CYTOGAM Solution for infusion (2018)

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CSL Behring AG

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1. Description

CYTOGAM, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV), is an immunoglobulin G (IgG) containing a standardized amount of antibody to Cytomegalovirus (CMV). CMV-IGIV is formulated in final ...

2. Clinical Pharmacology

CYTOGAM contains IgG antibodies representative of the large number of normal persons who contributed to the plasma pools from which the product was derived. The globulin contains a relatively high concentration ...

3. Indications and Usage

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 ...

4. Contraindications

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 ...

5. Warnings

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 ...

6. Precautions

Renal Function Assure that patients are not volume depleted prior to the initiation of IGIV. Periodic monitoring of renal function tests and urine output is particularly important in patients judged to ...

6.1. General

CYTOGAM does not contain a preservative. The vial should be entered only once for administration purposes and the infusion should begin within 6 hours. The infusion schedule should be adhered to closely ...

6.2. Information for Patients

Patients should be instructed to report all infections directly to their physician and to CSL Behring Pharmacovigilance at 1-866-915-6958. The risks and benefits of this product should be discussed with ...

6.3. Laboratory Tests

If signs and/or symptoms of hemolysis are present after IGIV infusion, appropriate confirmatory laboratory testing should be done (see PRECAUTIONS). If TRALI is suspected, appropriate tests should ...

6.4. Drug Interactions

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 ...

6.7. Pregnancy

Animal reproduction studies have not been conducted with Cytomegalovirus Immune Globulin Intravenous (Human). It is also not known whether Cytomegalovirus Immune Globulin Intravenous (Human) can cause ...

7. Adverse Reactions

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, ...

9. Overdosage

Although few data are available, clinical experience with other immunoglobulin preparations suggests that the major manifestations would be those related to volume overload.

10. Dosage and Administration

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 ...

11. How Supplied

CYTOGAM is supplied in a 50 mL single-dose vial (50 mg/mL). The product presentation includes a package insert and the following component: Presentation Carton NDC Number Component 2.5 g 44206-532-11 ...

12. Storage and Handling

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

13. Clinical Studies

Clinical studies have shown a 50% reduction in primary CMV disease in renal transplant patients given CMV-IGIV 3 and a 56% reduction in serious CMV disease4 in liver transplant patients ...

14. References

Snydman DR, McIver J, Leszczynski J, et al. A pilot trial of a novel cytomegalovirus immune globulin in renal transplant recipients. Transplantation 1984;38:553-557. Horowitz B, Wiebe ME, Lippin A, et ...