Rheumatoid Arthritis (RA)

ACTEMRA® (tocilizumab) is indicated 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).

Polyarticular Juvenile Idiopathic Arthritis (PJIA)

ACTEMRA® (tocilizumab) is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.

Systemic Juvenile Idiopathic Arthritis (SJIA)

ACTEMRA® (tocilizumab) is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.

Rheumatoid Arthritis

ACTEMRA may be used as monotherapy or concomitantly with methotrexate or other DMARDs. The recommended dose of ACTEMRA for adult patients given as a 60-minute single intravenous drip infusion is 4 mg per kg every 4 weeks followed by an increase to 8 mg per kg every 4 weeks based on clinical response.

• Reduction of dose from 8 mg per kg to 4 mg per kg is recommended for management of certain dose-related laboratory changes including elevated liver enzymes, neutropenia, and thrombocytopenia [see WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS].
• Doses exceeding 800 mg per infusion are not recommended in RA patients [see CLINICAL PHARMACOLOGY].

Polyarticular Juvenile Idiopathic Arthritis

ACTEMRA may be used alone or in combination with methotrexate. The recommended dose of ACTEMRA for PJIA patients given once every 4 weeks as a 60-minute single intravenous drip infusion is:

Recommended PJIA Dosage Every 4 Weeks

• A change in dose should not be made based solely on a single visit body weight measurement, as weight may fluctuate.
• Interruption of dosing may be needed for management of dose-related laboratory abnormalities including elevated liver enzymes, neutropenia, and thrombocytopenia.

Systemic Juvenile Idiopathic Arthritis

ACTEMRA may be used alone or in combination with methotrexate. The recommended dose of ACTEMRA for SJIA patients given once every 2 weeks as a 60-minute single intravenous drip infusion is:

Recommended SJIA Dosage Every 2 Weeks

• A change in dose should not be made based solely on a single visit body weight measurement, as weight may fluctuate.
• Interruption of dosing may be needed for management of dose-related laboratory abnormalities including elevated liver enzymes, neutropenia, and thrombocytopenia.

General Considerations for Administration

• ACTEMRA 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 co-stimulation modulators because of the possibility of increased immunosuppression and increased risk of infection.
• It is recommended that ACTEMRA 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).

ACTEMRA for intravenous infusion should be diluted by a healthcare professional using aseptic technique as follows:

• PJIA and SJIA patients less than 30 kg: utilize a 50 mL infusion bag or bottle, then follow steps 1 and 2 below.
• Adult Rheumatoid Arthritis, PJIA and SJIA patients at or above 30 kg weight: utilize a 100 mL infusion bag or bottle, then follow steps 1 and 2 below.
  • Step 1. Withdraw a volume of 0.9% Sodium Chloride Injection, USP, equal to the volume of the ACTEMRA injection required for the patient's dose from the infusion bag or bottle.
  • Step 2. Slowly add ACTEMRA for intravenous infusion from each vial into the infusion bag or bottle. To mix the solution, gently invert the bag to avoid foaming.
• The fully diluted ACTEMRA solutions for infusion may be stored at 2° to 8°C (36° to 46°F) or room temperature for up to 24 hours and should be protected from light. ACTEMRA solutions do not contain preservatives; therefore, unused product remaining in the vials should not be used.
• Allow the fully diluted ACTEMRA solution to reach room temperature prior to infusion.
• The infusion should be administered over 60 minutes, and must be administered with an infusion set. Do not administer as an intravenous push or bolus.
• ACTEMRA should not be infused concomitantly in the same intravenous line with other drugs. No physical or biochemical compatibility studies have been conducted to evaluate the co-administration of ACTEMRA with other drugs.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If particulates and discolorations are noted, the product should not be used. Fully diluted ACTEMRA solutions are compatible with polypropylene, polyethylene and polyvinyl chloride infusion bags and polypropylene, polyethylene and glass infusion bottles.

Dosage Modifications

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

Rheumatoid Arthritis

Liver Enzyme Abnormalities [see WARNINGS AND PRECAUTIONS]

Low Absolute Neutrophil Count (ANC) [see WARNINGS AND PRECAUTIONS]

Low Platelet Count [see WARNINGS AND PRECAUTIONS]

Polyarticular and Systemic Juvenile Idiopathic Arthritis

Dose reduction of ACTEMRA has not been studied in the PJIA and SJIA populations. Dose interruptions of ACTEMRA are recommended for liver enzyme abnormalities, low neutrophil counts, and low platelet counts in patients with PJIA and SJIA at levels similar to what is outlined above for patients with RA. If appropriate, concomitant methotrexate and/or other medications should be dose modified or stopped and ACTEMRA dosing interrupted until the clinical situation has been evaluated. In PJIA and SJIA the decision to discontinue ACTEMRA for a laboratory abnormality should be based upon the medical assessment of the individual patient.

Dosage Forms And Strengths

Single-use vials of ACTEMRA (20 mg per mL):

• 80 mg per 4 mL
• 200 mg per 10 mL
• 400 mg per 20 mL

Storage And Handling

ACTEMRA (tocilizumab) is supplied in single-use vials as a preservative-free, sterile concentrate (20 mg per mL) solution for intravenous infusion. The following packaging configurations are available:

Individually packaged, single-use vials:

NDC 50242-135-01 providing 80 mg per 4 mL
NDC 50242-136-01 providing 200 mg per 10 mL
NDC 50242-137-01 providing 400 mg per 20 mL

Storage and Stability: Do not use beyond expiration date on the container. ACTEMRA must be refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect the vials from light by storage in the original package until time of use. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If visibly opaque particles, discoloration or other foreign particles are observed, the solution should not be used.

Genentech, Inc. A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990, US License No. 1048. Revised: April 2013

Last reviewed on RxList: 5/16/2013
This monograph has been modified to include the generic and brand name in many instances.