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

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            Contraindicated (0)

              Serious - Use Alternative (70)

              • adalimumab

                adalimumab and muromonab CD3 both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • adenovirus types 4 and 7 live, oral

                muromonab CD3 decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of immunosuppressive therapy.

              • alefacept

                alefacept and muromonab CD3 both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • anakinra

                anakinra and muromonab CD3 both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • anthrax vaccine

                muromonab CD3 decreases effects of anthrax vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • antithymocyte globulin equine

                antithymocyte globulin equine and muromonab CD3 both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • antithymocyte globulin rabbit

                antithymocyte globulin rabbit and muromonab CD3 both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • axicabtagene ciloleucel

                muromonab CD3, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • azathioprine

                azathioprine and muromonab CD3 both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • basiliximab

                basiliximab and muromonab CD3 both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • BCG vaccine live

                muromonab CD3 decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • brexucabtagene autoleucel

                muromonab CD3, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • canakinumab

                canakinumab and muromonab CD3 both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • ciltacabtagene autoleucel

                muromonab CD3, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • cyclosporine

                cyclosporine and muromonab CD3 both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • diphtheria & tetanus toxoids

                muromonab CD3 decreases effects of diphtheria & tetanus toxoids by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • diphtheria & tetanus toxoids/ acellular pertussis vaccine

                muromonab CD3 decreases effects of diphtheria & tetanus toxoids/ acellular pertussis vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine

                muromonab CD3 decreases effects of diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • etanercept

                etanercept and muromonab CD3 both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • everolimus

                everolimus and muromonab CD3 both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • glatiramer

                glatiramer and muromonab CD3 both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • golimumab

                golimumab and muromonab CD3 both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • hepatitis A vaccine inactivated

                muromonab CD3 decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • hepatitis a/b vaccine

                muromonab CD3 decreases effects of hepatitis a/b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • hepatitis a/typhoid vaccine

                muromonab CD3 decreases effects of hepatitis a/typhoid vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • hepatitis b vaccine

                muromonab CD3 decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • human papillomavirus vaccine, nonavalent

                muromonab CD3 decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • human papillomavirus vaccine, quadrivalent

                muromonab CD3 decreases effects of human papillomavirus vaccine, quadrivalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • hydroxychloroquine sulfate

                hydroxychloroquine sulfate and muromonab CD3 both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • idecabtagene vicleucel

                muromonab CD3, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • infliximab

                infliximab and muromonab CD3 both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • influenza virus vaccine quadrivalent

                muromonab CD3 decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • influenza virus vaccine quadrivalent, adjuvanted

                muromonab CD3 decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

              • influenza virus vaccine quadrivalent, cell-cultured

                muromonab CD3 decreases effects of influenza virus vaccine quadrivalent, cell-cultured by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • influenza virus vaccine quadrivalent, intranasal

                muromonab CD3 decreases effects of influenza virus vaccine quadrivalent, intranasal by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • influenza virus vaccine trivalent

                muromonab CD3 decreases effects of influenza virus vaccine trivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • influenza virus vaccine trivalent, adjuvanted

                muromonab CD3 decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

              • Japanese encephalitis virus vaccine

                muromonab CD3 decreases effects of Japanese encephalitis virus vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • leflunomide

                leflunomide and muromonab CD3 both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • lisocabtagene maraleucel

                muromonab CD3, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • measles (rubeola) vaccine

                muromonab CD3 decreases effects of measles (rubeola) vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • measles mumps and rubella vaccine, live

                muromonab CD3 decreases effects of measles mumps and rubella vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • measles, mumps, rubella and varicella vaccine, live

                muromonab CD3 decreases effects of measles, mumps, rubella and varicella vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • meningococcal A C Y and W-135 polysaccharide vaccine combined

                muromonab CD3 decreases effects of meningococcal A C Y and W-135 polysaccharide vaccine combined by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • mycophenolate

                muromonab CD3 and mycophenolate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • pneumococcal vaccine 13-valent

                muromonab CD3 decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • pneumococcal vaccine heptavalent

                muromonab CD3 decreases effects of pneumococcal vaccine heptavalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • pneumococcal vaccine polyvalent

                muromonab CD3 decreases effects of pneumococcal vaccine polyvalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • rabies vaccine

                muromonab CD3 decreases effects of rabies vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants may interfere with development of active immunity.

