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ETOPOSIDE is a brand name for Etoposide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Recurrent or refractory testicular cancer Etoposide is indicated in combination with other approved chemotherapeutic agents for the treatment of recurrent or refractory testicular cancer in adults. Small cell lung cancer Etoposide is indicated in combination with other approved chemotherapeutic agents for the…
Verbatim from this product's MHRA label. Tap a section to expand.
4). Posology The dose of Etoposide capsules is based on the recommended intravenous dose taking into account the dose-dependent bioavailability of Etoposide capsules. A 100 mg oral dose would be comparable to a 75 mg intravenous dose; a 400 mg oral dose would be comparable to a 200 mg intravenous dose.
e. 2). Monotherapy The usual dose of etoposide administered orally is 100 to 200 mg/m2/day on days 1 to 5 or 200 mg/m2/day on days 1, 3 and 5 every 3 to 4 weeks. Daily doses greater than 200 mg should be divided and given twice per day.
Combination therapy The usual dose of etoposide administered orally is 100 to 200 mg/m2/day on days 1 to 5 or 200 mg/m2/day on days 1, 3 and 5 every 3 to 4 weeks in combination with other drugs approved for use in the disease to be treated.
4), which may have compromised bone marrow reserve. The doses after the initial dose should be adjusted if neutrophil count is below 500 cells/mm3 for more than 5 days. In addition, the dose should be adjusted in case of occurrence of fever, infections, or at a thrombocyte count below 25,000 cells/mm3, which is not caused by the disease.
Follow up doses should be adjusted in case of occurrence of grade 3 or 4 toxicities or if renal creatinine clearance is below 50 ml/min. At decreased creatinine clearance of 15 to 50 mL/min a dose reduction by 25% is recommended. Alternative dosage schedule An alternative dosage schedule for Etoposide capsules is 50 mg/m2/day for 2 to 3 weeks, with courses repeated after a one week rest period or upon recovery from myelosuppression.
Neutropenia and thrombocytopenia Patients should not begin a new cycle of treatment with etoposide if the neutrophil count is less than 1,500 cells/mm3 or the platelet count is less than 100,000 cells/mm3, unless caused by malignant disease.
2). Paediatric population The safety and efficacy of etoposide in children below 18 years of age have not been established. 2 but no recommendation on a posology can be made. Renal impairment In patients with impaired renal function, the following initial dose modification should be considered based on measured creatinine clearance.
Measured Creatinine Clearance Dose of Etoposide >50 mL/min 100% of dose 15-50 mL/min 75% of dose In patients with creatinine clearance less than 15 mL/min and on dialysis further dose reduction is likely to be required as etoposide clearance is further reduced in these patients.
Summary of the safety profile Dose limiting bone marrow suppression is the most significant toxicity associated with etoposide therapy. In clinical studies in which etoposide was administered as a single agent either orally or by injection the most frequent adverse reactions of any severity were leukopenia (60 to 91%), thrombocytopenia (22 to 41%), nausea and/or vomiting (31 to 43%), and alopecia (8 to 66%).
Tabulated summary of adverse reactions The following adverse reactions were reported from etoposide clinical studies and post-marketing experience. These adverse reactions presented by system organ class and frequency, which is defined by the following categories: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1, 000, <1/100), rare (≥1/10, 000, <1/1,000), not known (cannot be estimated from the available data).
, somnolence and fatigue), optic neuritis, seizure*** Cardiac disorders common arrythmia, myocardial infarction Vascular disorders common hypertension not known haemorrhage Respiratory, thoracic and mediastinal disorders rare interstitial pneumonitis, pulmonary fibrosis very common abdominal pain, anorexia, constipation, nausea and vomiting common diarrhoea, mucositis (including stomatitis and esophagitis) Gastrointestinal disorders rare dysgeusia, dysphagia very common hepatotoxicity Hepatobiliary disorders not known alanine aminotransferase increased, alkaline phosphatase increased, aspartate amino transferase increased, bilirubin increased very common alopecia, pigmentation common pruritus, rash, urticaria Skin and subcutaneous tissue disorders rare radiation recall dermatitis, Stevens- Johnsons syndrome, toxic epidermal necrolysis Reproductive system and breast disorders not known infertility very common asthenia, malaise General disorders and administration site conditions rare pyrexia *including opportunistic infections like pneumocystis jirovecii pneumonia **Myelosuppression with fatal outcome has been reported ***Seizure is occasionally associated with allergic reactions.
Etoposide should only be administered and monitored under the supervision of a qualified physician experienced in the use of anti-neoplastic medicinal products. In all instances where the use of etoposide is considered for chemotherapy, 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 judgment of the physician.
Reinstitution of etoposide therapy should be carried out with caution, and with adequate consideration of the further need for the drug and close attention to possible recurrence of toxicity. Within-patient variability The available efficacy data for etoposide in the different indications are generally based on studies in which etoposide was used intravenously.
e. between cycles) is larger with oral administration than after intravenous administration. e. 30 to 40%). , leading to greater variability in patients’ sensitivity to experience treatment-related toxicity from cycle to cycle, and potentially affecting overall efficacy of treatment in some patients.
