Posology : מינונים

4.2     Posology and method of administration

Treatment should be initiated under the supervision of a medical professional with experience in the treatment of Short Bowel Syndrome (SBS).

Treatment should not be initiated until it is reasonable to assume that a patient is stable following a period of intestinal adaptation. Optimisation and stabilisation of intravenous fluid and nutrition support should be performed before initiation of treatment.

Clinical assessment by the physician should consider individual treatment objectives and patient preferences. Treatment should be stopped if no overall improvement of the patient condition is achieved. Efficacy and safety in all patients should be closely monitored on an ongoing basis according to clinical treatment guidelines.

Posology
Adults
The recommended dose of Gattex is 0.05 mg/kg body weight once daily. The injection volume per body weight is provided below in Table 1. Due to the heterogeneity of the SBS population, a carefully monitored down-titration of the daily dose may be considered for some patients to optimise tolerability of the treatment. If a dose is missed, that dose should be injected as soon as possible on that day.
Treatment effect should be evaluated after 6 months. Limited data from clinical studies have shown that some patients may take longer to respond to treatment (i.e., those who still have presence of colon-in-continuity or distal/terminal ileum); if no overall improvement is achieved after 12 months, the need for continued treatment should be reconsidered.

Continued treatment is recommended for patients who have weaned off parenteral nutrition.

Table 1
Body weight                   Volume to be injected
38-41 kg                          0.20 ml
42-45 kg                          0.22 ml
46-49 kg                          0.24 ml
50-53 kg                          0.26 ml
54-57 kg                          0.28 ml
58-61 kg                          0.30 ml
62-65 kg                          0.32 ml
66-69 kg                          0.34 ml
70-73 kg                          0.36 ml
74-77 kg                          0.38 ml
78-81 kg                          0.40 ml
82-85 kg                          0.42 ml
86-89 kg                          0.44 ml
90-93 kg                          0.46 ml
Paediatric population (≥1 year)
Treatment should be initiated under the supervision of a medical professional with experience in the treatment of paediatric SBS.

The recommended dose of Gattex in children and adolescents (aged 1 to 17 years) is the same as for adults (0.05 mg/kg body weight once daily). The injection volume per body weight is provided in Table 2 below.

If a dose is missed, that dose should be injected as soon as possible on that day. A treatment period of 12 weeks is recommended after which treatment effect should be evaluated. There are no data available in paediatric patients after 12 weeks.

Table 2
Body weight                   Volume to be injected
10-11 kg                           0.05 ml
12-13 kg                           0.06 ml
14-17 kg                           0.08 ml
18-21 kg                           0.10 ml
22-25 kg                           0.12 ml
26-29 kg                           0.14 ml
30-33 kg                           0.16 ml
34-37 kg                           0.18 ml
38-41 kg                          0.20 ml
42-45 kg                          0.22 ml
46-49 kg                          0.24 ml
≥50 kg             See Table 1 under “Adults” section.
Special populations
Elderly
No dose adjustment is necessary in patients above the age of 65 years.

Renal impairment
No dose adjustment is necessary for adult or paediatric patients with mild renal impairment. In adult or paediatric patients with moderate and severe renal impairment (creatinine clearance less than 50 ml/min), and end-stage renal disease, the daily dose should be reduced by 50% (see section 5.2).

Hepatic impairment
No dose adjustment is necessary for patients with mild and moderate hepatic impairment based on a study conducted in Child-Pugh grade B subjects. Gattex has not been studied in patients with severe hepatic impairment (see sections 4.4 and 5.2).

Paediatric population
The safety and efficacy of Gattex in children below 1 year of age have not been established. No data are available.

Method of administration
The reconstituted solution should be administered by subcutaneous injection once daily, alternating sites between 1 of the 4 quadrants of the abdomen. In case the injection into the abdomen is hampered by pain, scarring or hardening of the tissue, the thigh can also be used. Gattex should not be administered intravenously or intramuscularly.

For instructions on reconstitution of the medicinal product before administration, see section 6.6.