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Actemra

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Actemra

Actemra

INDICATIONS

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.

DOSAGE AND ADMINISTRATION

Rheumatoid Arthritis

ACTEMRA may be used as monotherapy or concomitantly with methotrexate or other non-biologic DMARDs as an intravenous infusion or as a subcutaneous injection.

Recommended Intravenous (IV) Dosage Regimen

The recommended dosage 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.

Recommended Subcutaneous (SC) Dosage Regimen

Patients less than 100 kg weight 162 mg administered subcutaneously every other week, followed by an increase to every week based on clinical response
Patients at or above 100 kg weight 162 mg administered subcutaneously every week

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

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 [see Dose modification below, WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS].

Polyarticular Juvenile Idiopathic Arthritis

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

Recommended Intravenous PJIA Dosage Every 4 Weeks

Patients less than 30 kg weight 10 mg per kg
Patients at or above 30 kg weight 8 mg per kg

  • Do not change dose 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 [see Dose modification below].
  • Subcutaneous administration is not approved for PJIA.

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 Intravenous SJIA Dosage Every 2 Weeks

Patients less than 30 kg weight 12 mg per kg
Patients at or above 30 kg weight 8 mg per kg

  • Do not change a dose 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 [see Dose modification below].
  • Subcutaneous administration is not approved for SJIA.

General Considerations for Administration

  • ACTEMRA has not been studied 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. Avoid using ACTEMRA with biological DMARDs.
  • 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).

Preparation and Administration Instructions for Intravenous Infusion

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

  • PJIA and SJIA patients less than 30 kg: use a 50 mL infusion bag or bottle of 0.9% Sodium Chloride, and then follow steps 1 and 2 below.
  • Adult RA, PJIA and SJIA patients at or above 30 kg weight: use a 100 mL infusion bag or bottle, and then follow steps 1 and 2 below.
    • Step 1. Withdraw a volume of 0.9% Sodium Chloride injection, equal to the volume of the ACTEMRA injection required for the patient's dose from the infusion bag or bottle.

For Intravenous Use: Volume of ACTEMRA Injection per kg of Body Weight

Dosage Indication Volume of ACTEMRA injection per kg of body weight
4 mg/kg Adult RA 0.2mL/kg
8 mg/kg Adult RA SJIA and PJIA ( ≥ 30 kg of body weight) 0.4mL/kg
10 mg/kg PJIA ( < 30 kg of body weight) 0.5 mL/kg
12 mg/kg SJIA ( < 30 kg of body weight) 0.6mL/kg

    • Step 2. Withdraw the amount of ACTEMRA for intravenous infusion from the vial(s) and add slowly into the Sodium Chloride 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.

Preparation and Administration Instructions for Subcutaneous Injection for RA

ACTEMRA for subcutaneous injection is only indicated in the treatment in patients with adult RA and is not indicated for the treatment of patients with PJIA or SJIA. ACTEMRA for subcutaneous injection is not intended for intravenous drip infusion.

  • ACTEMRA subcutaneous injection is intended for use under the guidance of a healthcare practitioner. After proper training in subcutaneous injection technique, a patient may self-inject ACTEMRA or the patient's caregiver may administer ACTEMRA if a healthcare practitioner determines that it is appropriate. Patients, or patient caregivers, should be instructed to follow the directions provided in the Instructions for Use (IFU) for additional details on medication administration.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use ACTEMRA prefilled syringes (PFS) exhibiting particulate matter, cloudiness, or discoloration. ACTEMRA for subcutaneous administration should be clear and colorless to pale yellow. Do not use if any part of the PFS appears to be damaged.
  • Patients using ACTEMRA for subcutaneous administration should be instructed to inject the full amount in the syringe (0.9 mL), which provides 162 mg of ACTEMRA, according to the directions provided in the IFU.
  • Injection sites should be rotated with each injection and should never be given into moles, scars, or areas where the skin is tender, bruised, red, hard, or not intact.

Dosage Modifications due to Serious Infections or Laboratory Abnormalities

Hold ACTEMRA treatment if a patient develops a serious infection until the infection is controlled.

Rheumatoid Arthritis

Liver Enzyme Abnormalities [see WARNINGS AND PRECAUTIONS]

Lab Value Recommendation
Greater than 1 to 3x ULN Dose modify concomitant DMARDs if appropriate For persistent increases in this range:
  • For patients receiving intravenous ACTEMRA, reduce dose to 4 mg per kg or hold ACTEMRA until ALT or AST have normalized
  • For patients receiving subcutaneous ACTEMRA, reduce injection frequency to every other week or hold dosing until ALT or AST have normalized. Resume ACTEMRA at every other week and increase frequency to every week as clinically appropriate.
Greater than 3 to 5x ULN (confirmed by repeat testing) Hold ACTEMRA dosing until less than 3x ULN and follow recommendations above for greater than 1 to 3x ULN For persistent increases greater than 3x ULN, discontinue ACTEMRA
Greater than 5x ULN Discontinue ACTEMRA

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

Lab Value (cells per mm³) Recommendation
ANC greater than 1000 Maintain dose
ANC 500 to 1000 Hold ACTEMRA dosing When ANC greater than 1000 cells per mm³:
  • For patients receiving intravenous ACTEMRA, resume ACTEMRA at 4 mg per kg and increase to 8 mg per kg as clinically appropriate
  • For patients receiving subcutaneous ACTEMRA, resume ACTEMRA at every other week and increase frequency to every week as clinically appropriate
ANC less than 500 Discontinue ACTEMRA

Low Platelet Count [see WARNINGS AND PRECAUTIONS]

Lab Value (cells per mm³) Recommendation
50,000 to 100,000 Hold ACTEMRA dosing When platelet count is greater than 100,000 cells per mm³:
  • For patients receiving intravenous ACTEMRA, resume ACTEMRA at 4 mg per kg and increase to 8 mg per kg as clinically appropriate
  • For patients receiving subcutaneous ACTEMRA, resume ACTEMRA at every other week and increase frequency to every week as clinically appropriate
Less than 50,000 Discontinue ACTEMRA

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, dose modify or stop concomitant methotrexate and/or other medications and hold ACTEMRA dosing 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.

HOW SUPPLIED

Dosage Forms And Strengths

Single-use vials of ACTEMRA (20 mg per mL) for IV administration
  • 80 mg per 4 mL
  • 200 mg per 10 mL
  • 400 mg per 20 mL
Prefilled Syringe (PFS) for SC administration
  • A single-use prefilled glass syringe providing 162 mg of ACTEMRA in 0.9mL

Storage And Handling

For Intravenous Infusion

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

For Subcutaneous Injection

ACTEMRA (tocilizumab) for subcutaneous administration is supplied as a sterile preservative-free liquid solution in a single-use prefilled syringe. The following packaging configurations are available:

NDC 50242-138-01 prefilled syringe providing 162 mg per 0.9mL

Storage and Stability: Do not use beyond expiration date on the container, package or prefilled syringe. ACTEMRA must be refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect the vials and syringes from light by storage in the original package until time of use, and keep syringes dry. 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. Revised: October 2013

Last reviewed on RxList: 11/4/2013
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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