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Actemra (Tocilizumab) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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 TNF antagonist therapies.

DOSAGE AND ADMINISTRATION

Rheumatoid Arthritis

ACTEMRA may be used as monotherapy or concomitantly with methotrexate or other DMARDs. The recommended dose of ACTEMRA for adult patients given once every 4 weeks as a 60-minute single intravenous drip infusion is:

Recommended Adult Dosage Every 4 Weeks
Patients who have had an inadequate response to one or more TNF antagonists When used in combination with DMARDs or as monotherapy the recommended starting dose is 4 mg/kg followed by an increase to 8 mg/kg based on clinical response.

  • 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/mm3, platelet count below 100,000/mm3, or who have ALT or AST above 1.5 times the upper limit of normal (ULN).
  • Reduction of dose 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 [see Dosage and Administration, Warnings and Precautions, and Adverse Reactions].
  • Doses exceeding 800 mg per infusion are not recommended [see Clinical Pharmacology].

General Considerations for Administration

ACTEMRA for intravenous infusion should be diluted to 100 mL by a healthcare professional using aseptic technique as follows:

  • From a 100 mL infusion bag or bottle, withdraw a volume of 0.9% Sodium Chloride Injection, USP, equal to the volume of the ACTEMRA solution required for the patient's dose.
  • 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.
  • 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.
  • The fully diluted ACTEMRA solutions for infusion may be stored at 2-8C (36-46F) 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.

Dosage Modifications

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

Liver Enzyme Abnormalities [see Warnings and Precautions]:
Lab Value Recommendation
> 1 to 3x ULN Dose modify concomitant DMARDs if appropriate
For persistent increases in this range, reduce ACTEMRA dose to 4 mg/kg or interrupt ACTEMRA until ALT/AST have normalized
> 3 to 5x ULN Interrupt ACTEMRA dosing until < 3x ULN and follow recommendations above for >1 to 3x ULN
(confirmed by repeat testing) For persistent increases > 3x ULN, discontinue ACTEMRA
> 5x ULN Discontinue ACTEMRA
Low Absolute Neutrophil Count (ANC) [see Warnings and Precautions]:
Lab Value
(cells/mm3)
Recommendation
ANC > 1000 Maintain dose
ANC 500 to 1000 Interrupt ACTEMRA dosing
When ANC > 1000 cells/mm3 resume ACTEMRA at 4 mg/kg and increase to 8 mg/kg as clinically appropriate
ANC < 500 Discontinue ACTEMRA
Low Platelet Count [see Warnings and Precautions]:
Lab Value
(cells/mm3)
Recommendation
50,000 to 100,000 Interrupt ACTEMRA dosing
When platelet count is > 100,000 cells/mm3 resume ACTEMRA at 4 mg/kg and increase to 8 mg/kg as clinically appropriate
< 50,000 Discontinue ACTEMRA

DOSAGE FORMS AND STRENGTHS

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

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

HOW SUPPLIED/STORAGE AND HANDLING

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

Individually packaged, single-use vials:

NDC 50242-135-01 providing 80 mg/4 mL

NDC 50242-136-01 providing 200 mg/10 mL

NDC 50242-137-01 providing 400 mg/20 mL

Box of 4 single-use vials:

NDC 50242-135-04 providing 80 mg/4 mL

NDC 50242-136-04 providing 200 mg/10 mL

NDC 50242-137-04 providing 400 mg/20 mL

Storage and Stability: Do not use beyond expiration date on the container. ACTEMRA must be refrigerated at 2C to 8C (36F to 46F). 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.

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