Factor XIII (Specialist drug)

VERBATIM UK SPC §4.2 (Fibrogammin 250/1250 IU, powder and solvent for solution for injection or infusion): 'Important: The amount to be administered and the frequency of administration should always be orientated towards clinical efficacy in the individual case. Dosage The dosing regimen should be individualised based on body weight, laboratory values, and the patient's clinical condition. Routine prophylaxis dosing schedule for treatment of congenital FXIII deficiency Initial dose 40 International Units (IU) per kg body weight The injection rate should not exceed 4 ml per minute. Subsequent dosing Dosing should be guided by the most recent trough FXIII activity level, with dosing every 28 days (4 weeks) to maintain a trough FXIII activity level of approximately 5 to 20%. Recommended dosing adjustments of ± 5 IU per kg should be based on trough FXIII activity levels as shown in Table 1 and the patient's clinical condition.' TABLE 1 (Berichrom assay), VERBATIM: 'One trough level of <5% Increase by 5 units per kg Trough level of 5% to 20% No change Two trough levels of >20% Decrease by 5 units per kg One trough level of >25% Decrease by 5 units per kg'. SURGERY, VERBATIM: 'Between 21 and 28 days later - administer the patient's full prophylaxis dose immediately prior to surgery and the next prophylactic dose should be given 28 days later. Between 8 and 21 days later - an additional dose (full or partial) may be administered prior to surgery.' 'Within 7 days of last dose - additional dosing may not be needed.' 'In the case of major surgery and severe haemorrhage, the aim is to obtain values within the normal range for healthy people, i.e. 0.7 -1.4 IU/ml.' VOLUME, VERBATIM: '1 ml is equivalent to 62.5 IU, and 100 IU are equivalent to 1.6 ml'; §2: each vial contains nominally 250 or 1250 IU. The SPC prints no numeric on-demand dose for treating an acute bleed (only the surgery/major-haemorrhage target above) and no maximum dose, so none is given. Elderly, VERBATIM: 'The posology and method of administration in elderly people (> 65 years) has not been established in clinical studies.' Paediatric, VERBATIM: 'The posology and method of administration in children and adolescents is based on body weight and is therefore generally based on the same guidelines as for adults.' - no separate paediatric figure is printed, so none is given.