              • rabies vaccine chick embryo cell derived

                muromonab CD3 decreases effects of rabies vaccine chick embryo cell derived by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • rilonacept

                muromonab CD3 and rilonacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • rotavirus oral vaccine, live

                muromonab CD3 decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • rubella vaccine

                muromonab CD3 decreases effects of rubella vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • sirolimus

                muromonab CD3 and sirolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • smallpox (vaccinia) vaccine, live

                muromonab CD3 decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • tacrolimus

                muromonab CD3 and tacrolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • temsirolimus

                muromonab CD3 and temsirolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • tetanus toxoid adsorbed or fluid

                muromonab CD3 decreases effects of tetanus toxoid adsorbed or fluid by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • tick-borne encephalitis vaccine

                muromonab CD3 decreases effects of tick-borne encephalitis vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • tisagenlecleucel

                muromonab CD3, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • tocilizumab

                tocilizumab and muromonab CD3 both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • tofacitinib

                muromonab CD3, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • tongkat ali

                muromonab CD3 and tongkat ali both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • travelers diarrhea and cholera vaccine inactivated

                muromonab CD3 decreases effects of travelers diarrhea and cholera vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • typhoid polysaccharide vaccine

                muromonab CD3 decreases effects of typhoid polysaccharide vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • typhoid vaccine live

                muromonab CD3 decreases effects of typhoid vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • ustekinumab

                muromonab CD3 and ustekinumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • varicella virus vaccine live

                muromonab CD3 decreases effects of varicella virus vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • yellow fever vaccine

                muromonab CD3 decreases effects of yellow fever vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • zoster vaccine live

                muromonab CD3 decreases effects of zoster vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              Monitor Closely (24)

              • astragalus

                muromonab CD3 increases and astragalus decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • belatacept

                belatacept and muromonab CD3 both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.

              • cholera vaccine

                muromonab CD3 decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.

              • dengue vaccine

                muromonab CD3 decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.

              • denosumab

                muromonab CD3, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • echinacea

                muromonab CD3 increases and echinacea decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • fingolimod

                muromonab CD3 increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

              • haemophilus influenzae type b vaccine

                muromonab CD3 decreases effects of haemophilus influenzae type b vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Avoid vaccination during chemotherapy or radiation therapy if possible because antibody response might be suboptimal. Patients vaccinated within a 14-day period before starting or during immunosuppressive therapy should be revaccinated =3 months after therapy is discontinued if immune competence has been restored. .

              • influenza virus vaccine quadrivalent, recombinant

                muromonab CD3 decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

              • influenza virus vaccine trivalent, recombinant

                muromonab CD3 decreases effects of influenza virus vaccine trivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

              • isavuconazonium sulfate

                muromonab CD3 and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.

              • maitake

                muromonab CD3 increases and maitake decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • meningococcal group B vaccine

                muromonab CD3 decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.

              • mercaptopurine

                mercaptopurine and muromonab CD3 both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.

              • methotrexate

                methotrexate and muromonab CD3 both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Combination may increase risk of myelosuppression.

              • ocrelizumab

                muromonab CD3 and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with immunosuppressants may increase the risk of immunosuppression.

              • ofatumumab SC

                ofatumumab SC, muromonab CD3. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

              • olaparib

                muromonab CD3 and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.

              • ozanimod

                ozanimod, muromonab CD3. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration with immunosuppressive therapies may increase the risk of additive immune effects during therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs in order to avoid unintended additive immunosuppressive effects.

              • poliovirus vaccine inactivated

                muromonab CD3 decreases effects of poliovirus vaccine inactivated by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Avoid vaccination during chemotherapy or radiation therapy if possible because antibody response might be suboptimal. Patients vaccinated within a 14-day period before starting or during immunosuppressive therapy should be revaccinated =3 months after therapy is discontinued if immune competence has been restored. .

              • ponesimod

                ponesimod and muromonab CD3 both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • siponimod

                siponimod and muromonab CD3 both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • sipuleucel-T

                muromonab CD3 decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • zoster vaccine recombinant

                muromonab CD3 decreases effects of zoster vaccine recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce the effectiveness of zoster vaccine recombinant.

              Minor (0)

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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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                Patient Handout

                A Patient Handout is not currently available for this monograph.
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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.