Centocor Ortho Biotech Products, L.p.
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Centocor Ortho Biotech Products, L.p. Drugs
The recommended dose of ORTHOCLONE OKT3 for the treatment of acute renal, steroid-resistant cardiac, or steroid-resistant hepatic allograft rejection is 5 mg per day in a single (bolus) intravenous injection in less than one minute for 10 to 14 days. For acute renal rejection, treatment should begin upon diagnosis. For steroid-resistant cardiac or hepatic allograft rejection, treatment should begin when the treating physician deems a rejection has not been reversed by an adequate course of corticosteroid therapy. (See: CLINICAL PHARMACOLOGY; PRECAUTIONS: Sensitization, Laboratory Tests.)
The initial recommended dose is 2.5 mg per day in pediatric patients weighing less than or equal to 30 kg and 5 mg per day in pediatric patients weighing greater than 30 kg in a single (bolus) intravenous injection in less than one minute for 10 to 14 days. Daily increases in ORTHOCLONE OKT3 doses (i.e., 2.5 mg increments) may be required to achieve depletion of CD3 positive cells (<25 cells/mm3) and ensure therapeutic ORTHOCLONE OKT3 serum concentrations (> 800 ng/mL). Pediatric patients may require augmentation of the ORTHOCLONE OKT3 dose. For acute renal rejection, treatment should begin upon diagnosis. For steroid-resistant cardiac or hepatic allograft rejection, treatment should begin when the treating physician deems a rejection has not been reversed by an adequate course of corticosteroid therapy. (See: CLINICAL PHARMACOLOGY; PRECAUTIONS: Laboratory Tests; Pediatric Use.)
For the first few doses, patients should be monitored in a facility equipped and staffed for cardiopulmonary resuscitation (CPR). Patients receiving subsequent doses of ORTHOCLONE OKT3, should also be monitored in a facility equipped and staffed for CPR. Vital signs should be monitored frequently. Patients receiving ORTHOCLONE OKT3 should also be carefully monitored for signs and symptoms of Cytokine Release Syndrome, particularly after the first few doses but also after a treatment hiatus with resumption of therapy. The patient's temperature should be lowered to <37.8°C (100°F) before the administration of any dose of ORTHOCLONE OKT3.
Prior to administration of ORTHOCLONE OKT3, the patient's volume status should be assessed carefully. It is imperative, especially prior to the first few doses, that there be no clinical evidence of volume overload, uncontrolled hypertension, or uncompensated heart failure. Patients should have a clear chest X-ray and should not weigh more than 3% above their minimum weight during the week prior to injection.
To decrease the incidence and severity of Cytokine Release Syndrome, associated with the first dose of ORTHOCLONE OKT3, it is strongly recommended that methylprednisolone sodium succinate 8.0 mg/kg be administered intravenously 1 to 4 hours prior to the initial dose of ORTHOCLONE OKT3. Acetaminophen and antihistamines given concomitantly with ORTHOCLONE OKT3 may also help to reduce some early reactions. (See: WARNINGS and ADVERSE EVENTS: Cytokine Release Syndrome.)
When using concomitant immunosuppressive drugs, the dose of each should be reduced to the lowest level compatible with an effective therapeutic response in order to reduce the potential for malignancy and infections. Maintenance immunosuppression should be resumed approximately three days prior to the cessation of ORTHOCLONE OKT®3 therapy. (See: WARNINGS and ADVERSE EVENTS: Infection, Neoplasia.)
Reduced T cell clearance or low plasma ORTHOCLONE OKT3 levels provide a basis for adjusting ORTHOCLONE OKT3 dosage or for discontinuing therapy. (See: WARNINGS: Anaphylactic Reactions; PRECAUTIONS: Laboratory Tests; ADVERSE EVENTS: Hypersensitivity Reactions.)
Administration InstructionsBefore administration, ORTHOCLONE OKT3 should be inspected for particulate matter and discoloration. Because ORTHOCLONE OKT3 is a protein solution, it may develop fine translucent particles (shown not to affect potency). No bacteriostatic agent is present in this product. Adherence to aseptic technique is advised. Once the ampule is opened, use immediately and discard the unused portion. Prepare ORTHOCLONE OKT3 for injection by drawing solution into a syringe through a low protein-binding 0.2 or 0.22 micrometer (µm) filter. Detach filter and attach a new needle for a single intravenous (bolus) injection. Because no data is available on compatibility of ORTHOCLONE OKT3 with other intravenous substances or additives, other medications/substances should not be added or infused simultaneously through the same intravenous line. If the same intravenous line is used for sequential infusion of several different drugs, the line should be flushed with saline before and after injection of ORTHOCLONE OKT3. Administer ORTHOCLONE OKT3 as a single intravenous (bolus) injection in less than one minute. Do not administer by intravenous infusion or in conjunction with other drug solutions.
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