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(MYOO-row-MOE-nab-CD3)
Orthoclone OKT3
Injection
5 mg/5 mL
Class: Murine monoclonal antibody

 Actions Blocks 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). During treatment with 5 mg/day for 14 days, mean serum trough levels rose over the first 3 days and then averaged 0.9 mcg/mL on days 3 to 14.

 Indications Treatment of renal, cardiac, or hepatic allograft rejection.

Prophylaxis and treatment of acute graft-versus-host disease (GVHD) in allogenic bone marrow transplantation.

 Contraindications Hypersensitivity to any product of murine origin; antimouse antibody titers ³ 1:1000; fluid overload or uncompensated heart failure; seizures or predisposition to seizures; pregnancy; breastfeeding.

 Route/Dosage Adults: IV 5 mg/day as bolus over < 1 min for 10 to 14 days.

Interactions

Immunosuppressants (eg, azathioprine, corticosteroids, cyclosporine)

Psychosis, infections, malignancies, seizures, encephalopathy, and thrombotic events have occurred with immunosuppressants alone and in conjunction with muromonab-CD3.

Indomethacin

May increase risk of encephalopathy and other CNS effects.

Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Cardiovascular 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. CNS: Headache; 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. DERMATOLOGIC: Rash; urticaria; pruritus; erythema; flushing; diaphoresis. GI: Anorexia; bowel infarction; elevated LFTs; hepatomegaly; splenomegaly or hepatitis. GU: Anuria; oliguria; delayed renal graft function; transient and reversible increases in blood urea nitrogen and serum creatinine; abnormal urinary cytology. HEMATOLOGIC: Pancytopenia; aplastic anemia; neutropenia; leukopenia; thrombocytopenia; lymphopenia; leukocytosis; lymphadenopathy; disturbances of coagulation. HYPERSENSITIVITY: Anaphylactic reaction, usually occurring with 10 min of administration; angioedema; reduced efficacy; serum sickness; arthritis; allergic interstitial nephritis; immune complex deposition. MUSCULOSKELETAL: Arthralgia; arthritis; myalgia; stiffness. RESPIRATORY: Dyspnea; shortness of breath; tachypnea; bronchospasm; respiratory arrest; adult respiratory distress syndrome; hypoxemia; apnea can occur during Cytokine Release Syndrome; nasal stuffiness. SPECIALSENSES: Blindness; blurred vision; diplopia; photophobia; conjunctivitis; hearing loss; otitis media; tinnitus; ear stuffiness. OTHER: Lymphoproliferative disorders including lymphomas; patients who receive > 1 course may have an increased risk of malignancy; infections; immunosuppression. Cytokine Release Syndrome (CRS): 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.

 Precautions

Pregnancy: Category C. Lactation: Undetermined. Children: Safety and efficacy not established. CRS: Temporally 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 cardiovascular and CNS manifestations. Common reactions include high, spiking fever; chills; rigors; headache; tremor; nausea; vomiting; diarrhea; abdominal pain; malaise; muscle and joint aches; weakness. Cardio-respiratory findings include dyspnea; shortness of breath; bronchospasm; tachypnea; respiratory arrest; cardiovascular 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. Hypersensitivity: Anaphylactic or anaphylactoid reactions may occur after administration of any dose or course of drug. Serious and occasionally life-threatening systemic, cardiovascular, and CNS reactions have been reported, including pulmonary edema (especially in patients with volume overload), shock, cardiovascular collapse, cardiac or respiratory arrest, seizures, and coma. Immunosuppression: Increases risk, severity and morbidity from infectious complications. Intravascular thrombosis: Arterial or venous thromboses of allografts and other vascular beds have been reported. Neoplasia: Immunosuppression can increase risk of malignancies developing. Neuropsychiatric events: Have occurred even after first dose and include seizures, encephalopathy, cerebral edema, aseptic meningitis syndrome, headache. Serum creatinine: During 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. Fluid status: Assess patients 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% above the patient’s minimum weight during the week prior to injection. Seizures: Seizures, some with loss of consciousness, cardiorespiratory arrest, or death, have occurred. Encephalopathy: May include impaired cognition, confusion, altered mental status, psychosis, mood changes, hyperreflexia, monoclonus, tremor, asterixis, major motor seizures, lethargy, auditory/visual hallucinations. Cerebral edema: Signs of increased vascular permeability (eg, otitis media, nasal and ear stuffiness). Headache: Headache is frequently seen after first few doses. Aseptic meningitis syndrome: The 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 coexisiting signs and symptoms of encephalopathy.

