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Tocilizumab Dosage

Medically reviewed by Drugs.com. Last updated on Jul 10, 2019.

Applies to the following strengths: 20 mg/mL; 162 mg/0.9 mL

Usual Adult Dose for Rheumatoid Arthritis

IV:
4 mg/kg IV as a 60-minute single drip infusion once every 4 weeks, followed by an increase to 8 mg/kg IV given once every 4 weeks as a 60-minute single drip infusion based on clinical response
Dose adjustment: Reduction from 8 mg/kg to 4 mg/kg is recommended for management of certain dose-related laboratory changes including elevated liver enzymes, neutropenia, and thrombocytopenia.
Maximum dose: 800 mg per infusion

Subcutaneous:
-Patients less than 100 kg: 162 mg subcutaneously every other week, followed by an increase to every week based on clinical response
-Patients 100 kg or greater: 162 mg subcutaneously every week
-Interruption of dose or reduction in frequency of administration from every week to every other week is recommended for certain dose-related laboratory changes (e.g., elevated liver enzymes, neutropenia, thrombocytopenia).

Comments:
-This drug may be used as monotherapy or with methotrexate or other non-biologic DMARDs.
-When transitioning from IV to subcutaneous, give the first subcutaneous dose instead of the next IV dose.

Use: For adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs)

Usual Adult Dose for Giant Cell Arteritis

162 mg subcutaneously once a week in combination with a tapering course of glucocorticoids; 162 mg subcutaneously every other week in combination with a tapering course of glucocorticoids may be appropriate based on clinical considerations

Comments:
-This drug may be used alone following discontinuation of glucocorticoids.

Use: For giant cell arteritis (GCA)

Usual Adult Dose for Cytokine-Associated Toxicity

-Weight less than 30 kg: 12 mg/kg IV over 60 minutes
-Weight 30 kg or above: 8 mg/kg IV over 60 minutes
-If no clinical improvement in CRS occurs after the first dose, up to 3 additional doses may be administered. The interval between consecutive doses should be at least 8 hours.
-Maximum dose: 800 mg per infusion

Comments:
-This drug may be used alone or in combination with corticosteroids.
-Subcutaneous route not approved for CRS.

Use: For cytokine chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS)

Usual Pediatric Dose for Juvenile Idiopathic Arthritis

Polyarticular Juvenile Idiopathic Arthritis (PJIA):
2 years or older:
IV:
-Weight less than 30 kg: 10 mg/kg IV over 60 minutes every 4 weeks
-Weight 30 kg or more: 8 mg/kg IV over 60 minutes every 4 weeks
SUBCUTANEOUS:
-Weight less than 30 kg: 162 mg subcutaneously once every 3 weeks
-Weight 30 kg or more: 162 mg subcutaneously once every 2 weeks

Systemic Juvenile Idiopathic Arthritis (SJIA):
2 years or older:
IV:
-Weight less than 30 kg: 12 mg/kg IV over 60 minutes every 2 weeks
-Weight 30 kg or more: 8 mg/kg IV over 60 minutes every 2 weeks
SUBCUTANEOUS:
-Weight less than 30 kg: 162 mg subcutaneously once every 2 weeks
-Weight 30 kg or more: 162 mg subcutaneously once a week

Comments:
-This drug may be used as monotherapy or concomitantly with methotrexate.
-Weight may fluctuate; therefore, dose adjustments should not be based on a single weight measurement.
-When transitioning from IV to subcutaneous, administer the first
subcutaneous dose instead of the next IV dose.

Uses:
-For patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA)
-For patients 2 years of age and older with active systemic juvenile idiopathic arthritis (SJIA)

Usual Pediatric Dose for Cytokine-Associated Toxicity

2 years and older:
-Weight less than 30 kg: 12 mg/kg IV over 60 minutes
-Weight 30 kg or above: 8 mg/kg IV over 60 minutes
-If no clinical improvement in cytokine release syndrome (CRS) occurs after the first dose, up to 3 additional doses may be administered. The interval between consecutive doses should be at least 8 hours.
Maximum dose: 800 mg per infusion

Comments:
-This drug may be used alone or in combination with corticosteroids.
-Subcutaneous route not approved for CRS.

