When platelet count is greater than 100,000 cells per mm3 resume ACTEMRA at 4 mg per kg and increase to 8 mg per kg as clinically appropriate
Less than 50,000 Discontinue ACTEMRA

Systemic Juvenile Idiopathic Arthritis:

Dose reduction of ACTEMRA has not been studied in the SJIA population. Dose interruptions of ACTEMRA are recommended for liver enzyme abnormalities, low neutrophil counts, and low platelet counts in patients with 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 eva luated. In SJIA the decision to discontinue ACTEMRA for a laboratory abnormality should be based upon the medical assessment of the individual patient.

3DOSAGE 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
4CONTRAINDICATIONS
ACTEMRA should not be administered to patients with known hypersensitivity to ACTEMRA [see Warnings and Precautions (5.5)].

5WARNINGS AND PRECAUTIONS
5.1Serious 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, sepsis and bacterial arthritis [see Adverse Reactions (6.1)]. Among opportunistic infections, tuberculosis, cryptococcus, aspergillosis, candidiasis, and pneumocystosis were reported with ACTEMRA. Other serious infections, not reported in clinical studies, may also occur (e.g., histoplasmosis, coccidioidomycosis, listeriosis). Patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids which in addition to rheumatoid arthritis may predispose them to infections.

ACTEMRA should not be administered in patients with an active infection, including localized infections. The risks and benefits of treatment should be considered prior to initiating ACTEMRA in patients:

with chronic or recurrent infection;
who have been exposed to tuberculosis;
with a history of serious or an opportunistic infection;
who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or
with underlying conditions that may predispose them to infection.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ACTEMRA, as signs and symptoms of acute inflammation may be lessened due to suppression of the acute phase reactants [see Dosage and Administration (2.3), Adverse Reactions (6.1), and Patient Counseling Information (17)].

ACTEMRA should be interrupted if a patient develops a serious infection, an opportunistic infection, or sepsis. A patient who develops a new infection during treatment with ACTEMRA should undergo a prompt and complete diagnostic workup appropriate for an immunocompromised patient, appropriate antimicrobial therapy should be initiated, and t