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In areas outside of cancer, we introduced the world's first therapeutic monoclonal antibody derived from biotechnology, ORTHOCLONE OKT3. OKT3 is a treatment used to treat rejection of transplanted organs, including the heart, kidneys and liver.
Important Safety Information
Only physicians experienced in immunosuppressive therapy and management of solid organ transplant patients should use ORTHOCLONE OKT3. Patients treated with ORTHOCLONE OKT3 must be managed in a facility equipped and staffed for cardiopulmonary resuscitation and where the patient can be closely monitored for an appropriate period prior based on his or her health status.
Anaphylactic or anaphylactoid reactions may occur following administration of any dose or course of ORTHOCLONE OKT3. In addition, serious, occasionally life-threatening or lethal, systemic, cardiovascular, and central nervous system reactions have been reported following administration of ORTHOCLONE OKT3. These have included: pulmonary edema, especially in patients with volume overload; shock, cardiovascular collapse, cardiac or respiratory arrest, seizures, coma, cerebral edema, cerebral herniation, blindness and paralysis.
Fluid status should be carefully monitored prior to and during ORTHOCLONE OKT3 administration. Pretreatment with methylprednisolone is recommended to minimize symptoms of Cytokine Release Syndrome. (See: WARNINGS: Cytokine Release Syndrome, Central Nervous System Events, Anaphylactic Reactions; DOSAGE AND ADMINISTRATION.)
Please speak with your physician about important contraindications, warnings and precautions.
Commonly reported adverse events in clinical trials include weakness (10%), chills (43%), fever (77%), high (19%) or low (25%) blood pressure, fast heart rate (26%), headache (28%), tremor (14%), diarrhea (37%), nausea (32%), vomiting (25%), edema (12%), difficulty breathing (16%) and rash (14%).
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