Cytomegalovirus Immune Globulin (Intravenous-Human)

Pronunciation

(sye toe meg a low VYE rus i MYUN GLOB yoo lin in tra VEE nus HYU man)

U.S. Brand Names

CytoGam®

Synonyms

CMV-IGIV

Generic Available

No

Use

Prophylaxis of cytomegalovirus (CMV) disease associated with kidney, lung, liver, pancreas, and heart transplants; concomitant use with ganciclovir should be considered in organ transplants (other than kidney) from CMV seropositive donors to CMV seronegative recipients

Use - Unlabeled/Investigational

Adjunct therapy in the treatment of CMV disease in immunocompromised patients

Pregnancy Risk Factor

C

Pregnancy Implications

Reproduction studies have not been conducted.

Lactation

Excretion in breast milk unknown

Contraindications

Hypersensitivity to CMV-IGIV, other immunoglobulins, or any component of the formulation; immunoglobulin A deficiency

Warnings/Precautions

Monitor for anaphylactic reactions; epinephrine and diphenhydramine should be available during infusion. Made from pooled human plasma; may theoretically transmit blood-borne viruses. Human immune globulins are associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death; risk is increased in products containing sucrose. Use with caution in patients with renal insufficiency, diabetes mellitus, patients >65 years of age, volume depletion, sepsis, paraproteinemia, or patients on concomitant nephrotoxic drugs. Administer only if patient is euvolemic prior to therapy. Aseptic meningitis syndrome (AMS) may occur within hours to 2 days of treatment; occurs more frequently with high-dose treatment. Stabilized with sucrose and albumin, contains no preservative.

Adverse Reactions

<6%:

Cardiovascular: Flushing

Central nervous system: Fever, chills

Gastrointestinal: Nausea, vomiting

Neuromuscular & skeletal: Arthralgia, back pain, muscle cramps

Respiratory: Wheezing

<1%: Blood pressure decreased

Postmarketing and/or case reports: Acute renal failure, acute tubular necrosis, anaphylactic shock, angioneurotic edema, anuria, aseptic meningitis syndrome (AMS), BUN increased, serum creatinine increased, oliguria, osmotic nephrosis, proximal tubular nephropathy

Overdosage/Toxicology

Symptoms related to volume overload would be expected to occur with overdose; treatment is symptom-directed and supportive.

Drug Interactions

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

Stability

Store between 2°C and 8°C (35.6°F and 46.4°F). Use reconstituted product within 6 hours; do not admix with other medications; do not use if turbid. Do not shake vials. Dilution is not recommended. Infusion with other products is not recommended. If unavoidable, may be piggybacked into an I.V. line of sodium chloride, 2.5% dextrose in water, 5% dextrose in water, 10% dextrose in water, or 20% dextrose in water. Do not dilute more than 1:2.

Compatibility

Infusion with other products is not recommended. If unavoidable, may be piggybacked into an I.V. line of sodium chloride, 2.5% dextrose in water, 5% dextrose in water, 10% dextrose in water, or 20% dextrose in water. Do not dilute more than 1:2.

Mechanism of Action

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

Dosage

I.V.: Adults:

Kidney transplant:

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

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

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

Liver, lung, pancreas, or heart transplant:

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

2-, 4-, 6-, and 8 weeks after transplant: 150 mg/kg/dose

12 and 16 weeks after transplant: 100 mg/kg/dose

Severe CMV pneumonia: Various regimens have been used, including 400 mg/kg CMV-IGIV in combination with ganciclovir on days 1, 2, 7, or 8, followed by 200 mg/kg CMV-IGIV on days 14 and 21

Elderly: Use with caution in patients >65 years of age, may be at increased risk of renal insufficiency

Dosage adjustment in renal impairment: Use with caution; specific dosing adjustments are not available. Infusion rate should be the minimum practical; do not exceed 180 mg/kg/hour

Administration

Administer through an I.V. line containing an in-line filter (pore size 15 micron) using an infusion pump. Do not mix with other infusions; do not use if turbid. Begin infusion within 6 hours of entering vial, complete infusion within 12 hours.

Infuse at 15 mg/kg/hour. If no adverse reactions occur within 30 minutes, may increase rate to 30 mg/kg/hour. If no adverse reactions occur within the second 30 minutes, may increase rate to 60 mg/kg/hour; maximum rate of infusion: 75 mL/hour. When infusing subsequent doses, may decrease titration interval from 30 minutes to 15 minutes. If patient develops nausea, back pain, or flushing during infusion, slow the rate or temporarily stop the infusion. Discontinue if blood pressure drops or in case of anaphylactic reaction.

Monitoring Parameters

Vital signs (throughout infusion), flushing, chills, muscle cramps, back pain, fever, nausea, vomiting, wheezing, decreased blood pressure, or anaphylaxis; renal function and urine output

Patient Education

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 vaccinations for the next 3 months without consulting prescriber. Immediately report chills, muscle cramping, low back pain, chest pain or tightness, or respiratory difficulty. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.

Dental Health: Effects on Dental Treatment

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Mental Health: Effects on Mental Status

None reported

Mental Health: Effects on Psychiatric Treatment

None reported

Oncology: Emetic Potential

Very low (<10%)

Oncology: Vesicant

No

Dosage Forms

Injection, solution [preservative free]: 50 mg ± 10 mg/mL (50 mL) [contains human albumin and sucrose]

References

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.

"Renal Insufficiency and Failure Associated With Immune Globulin Intravenous Therapy - United States, 1985-1998."MMWR Morb Mortal Wkly Rep, 1999, 48(24):518-21.

Snydman DR, "Cytomegalovirus Immunoglobulins in the Prevention and Treatment of Cytomegalovirus Disease,"Rev Infect Dis, 1990, 12(Suppl 7):839-48.