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Tocilizumab Dosage

Medically reviewed by Drugs.com. Last updated on July 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, doses exceeding 800 mg per infusion are not recommended
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

Comments:
-This drug may be used as monotherapy or concomitantly 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 the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

Usual Adult Dose for Giant Cell Arteritis

SUBCUTANEOUS:
-In combination with a tapering course of glucocorticoids, 162 mg subcutaneously once a week
-Based on clinical considerations, 162 mg subcutaneously once every other week in combination with a tapering course of glucocorticoids may be prescribed

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

Use: For the treatment of giant cell arteritis (GCA) in adult patients

Usual Adult Dose for Cytokine-Associated Toxicity

IV:
-Weight less than 30 kg: 12 mg/kg IV over 60 minutes
-Weight 30 kg or above: 8 mg/kg IV over 60 minutes

Comments:
-Doses exceeding 800 mg per infusion are not recommended.
-If no clinical improvement occurs after the first dose, up to 3 additional doses may be administered.
-The interval between consecutive doses should be at least 8 hours.
-This drug may be used alone or in combination with corticosteroids.
-Patients with severe or life-threatening CRS frequently have cytopenias or elevated ALT or AST due to the underlying malignancy, preceding lymphodepleting chemotherapy or the CRS.
-Subcutaneous route not approved for CRS.

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

Usual Pediatric Dose for Juvenile Idiopathic Arthritis

Polyarticular Juvenile Idiopathic Arthritis (PJIA):
IV formulation: 2 years or older
-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 formulation:
-Weight less than 30 kg: 162 mg once every 3 weeks
-Weight 30 kg or more: 162 mg once every 2 weeks

Systemic Juvenile Idiopathic Arthritis (SJIA):
IV formulation: 2 years or older:
-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 formulation:
-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 the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older
-For the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients 2 years of age and older

Usual Pediatric Dose for Cytokine-Associated Toxicity

IV:
-Weight less than 30 kg: 12 mg/kg IV over 60 minutes
-Weight 30 kg or above: 8 mg/kg IV over 60 minutes

Comments:
-Doses exceeding 800 mg per infusion are not recommended.
-If no clinical improvement occurs after the first dose, up to 3 additional doses may be administered.
-The interval between consecutive doses should be at least 8 hours.
-This drug may be used alone or in combination with corticosteroids.
-Patients with severe or life-threatening CRS frequently have cytopenias or elevated ALT or AST due to the underlying malignancy, preceding lymphodepleting chemotherapy or the CRS.
-Subcutaneous route not approved for CRS.

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

Renal Dose Adjustments

Mild to 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, and therefore no dose recommendation can be made.

LIVER ENZYME ABNORMALITIES:
Dose Modification Recommendations for RA, GCA, pJIA or sJIA:
-Elevation of liver enzymes greater than 1 to 3 x ULN:
-Modify dose of concomitant DMARDs (RA) or immunomodulatory agents (GCA) 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 persistent increases in this range, reduce the subcutaneous administration injection frequency to every other week or interrupt therapy until ALT/AST have normalized and resume at every other week and increase injections to every week as clinically appropriate
-Elevation of liver enzymes greater than 3 to 5 x ULN:
-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, and confirmed by repeated testing, discontinue therapy
-Elevation of liver enzymes greater than 5 x ULN: Discontinue therapy

Dose Adjustments

LOW ABSOLUTE NEUTROPHIL COUNT (ANC):
Dose Modification Recommendations for RA, GCA, pJIA or sJIA:
-ANC greater than 1000 cells/mm3: Maintain current dose
-ANC 500 cells/mm3 to 1000 cells/mm3: Interrupt therapy
-For patients receiving the intravenous formulation, when greater than 1000 cells per mm3 resume at 4 mg/kg and increase to 8 mg/kg as clinically appropriate
-For patients receiving the subcutaneous formulation, when greater than 1000 cells per mm3 resume injection every other week and increase frequency to every week, as clinically appropriate
-ANC less than 500 cells/mm3: Discontinue therapy

LOW PLATELET COUNT:
Dose Modification Recommendations for RA, GCA, pJIA or sJIA:
-Platelet count 50,000 to 100,000 cells/mm3: Interrupt therapy
-When the platelet count is greater than 100,000 cells per mm3, resume IV therapy at 4 mg/kg and increase to 8 mg/kg as clinically appropriate
-For subcutaneous therapy, when platelet count is greater than 100,000 cells per mm3, resume 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

Precautions

US BOXED 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.
-If a serious infection develops, interrupt treatment until the infection is controlled.
-The risks and benefits of treatment 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, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

CONTRAINDICATIONS: -Hypersensitivity to any component of the product

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:
-It is recommended that this product 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).
-Safety and efficacy of the intravenous formulation have not been established in patients younger than 18 years with conditions other than pJIA, sJIA or CRS.
-Safety and effectiveness in pediatric patients below the age of 2 have not been established in PJIA, SJIA, or CRS.
-Therapy should be interrupted if a patient develops a serious infection until the infection is controlled.
-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.
-Prior to injection, allow the product to reach room temperature.

Storage Requirements:
-Store the product at 2C to 8C.
-Do not freeze the product.
-Keep in the original container and protect from moisture and light.
-The subcutaneous injection should not be kept above 30C and must be administered within 8 hours once removed from the refrigerator.
-The prepared IV solution should be administered immediately, but if necessary, may be stored at 2C to 8C for not more than 24 hours.

Patient Advice:
-Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during and for several months after therapy.
-Advise patients to avoid driving and activities such as operating machinery until you know how this drug affects you.
-Advice patients that this drug may increase their risk to infections.
-Advice patients report any symptom of severe, persistent abdominal pain.
-Advise patients to seek immediate medical attention if they experience any symptom of serious allergic reactions.

Frequently asked questions

Further information

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