Product Dossier
VEPESID
Product Dossier for VEPESID (etoposide, Link Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Link Pharmaceuticals
- Active ingredient: etoposide
- Therapeutic area: Oncology
- Related brand: ETOPOPHOS
- Same area: TALZENNA
- Same area: ZARZIO
What it is
VEPESID is an oral capsule formulation of etoposide, available in 50 mg and 100 mg strengths. The capsules are opaque and pink soft gelatin formulations. Etoposide is a semisynthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases.
Approved indications —
Small cell carcinoma of the lung. — Acute monocytic and myelomonocytic leukaemia. — Hodgkin's disease. — Non-Hodgkin's lymphoma.
Dosing overview
The suggested starting dose is approximately 100–200 mg/m² per day on days 1 to 5, with total dose not exceeding 650 mg/m² per course. Capsules should be taken on an empty stomach. For patients with impaired renal function and measured creatinine clearance of 15–50 mL/min, a dose of 75 per cent is recommended, while patients with creatinine clearance above 50 mL/min receive 100 per cent of the standard dose.
Key safety warnings
Severe myelosuppression with resulting infection or bleeding may occur, and fatal myelosuppression has been reported following etoposide administration. Dose-limiting bone marrow suppression is the most significant toxicity associated with VEPESID therapy. Patients being treated with VEPESID must be observed carefully and frequently both during and after therapy, with platelet count, haemoglobin, white blood cell count and differential obtained at the start of therapy and prior to each subsequent course. The occurrence of acute leukaemia with or without a myelodysplastic syndrome has been described 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 leukaemia are known, and the roles of administration schedules and cumulative doses of etoposide have been suggested but have not been clearly defined. Anaphylactic reactions manifested by chills, fever, tachycardia, bronchospasm, dyspnoea and hypotension can be fatal. Administration of VEPESID should be terminated immediately, followed by administration of pressor agents, corticosteroids, antihistamines, or volume expanders at the discretion of the physician. 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, especially in those with bulky treatment-sensitive tumours and renal insufficiency, with appropriate preventive measures considered in at-risk patients.
Contraindications
Patients with severe hepatic dysfunction. Patients with severely impaired renal function (creatinine clearance less than 15 mL/min). Patients who have demonstrated hypersensitivity to etoposide, etoposide phosphate, or any of the ingredients. Severe bone marrow failure (WBC less than 2000 cells/mm³ or platelet count less than 75,000 cells/mm³) not due to malignant disease.
PBS listing
The 50 mg capsule is listed on the PBS with an ex-manufacturer price of A$391.11, and the 100 mg capsule is listed with an ex-manufacturer price of A$340.69, with both items having unrestricted access as of May 2026.
Regulatory history
VEPESID 50 mg and 100 mg capsule formulations were first registered on the ARTG on 12 July 1991.