ORTHOCLONE OKT3 Rx

Should be administered by physician experienced in immunosuppressive therapy and management of solid organ transplant patients. Discontinue if hypersensitivity is suspected; do not resume therapy or re-expose patient. Have epinephrine and other emergency life-support equipment available. Monitor for cytokine release syndrome with administration of the first 2 to 3 doses; may have serious cardiovascular or CNS manifestations; increased risk with unstable angina, recent MI, symptomatic ischemic heart disease, heart failure, pulmonary edema, intravascular volume overload or depletion, cerebrovascular disease, symptomatic vascular disease or neuropathy, history of seizures, septic shock; stabilize background conditions before initiation of therapy. Assess fluid status and perform chest X-ray to rule out volume overload, uncontrolled hypertension, or uncompensated heart failure prior to administration. Patients should not weight >3% above their minimum weight during the week prior to injection. Monitor for convulsions and manifestations of encephalopathy (w/ coexisting aseptic meningitis syndrome). Perform lumbar punctures on children with symptoms suggestive of meningeal irritation to rule out infection. Monitor for infection and neoplasia development during therapy. History of thrombosis. Reduce fevers with antipyretics before administering. Monitor BUN, serum creatinine, LFTs, bilirubin, WBCs, platelets prior to and during therapy. Periodically monitor Orthoclone OKT3 levels or T cell clearance; children: monitor daily. Elderly. Pregnancy (Cat.C).