Loading…
REVESTIVE is a brand name for Teduglutide, supplied as a kit. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
, Dosing Considerations, Patients with Renal Impairment; 10 CLINICAL PHARMACOLOGY, Pharmacokinetics, Renal Insufficiency). No pediatric patients with renal insufficiency were included in trials. Population pharmacokinetic modelling suggests response in pediatric patients with renal insufficiency would be consistent with that of adults with renal insufficiency.
1 Pregnancy There are no data from the use of REVESTIVE in pregnant women. 05 mg/kg). 05 mg/kg). Because animal reproductive studies are not always predictive of human response, REVESTIVE should be used during pregnancy only if clearly needed.
2 Breastfeeding It is not known whether teduglutide is present in human milk. 05 mg/kg). Because of the potential for serious adverse reactions to nursing infants from REVESTIVE and because of the potential for tumorigenicity shown for teduglutide in mice and rats, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
3 Pediatrics Safety and efficacy in pediatric patients under 1 year of age have not been established. The safety and efficacy of REVESTIVE in the treatment of SBS have been established in pediatric patients 1 through 17 years of age.
Use in this population is supported by adequate and well controlled studies in adults, as well as safety, pharmacokinetic and pharmacodynamic data from 2 studies in pediatric patients up to 24 weeks duration. These studies included 87 pediatric patients treated with REVESTIVE in the following groups: 5 infants (1 year to less than 2 years), 75 children (2 years to less than 12 years) and 7 adolescents (12 years to less than 18 years).
05 mg/kg daily. In these 2 studies and the corresponding open-label extension studies, 89 pediatric patients were administered REVESTIVE prospectively for up to 69 weeks. 0%) patients. Adverse reactions observed in these studies were similar in pediatric patients who received REVESTIVE to those seen in the adult population (see 8 ADVERSE REACTIONS, Clinical Trial Adverse Reactions -Pediatrics).
4 Geriatrics Of the 595 subjects treated with REVESTIVE in clinical studies, 43 subjects were 65 years or older, whereas 6 subjects were 75 years of age or older. No clinically significant differences were observed between subjects younger than 65 years and those older than 65 years.
1 Adverse Reaction Overview Across all clinical studies in adults, 595 subjects were exposed to at least one dose of REVESTIVE (249 patient-years of exposure; mean duration of exposure was 22 weeks). 10 mg/kg/day). 9%). In the core pediatric studies, 87 patients aged 1-17 years were exposed to teduglutide.
05 mg/kg/day. 0% experienced drug-related adverse reactions. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. Therefore, the frequencies of adverse reactions observed in the clinical trials may not reflect frequencies observed in clinical practice and should not be compared to frequencies reported in clinical trials of another drug.
, Clinical Trial Adverse Reactions -Pediatrics). 4 Geriatrics Of the 595 subjects treated with REVESTIVE in clinical studies, 43 subjects were 65 years or older, whereas 6 subjects were 75 years of age or older. No clinically significant differences were observed between subjects younger than 65 years and those older than 65 years.
1 Adverse Reaction Overview Across all clinical studies in adults, 595 subjects were exposed to at least one dose of REVESTIVE (249 patient-years of exposure; mean duration of exposure was 22 weeks). 10 mg/kg/day). 9%). In the core pediatric studies, 87 patients aged 1-17 years were exposed to teduglutide.
05 mg/kg/day. 0% experienced drug-related adverse reactions. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. Therefore, the frequencies of adverse reactions observed in the clinical trials may not reflect frequencies observed in clinical practice and should not be compared to frequencies reported in clinical trials of another drug.
The rates of adverse reactions in adult patients with SBS participating in 2 randomized, placebo controlled, 24-week, double-blind clinical studies (Studies CL0600-020 and CL0600 004) are summarized in Table 4. Only those reactions with a rate of at least 5% in the REVESTIVE group and occurring greater than in the placebo group are summarized.
The majority of these reactions were mild or moderate. 1% (n=49/59) for placebo. Many of these adverse reactions have been reported in association with the underlying disease and/or parenteral nutrition. 05 mg/kg/day of REVESTIVE for up to 42 months in long-term open-label extension studies.
Adverse Reactions of Special Interests Concomitant Oral Medication:
REVESTIVE can increase the absorption of concomitant oral medications such as benzodiazepines and psychotropic agents. 05 mg/kg/day group (on prazepam) experienced dramatic deterioration in mental status progressing to coma during her first week of REVESTIVE therapy.
, Monitoring and Laboratory Tests) prior to starting treatment with REVESTIVE. 1 Pediatrics Pediatrics (≥1 year of age to <18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of REVESTIVE in pediatric patients has been established; therefore, Health Canada has authorized an indication for pediatric use (see 14 CLINICAL TRIALS).
If no overall improvement is achieved after 6 months, the need for continued treatment should be assessed. 2 Geriatrics Geriatrics (>65 years of age): Evidence from clinical studies and experience suggests that no clinically significant differences in safety and efficacy were observed between subjects younger than 65 years and those older than 65 years.
