No

Immune Globulin

Attenuation of primary CMV disease associated with immunosuppressed recipients of kidney transplantation; especially indicated for CMV-negative recipients of CMV-positive donor; has been used as adjunct therapy in the treatment of CMV disease in immunocompromised patients

C

Hypersensitivity to any component, patients with selective immunoglobulin A deficiency ( potential for anaphylaxis); persons with IgA deficiency

Studies indicate that product carries little or no risk for transmission of HIV; give with caution to patients with prior allergic reactions to human immunoglobulin preparations; do not perform skin testing

1% to 10%:

Cardiovascular: Flushing of face

Gastrointestinal: Nausea, vomiting

Neuromuscular & skeletal: Muscle cramps, back pain

Respiratory: Wheezing

Miscellaneous: Diaphoresis

<1%: Tightness in the chest, dizziness, fever, headache, chills, aseptic meningitis syndrome, hypersensitivity reactions

May inactivate live virus vaccines (eg, measles, mumps, rubella); if IGIV administration within 3 months of vaccination with live virus products, revaccinate

Use reconstituted product within 6 hours; do not admix with other medications

CMV-IGIV is a preparation of immunoglobulin G derived from pooled healthy blood donors with a high titer of CMV antibodies; administration provides a passive source of antibodies against cytomegalovirus

I.V.:

Initial dose (within 72 hours after transplant): 150 mg/kg/dose

2, 4, 6, 8 weeks after transplant: 100 mg/kg/dose

12 and 16 weeks after transplant: 50 mg/kg/dose

Severe CMV pneumonia: Regimens of 400 mg/kg on days 1, 2, 7 or 8, followed by 200 mg/kg have been used

Administration rate: Administer at 15 mg/kg/hour initially, then increase to 30 mg/kg/hour after 30 minutes if no untoward reactions, then increase to 60 mg/kg/hour after another 30 minutes; volume not to exceed 75 mL/hour

This medication can only be administered by infusion. You will be monitored closely during the infusion. If you experience nausea ask for assistance, do not get up alone. Do not have any vaccination for the next 3 months without consulting prescriber. Immediately report chills, muscle cramping, low back pain, chest pain or tightness, or difficulty breathing. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Consult prescriber if breast-feeding.

I.V. use only; administer as separate infusion if pre-existing line; must be used diluted no more than 1:2

Powder for injection, lyophilized, detergent treated: 2500 mg ± 250 mg (50 mL)

Levinson ML and Jacobson PA, "Treatment and Prophylaxis of Cytomegalovirus Disease," Pharmacotherapy, 1992, 12(4):300-18.

Reed EC, Bowden RA, Dandliker PS, et al, "Efficacy of Cytomegalovirus Immunoglobulin in Marrow Transplant Recipients With Cytomegalovirus Pneumonia," J Infect Dis, 1987, 156:641-5.

Reed EC, Bowden RA, Dandliker PS, et al, "Treatment of Cytomegalovirus Pneumonia With Ganciclovir and Intravenous Cytomegalovirus Immunoglobulin in Patients With Bone Marrow Transplants," Ann Intern Med, 1988, 109:783-8.

Snydman DR, "Cytomegalovirus Immunoglobulins in the Prevention and Treatment of Cytomegalovirus Disease," Rev Infect Dis, 1990, 12(Suppl 7):S839-48.