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Actemra IV

Actemra IV Dosage/Direction for Use

tocilizumab

Manufacturer:

Roche

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
General: Substitution by any other biological medicinal product requires the consent of the prescribing physician.
For adult patients with RA, tocilizumab may be administered as an IV infusion.
For patients with pJIA, tocilizumab is administered as an IV infusion.
For patients with sJIA, tocilizumab is administered as an IV infusion.
For adult patients with COVID-19, tocilizumab is administered as an IV infusion.
Tocilizumab IV formulation is not intended for subcutaneous administration.
Tocilizumab IV formulation should be diluted by a healthcare professional with sterile 0.9% w/v sodium chloride solution using aseptic technique (see Special Instructions for Use, Handling and Disposal under Cautions for Usage). The recommended duration of IV infusion is 1 hour.
Rheumatoid Arthritis: The recommended dose of tocilizumab for adult patients is 8 mg/kg given once every four weeks as an IV infusion. Tocilizumab can be used alone or in combination with MTX and/or other DMARDs.
For individuals whose body weight is more than 100 kilograms (kg), doses exceeding 800 mg per infusion are not recommended (see Pharmacology: Pharmacokinetics under Actions).
Dose Modification Recommendations for RA: (see General under Precautions.) (See Table 13.)

Click on icon to see table/diagram/image

COVID-19: The recommended dose of tocilizumab for treatment of adult patients with COVID-19 is a single 60-minute infusion of 8 mg/kg in patients who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.
If clinical signs or symptoms worsen or do not improve after the first dose, one additional infusion of tocilizumab 8 mg/kg may be administered at least 8 hours after the initial infusion.
For individuals whose body weight is more than 100 kg, doses exceeding 800 mg per infusion are not recommended.
Administration of Actemra is not recommended in patients with COVID-19 who have any of the following laboratory abnormalities: (See Tables 14.)

Click on icon to see table/diagram/image

Polyarticular Juvenile Idiopathic Arthritis (pJIA): A change in dose should only be based on a consistent change in the patient's body weight over time. Tocilizumab can be used alone or in combination with MTX.
The recommended dose of IV tocilizumab for patients with pJIA is: 10 mg/kg for patients below 30 kg, 8 mg/kg for patients ≥ 30 kg, given once every four weeks as an IV infusion.
Systemic Juvenile Idiopathic Arthritis (sJIA): A change in dose should only be based on a consistent change in the patient's body weight over time. Tocilizumab can be used alone or in combination with MTX.
The recommended dose of IV tocilizumab for patients with sJIA is: 12 mg/kg for patients below 30 kg, 8 mg/kg for patients ≥ 30 kg, given once every two weeks as an IV infusion.
Dose Modification Recommendations for pJIA and sJIA: Dose reduction of tocilizumab has not been studied in the pJIA or sJIA population. Dose interruptions of tocilizumab for laboratory abnormalities are recommended in patients with pJIA or sJIA and are similar to what is outlined previously for patients with RA (also see General under Precautions). If appropriate, concomitant methotrexate and/or other medications should be dose modified or stopped and tocilizumab dosing interrupted until the clinical situation has been evaluated. In pJIA or sJIA, the decision to discontinue tocilizumab for a laboratory abnormality should be based upon the medical assessment of the individual patient.
Special Dosage Instructions: Pediatric use: The safety and efficacy in patients aged less than 2 years in pJIA has not been established. The safety and efficacy in patients aged less than 2 years with IV tocilizumab in sJIA have not been established.
Geriatric use: No dose adjustment is required in elderly patients > 65 years of age.
Renal impairment: No dose adjustment is required in patients with mild or moderate renal impairment (see Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions). Tocilizumab has not been studied in patients with severe renal impairment.
Hepatic impairment: The safety and efficacy of tocilizumab has not been studied in patients with hepatic impairment (see General under Precautions).
Route of Administration: Intravenous (IV) infusion.
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