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For adult patients with RA, tocilizumab may be administered as an IV infusion or a SC injection.
For adult patients with GCA, tocilizumab is administered as a SC injection.
For patients with pJIA, tocilizumab is administered as an IV infusion or a SC injection.
For patients with sJIA, tocilizumab is administered as an IV infusion or a SC injection.
Intravenous Administration: 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.
Subcutaneous Administration: Tocilizumab SC formulation is not intended for intravenous administration.
Tocilizumab SC formulation is administered with a single-use PFS+NSD. The first injection should be performed under the supervision of a qualified health care professional. A patient can self-inject ACTEMRA only if the physician determines that it is appropriate and the patient agrees to medical follow-up as necessary and has been trained in proper injection technique. The recommended injection sites (abdomen, thigh and upper arm) should be rotated and injections should never be given into moles, scars, or areas where the skin is tender, bruised, red, hard, or not intact.
Patients who transition from tocilizumab IV therapy to SC administration should administer the first SC dose at the time of the next scheduled IV dose under the supervision of a qualified health care professional.
Assess suitability of patient or parent/guardian for SC home administration and instruct the patient or parent/guardian to inform a healthcare professional before administering the next dose, if any symptoms of allergic reaction are experienced. Patients should seek immediate medical attention if they develop symptoms of serious allergic reactions (see General under Precautions and Adverse Reactions).
Rheumatoid Arthritis [IV and SC formulations]: Intravenous Dosing Regimen: 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).
Subcutaneous Dosing Regimen: The recommended dose of tocilizumab for adult patients is 162 mg given once every week as a subcutaneous injection. Tocilizumab can be used alone or in combination with MTX and/or other DMARDs.
Giant Cell Arteritis (GCA) [SC formulation only]: The recommended dose of tocilizumab for adult patients with GCA is 162 mg given once every week as a subcutaneous injection, in combination with a tapering course of glucocorticoids. Tocilizumab can be used alone following discontinuation of glucocorticoids.
In the event of patients experiencing a relapse of GCA during the course of tocilizumab therapy, the treating physician should consider re-introducing and/or escalating the dose of concomitant glucocorticoids (or restarting glucocorticoid therapy if it has been discontinued) according to best medical judgement/treatment guidelines.
Dose Modification Recommendations for RA and GCA: (see General under Precautions). (See Tables 15, 16 and 17.)
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Click on icon to see table/diagram/image
Click on icon to see table/diagram/imagePolyarticular Juvenile Idiopathic Arthritis (pJIA) [IV and SC formulations]: 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.
Intravenous Dosing Regimen: 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.
Subcutaneous Dosing Regimen: The recommended dose of SC tocilizumab for patients with pJIA is: 162 mg once every three weeks for patients below 30 kg, 162 mg once every two weeks for patients ≥ 30 kg.
The PFS+NSD can be used to treat paediatric patients of all approved ages.
Systemic Juvenile Idiopathic Arthritis (sJIA) [IV and SC formulations]: 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.
Intravenous Dosing Regimen: 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.
Subcutaneous Dosing Regimen: The recommended dose of SC tocilizumab for patients with sJIA is: 162 mg once every two weeks for patients below 30 kg, 162 mg once every week for patients ≥ 30 kg; Patients between 1 year and 2 years of age must have a minimum body weight of 10 kg when receiving 162 mg SC tocilizumab.
The PFS+NSD can be used to treat paediatric patients of all ages.
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 as previously mentioned for patients with RA and GCA (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 TCZ in sJIA or less than 1 year with SC TCZ 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).
