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ORTHOCLONE OKT3
Organ rejection prophylaxis
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Drug Name:

ORTHOCLONE OKT3 Rx

Generic Name and Formulations:
Muromonab-CD3 1mg/mL; soln for IV inj.

Company:
Janssen Biotech, Inc.

Therapeutic Use:

Indications for ORTHOCLONE OKT3:

Treatment of acute allograft rejection in renal transplant. Treatment of steroid-resistant acute allograft rejection in cardiac and hepatic transplant.

Adult:

Monitor for the first few doses. Give as a single (bolus) IV inj in less than 1 minute. 5mg/day for 10–14 days. For acute renal rejection treatment should begin upon diagnosis. For steroid-resistant cardiac or hepatic allograft rejection, treatment should begin when treating physician deems a rejection has not been reversed by an adequate course of corticosteroids.

Children:

<1 month: not recommended. Monitor for the first few doses. Give as a single (bolus) IV inj in less than 1 minute. ≤30kg: 2.5mg/day; >30kg: 5mg/day. Both for 10–14 days. Daily dose increases (eg, 2.5mg increments) may be required to achieve depletion of CD3+ cells (<25 cells/mm3) and ensure therapeutic concentrations (>800ng/mL). For acute renal rejection treatment should begin upon diagnosis. For steroid-resistant cardiac or hepatic allograft rejection, treatment should begin when treating physician deems a rejection has not been reversed by an adequate course of corticosteroids.

Contraindications:

Anti-mouse antibody titers ≥1:1000. Uncompensated heart failure. Fluid overload. Uncontrolled hypertension. History of seizures or predisposed to seizures. Determined or suspected to be pregnant. Nursing mothers.

Warnings/Precautions:

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).

Interactions:

Concomitant immunosuppressants: reduce dose to lowest level compatible with effective therapeutic response.

Pharmacological Class:

Monoclonal antibody (CD3 antigen of human T-cells).

Adverse Reactions:

Flu-like symptoms, cardiovascular symptoms (eg, hypotension, hypertension, tachycardia), CNS symptoms (eg, headache, tremor), GI upset, edema, dyspnea, rash, others; cytokine release syndrome, infections, neoplasia, hypersensitivity reactions.

How Supplied:

Ampules (5mL)—5

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