Cytomegalovirus immunoglobulin human parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Infusions of cytomegalovirus immunoglobulin human.
Drugs List
Therapeutic Indications
Uses
Prevention of CMV disease in patients receiving immunosuppressive therapy
Dosage
Administration should be initiated on the day of transplantation. In the case of bone marrow transplantation, prophylaxis up to 10 days prior to transplantation can be expected, particularly in cytomegalovirus sero-positive patients. A total of 6 single doses at 2 to 3 week intervals should be given.
Adults
Single dose: 1ml/kg bodyweight.
Children
Single dose: 1ml/kg bodyweight.
Additional Dosage Information
In the case of adverse reaction, the rate of administration must be reduced or the infusion stopped. If well tolerated the rate of administration may be gradually increased to a maximum of 0.8ml/kg bodyweight per hour for the remainder of the infusion.
Administration
For intravenous infusion at an initial rate of 0.08ml/kg bodyweight per hour for 10 minutes.
Contraindications
Immunoglobulin A deficiency with IgA antibodies
Precautions and Warnings
Elderly
Obesity
Predisposition to thromboembolic disease
Untreated infection or underlying chronic inflammation
Breastfeeding
Diabetes mellitus
Hypovolaemia
Pregnancy
Renal impairment
Live virus vaccine should not be given for 3 months after treatment
Advise ability to drive/operate machinery may be affected by side effects
Derived from human blood - transmission of infectious agents possible
Do not mix with other drugs or substances
If adverse reactions occur, reduce rate or temporarily stop infusion
Monitor throughout infusion and for 1 hour post first infusion
Record name and batch number of administered product
Monitor renal function before treatment and regularly during treatment
Ensure adequate hydration prior to infusion
Monitor patient closely for haemolysis
Monitor serum creatine periodically
Monitor urine output
Discontinue if signs of pulmonary distress
Management of cases of shock should follow current medical standards
May affect results of some laboratory tests
Discontinue if Aseptic Meningitis Syndrome occurs
Discontinue if renal function deteriorates
Measles vaccine may not be effective for up to 1 year after treatment
Patients naive to human immunoglobulin, patients switched from an intravenous human immunoglobulin product or when there has been a long interval since the previous infusion, should be monitored at the hospital during the first infusion and for the first hour after the infusion in order to detect potential adverse signs. All other patients should be observed for at least 20 minutes after administration.
In patients at risk of thromboembolic adverse reactions or acute renal failure, intravenous human immunoglobulin products should be administered at the minimum rate of infusion and dose practicable.
Risk factors for acute renal failure should identified, such as pre-existing renal insufficiency, diabetes mellitus, hypovolaemia, overweight, concomitant nephrotoxic medicinal products or age over 65 years.
Patients showing signs of aseptic meningitis syndrome (AMS) should receive a thorough neurological examination, including cerebrospinal fluid (CSF) analysis to rule out other causes of meningitis.
Pregnancy and Lactation
Pregnancy
Use cytomegalovirus immunoglobulin human with caution during pregnancy.
The manufacturer advises caution if cytomegalovirus immunoglobulin human is used during pregnancy. At the time of writing there is limited published information regarding the use of cytomegalovirus immunoglobulin human during pregnancy. Intravenous human immunoglobulin products have been shown to cross the placenta, increasingly during the third trimester. Potential risks are unknown.
Lactation
Use cytomegalovirus immunoglobulin human with caution during breastfeeding.
The manufacturer advises caution if cytomegalovirus immunoglobulin human is used when breastfeeding. Whilst available data indicates immunoglobulins are present in human breast milk, the quantity is not considered to be sufficient to cause adverse effects in the breastfed infant. Effects on exposed infants are unknown.
Side Effects
Acute renal failure
Allergic reaction
Anaphylactic reaction
Anaphylactic shock
Anaphylactoid reaction
Arthralgia
Aseptic meningitis
Back pain
Chills
Decrease in blood pressure
Deep vein thrombosis (DVT)
Dizziness
Erythema
Fatigue
Fever
Fixed drug eruption
Haemolytic anaemia
Haemolytic transfusion reaction
Headache
Hypersensitivity reactions
Lupus erythematosus
Myocardial infarction
Nausea
Pruritus
Pulmonary embolism
Pyrexia
Rash
Serum creatinine increased
Stroke
Thromboembolic complications
Transfusion related acute lung injury (TRALI)
Vomiting
Effects on Laboratory Tests
Administration of immunoglobulin may cause the transient rise of various antibodies in the patient's blood. This may result in misleading positive results in serological testing for red cell antibodies, for example the direct antiglobulin test (Coombs' test).
Further Information
Last Full Review Date: April 2020
Reference Sources
Summary of Product Characteristics: Cytotect CP Biotest 100 U/ml solution for infusion. Biotest Pharma GmbH. Revised January 2020.
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