Dosing and Administration
Dosing and administration1
Revestive is given by subcutaneous injection once daily.
The recommended dose is 0.05 mg/kg.
Two vial sizes are available:
- 5.0 mg per vial
- 1.25 mg per vial (an option for children who weigh less than 20 kg)
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.
Adults1
Dosing table: 5.0 mg vial
| BODY WEIGHT | |
|---|---|
| 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 |
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.
Children1
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 | 1.25 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.
Instructions for Use (IFU) videos
References
- Revestive (teduglutide) Summary of Product Characteristics. Shire Pharmaceuticals Ireland Limited, Dublin, Ireland. November 2017.