Use: For cytokine chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in pediatric patients 2 years and older

Renal Dose Adjustments

Mild or moderate renal impairment: No adjustment recommended.
Severe renal impairment: Data not available

Liver Dose Adjustments

The safety and efficacy of this drug has not been studied in patients with hepatic impairment, including patients with positive HBV and HCV serology.

LIVER ENZYME ABNORMALITIES:
-Liver enzyme elevations greater than 1 to 3 x ULN, modify the dose of concomitant DMARDs if appropriate. For persistent increases in this range, reduce the IV dose to 4 mg/kg or interrupt therapy until the ALT/AST levels have normalized. For subcutaneous administration, reduce the injection frequency to every other week or interrupt therapy until ALT or AST have normalized. Resume at every other week and increase to every week as clinically appropriate.
-For liver enzyme elevations greater than 3 to 5 x ULN (confirmed by repeat testing), interrupt therapy until less than 3 x ULN and follow the recommendations for lab values greater than 1 to 3 x ULN. For persistent increases greater than 3 x ULN discontinue therapy.
-Discontinue therapy for liver enzyme elevations greater than 5 x ULN.

Dose Adjustments

This drug should 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).

Hold therapy if a patient develops a serious infection until the infection is controlled.

LOW ABSOLUTE NEUTROPHIL COUNT (ANC):
-ANC greater than 1000 cells/mm3: Maintain current dose
-ANC from 500 cells/mm3 to 1000 cells/mm3: Interrupt therapy; when the ANC is greater than 1000 cells/mm3, resume IV therapy at 4 mg/kg and increase to 8 mg/kg as clinically appropriate. For subcutaneous therapy, resume at every other week and increase frequency to every week as clinically appropriate.
-ANC less than 500 cells/mm3: Discontinue therapy

LOW PLATELET COUNT:
-Platelet count 50,000 to 100,000 cells/mm3: Interrupt therapy; when the platelet count is greater than 100,000 cells/mm3, resume IV therapy at 4 mg/kg and increase to 8 mg/kg as clinically appropriate. For subcutaneous therapy, reduce the injection frequency to every other week and increase to every week as clinically appropriate.
-Platelet count less than 50,000 cells/mm3: Discontinue therapy

Polyarticular and Systemic Juvenile Idiopathic Arthritis:
-Dose reduction has not been studied in the PJIA and SJIA populations.
-Dose interruptions are recommended for liver enzyme abnormalities, low neutrophil counts, and low platelet counts in patients with PJIA and SJIA at levels like what is outlined for adult patients with RA.
-If appropriate, dose modify or stop concomitant methotrexate and/or other medications and hold therapy until the clinical situation has been evaluated.
-In PJIA and SJIA the decision to discontinue therapy for a laboratory abnormality should be based on the individual patient.

Precautions

US BOXED WARNINGS:
WARNING: RISK OF SERIOUS INFECTIONS:
-Patients treated with this drug are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
-If a serious infection develops, interrupt therapy until the infection is controlled.
INFECTIONS INCLUDE:
1) Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before beginning and during therapy. Treatment for latent infection should be initiated prior to therapy.
2) Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
3) Bacterial, viral and other infections due to opportunistic pathogens.
-The risks and benefits of this drug should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.
-Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with this drug, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

CONTRAINDICATIONS:
-Hypersensitivity to the active component or any of the ingredients

Safety and efficacy have not been established in patients younger than 2 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-This drug may be used as monotherapy or concomitantly with methotrexate or other non-biologic DMARDs as an IV infusion or as a subcutaneous injection.
-Patients should be closely monitored during the infusion for hypersensitivity reactions. Appropriately trained personnel, equipment, treatments, and protocols should be in place to manage an acute anaphylactic reaction.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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