Actemra, 20mg/ml (80mg/4ml) 4ml

Rheumatoid arthritisRheumatoid arthritis with moderate to high levels of activity in adults, either as monotherapy or in combination with methotrexate (MT) and/or other basal anti-inflammatory drugs (BART).

Active ingredient

Composition

How to take, the dosage

Standard dosing

Intravenously by IV drip at a dose of 8 mg/kg for at least 1 hour, once every 4 weeks.

Aktemra® is diluted to 100 ml with sterile 0.9% sodium chloride solution under aseptic conditions.

Preparing the solution

1. Calculate the amount of the drug required to administer to the patient (at the rate of 0.4 ml/kg).

2: From the infusion bottle (bag) containing 100 ml of 0.9% sodium chloride solution (the solution must be sterile and apyrogenic), under aseptic conditions, draw a single-use sterile syringe with 0.9% sodium chloride solution equal to the calculated amount of Actemra® medicine to be injected.

3. With another disposable sterile syringe, under aseptic conditions, take the calculated amount of the drug from the Actemra® bottle and inject it into the infusion bottle (bag) with 0.9% sodium chloride solution; the resulting volume of the prepared solution should be equal to 100 ml.

4. Gently invert the bottle (bag) to mix to avoid foaming.

5. Before administering, the resulting solution should be inspected to ensure that there are no foreign particles or discoloration.

Only clear or opalescent, colorless or light yellow solutions without visible debris should be administered.

Storage rules for the solution

The prepared Actemra® infusion solution is physically and chemically stable in 0.9% sodium chloride solution for 24 hours at 30 °C.

From a microbiological point of view, the prepared solution should be used immediately.

If the product is not used immediately, the time and conditions of storage of the prepared solution are the responsibility of the user and should not exceed 24 h at 2-8 °C and only if the solution was prepared under controlled and validated aseptic conditions.

Dose adjustments for changes in laboratory values (see side effects section) are presented in Tables 1-3.

Table 1

Dose adjustment for increased liver enzyme activity

Table 2

Dose correction for low absolute neutrophil count (ALN)

Table 3

Dose adjustment for low platelet count

sup>3/μl) Treatment correction 50-100 Interrupt treatment with Actemra® . If it increases to >100-103/μL, resume treatment with the drug at a dose of 4 mg/kg and increase the dose to 8 mg/kg as clinically necessary <50 Discontinue treatment with Actemra®

Dosing in Special Cases

Children: The safety and effectiveness of tocilizumab in children have not been established.

Elderly patients: No dose adjustment is required in elderly patients (≥65 years).

Patients with renal impairment: Dose adjustment in patients with mild renal impairment is not required. The use of tocilizumab in patients with moderate to severe renal impairment has not been studied.

Patients with hepatic impairment: The safety and efficacy of tocilizumab in patients with hepatic impairment have not been studied.

Interaction

Special Instructions

Contraindications

Side effects

Overdose

Pregnancy use