PATIENT CARE CONSIDERATIONS

 Administration/Storage

  • Unopened ampules are stable at room temperature for 48 hr.
  • Muromonab-CD3 is stable for £ 24 hr at room temperature or refrigerated when stored in plastic Becton-Dickinson syringes.
  • Withdraw medication through 0.2 to 0.22 mcg filter into syringe. Replace filter with needle.
  • Do not mix other medications in same IV line. If IV line must be used for other medications, flush line with saline before and after use.
  • Administer as IV bolus.
  • Store in refrigerator. Do not freeze or shake.

 Assessment/Interventions

  • Reassess for signs and symptoms of fluid overload, fever, chills, malaise, dyspnea, and neuropsychiatric events immediately after administration and for £ 6 hr after first dose.
  • Ensure availability of resuscitative equipment.
  • Reduce incidence and severity of CRS with premedication which is usually required only before the first dose. More serious complications of CRS may develop in patients with underlying cardiac, pulmonary, or neurologic disease. All patients should receive the following medications: methylprednisolone 8 mg/kg IV 1 to 4 hr before muromonab-CD3; diphenhydramine 50 mg PO or IV as a single dose given 30 min before muromonab-CD3 for adults; acetaminophen 650 mg PO or rectally as a single dose given 30 min before muromonab-CD3 in adults.
  • Assess patient’s volume status prior to administration. Patients should have a clear chest radiograph and £ 3% increase in weight over the last 7 days. Monitor I&O and weight daily.
  • Check temperature before administration. Do not give if patient’s temperature is > 37.8°C (100°F).
  • Monitor renal, hepatic, and hematopoietic function at baseline and periodically during therapy. Monitor immunologic tests, including 1 of the following: plasma muromonab-CD3 levels (desired concentration ³ 800 ng/mL); quantitative T-lymphocyte surface phenotyping, including CD3, CD4, and CD8 (desired target CD3(+) T cells < 25/mm3); human anti-mouse antibody (HAMA) titer. Desire titer < 1:1000. Patients may develop antibodies after treatment. In patients who have received ³ 1 course, measure HAMA before giving subsequent courses. Do not give if HAMA titer ³ 1:1000.
  • Consider reducing the dose of other immunosuppressants when starting muromonab-CD3. The previous maintenance dose can be resumed 3 days before stopping muromonab-CD3.
  • Initial response occurs in » 3.3 days. T-lymphocyte function returns to normal » 1 wk after discontinuation.
OVERDOSAGE: SIGNS & SYMPTOMS
  Hyperthermia; severe chills; myalgia; vomiting; diarrhea; edema; oliguria; pulmonary edema; acute renal failure; microangiopathic hemolytic anemia syndrome

 Patient/Family Education

  • Explain that it will be necessary to resume lifelong therapy with other immunosuppressive drugs after completing course of muromonab.
  • Instruct patient to report these symptoms to health care provider: chest pain, difficulty breathing, nausea, vomiting, fever, chills, sore throat, rash, rapid heartbeat, or swelling.
  • Advise patients of the signs and symptoms associated with CRS (eg, systemic, cardiovascular, neuro-psychiatric events) and the serious nature of these symptoms.
  • Advise patients to know how they might react before operating an automobile or machinery or engaging in activities requiring mental alertness, coordination, or physical dexterity.

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