Experience in subjects 75 years and older is limited. 2 Contraindications REVESTIVE is contraindicated in patients who: • are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING, • have active gastrointestinal (GI) malignancy (GI tract, hepatobiliary, pancreatic), • have a history of malignancies in the gastrointestinal tract and/or the hepatobiliary system including pancreas within the last 5 years.
1 Dosing Considerations Geriatrics (>65 years of age) Evidence from clinical studies and post-marketing experience suggest that no dose adjustment is necessary in patients above the age of 65 years. Patients with Renal Impairment Reduce the dose by 50% in adult patients with moderate and severe renal impairment (creatinine clearance less than 50 mL/min), and end-stage renal disease.
No dose adjustment is necessary for patients with mild renal impairment. No pediatric patients with renal insufficiency were included in trials. Population pharmacokinetic modelling suggests response in pediatric patients with renal insufficiency would be consistent with that of adults with renal insufficiency.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
The rates of adverse reactions in adult patients with SBS participating in 2 randomized, placebo controlled, 24-week, double-blind clinical studies (Studies CL0600-020 and CL0600 004) are summarized in Table 4. Only those reactions with a rate of at least 5% in the REVESTIVE group and occurring greater than in the placebo group are summarized.
The majority of these reactions were mild or moderate. 1% (n=49/59) for placebo. Many of these adverse reactions have been reported in association with the underlying disease and/or parenteral nutrition. 05 mg/kg/day (N=77) n (%) Placebo (N=59) n (%) Gastrointestinal Disorders Abdominal Pain 29 (38) 16 (27) Nausea 19 (25) 12 (20) Abdominal […]
She was admitted to the Intensive Care Unit where her benzodiazepine level was >300 mcg/L. REVESTIVE and prazepam were discontinued, and the coma resolved 5 days later. In the pediatric clinical studies (up to 69 weeks of exposure), there were no adverse events associated with increased absorption of oral medications.
05 mg/kg/day. 6%), 1 of whom was reported as a serious adverse event and the other as non-serious. The serious case had onset at 6 months, and was REVESTIVE® (teduglutide for injection) Page 16 of 47 possibly associated with previously undiagnosed hypothyroidism and/or cardiac dysfunction.
025 mg/kg/day group. 05 mg/kg/day dose group. No cases were reported in the placebo group. One of these 3 cases had gallbladder perforation and underwent cholecystectomy the next day. The remaining 2 cases underwent elective cholecystectomy at a later date.
In the adult extension studies, 4 subjects had an episode of acute cholecystitis; 4 subjects had new-onset cholelithiasis; and 1 subject experienced cholestasis secondary to an obstructed biliary stent. For pancreatic disease in […]
Patients with Hepatic Impairment No dosage adjustment is necessary for patients with mild and moderate hepatic impairment based on a study conducted in Child-Pugh grade B subjects. REVESTIVE has not been studied in subjects with severe hepatic impairment.
There are no data available from pediatric patients with active, severe, or unstable hepatic impairment. 05 mg/kg body weight administered by subcutaneous injection once daily. Alternation of sites for subcutaneous injection is recommended, and can include the thighs, upper arms, and the abdomen.
REVESTIVE should not be administered intravenously or intramuscularly. REVESTIVE should not be administered to pediatric patients weighing less than 10 kg. 5 mL of preservative-free Sterile Water for Injection provided in the pre-filled syringe.
Allow the vial containing REVESTIVE and water to stand for approximately 30 seconds and then gently roll the vial between your palms for about 15 seconds. Do not shake the vial. Allow the mixed contents to stand for about 2 minutes. Inspect the vial for any undissolved powder.
If undissolved powder is observed, gently roll the vial again until all material is dissolved. Do not shake the vial. The solution should be clear and colorless to light straw colored and free from visible particles. Do not use if the product remains undissolved or is discolored.
REVESTIVE® (teduglutide for injection) Page 6 of 47 Once the drug is completely dissolved, remove the empty syringe and replace with an injection syringe. 02 mL or lower). If two vials are needed, the procedure for the second vial must be repeated and the additional solution withdrawn into the injection syringe containing the solution from the first vial.
Any volume exceeding the prescribed dose in mL must be expelled and discarded. 8 mg teduglutide can be withdrawn) Vials of REVESTIVE and pre-filled syringes of Sterile Water for Injection do not contain any preservatives and are for single-use only.
After reconstitution, the solution should be used immediately. Microbial, chemical and physical stability have been demonstrated for up to 3 hours when stored below 25ºC after reconstitution. Any unused product or waste material should be disposed of in accordance with local requirements.
In the absence of compatibility studies, REVESTIVE should not be mixed with other medicinal products. 4 Administration Each single-use vial of REVESTIVE contains 5 mg of teduglutide as a white lyophilized powder for solution for subcutaneous injection.
5 mL of Sterile Water for Injection, which is provided in a pre-filled syringe. A 10 mg/mL sterile solution is obtained after reconstitution (see Reconstitution below). The prepared solution must be injected subcutaneously into a cleaned area on the abdomen, upper arm, or thigh using a thin needle for subcutaneous injection.
Detailed instructions on the preparation and injection of REVESTIVE are provided in the Patient Medication Information. 05 mg/kg/day. The physician should at each visit weigh the patient, determine the daily dose to be administered until next visit and inform the patient accordingly.
The injection volume per […]