r an immunocompromised patient, appropriate antimicrobial therapy should be initiated, and the patient should be closely monitored.
Tuberculosis
Patients should be eva luated for tuberculosis risk factors and tested for latent infection prior to initiating ACTEMRA.
Anti-tuberculosis therapy should also be considered prior to initiation of ACTEMRA in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Consultation with a physician with expertise in the treatment of tuberculosis is recommended to aid in the decision whether initiating anti-tuberculosis therapy is appropriate for an individual patient.
Patients should be closely monitored for the development of signs and symptoms of tuberculosis including patients who tested negative for latent tuberculosis infection prior to initiating therapy.
It is recommended that patients be screened for latent tuberculosis infection prior to starting ACTEMRA. The incidence of tuberculosis in worldwide clinical development programs is 0.1%. Patients with latent tuberculosis should be treated with standard antimycobacterial therapy before initiating ACTEMRA.
Viral Reactivation
Viral reactivation has been reported with immunosuppressive biologic therapies and cases of herpes zoster exacerbation were observed in clinical studies with ACTEMRA. No cases of Hepatitis B reactivation were observed in the trials; however patients who screened positive for hepatitis were excluded.
5.2 Gastrointestinal Perforations
Events of gastrointestinal perforation have been reported in clinical trials, primarily as complications of diverticulitis. ACTEMRA should be used with caution in patients who may be at increased risk for gastrointestinal perforation. Patients presenting with new onset abdominal symptoms should be eva luated promptly for early identification of gastrointestinal perforation [see Adverse Reactions (6.1)].
5.3 Laboratory Parameters
Neutrophils
Treatment with ACTEMRA was associated with a higher incidence of neutropenia. Infections have been uncommonly reported in association with treatment-related neutropenia in long-term extension studies and postmarketing clinical experience.
–
It is not recommended to initiate ACTEMRA treatment in patients with a low neutrophil count i.e., absolute neutrophil count (ANC) <2000/mm3. In patients who develop an absolute neutrophil count <500/mm3 treatment is not recommended.
–
Neutrophils should be monitored every 4 to 8 weeks [see Clinical Pharmacology (12.2)]. For recommended modifications based on ANC results see Dosage and Administration (2.3).
Platelets
Treatment with ACTEMRA was associated with a reduction in platelet counts. Treatment-related reduction in platelets was not associated with serious bleeding events in clinical trials [see Adverse Reactions (6.1)].
–
It is not recommended to initiate ACTEMRA treatment in patients with a platelet count below 100,000/mm3. In patients who develop a platelet count <50,000/mm3 treatment is not recommended.
–
Platelets should be monitored every 4 to 8 weeks. For recommended modifications based on platelet counts see Dosage and Administration (2.3).
Liver Function Tests
Treatment with ACTEMRA was associa |
