muromonab CD3 (Discontinued)

Brand and Other Names:Orthoclone OKT3
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 1mg/mL

Acute Allograft Rejection or Acute Graft-Vs-Host Disease Treatment

5 mg IVP qDay x 10-14 days

Cardiac or Hepatic Allograft Rejection, Steroid Resistant

5 mg IVP qDay x 10-14 days

Dosage Forms & Strengths

injectable solution

  • 1mg/mL

Acute Allograft Rejection or Acute Graft-Vs-Host Disease Treatment

<30 kg: 2.5 mg IVP qDay x 10-14 days

>30 kg: 5 mg IVP qDay x 10-14 days; may titrate daily by 2.5 mg to achieve CD3+ cells < 25/mm³ and serum muromonab-CD3 > 800 ng/mL

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Interactions

Interaction Checker

and muromonab CD3

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10% (Cytokine Release Syndrome 1st 48 Hr)

            Pyrexia (90%)

            Chills (59%)

            Dyspnea (21%)

            Nausea/Vomiting (19%)

            Chest pain (14%)

            Diarrhea (14%)

            Tremor (13%)

            Wheezing (13%)

            Headache (11%)

            >10% (Overall Incidence)

            Pyrexia (77%)

            Chills (43%)

            Diarrhea (37%)

            Nausea (32%)

            Headache (28%)

            Tachycardia (26%)

            Hypotension (25%)

            Vomiting (25%)

            Hypertension (19%)

            Dyspnea (16%)

            Rash (14%)

            Edema (12%)

            1-10%

            Abnl chest sound (10%)

            Anorexia (10%)

            Tachycardia (10%)

            Chest pain (9%)

            Fatigue (9%)

            HTN (8%)

            Arthralgia (7%)

            Diaphoresis (7%)

            GI pain (7%)

            Hyperventilation (7%)

            Leukopenia (7%)

            Pruritis (7%)

            Vasodilation (7%)

            Abd pain (6%)

            Confusion (6%)

            Dizziness (6%)

            Lethargy (6%)

            Wheezing (6%)

            Anemia (2-5%)

            Arrhythmia (2-5%)

            Bradycardia (2-5%)

            Depression (2-5%)

            Malaise (2-5%)

            Nervousness (2-5%)

            Pulmonary edema (2-5%)

            Somnolence (2-5%)

            Thrombocytopenia, (2-5%)

            <1%

            Anaphylaxis (rare)

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            Warnings

            Black Box Warnings

            Only physicians experienced in immunosuppressive therapy and management of solid organ transplant patients should prescribe

            Anaphylactic or anaphylactoid reactions may occur following administration of any dose or course

            Serious and occasionally life-threatening systemic, cardiovascular, and CNS reactions (eg, pulmonary edema, especially in patients with volume overload; shock; cardiovascular collapse; cardiac or respiratory arrest; seizures; coma) have been reported

            Must be managed in a facility equipped and staffed for cardiopulmonary resuscitation

            Contraindications

            Hypersensitivity to any murine-derived products

            Anti-mouse Ab titers ≥ 1:1000

            Uncontrolled CHF or fluid overload, uncontrolled HTN, H/O seizures, pregnancy, breastfeeding

            Cautions

            Pretreatment with methylprednisone recommended

            Risk of anaphylaxis, cytokine-release syndrome (CRS: flu-like symptoms or shock), severe pulmonary edema; stabilize any cardiovascular pathologies before administration

            Anaphylaxis usually appears within 10 min of administration; CRS appears 30-60 min later

            Risk of seizure; monitor neurologic symptoms carefully during first 24 hr following the first few doses

            Risk of viral infection, lymphoproliferative neoplasia

            If temp >100°F, lower by antipyretics before next administration

            Monitor renal function, LFTs, WBCs, platelets; during treatment, monitor muromonab-CD3 levels & T cell clearance daily

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: not known if excreted in breast milk

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Blocks function of CD3 in T lymphocytes (involved in Ag recognition & signal transduction)

            Pharmacokinetics

            Onset: Minutes

            Duration: 1 week

            Minimum effective serum concentration: 800 ng/mL

            CD3+ cells return to normal levels within 1 week of discontinuation

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            Administration

            IV Administration

            Give IV push over <1 min undiluted

            Do not give IM

            Methylprednisolone sodium succinate 1 mg/kg IV given prior to first muromonab-CD3 administration, & IV hydrocortisone sodium succinate 50-100 mg, given 30 min after administration are strongly recommended to decrease the incidence of reaction to the first dose

            Filter each dose through a low protein-binding 0.22 micron filter before administration

            Pt temperature should not exceed 37.8°C (100°F) at time of administration

            Storage

            Refrigerate

            Do not shake or freeze

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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.