Human cytomegalovirus immune globulin

Cytomegalovirus Immune Globulin Intravenous (Human) 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.

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 Preparation for Administration. Remove the tab portion of the vial cap and clean the rubber stopper with 70% alcohol or equivalent. DO NOT SHAKE VIAL, AVOID FOAMING. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

CytoGam ® should not be used 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 ®.

Because CMV-IGIV is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The risk of transmission of recognized blood-borne viruses is considered to be low because of the viral inactivation and removal properties in the Cohn-Oncley cold ethanol precipitation procedure used for purification of immune globulin products (13-15). Until 1993, cold ethanol manufactured immune globulins licensed in the United States had not been documented to transmit any viral agent. However, during a brief period in late 1993 to early 1994, intravenous immune globulin made by one U.S. manufacturer was associated with transmission of Hepatitis C virus.

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 of CytoGam ®, Cytomegalovirus Immune Globulin Intravenous (Human). The incidence of these reactions during the clinical trials was less than 6.0% of all infusions and such reactions were most often related to infusion rates. A decrease in blood pressure was observed in 1 of 1039 infusions in clinical trials of CytoGam ®. If a patient develops a minor side effect, slow the rate immediately or temporarily interrupt the infusion. 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.

Antibodies present in immune globulin preparations may interfere with the immune response to live virus vaccines such as measles, mumps, and rubella, therefore, vaccination with live virus vaccines should be deferred until approximately three months after administration of CytoGam ®. If such vaccinations were given shortly after CytoGam ®, a revaccination may be necessary. Admixtures of CytoGam ® with other drugs have not been evaluated. It is recommended that CytoGam ® be administered separately from other drugs or medications which the patient may be receiving.

CytoGam ® should be stored between 2-8°C (36-46°F) and used within 6 hours after entering the vial.