ter than 1 to 3× 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 5× ULN Hold ACTEMRA dosing until less than 3× ULN and follow recommendations above for greater than 1 to 3× ULN
(confirmed by repeat testing) For persistent increases greater than 3× ULN, discontinue ACTEMRA
Greater than 5× ULN Discontinue ACTEMRA
Low Absolute Neutrophil Count (ANC) [see WARNINGS AND PRECAUTIONS (5.3)]:
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 (5.3)]:
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 eva luated. In PJIA and SJIA the decision to discontinue ACTEMRA for a laboratory abnormality should be based upon the medical assessment of the individual patient.
3 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
4 CONTRAINDICATIONS
ACTEMRA is contraindicated in patients with known hypersensitivity to ACTEMRA [see WARNINGS AND PRECAUTIONS (5.5)].
5 WARNINGS AND PRECAUTIONS
5.1 Serious Infections
Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, protozoal, or other opportunistic pathogens have been reported in patients receiving immunosuppressive agents including ACTEMRA for rheumatoid arthritis. The most common serious infections included pneumonia, urinary tract infection, cellulitis, herpes zoster, gastroenteritis, diverticulitis, sepsi |