For this reason, it is critical that the advantages of the oral administration route are carefully weighed against the disadvantages of larger within-patient variability in exposure after oral administration. 2). Myelosuppression Dose limiting bone marrow suppression is the most significant toxicity associated with etoposide therapy.
Fatal myelosuppression has been reported following etoposide administration. Patients being treated with etoposide must be observed for myelosuppression carefully and frequently both during and after therapy. The following haematological parameters should be measured at the start of therapy and prior to each subsequent dose of etoposide: platelet count, haemoglobin, white blood cell count and differential.
1. 5). 6)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4). 9). Method of administration Capsules should be taken on an empty stomach.
Description of selected adverse reactions In the paragraphs below the incidences of adverse events, given as the mean percent, are derived from studies that utilized single agent etoposide therapy. 4) with fatal outcome has been reported following administration of etoposide.
Myelosuppression is most often dose-limiting. Bone marrow recovery is usually complete by day 20, and no cumulative toxicity has been reported. Granulocyte and platelet nadirs tend to occur about 10 to 14 days after administration of etoposide depending on the way of administration and treatment scheme.
Nadirs tend to occur earlier with intravenous administration compared to oral administration. Leukopenia and severe leukopenia (less than 1,000 cells/mm3) were observed in 60 to 91% and 3 to 17%, respectively, for etoposide. Thrombocytopenia and severe thrombocytopenia (less than 50,000 platelets/mm3) were seen in 22 to 41% and 1 to 20%, respectively, for etoposide.
Reports of fever and infection were also very common in patients with neutropenia treated with etoposide. Gastrointestinal Toxicity Nausea and vomiting are the major gastrointestinal toxicities of etoposide. The nausea and vomiting can usually be controlled by antiemetic therapy.
Alopecia Reversible alopecia, sometimes progressing to total baldness, was observed in up to 66% of patients treated with etoposide. Hypertension In clinical studies involving etoposide, episodes of hypertension have been reported. If clinically significant hypertension occurs in patients receiving etoposide, appropriate supportive therapy should be initiated.
Hypersensitivity Anaphylactic reactions manifested by chills, fever, tachycardia, bronchospasm, dyspnoea, and hypotension which can be fatal can occur with the initial dose of etoposide. Acute fatal reactions associated with bronchospasm have been reported with etoposide.
Syncope, face oedema, swelling face, tongue oedema and swelling tongue can also occur with etoposide. 4). Etoposide contains sodium ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate Etoposide capsules contain sodium ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).
Paediatric population Safety and effectiveness of etoposide in paediatric patients has not been systematically studied. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
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If radiotherapy or chemotherapy has been given prior to starting etoposide treatment, an adequate interval should be allowed to enable the bone marrow to recover. Etoposide should not be administered to patients with neutrophil counts less than 1,500 cell/mm3 or platelet counts less than 100,000 cells/mm3, unless caused by malignant disease.
Doses subsequent to initial dose should be adjusted if neutrophil count less than 500 cells/mm3 occurs for more than 5 days or is associated with fever or infection, if platelet count less than 25,000 cells/mm3 occurs, if any grade 3 or 4 toxicity develops or if renal clearance is less than 50 ml/min.
Severe myelosuppression with resulting infection or haemorrhage may occur. Bacterial infections should be brought under control before treatment with etoposide. Secondary leukaemia The occurrence of acute leukaemia, which can occur with or without myelodysplastic syndrome, has been described in patients that were treated with etoposide containing chemotherapeutic regimens.
Neither the cumulative risk, nor the predisposing factors related to the development of secondary leukaemia 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 leukaemia in patients who have received epipodophyllotoxins. This abnormality has also been seen in patients developing secondary leukaemia after being treated with chemotherapy regimens not containing epipodophyllotoxins and in leukaemia occurring de novo.
Another characteristic that has been associated with secondary leukaemia in patients who have received epipodophyllotoxins appears to be a short latency period, with average median time to development of leukaemia being approximately 32 months.
Hypersensitivity Physicians should be aware of the possible occurrence of an anaphylactic reaction with etoposide, manifested by chills, pyrexia, tachycardia, bronchospasm, dyspnoea and hypotension, which can be fatal. Treatment is symptomatic.
Etoposide should be terminated immediately, followed by the administration of pressor agents, corticosteroids, antihistamines, or volume expanders at the discretion of the physician. Low serum albumin Low serum albumin is associated with increased exposure to etoposide.
Therefore, patients with low serum albumin may be at increased risk for etoposide-associated toxicities. 2). Haematological parameters should be measured and dose adjustments in subsequent cycles considered based on haematological toxicity and clinical effect in moderate and severe renal impaired patients.
Impaired hepatic function Patients with impaired hepatic function should regularly have their hepatic function monitored due to the risk of accumulation. Tumour lysis syndrome 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.
Mutagenic potential Given the mutagenic […]