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Tocilizumab Dosage

Applies to the following strength(s): 20 mg/mL162 mg/0.9 mL

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Rheumatoid Arthritis

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.

RECOMMENDED IV DOSAGE REGIMEN: 4 mg/kg IV given once every 4 weeks as a 60 minute single drip infusion, 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
Maximum dose: 800 mg per infusion in RA patients

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 subcutaneously every week

Comments:
-This drug should not be administered as an IV push or bolus.
-When transitioning from IV to subcutaneous therapy, give the first subcutaneous dose instead of the next scheduled IV dose.
-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).

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 Pediatric Dose for Juvenile Idiopathic Arthritis

This drug may be used as monotherapy or concomitantly with methotrexate:
POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS:
2 years or older:
-Weight less than 30 kg: 10 mg/kg IV given once every 4 weeks as a 60 minute single drip infusion
-Weight 30 kg or more: 8 mg/kg given once every 4 weeks as a 60 minute single drip infusion

This drug may be used as monotherapy or concomitantly with methotrexate:
SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS:
2 years or older:
-Weight less than 30 kg: 12 mg/kg IV given once every 2 weeks as a 60 minute single drip infusion
-Weight 30 kg or more: 8 mg/kg IV given once every 2 weeks as a 60 minute single drip infusion

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

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

Renal Dose Adjustments

-Mild renal impairment: No adjustment recommended
-Moderate to severe renal impairment: Data not available (renal function should be monitored closely in these patients)

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, 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.
-Liver enzyme elevations greater than 3 to 5 x ULN (confirmed by repeat testing), the recommendation is to interrupt tocilizumab dosing 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 tocilizumab.
-Liver enzyme elevations greater than 5 x ULN, tocilizumab should be discontinued.

Dose Adjustments

RHEUMATOID ARTHRITIS:
-Reduction of the 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 the 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

LOW ABSOLUTE NEUTROPHIL COUNT (ANC):
-ANC greater than 1000 cells/mm3: Maintain current dose.
-ANC from 500 cells/mm3 to 1000 cells/mm3, 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, discontinue tocilizumab.

LOW PLATELET COUNT:
-Platelet count 50,000 to 100,000 cells/mm3, 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.
-Platelet count less than 50,000 cells/mm3, 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

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.
REPORTED INFECTIONS INCLUDE:
1) Active tuberculosis, 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.

Safety and efficacy of the IV formulation of this drug have not been established in patients younger than 2 years.

Safety and efficacy of the subcutaneous formulation of this drug have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
Patients should be closely monitored during the infusion for signs and symptoms of a hypersensitivity reaction. Appropriately trained personnel, equipment, treatments, and protocols should be in place to manage an acute anaphylactic reaction.

Storage requirements:
Consult the manufacturer product information.

Reconstitution/preparation techniques:
Consult the manufacturer product information.

IV compatibility:
Consult the manufacturer product information.

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