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|Muromonab-CD3 |
Drugs search, click the first letter of a drug name: | A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z | 1 | 2 | 3 | 4 | 5 | 6 | 8 | 9 Home Muromonab-CD3Pronouncation: (MYOO-row-MOE-nab-CD3)Class: Immunosuppressive Trade Names: Mechanism of ActionPharmacologyBlocks T-cell function, which plays major role in graft rejection, by reacting with and blocking T3 (CD3) molecule on membrane of human T cells associated with antigen recognition. Serum levels are measured with an enzyme-linked immunosorbent assay (ELISA). PharmacokineticsAbsorptionTime to steady-state trough levels is 3 days and C min is 0.9 mcg/mL with 5 mg/day (steady-state). OnsetOnset within minutes. DurationDuration is approximately 1 wk. Indications and UsageTreatment of renal, steroid resistant cardiac, or hepatic allograft rejection. ContraindicationsHypersensitivity to any product of murine origin; anti-mouse antibody titers at least 1:1,000; fluid overload or uncompensated heart failure; seizures or predisposition to seizures; pregnancy; breastfeeding; uncontrolled hypertension. Dosage and AdministrationAdultsIV 5 mg/day as bolus given over less than 1 min for 10 to 14 days. PediatricIV 2.5 mg/day in patients weighing 30 kg or less, and 5 mg/day in patients over 30 kg. As a single bolus given over less than 1 min for 10 to 14 days. Daily increases in doses (ie, 2.5 mg increments) may be required. General Advice
Storage/StabilityStore unopened vials in refrigerator (36° to 46° F). Do not freeze or shake. Drug InteractionsImmunosuppressants (eg, azathioprine, corticosteroids, cyclosporine)Psychosis, infections, malignancies, seizures, encephalopathy, and thrombotic events have occurred with immunosuppressants alone and in conjunction with muromonab-CD3. IndomethacinMay increase risk of encephalopathy and other CNS effects. Laboratory Test InteractionsNone well documented. Adverse ReactionsCardiovascularCV collapse; angina; MI; chest pain/tightness; bradycardia; tachycardia; hypertension; profound hypotension including shock, heart failure, pulmonary edema, arrhythmias; intravascular thrombosis; cerebrovascular accidents; transient ischemic attacks; hemodynamic instability, left ventricular dysfunction (postmarketing). CNSHeadache; tremor; dizziness; confusion; agitation; auditory and visual hallucinations; obtundation; mood changes; hypotonus; encephalopathy; cerebral edema; aseptic meningitis; encephalitis; aphasia; quadri- or paraparesis; hemiparesis; subarachnoid hemorrhage; vertigo; sixth cranial nerve palsy; hyperreflexia; myoclonus; hypotonus; asterixis; involuntary movements; tremor; cerebritis, cerebral herniation, cerebrovascular accident, CNS infection, CNS malignancy, intracranial hemorrhage, impaired cognition, status epilepticus, stupor, transient ischemic attack (postmarketing). DermatologicRash; urticaria; pruritus; erythema; flushing; diaphoresis; Stevens-Johnson syndrome (postmarketing). GIAnorexia; bowel infarction; elevated LFTs; hepatomegaly; splenomegaly or hepatitis. GenitourinaryAnuria; oliguria; delayed renal graft function; transient and reversible increases in blood urea nitrogen and serum creatinine; abnormal urinary cytology (eg, exfoliation of damaged lymphocytes and cellular casts); azotemia (postmarketing). HematologicPancytopenia; aplastic anemia; neutropenia; leukopenia; thrombocytopenia; lymphopenia; leukocytosis; lymphadenopathy; disturbances of coagulation; arterial venous and capillary thrombosis of allografts and other vascular beds (eg, bowel, brain, heart, lung), disseminated intravascular coagulation, microangiopathic changes (eg, platelet microthrombi), microangiopathic hemolytic anemia (postmarketing). HypersensitivityAnaphylactic reaction, usually occurring with 10 min of administration; angioedema; reduced efficacy of treatment; serum