Dosing and uses of CytoGam, cmv ig (cytomegalovirus immune globulin (CMV IG))
Adult dosage forms and strengths
injectable solution
- 50±10mg/mL (20mL, 50mL)
Cytomegalovirus Prophylaxis
Monitor vital signs preinfusion, during infusion & postinfusion, renal function
Kidney Transplant
- 150 mg/kg IV infusion within 72 hours of transplant, THEN 100 mg/kg 2, 4, 6, 8 weeks posttransplant, THEN 50 mg/kg 12 & 16 weeks posttransplant
Liver, Pancreas, Heart, Lung Transplant
- 150 mg/kg IV infusion within 72 hours of transplant & 2, 4, 6, 8 weeks posttransplant, THEN 100 mg/kg 12 & 16 weeks posttransplant
CMV Pneumonia (Orphan)
For use in conjunction with ganciclovir sodium for the treatment of cytomegalovirus pneumonia in bone marrow transplant patients
Orphan indication sponsor
- Bayer Corporation, Pharmaceutical Division, Biological Products; 400 Morgan Lane; New Haven, CT 06516
Pediatric dosage forms and strengths
injectable solution
- 50±10mg/mL (20mL, 50mL)
Congenital CMV (Orphan)
Prevention of congenital cytomegalovirus (CMV) infection following primary CMV infection in pregnant women
Orphan indication sponsor
- Biotest Pharmaceuticals Corporation; 5800 Park of Commerce Blvd, NW; Boca Raton, FL 33487
CytoGam, cmv ig (cytomegalovirus immune globulin (CMV IG)) adverse (side) effects
1-10%
Diaphoresis
Flushing, FaciaL
Fever
Shivering
Nausea, Vomiting
Arthralgia
Backache
Muscle cramps
Wheezing
<1%
Anaphylaxis (rare)
Aseptic meningitis (Rare)
Warnings
Contraindications
History of severe rxn to immune globulins
Cautions
Made from human donors, so theoretical risk of pathogen transmission
Contains sucrose as stabilizer, associated with higher risk of IV immune globulin-related renal dysfunction
Possibility of other adverse rxns associated with IV immune globulins, eg, aseptic meningitis synd, transfusion-related acute lung injury
Renal impairment
Pregnancy and lactation
Pregnancy category: C
Lactation: excretion in milk unknown
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of CytoGam, cmv ig (cytomegalovirus immune globulin (CMV IG))
Metabolism: N/A
Excretion: N/A
Mechanism of action
IgG antibodies to CMV pooled from human donors
Administration
IV Administration
Does not contain preservatives so begin infusion within 6 hr of entering into vial & complete within 12 hr
Do not dilute
Do not shake vial: avoid foaming
Do not use if discoloration/particulate matter/turbidity
Administer thru IV line with in-line filter (15 micron) & infusion pump. Separate IV line preferred but may be given IVPB into preexisting line with NS or D20W, D10W, D5W & D2.5W with or without NaCl. If preexisiting line must be used, do not dilute CytoGam more than 1:2
Administer initial dose at 15 mg/kg/hr, after 30 min incr to 30 mg/kg/hr x 30 min, then to 60 mg/kg/hr provided no adverse rxns occur at either step. NMT 75 mL/hr Subsequent doses start 15 mg/kg/hr x15 min, then 30 mg/kg/hr x15 min, then 60 mg/kg/hr provided no adverse rxns; NMT 75 mL/hr
Adverse rxns may require slowing/interrupting infusion
