Bleomycin

UNITS WARNING (from the SPC): posology for all therapeutic indications is given in International Units (IU), NOT mg. Some hospital protocols state mg — that mg value refers to mg-activity, not mg-dry material. The SPC recommends ignoring posology in mg and prescribing only in IU; 1 mg dry substance is equivalent to at least 1500 IU, but the SPC strongly recommends NOT using this conversion because it may result in overdosage. Bleomycin should only be used under the strictest supervision of a physician specialised in oncolytic medicinal products, preferably in a hospital experienced in such therapies. OTHER INDICATIONS (SPC §4.2): (a) Squamous cell carcinoma — alternatively IV infusion of 10–15 x 10^3 IU/m2/day over 6–24 hours on 4 to 7 consecutive days, at intervals of 3–4 weeks. (b) Hodgkin's disease and non-Hodgkin's lymphoma — when used alone, IM or IV injection of 5–15 x 10^3 IU/m2 once or twice a week, up to a cumulative total of 225 x 10^3 IU; because of the possibility of anaphylactoid reactions, lymphoma patients should be treated with lower doses (for instance 2 x 10^3 IU) for the first two applications, and if there are no acute reactions after 4 hours of observation the normal dose schedule can be followed. (c) Testicular tumours — IM or IV injection of 10–15 x 10^3 IU/m2 once or twice a week at intervals of 3–4 weeks up to a total cumulative dose of 400 x 10^3 IU; or IV infusion of 10–15 x 10^3 IU/m2/day over 6–24 hours on 5–6 consecutive days, at intervals of 3–4 weeks. (d) Malignant pleural effusion — 60 x 10^3 IU in 100 ml physiological saline intrapleurally as a single dose, repeatable after 2–4 weeks depending on response; approximately 45% is absorbed and this must be counted towards the lifetime cumulative dose. The development of stomatitis is the most useful guide to individual tolerance with respect to the maximum dose. ELDERLY (from the age of 60) — total dose must be reduced per the SPC table: 80 years and over, total 100 x 10^3 IU, 15 x 10^3 IU per week; 70–79 years, total 150–200 x 10^3 IU, 30 x 10^3 IU per week; 60–69 years, total 200–300 x 10^3 IU, 30–60 x 10^3 IU per week; under 60, total 400 x 10^3 IU, 30–60 x 10^3 IU per week. PAEDIATRIC — there is insufficient experience; bleomycin should only be administered in children in exceptional circumstances and at special facilities. If indicated as part of a combination regimen the dosage is usually calculated on body surface area and adjusted to the individual patient; current specialised protocols and guidelines should be consulted. No numeric paediatric per-kg dose is given in the source. COMBINATION THERAPY — the dose may require adjustment; reduce the bleomycin dose in conjunction with radiotherapy since the risk of mucosal damage is increased. PREPARATION — dissolve the entire contents of a vial (15000 IU) in the appropriate quantity of solvent and withdraw the required units from that solution: IM, 1–5 ml physiological saline solution (rotate injection sites; 1.5–2 ml lidocaine HCl 1% may be added to the injection solution for excessive local discomfort); IV injection, 5–10 ml physiological saline; IV infusion, 200–1,000 ml physiological saline; intra-arterial injection, at least 5 ml physiological saline given over 5–10 minutes.