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Tocilizumab Dosage

Applies to the following strength(s): 20 mg/mL ; 162 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 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
-Dose adjustment: Interruption of dose or reduction in frequency of administration from every week to every other week is recommended for management of certain dose-related laboratory changes including elevated liver enzymes, neutropenia, and thrombocytopenia.

Comments:
-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.
-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 Adult Dose for Giant Cell Arteritis

162 mg subcutaneously once a week in combination with a tapering course of glucocorticoids
Dose adjustment: 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.
-Interruption of dosing may be needed for management of dose-related laboratory abnormalities including elevated liver enzymes, neutropenia, and thrombocytopenia.
-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).
-IV administration is not approved for GCA.

Use: For giant cell arteritis (GCA)

Usual Pediatric Dose for Juvenile Idiopathic Arthritis

Polyarticular Juvenile Idiopathic Arthritis (PJIA):
2 years or older:
-Weight less than 30 kg: 10 mg/kg IV as a 60-minute single drip infusion
once every 4 weeks
-Weight 30 kg or more: 8 mg/kg as a 60-minute single drip infusion
once every 4 weeks

Systemic Juvenile Idiopathic Arthritis (SJIA):
2 years or older:
-Weight less than 30 kg: 12 mg/kg IV as a 60-minute single drip infusion
once every 2 weeks
-Weight 30 kg or more: 8 mg/kg IV as a 60-minute single drip infusion
once every 2 weeks

Comments:
-This drug may be used as monotherapy or concomitantly with methotrexate.
-The weight of the patient may fluctuate; therefore, a dose adjustment should not be based on a single visit body weight measurement.
-Interruption of dosing may be needed for management of dose-related laboratory abnormalities including elevated liver enzymes, neutropenia, and thrombocytopenia.
-Subcutaneous administration is not approved for PJIA or SJIA.
-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, 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

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.
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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