IntravenousProphylaxis of cytomegalovirus infection in organ transplantationAdult: For kidney transplant recipients: Initially, 150 mg/kg given within 72 hours of transplantation, followed by 100 mg/kg once every 2 weeks for 4 doses (2-,4-,6- and 8 weeks post-transplant), then 50 mg/kg once every 4 weeks for 2 doses (12- and 16 weeks post-transplant), thereafter. For heart, liver, lung, and pancreas transplant recipients: Initially, 150 mg/kg given within 72 hours of transplantation, then once every 2 weeks for 4 more doses (2-,4-,6- and 8 weeks post-transplant), followed by 100 mg/kg every 4 weeks for 2 doses (12- and 16 weeks post-transplant), thereafter. All doses are given via IV infusion at a rate of 15 mg/kg/hour, may be increased gradually according to patient safety. Max rate: 60 mg/kg/hour. In case of organ transplants from CMV seropositive donors to CMV seronegative recipients, concomitant use with ganciclovir may be considered. Dosing information may vary among countries, refer to specific product guideline or local guidelines.
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Hypersensitivity. Selective immunoglobulin A (IgA) deficiency.
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Patient with predisposing factors to acute renal failure (e.g. sepsis, paraproteinaemia, diabetes mellitus, volume depletion, receiving nephrotoxic drugs), pre-existing factors for thrombotic events (e.g. hypertension, advanced age, history of vascular disease or thrombotic episodes, known or suspected hyperviscosity, impaired cardiac output, prolonged periods of immobilisation, severe hypovolaemia, acquired or inherited thrombophilic disorders). Obese patient. Patient naive to human Ig, switched from another human Ig product, or who had a long infusion interval since the previous one. Renal impairment. Pregnancy.
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Significant: Hypersensitivity/anaphylactic reactions with hypotension; haemolytic anaemia, transfusion related acute lung injury (acute noncardiogenic pulmonary oedema), thromboembolic events (e.g. MI, stroke, DVT, pulmonary embolism), decreased neutrophil and/or neutropenia. Rarely, aseptic meningitis syndrome (high doses), acute renal impairment (including acute renal failure, increased serum creatinine, oliguria, osmotic nephrosis), haemolysis.
Gastrointestinal disorders: Nausea, vomiting.
General disorders and administration site conditions: Chills, fatigue, pyrexia.
Investigations: Increased BUN.
Musculoskeletal and connective tissue disorders: Arthralgia, back pain, muscle cramps.
Nervous system disorders: Headache, dizziness.
Respiratory, thoracic and mediastinal disorders: Wheezing.
Skin and subcutaneous tissue disorders: Rash, pruritus, drug eruption, erythema.
Vascular disorders: Flushing.
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Assess for volume depletion prior to therapy. Monitor urine output; renal function (e.g. BUN, serum creatinine prior to initiation and periodically thereafter); vital signs including blood pressure (during infusion); blood viscosity at baseline (in at-risk patients). Check for the presence of antineutrophil antibodies (if clinically indicated). Assess for signs and symptoms of anaphylactic reactions, infusion-related reactions (during and after infusion), and haemolytic anaemia.
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May diminish the therapeutic effect of live vaccines (e.g. measles, mumps, rubella, varicella vaccines).
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May cause false-positive results in serological tests (e.g. direct Coombs test).
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Description:
Mechanism of Action: Cytomegalovirus immunoglobulin is an immunoglobulin G (IgG) preparation that contains a high concentration of antibodies directed against cytomegalovirus (CMV). It raises the relevant antibodies to a level that is sufficient to attenuate or decrease the incidence of serious CMV disease in case of exposure.
Pharmacokinetics:
Distribution: Rapidly distributed between plasma and extravascular fluid. Crosses the placenta and enters breastmilk.
Excretion: Elimination half-life: 8-24 days.
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Store between 2-8°C. Do not freeze. Protect from light.
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J06BB09 - cytomegalovirus immunoglobulin ; Belongs to the class of specific immunoglobulins. Used in passive immunizations.
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Anon. Cytomegalovirus Immune Globulin (Intravenous-Human). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 30/06/2020. Anon. Cytomegalovirus Immune Globulin IV. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 30/06/2020. Buckingham R (ed). Cytomegalovirus Immunoglobulins. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 30/06/2020. Cytogam (CSL Behring AG). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 30/06/2020. Cytotect CP Biotest 100 U/mL Solution for Infusion (Biotest Pharma GmbH). MHRA. https://products.mhra.gov.uk/. Accessed 30/06/2020. Joint Formulary Committee. Cytomegalovirus Immunoglobulin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 30/06/2020.
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