4/21/2018 · Storage and Stability: Do not use beyond expiration date on the container. ACTEMRA must be refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect the vials from light by storage in the original package until time of use.
ACTEMRA (IV only) in combination with methotrexate has been shown to reduce the rate of progression of radiographic joint damage at Week 52. ACTEMRA is to be given in combination with methotrexate (MTX) or other DMARDs however, in cases of intolerance to MTX or where treatment with MTX is not appropriate ACTEMRA may also be given as monotherapy.
Allow the fully diluted ACTEMRA solution to reach room temperature prior to infusion. 6. The infusion should be administered over 60 minutes, and must be administered with an infusion set. Do not administer as an intravenous push or bolus. 7. ACTEMRA should not be infused concomitantly in the same intravenous line with other drugs. No physical, Before your IV infusion. Here are some tips for your first IV infusion appointment: Arrive a little bit early to take care of any paperwork. Bring your insurance card or any ACTEMRA co-pay program cards every time you get an IV infusion. Wear comfortable clothing, if possible. Your IV infusion will last about 1 hour.
• It is recommended that ACTEMRA not be initiated in patients with an absolute neutrophil count (ANC) below 2000 per mm. 3, platelet count below 100,000 per mm. 3, or who have ALT or AST above 1.5 times the upper limit of normal (ULN). (2.1, 5. 4 ) • ACTEMRA doses exceeding 800 mg per infusion are not recommended in RA or CRS patients.
HIGHLIGHTS OF PRESCRIBING INFORMATION ACTEMRA. Dose …
ACTEMRA® (tocilizumab) – GlobalRPH, ACTEMRA® (tocilizumab) – GlobalRPH, PRODUCT MONOGRAPH – rochecanada.com, 12/1/2020 · The safety of Actemra-IV was studied in 188 pediatric patients 2 to 17 years of age with PJIA who had an inadequate clinical response or were intolerant to methotrexate. The total patient exposure in the Actemra-IV all exposure population (defined as patients who received at least one dose of Actemra-IV) was 184.4 patient years.
Administer 4 mg/kg intravenously every 4 weeks May increase to 8 mg/kg every 4 weeks based on clinical response, up to a maximum of 800 mg per dose. Polyarticular Juvenile Idiopathic Arthritis Weight ? 30 kg Administer 8 mg/kg intravenously every 4 weeks Weight 4 weeks, • It is recommended that ACTEMRA not be initiated in patients with an absolute neutrophil count (ANC) below 2000 per mm3, platelet count below 100,000 per mm3, or who have ALT or AST above 1.5 times the upper limit of normal (ULN). (2.1, 5. 4 ) • ACTEMRA doses exceeding 800 mg per infusion are not recommended in RA or CRS patients.
The recommended posology in patients above 2 years of age is 8 mg/kg once every 4 weeks in patients weighing greater than or equal to 30 kg or 10 mg/kg once every 4 weeks in patients weighing less than 30 kg. The dose should be calculated based on the patient’s body weight at each administration.
RoActemra is supplied as a sterile liquid concentrate for solution for intravenous ( iv ) infusion available at a concentration of 20 mg/mL. Three presentations of tocilizumab are intended for registration. These are 80 mg, 200 mg and 400 mg and have been selected to provide flexible combinations over the likely body weight range of patients
