Streptozocin (Specialist drug)

Source: UK SPC (eMC) for Zanosar 1 g, powder for concentrate for solution for infusion, §4.2 (https://www.medicines.org.uk/emc/product/9877/smpc). ⚠ INDICATION SCOPE: §4.1 (Therapeutic indications) was NOT retrieved in this bundle, so the licensed indication is not quoted here and must not be inferred. §4.2 is the SPC's only posology and does not name a tumour type; it refers to 'patients with functional tumours' (serial monitoring of biological markers allows determination of biochemical response) and 'patients with either functional or nonfunctional tumours' (response determined by measurable reductions of tumour size on imaging). The figures above are that single §4.2 regimen — there is no competing indication-specific regimen in this label to confuse it with. Confirm the indication against §4.1 before clinical use. It does not affect the dose above, which is molecule-specific. 'Other dosing regimens, with similar dose intensity, have been used in clinical studies with comparable efficacy and safety results.' SUPERVISION: administer only under the supervision of a physician experienced in the use of anti-cancer chemotherapeutic agents; the patient should have access to a facility with a laboratory and supportive resources sufficient to monitor drug tolerance and to protect and maintain a patient compromised by drug toxicity. 🔴 RENAL DOSE BANDS (§4.2, based on clinical practice — dose reduction or treatment discontinuation is MANDATORY in the presence of significant renal toxicity): eGFR > 60 ml/min → full dose; ≤ 60 and > 45 ml/min → dose reduced by 50%; ≤ 45 and > 30 ml/min → evaluation of the benefit/risk ratio (a thorough multidisciplinary evaluation including a nephrologist's opinion, balancing potential benefit against the known risk of serious renal damage); ≤ 30 ml/min → CONTRAINDICATED. HYDRATION: 'Adequate hydration with at least one litre of sodium chloride 0.9% before the administration of Zanosar may help reduce the risk of toxicity to the renal tubular epithelium.' Do not use concomitantly with other potentially nephrotoxic drugs. HEPATIC IMPAIRMENT: dose reduction should be considered. ELDERLY: safety and efficacy in patients aged ≥ 65 years have not been established; regimen selection should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapies. PAEDIATRIC: safety and efficacy in patients below 18 years have not been established — paedDose is null and no paediatric figure exists in this label; do not scale the adult BSA dose. SOURCE NOTE: §4.4 and §4.8 in this bundle are truncated at the source-fetch limit and §4.5 was not retrieved — verify the full warnings, adverse-reaction and interaction sections before use. §4.2 was retrieved complete and is the basis of every figure above.