olled.
Liver Enzyme Abnormalities [see Warnings and Precautions (5.3)]:
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 (5.3)]:
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 (5.3)]:
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
3 DOSAGE FORMS AND STRENGTHS
Single-use vials of ACTEMRA (20 mg/mL):
80 mg/4 mL
200 mg/10 mL
400 mg/20 mL
4 CONTRAINDICATIONS
None
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, 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 (17.1)].
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 fo |
