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muromonab CD3 (Rx)Brand and Other Names:Orthoclone OKT3

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 1mg/mL
more...

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

5 mg IVP qDay x 10-14 days

Other Indications & Uses

Treatment of acute allograft rejection in renal transplant, with other immunosuppressants

Treatment of steroid-resistant acute allograft rejection in cardiac or hepatic transplant, with other immunosuppressants

Dosage Forms & Strengths

injectable solution

  • 1mg/mL
more...

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/cu.mm and serum muromonab-CD3 > 800 ng/mL

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Interactions

Interaction Checker

muromonab CD3 and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            Sort by :  
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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 w/ methylprednisone recommended

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

            Anaphylaxis usually appears w/in 10 min of administration; CRS appears 30-60 min later

            Risk of seizure; monitor neurologic Sx 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, Plts; during Tx, 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.

            more...
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            Pharmacology

            Onset: minutes

            Duration: 1 wk

            Minimum effective serum concentration: 800 ng/mL

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

            Mechanism of Action

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

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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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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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