Short Bowel Syndrome with intestinal failure (SBS-IF) is defined as the reduction of gut function below the minimum necessary for the absorption of macronutrients and/or water and electrolytes, such that intravenous (IV) supplementation is required to maintain health and/or growth.1
SBS-IF is most commonly caused by congenital diseases including:2-5
What if you could free your paediatric patients with short bowel syndrome-intestinal
failure (SBS-IF) from parenteral nutrition/IV fluids?
It may be possible with Revestive8
Revestive is the first and only long-term therapy indicated for the treatment of patients with SBS-IF.8-11
In children with SBS-IF*, Revestive reduced PN/IV requirements11
At 24 weeks, 69% of patients treated with Revestive at the approved dose (0.05 mg/kg/day) achieved at least a 20% reduction from baseline in weekly PN/IV volume (n=26 patients)1,11
Revestive was well tolerated across multiple clinical trials in adults
and children with short bowel syndrome intestinal
In two completed clinical trials§ in children aged 1–17 years-old with short bowel syndrome-intestinal failure treated with Revestive for up to 6 months:8
No new safety signals seen in long-term pooled paediatric data^ of 89 patients treated with Revestive for 51.7 weeks (median; range 5.0–94.7) and followed up for 83 weeks16
*Revestive was studied in a 12-week, open-label, clinical study in 42 paediatric patients aged 1 year through 14 years with SBS who were dependent on PN/IV. Three (3) doses of Revestive, 0.0125 mg/kg/day (n=8), 0.025 mg/kg/day (n=14), and 0.05 mg/kg/day (n=15), were investigated for 12 weeks. Five (5) patients were enrolled in an SOC cohort. An additional 24-week, randomised, double-blind, multicentre study was conducted in 59 paediatric patients aged 1 year through 17 years who were dependent on PN/IV. Two (2) doses of Revestive were studied: 0.025 mg/kg/day (n=24) and 0.05 mg/ kg/day (n=26); nine (9) patients were enrolled in an SOC arm.
^Safety data of 89 paediatric patients aged 1-17 years-old treated with REVESTIVE from 4 clinical trials were pooled. Data from the completed 12-week and 24-week clinical trials* and interim data from ongoing open-label extension studies to 12-week and 24-week trials were included. The study objective was to assess the safety of REVESTIVE in children with SBS-IF including when used beyond 24-weeks.
Revestive is given by subcutaneous injection once daily.
The recommended dose is 0.05 mg/kg.
Two vial sizes are available:
Vials should be reconstituted with the supplied solvent (0.5 mL).
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.
Revestive should not be administered intravenously or intramuscularly.
If a dose is missed, that dose should be injected as soon as possible on that day.
Dosing table: 1.25 mg vial
|BODY WEIGHT||1.25 mg/0.5 mL
Volume to be injected
|5-6 kg||0.10 ml|
|7-8 kg||0.14 ml|
|9-10 kg||0.18 ml|
|11-12 kg||0.22 ml|
|13-14 kg||0.26 ml|
|15-16 kg||0.30 ml|
|17-18 kg||0.34 ml|
|19-20 kg||0.38 ml|
|>20 kg||Use the 5mg strength vial|
Dosing table: 5.0 mg vial
|BODY WEIGHT||5 mg/0.5 mL
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 “Adults” section|
A treatment period of 6 months is recommended after which treatment effect should be evaluated. In children below the age of two years, treatment should be evaluated after 12 weeks. There are no data available in paediatric patients after 6 months.
*Children with SBS-IF aged 1 – 17 (<18) years, all patients were unable to reduce their PN/IV dependence for at least 3 months prior to study entry.
** Weight normalised reduction.
*** Standard deviation for Revestive: -1.3±2. 6.6 days/week baseline PN/IV requirement for Revestive study population, 6.6 days/week baseline PN/IV requirement for SOC study population.
† Patients treated with Revestive 0.05 mg/kg/day.
‡ Standard deviation for Revestive: -41.6±28.90; SOC: -10.2±13.5926.
§ In a 21-day, Phase II, open-label, multicentre,
dose-ranging study evaluating the safety and effect of Revestive in 17 patients with SBS-IF,
treatment with Revestive at doses from 0.03 to 0.15 mg/kg/day in single or divided doses. 8 of
10 patients with end jejunostomy were biopsied and found to
have increased intestinal villus height and crypt depth, compared with baseline.
GLP-2= glucagon-like peptide-2; SBS-IF= short bowel syndrome – intestinal failure
^^3/26 paediatric patients stable on their PN/IV for at least 3 months at baseline and treated with REVESTIVE completely weaned from PN/IV by Week 24 vs 0/9 patients on SoC 8,11
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