sickness; arthritis; allergic interstitial nephritis; immune complex deposition resulting in glomerulonephritis, vasculitis (including temporal and retinal) and eosinophilia. MusculoskeletalArthralgia; arthritis; myalgia; stiffness. RespiratoryDyspnea; shortness of breath; tachypnea; bronchospasm; respiratory arrest; adult respiratory distress syndrome; hypoxemia; apnea can occur during Cytokine Release Syndrome (CRS); nasal stuffiness. Special SensesBlindness; blurred vision; diplopia; photophobia; conjunctivitis; hearing loss; otitis media; tinnitus; ear stuffiness. MiscellaneousLymphoproliferative disorders including lymphomas; patients who receive more than 1 course may have an increased risk of malignancy; infections; immunosuppression; fever, chills, rigors, headache, tremor, nausea, vomiting, diarrhea, abdominal pain, malaise, muscle aches, joint aches, generalized weakness, most frequently develops within 30 to 60 min of administering the first 2 to 3 doses (CRS); flu-like syndrome (postmarketing). Precautions
PregnancyCategory C . LactationUndetermined. ChildrenSafety and effectiveness have been established in infants (1 mo to 2 yr of age); children (2 yr to 12 yr of age); and adolescents (12 yr to 16 yr of age). Aseptic meningitis syndromeThe incidence of aseptic meningitis syndrome was 6%. Fever (89%), headache (44%), meningismus (14%), and photophobia (10%) were the most common symptoms. Approximately 1/ 3 with this diagnosis had coexisting signs and symptoms of encephalopathy. Cerebral edemaSigns of increased vascular permeability (eg, otitis media, nasal and ear stuffiness). CRSTemporally associated with administration of first few doses of drug and linked to release of cytokines. Reactions range from mild flu-like illness to more rare and serious shock-like CV and CNS manifestations. Common reactions include high, spiking fever; chills; rigors; headache; tremor; nausea; vomiting; diarrhea; abdominal pain; malaise; muscle and joint aches; weakness. Cardiorespiratory findings include dyspnea; shortness of breath; bronchospasm; tachypnea; respiratory arrest; CV collapse; cardiac arrest; angina; MI; chest pain; tachycardia; hypertension; hemodynamic instability; hypotension; adult respiratory distress syndrome; pulmonary edema; hypoxemia; apnea; arrhythmias. Decreased urine output may occur. EncephalopathyMay include impaired cognition, confusion, altered mental status, psychosis, mood changes, hyperreflexia, monoclonus, tremor, asterixis, major motor seizures, lethargy, auditory/visual hallucinations. Fluid statusAssess patient"s fluid status prior to administration. No clinical evidence of volume overload or uncompensated heart failure, including a clear chest x-ray and weight restriction of 3% or less above the patient"s minimum weight during the week prior to injection. HeadacheHeadache is frequently seen after first few doses. ImmunosuppressionIncreases risk, severity, and morbidity from infectious complications. Intravascular thrombosisArterial or venous thromboses of allografts and other vascular beds have been reported. NeoplasiaImmunosuppression can increase risk of malignancies developing. Neuropsychiatric eventsHave occurred even after first dose and include seizures, encephalopathy, cerebral edema, aseptic meningitis syndrome, headache. SeizuresSeizures, some with loss of consciousness, cardiorespiratory arrest, or death, have occurred. Serum creatinineDuring the first 1 to 3 days of therapy, some patients have experienced an acute and transient decline in glomerular filtration rate and diminished urine output with an increase in serum creatinine. OverdosageSymptomsHyperthermia; severe chills; myalgia; vomiting; diarrhea; edema; oliguria; pulmonary edema; acute renal failure; microangiopathic hemolytic anemia syndrome. Patient Information
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