposide > 50 mL/min 100 % of dose 15 – 50 mL/min 75 % of dose Subsequent dosing should be based on patient tolerance and clinical effect. Data are not available in patients with creatinine clearance <15 mL/min and further dose reduction should be considered in those patients.
Health Canada has not authorized an indication for pediatric use. 3 Administration Capsules should be taken on an empty stomach. 4 Missed dose Missed doses should not be replaced by double doses and medication should be resumed at the usual time.
VEPESID (etoposide) is contraindicated • in patients who are hypersensitive to this drug 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.
Product Monograph February 2024 VEPESID, etoposide Page 5 of 37 • in patients having severe leukopenia, thrombocytopenia and severe hepatic and/or renal impairment.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Etoposide in Canada.
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3 Pediatrics No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. Safety and effectiveness in pediatric patients have not been systematically studied. Clinical experience in childhood malignancies is very limited.
4 Geriatrics No data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use. 1 Adverse Reaction Overview The most commonly reported adverse reactions are leukopenia, thrombocytopenia, nausea and vomiting, anorexia and alopecia.
The following data on adverse events are based on both oral and intravenous administration of VEPESID (etoposide) as a single agent, using several different dose schedules for treatment of a wide variety of malignancies. The incidences of adverse reactions are derived from multiple data bases from studies in patients when VEPESID was used either orally or by injection as a single agent.
Blood and lymphatic system disorders:
Leukopenia (less than 4,000 cells/mm3) and severe leukopenia (less than 1,000 cells/mm3) were observed in 60% to 91% and 3% to 17%, respectively, of patients treated with single agent VEPESID. Thrombocytopenia (less than 100,000 platelets/mm3) and severe thrombocytopenia (less than 50,000 platelets/mm3) were seen in 22% to 41% and 1% to 20 %, respectively, of this same group of patients.
Anemia was observed in 0% to 33% of patients. Since leukopenia (including neutropenia) and thrombocytopenia have been reported in patients on VEPESID therapy, platelets and white blood cell counts should be performed prior to each cycle (see 7 WARNINGS AND PRECAUTIONS).
Myelosuppression with fatal outcome has been reported following etoposide administration (see 7 WARNINGS AND PRECAUTIONS).
Cardiac disorders:
Myocardial infarction (some with a fatal outcome) and arrhythmia have been reported.
Gastrointestinal disorders:
Nausea and vomiting are the major gastrointestinal toxicities. They have been noted in 31% to 43% of patients given intravenous VEPESID. The severity of such nausea and vomiting is generally mild to moderate with treatment discontinuation required in 1% of patients.
Nausea and vomiting can usually be controlled with standard antiemetic therapy. Gastrointestinal toxicities are slightly more frequent after oral administration than after intravenous infusion. Anorexia was seen in 10% to 13% and stomatitis in 1% to 6%.
of those patients given intravenous VEPSID. Abdominal pain and diarrhea were noted in 0% to 2% and in 1% to 13%, respectively. Mild to severe mucositis/esophagitis may occur. Mouth ulceration has been Product Monograph February 2024 VEPESID, etoposide Page 12 of 37 reported in 2% of the patients.
Constipation, dysgeusia and dysphagia have been reported rarely.
General disorders and administration site conditions:
Asthenia has been reported in 3% of the patients. Fatigue, malaise and pyrexia have been reported rarely.
Hepatobiliary disorders:
Hepatotoxicity has been reported rarely.
Immune system disorders:
Anaphylactic-like reactions have occurred very rarely in patients treated with oral capsules. 7% - 2% of patients. Higher rates of anaphylactic- like reactions have been reported in children who received VEPESID infusions at concentrations higher than those recommended.
The role that concentration of infusion (or rate of infusion) plays in the development of anaphylactic-like reactions is uncertain. Anaphylactic-like reactions have usually responded promptly to the cessation of the infusion of VEPESID, and […]
5 OVERDOSAGE The anticipated acute complications would be related to VEPESID's hematotoxicity. 5 g/m2 administered intravenously over three days resulted in severe mucositis and myelotoxicity. Metabolic acidosis and cases of serious hepatic toxicity have been reported in patients receiving higher than recommended intravenous doses of etoposide.
There is no known antidote and therefore symptomatic measures should be taken to sustain the patient through any period of toxicity that might occur. Patients' renal and hepatic functions should be monitored for 3-4 weeks in case of delayed toxicity.
For management of a suspected drug overdose, contact your regional poison control centre. Product Monograph February 2024 VEPESID, etoposide Page 7 of 37 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 2: Dosage Forms, Strengths, Composition and Packaging Each liquid-filled, soft gelatin pink capsule contains 50 mg of etoposide.
VEPESID 50 mg capsules are available in bottles of 20. 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. General The physician must evaluate the need and usefulness of the drug against the risk of adverse reactions.
Most such adverse reactions are reversible if detected early. If severe reactions occur, the drug should be reduced in dosage or discontinued and appropriate corrective measures should be taken according to the clinical judgement of the physician.
Reinstitution of VEPESID (etoposide) therapy should be carried out with caution, and with adequate consideration of the further need for the drug and alertness to the possible recurrence of toxicity. VEPESID should be administered by individuals experienced in the use of antineoplastic therapy.
Bacterial infection must be brought under control before the administration of VEPESID therapy because of the risk of septicemia. Carcinogenesis and Mutagenesis Carcinogenicity tests with VEPESID have not been conducted in laboratory animals.
Given its mechanism of action, it should be considered a possible carcinogen in humans. Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Capsules, 50 mg, etoposide Capsule filling: Citric acid, glycerol, polyethylene glycol 400, purified water.
Capsule shell: gelatin, glycerol, parabens (ethyl and propyl), purified water, red iron oxide, sorbitol, titanium dioxide Product Monograph February 2024 VEPESID, etoposide Page 8 of 37 The occurrence of acute leukemia, which can occur with or without a preleukemic phase, has been reported rarely in patients treated with VEPESID in association with other antineoplastic drugs.
Neither the cumulative risk, nor the predisposing factors related to the development of secondary leukemia are known. The roles of both administration schedules and cumulative doses of etoposide have been suggested but have not been clearly defined.
An 11q23 chromosome abnormality has been observed in some cases of secondary leukemia in patients who have received epipodophyllotoxins. This abnormality has also been seen in patients developing secondary leukemia after being treated with chemotherapy regimens not containing epipodophyllotoxins and in leukemia occurring de novo.
Another characteristic that has been associated with secondary leukemia in patients who have received epipodophyllotoxins appears to be a short latency period, with average median time to development of leukemia being approximately 32 months.
Endocrine and Metabolism Tumour lysis syndrome (sometimes fatal) has been reported following the use of etoposide in association with other chemotherapeutic drugs. Close monitoring of patients is needed to detect early signs of tumour lysis syndrome, especially in patients with risk factors such as bulky treatment-sensitive tumours, and renal insufficiency.
Appropriate preventive measures should also be considered in patients at risk of this complication of therapy. Contamination Professional staff administering VEPESID should exercise particular care to […]