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Cytogam Generic Name & Formulations
Legal Class
Rx
General Description
Cytomegalovirus immune globulin (human) 50mg/mL; soln for IV infusion; preservative-free; contains sucrose.
Pharmacological Class
Immune globulin.
How Supplied
Single-dose vial (50mL)—1
Manufacturer
Cytogam Indications
Indications
For the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas and heart.
Cytogam Dosage and Administration
Adult
Kidney transplant: 150mg/kg within 72hrs of transplant, then 100mg/kg at 2 weeks, 4 weeks, 6 weeks, and 8 weeks post transplant, then 50mg/kg 12 weeks and 16 weeks post transplant. Liver, pancreas, lung, heart: 150mg/kg within 72hrs of transplant, then 150mg/kg 2 weeks, 4 weeks, 6 weeks. and 8 weeks post transplant, then 100mg/kg 12 weeks and 16 weeks post transplant. Initial dose: 15mg/kg/hr; if no adverse reactions after 30 minutes, may increase to 30mg/kg/hr; if no reactions after another 30 minutes, may increase to max 60mg/kg/hr (volume not to exceed 75mL/hr). Subsequent doses: 15mg/kg/hr for 15 minutes; if no reaction, increase to 30mg/kg/hr for 15 minutes and then to max rate of 60mg/kg/hr.
Children
Not recommended.
Cytogam Contraindications
Contraindications
Selective immunoglobulin A deficiency.
Cytogam Boxed Warnings
Not Applicable
Cytogam Warnings/Precautions
Warnings/Precautions
Renal insufficiency, diabetes, >65yrs, volume depletion, sepsis, paraproteinemia: increased risk of renal dysfunction or acute renal failure; monitor urine output, BUN, serum creatinine before and during treatment; consider discontinuing if renal function deteriorates. Correct hypovolemia before starting treatment. Contains human plasma; monitor for possible infection transmission. Cardiovascular disease. Coagulation disorders. Immobilized for long periods. Hyperviscosity (perform baseline assessment of blood viscosity). Monitor for hemolysis and hemolytic anemia. Monitor for pulmonary dysfunction; perform test for anti-neutrophil antibodies if transfusion-related acute lung injury (TRALI) suspected. Have epinephrine inj and diphenhydramine available; discontinue if hypotension or anaphylaxis occurs. Elderly. Neonates. Infants. Pregnancy (Cat.C).
Cytogam Pharmacokinetics
See Literature
Cytogam Interactions
Interactions
Avoid live viral vaccines. Concomitant nephrotoxic drugs: increased risk of acute renal failure.
Cytogam Adverse Reactions
Adverse Reactions
Flushing, chills, muscle cramps, back pain, fever, GI upset, arthralgia, wheezing; renal dysfunction (may be fatal); rare: hemolytic anemia, aseptic meningitis syndrome (esp. high dose of 2g/kg), TRALI, thrombosis.
Cytogam Clinical Trials
See Literature
Cytogam Note
Not Applicable
Cytogam Patient Counseling
See Literature
