Tocilizumab Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Rheumatoid Arthritis

When used in combination with disease-modifying antirheumatic drugs (DMARDs) or as monotherapy:

Recommended IV Dosage Regimen:
Starting dose: 4 mg/kg given once every 4 weeks as a 60-minute single intravenous drip infusion, followed by an increase to 8 mg/kg based on clinical response

Doses exceeding 800 mg per infusion are not recommended.

Recommended Subcutaneous Dosage Regimen:
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 administered subcutaneously every week.

When transitioning from intravenous therapy to subcutaneous administration, give the first subcutaneous dose instead of the next scheduled intravenous dose.

Usual Pediatric Dose for Juvenile Idiopathic Arthritis

Polyarticular Juvenile Idiopathic Arthritis:
2 years or older:
Less than 30 kg: 10 mg/kg given once every 4 weeks as a 60-minute single intravenous infusion.
30 kg or more: 8 mg/kg given once every 4 weeks as a 60-minute single intravenous infusion.

Systemic Juvenile Idiopathic Arthritis
2 years or older:
Less than 30 kg: 12 mg/kg given once every 2 weeks as a 60-minute single intravenous drip infusion.
30 kg or more: 8 mg/kg given once every 2 weeks as a 60-minute single intravenous drip infusion.

Comments:
-A patient's weight may fluctuate; therefore, a dose adjustment should not be based on a single visit body weight measurement.
-Tocilizumab may be used as monotherapy or in combination with methotrexate.
-Not recommended for use in children less than 2 years of age.

Renal Dose Adjustments

No dose adjustment is required in patients with mild renal impairment. Tocilizumab has not been studied in patients with moderate to severe renal impairment.

Liver Dose Adjustments

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

Dose Adjustments

Tocilizumab treatment should be interrupted if a patient develops a serious infection until the infection is controlled.

Rheumatoid Arthritis:
Reduction of IV dose from 8 mg per kg to 4 mg per kg is recommended for the management of certain dose-related laboratory changes including elevated liver enzymes, neutropenia, and thrombocytopenia.

Interruption of dose or reduction in frequency of administration of subcutaneous dose from every week to every other week dosing is recommended for management of certain dose-related laboratory changes including elevated liver enzymes, neutropenia, and thrombocytopenia

1) Liver Enzyme Abnormalities:
If the lab value is greater than 1 to 3x ULN, the recommendation is to dose modify concomitant DMARDs if appropriate. For persistent increases in this range, reduce the IV tocilizumab dose to 4 mg/kg or interrupt tocilizumab until the ALT/AST levels have normalized. For subcutaneous tocilizumab, reduce the injection frequency to every other week or hold dosing until ALT or AST have normalized. Resume at every other week and increase to every week as clinically appropriate.

If the lab value is greater than 3 to 5x ULN (confirmed by repeat testing), the recommendation is to interrupt tocilizumab dosing until less than 3x ULN and follow the recommendations for lab values greater than 1 to 3x ULN. For persistent increases greater than 3x ULN, discontinue tocilizumab.

If the lab value is greater than 5x ULN, tocilizumab should be discontinued.

2) Low Absolute Neutrophil Count (ANC)
If the lab value is an ANC greater than 1000 cells/mm3, the recommendation is to maintain the dose.

If the lab value is an ANC from 500 cells/mm3 to 1000 cells/mm3, the recommendation is to interrupt tocilizumab dosing. When the ANC is greater than 1000 cells/mm3, resume IV tocilizumab at 4 mg/kg and increase to 8 mg/kg as clinically appropriate. For patients receiving subcutaneous tocilizumab, resume at every other week and increase frequency to every week as clinically appropriate.

If the lab value is an ANC less than 500 cells/mm3, the recommendation is to discontinue tocilizumab.

3) Low Platelet Count:
If the lab value is from 50,000 to 100,000 cells/mm3, the recommendation is interrupt tocilizumab dosing. When the platelet count is greater than 100,000 cells/mm3, resume IV tocilizumab at 4 mg/kg and increase to 8 mg/kg as clinically appropriate. Resume subcutaneous tocilizumab at every other week and increase frequency to every week as clinically appropriate.

If the lab value is less than 50,000 cells/mm3, the recommendation is to discontinue tocilizumab.

Polyarticular and Systemic Juvenile Idiopathic Arthritis:
-Dose reduction has not been studied.
-Dose interruptions are recommended in a similar manner to what is outlined above for patients with rheumatoid arthritis.
-Consider dose modification/interruption of concomitant methotrexate/other medications until the clinical situation has been evaluated.

Precautions

Tocilizumab has not been studied and its use should be avoided in combination with biological DMARDs such as TNF antagonists, IL-1R antagonists, anti-CD20 monoclonal antibodies, and selective costimulation modulators because of the possibility of increased immunosuppression and increased risk of infection.

It is recommended that tocilizumab not be initiated in patients with an absolute neutrophil count (ANC) below 2000/mm3, platelet count below 100,000/mm3, or who have ALT or AST above 1.5 times the upper limit of normal (ULN).

Dialysis

Data not available

Other Comments

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for tocilizumab. It includes a communication plan. Additional information is available at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm.

Tocilizumab should be administered over 60 minutes; it should not be given as an intravenous push or bolus. Tocilizumab should not be infused concomitantly in the same intravenous line with other drugs.

Tocilizumab infusion solutions are compatible with polypropylene, polyethylene, and polyvinyl chloride infusion bags and polypropylene, polyethylene and glass infusion bottles.

Tocilizumab solution for infusion should be allowed to reach room temperature prior to infusion.

The manufacturer's product information should be consulted for current dilution recommendations. Following dilution, the solution for infusion may be stored at 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit) or room temperature for up to 24 hours and it should be protected from light.

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