idence of pancytopenia.
Withhold Campath for severe cytopenias (except lymphopenia). Discontinue for autoimmune cytopenias or recurrent/persistent severe cytopenias (except lymphopenia) [see DOSAGE AND ADMINISTRATION (2.3)]. No data exist on the safety of Campath resumption in patients with autoimmune cytopenias or marrow aplasia [see ADVERSE REACTIONS (6.1)].
5.2 Infusion Reactions
Adverse reactions occurring during or shortly after Campath infusion include pyrexia, chills/rigors, nausea, hypotension, urticaria, dyspnea, rash, emesis, and bronchospasm. In clinical trials, the frequency of infusion reactions was highest in the first week of treatment. Monitor for the signs and symptoms listed above and withhold infusion for Grade 3 or 4 infusion reactions [see ADVERSE REACTIONS (6.1)].
The following serious, including fatal, infusion reactions have been identified in post-marketing reports: syncope, pulmonary infiltrates, acute respiratory distress syndrome (ARDS), respiratory arrest, cardiac arrhythmias, myocardial infarction, acute cardiac insufficiency, cardiac arrest, angioedema, and anaphylactoid shock.
Initiate Campath according to the recommended dose-escalation scheme [see DOSAGE AND ADMINISTRATION (2)]. Premedicate patients with an antihistamine and acetaminophen prior to dosing. Institute medical management (e.g., glucocorticoids, epinephrine, meperidine) for infusion reactions as needed [see DOSAGE AND ADMINISTRATION (2.2)]. If therapy is interrupted for 7 or more days, reinstitute Campath with gradual dose escalation [see DOSAGE AND ADMINISTRATION (2.3) and ADVERSE REACTIONS (6)].
5.3 Immunosuppression/Infections
Campath treatment results in severe and prolonged lymphopenia with a concomitant increased incidence of opportunistic infections [see ADVERSE REACTIONS (6.1)]. Administer PCP and herpes viral prophylaxis during Campath therapy and for a minimum of 2 months after completion of Campath or until the CD4+ count is ≥ 200 cells/µL, whichever occurs later [see DOSAGE AND ADMINISTRATION (2.2)]. Prophylaxis does not eliminate these infections.
Routinely monitor patients for CMV infection during Campath treatment and for at least 2 months following completion of treatment. Withhold Campath for serious infections and during antiviral treatment for CMV infection or confirmed CMV viremia (defined as polymerase chain reaction (PCR) positive CMV in ≥ 2 consecutive samples obtained 1 week apart) [see ADVERSE REACTIONS (6.1)]. Initiate therapeutic ganciclovir (or equivalent) for CMV infection or confirmed CMV viremia [see DOSAGE AND ADMINISTRATION (2.3)].
Administer only irradiated blood products to avoid transfusion associated Graft versus Host Disease (TAGVHD), unless emergent circumstances dictate immediate transfusion.1
In patients receiving Campath as initial therapy, recovery of CD4+ counts to ≥ 200 cells/µL occurred by 6 months post-treatment; however at 2 months post-treatment, the median was 183 cells/µL. In previously treated patients receiving Campath, the median time to recovery of CD4+ counts to ≥ 200 cells/µL was 2 months; however, full recovery (to baseline) of CD4+ and CD8+ counts may take more than 12 months [see BOXED WARNING and ADVERSE REACTIONS (6)].
5.4 Laboratory Monitoring
Obtain complete blood counts (CBC) at weekly intervals during Campath therapy and more frequently if worsening ane |
