Factor VIII (Specialist drug)

TREATMENT SETTING, verbatim: 'Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia and with resuscitation support immediately available in case of anaphylaxis.' The dose and duration of substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding, and on the patient's clinical condition; the amount and frequency 'should always be oriented to the clinical effectiveness in the individual case', and under certain circumstances such as a low-titre inhibitor, doses larger than those calculated by the formula may be necessary. Dose based on bodyweight may require adjustment in underweight or overweight patients. || TARGET FACTOR VIII LEVELS AND INTERVALS — the label's Table 1, reproduced in full because the formula above is unusable without it. The factor VIII activity should not fall below the given plasma activity level (in % of normal or IU/dl) for the corresponding period. HAEMORRHAGE. Early haemarthrosis, muscle bleeding or oral bleeding: 20-40% (IU/dl); repeat injections every 12 to 24 hours (8 to 24 hours for patients under the age of 6) for at least 1 day, until the bleeding episode, as indicated by pain, is resolved or healing is achieved. More extensive haemarthrosis, muscle bleeding or haematoma: 30-60%; every 12 to 24 hours (8 to 24 hours for patients under 6) for 3-4 days or more until pain and acute disability are resolved. Life-threatening haemorrhages: 60-100%; every 8 to 24 hours (6 to 12 hours for patients under 6) until the threat is resolved. SURGERY. Minor, including tooth extraction: 30-60%; every 24 hours (12 to 24 hours for patients under 6), at least 1 day, until healing is achieved. Major: 80-100% pre- and post-operative; every 8 to 24 hours (6 to 24 hours for patients under 6) until adequate wound healing, then continue therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dl). || PROPHYLAXIS, verbatim: 'For long-term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses are 20 to 40 IU of factor VIII per kg body weight at intervals of 2 to 3 days. In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary.' Because the label expressly permits higher doses, no maximum dose is stated on this card — the 40 IU/kg upper figure is the usual upper end of prophylaxis, not a ceiling. || PAEDIATRIC, verbatim: 'For on demand treatment dosing in paediatric patients (0 to 18 years of age) does not differ from adult patients. In patients under the age of 6, doses of 20 to 50 IU of factor VIII per kg body weight 3 to 4 times weekly are recommended for prophylactic therapy.' paedDose is left null rather than reduced to a single per-kg number: on-demand paediatric dosing is the adult formula (weight x desired rise x 0.5), not a flat multiply-by-weight figure, and the under-6 prophylaxis figure is a 20-50 IU/kg range that no simple weight calculator can represent without the prescriber choosing a point in it. || UNITS: the number of units of factor VIII administered is expressed in International Units (IU), related to the current WHO concentrate standard for factor VIII products. One IU of factor VIII activity is equivalent to that quantity of factor VIII in one ml of normal human plasma. Plasma factor VIII activity is expressed either as a percentage of normal plasma or, preferably, in International Units. || The bundle then held only the SPC for 'FEIBA 100 u/ml powder and solvent for solution for infusion', an anti-inhibitor coagulant complex — a factor VIII inhibitor BYPASSING agent dosed in FEIBA units, not factor VIII concentrate. Its 50-100 U/kg regimens and its 200 U/kg daily maximum have been removed from this draft entirely and must never appear on a factor VIII page. The bundle now holds ADVATE, a recombinant human coagulation factor VIII and the first brand listed on this page, so the mismatch is resolved rather than merely re-described.