Indication1
Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV) is indicated for the prophylaxis of cytomegalovirus
(CMV) disease associated with transplantation of kidney, lung, liver, pancreas, and heart. In transplants of these
organs other than kidney from CMV seropositive donors into seronegative recipients, prophylactic CMV-IGIV should
be considered in combination with ganciclovir.

Product Description1
Cytogam® Cytomegalovirus Immune Globulin Intravenous (Human) is an immunoglobulin G (IgG) containing a standardized
amount of antibody to CMV.
• CMV-IGIV is formulated in final vial as a sterile liquid.
• The globulin is stabilized with 5% sucrose and 1% albumin (Human).
• Cytogam contains no preservatives.
• Cytogam is supplied in a 50 mL single-dose vial (50 mg/mL).
• Cytogam should be stored between 2-8°C (36-46°F) and used within 6 hours after entering the vial.

 

NDC Code Size Concentration
  NDC 44206-532-90
50 mL vial 50 mg/mL

 

Dosage and Administration1


Dosage


Dosing is based on body weight. The maximum recommended total dosage per infusion is 150 mg Ig/kg, administered
according to the following schedule:

                                                                                                                         Type of Transplant


Kidney Liver, Pancreas, Lung, Heart
Within 72 hours of transplant 150 mg/kg 150 mg/kg
2 weeks post transplant 100 mg/kg 150 mg/kg
4 weeks post transplant 100 mg/kg 150 mg/kg
6 weeks post transplant 100 mg/kg 150 mg/kg
8 weeks post transplant 100 mg/kg 150 mg/kg
12 weeks post transplant 50 mg/kg 100 mg/kg
16 weeks post transplant 50 mg/kg 100 mg/kg

Administration


Cytogam is for intravenous infusion only. Infusion should begin within 6 hours after entering the vial and should be
complete within 12 hours of entering the vial.

Vital signs should be taken preinfusion, mid-way and post-infusion as well as before any rate increase.

Initial Dose:
• Administer intravenously at 15 mg Ig/kg/hr.
• If no adverse reactions occur after 30 minutes, the rate may be increased to 30 mg Ig/kg/hr.
• If no adverse reactions occur after a subsequent 30 minutes, then the infusion may be increased to 60 mg Ig/kg/hr
(volume not to exceed 75 mL/hr).
• DO NOT EXCEED THIS RATE OF ADMINISTRATION.

The patient should be monitored closely during and after each rate change.

Subsequent Doses:
• Administer at 15 mg Ig/kg/hr for 15 minutes.
• If no adverse reactions occur, increase to 30 mg Ig kg per hr for 15 minutes.
• Then increase to a maximum rate of 60 mg Ig/kg/hr (volume not to exceed 75 mL/hr).
• DO NOT EXCEED THIS RATE OF ADMINISTRATION.

The patient should be monitored closely during and after each rate change.

Infusion:
• Cytogam should be administered through an intravenous line using an administration set that contains an in-line
filter and a constant infusion pump.
• Predilution of Cytogam before infusion is not recommended.
• Cytogam should be administered through a separate intravenous line.

Storage and Handling1


Cytogam should be stored between 2-8°C (36-46°F) and used within 6 hours after entering the vial. Do not freeze.
Do not use after the expiration date.

For Cytogam product inquiries, call 877-CMV-2449

 

 

Selected Important Safety Information for Cytogam® (Cytomegalovirus Immune Globulin Intravenous [Human])

Cytogam is indicated for the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas, and heart. In transplants of these organs other than kidney from CMV seropositive donors into seronegative recipients, prophylactic CMV-IGIV should be considered in combination with ganciclovir.

Cytogam is contraindicated in individuals with a history of a prior severe reaction associated with the administration of this or other human immunoglobulin preparations. Persons with selective immunoglobulin A deficiency have the potential for developing antibodies to immunoglobulin A and could have anaphylactic reactions to subsequent administration of blood products that contain immunoglobulin A, including Cytogam.

Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients with any degree of preexisting renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentrations available and the minimum rate of infusion practicable. Agents containing sucrose as a stabilizer (Cytogam contains sucrose) have been associated with reports of renal dysfunction given at daily doses of 350 mg/kg or greater.

During administration, the patient’s vital signs should be monitored continuously, and careful observation made for any symptoms throughout the infusion. Epinephrine and diphenhydramine should be available for the treatment of an acute anaphylactic reaction.

Increases in serum creatinine and blood urea nitrogen (BUN) have been observed as soon as one to two days following IGIV infusion. Progression to oliguria or anuria requiring dialysis has been observed.

Immune Globulin Intravenous (Human) products can contain blood group antibodies which may act as hemolysins and induce in vivo coating of red blood cells with immunoglobulin, causing a positive direct antiglobulin reaction and, rarely, hemolysis.

Cytogam is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

Minor reactions, such as flushing, chills, muscle cramps, back pain, fever, nausea, vomiting, arthralgia, and wheezing, were the most frequent adverse reactions observed during the clinical trials for Cytogam.

Please see Prescribing Information for full prescribing details.

To report SUSPECTED ADVERSE REACTIONS, contact Saol Therapeutics at 1-833-644-4216 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

1 Cytogam Prescribing Information May 2018