Cytomegalovirus immune globulin (CMV IG) (injection)

CMV IG is a clean solution made from human plasma. It has antibodies that help your body defend itself against infection from cytomegalovirus.

CMV IG is used to help prevent cytomegalovirus infection in people who are getting an organ transplant (kidney, heart, liver, lung, or pancreas).

CMV IG may also be used for reasons not mentioned in this medication guide.

CMV IG is given as an injection into a vein using an IV. A healthcare provider will administer this injection.

CMV IG is typically given within 72 hours after your transplant. You will then get several more doses every 2 to 4 weeks after that.

While you are receiving CMV IG, you may need to have frequent blood tests. Your kidney function may also need to be monitored.

You should not use this medicine if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA.

You should not use cytomegalovirus immune globulin (CMV IG) if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA.

To make sure CMV IG is safe for you, tell your doctor if you have:

• kidney disease;
• diabetes;
• a history of heart disease or stroke;
• if you are older than 65;
• if you have been sick with vomiting or diarrhea; or
• if you are dehydrated or have low blood pressure.

FDA pregnancy category C. It is not known whether CMV IG will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

CMV IG is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

It is not known whether CMV IG passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficulty breathing; dizziness, feeling like you might faint; swelling of your face, lips, tongue, or throat.

Stop using cytomegalovirus immune globulin (CMV IG) and call your doctor right away if you have:

• blue lips, pale or blue color in your fingers or toes;
• symptoms of a red blood cell disorder—pale or yellowed skin, dark urine, confusion or weakness;
• signs of a kidney problem—swelling, rapid weight gain, and little or no urination;
• lung problems—chest pain, severe shortness of breath, wheezing, cough with foamy mucus, fast or irregular heart rate; or
• signs of a new infection—high fever, flu-like symptoms, mouth sores, severe headache, neck stiffness, increased sensitivity to light, nausea and vomiting; or
• signs of a blood clot—sudden numbness or weakness, slurred speech, vision or balance problems; sudden cough, rapid breathing, coughing up blood; pain, swelling, warmth, or redness in one or both legs.

Common side effects of cytomegalovirus immune globulin (CMV IG) may include:

• chills;
• mild nausea, vomiting;
• joint pain;
• back pain, muscle cramps; or
• flushing (warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for CMV Prophylaxis:

Kidney transplant:Within 72 hours of transplant: 150 mg/kg2 weeks post transplant: 100 mg/kg4 weeks post transplant: 100 mg/kg6 weeks post transplant: 100 mg/kg8 weeks post transplant: 100 mg/kg12 weeks post transplant: 50 mg/kg16 weeks post transplant: 50 mg/kgMaximum dose: 150 mg immunoglobulin/kgLiver, pancreas, lung, or heart transplant:Within 72 hours of transplant: 150 mg/kg2 weeks post transplant: 150 mg/kg4 weeks post transplant: 150 mg/kg6 weeks post transplant: 150 mg/kg8 weeks post transplant: 150 mg/kg12 weeks post transplant: 100 mg/kg16 weeks post transplant: 100 mg/kgMaximum dose: 150 mg immunoglobulin/kgComments:-In organ transplants other than kidney from cytomegalovirus seropositive donors into seronegative recipients, consider using prophylactically in combination with ganciclovir.Use: Prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas, and heart

Usual Pediatric Dose for CMV Prophylaxis:

Kidney transplant:Within 72 hours of transplant: 150 mg/kg2 weeks post transplant: 100 mg/kg4 weeks post transplant: 100 mg/kg6 weeks post transplant: 100 mg/kg8 weeks post transplant: 100 mg/kg12 weeks post transplant: 50 mg/kg16 weeks post transplant: 50 mg/kgMaximum dose: 150 mg immunoglobulin/kgLiver, pancreas, lung, or heart transplant:Within 72 hours of transplant: 150 mg/kg2 weeks post transplant: 150 mg/kg4 weeks post transplant: 150 mg/kg6 weeks post transplant: 150 mg/kg8 weeks post transplant: 150 mg/kg12 weeks post transplant: 100 mg/kg16 weeks post transplant: 100 mg/kgMaximum dose: 150 mg immunoglobulin/kgComments:-In organ transplants other than kidney from cytomegalovirus seropositive donors into seronegative recipients, consider using prophylactically in combination with ganciclovir.Use: Prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas, and heart

Call your doctor for guidance if you miss a dose of cytomegalovirus immune globulin (CMV IG) (injection).

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Do not get a "live" vaccine while using CMV IG. The vaccine may not be as effective during this time and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

CMV IG can harm your kidneys. This risk is higher if you also take certain other medicines, including: antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, injectable osteoporosis medication, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

Other drugs may interact with cytomegalovirus immune globulin, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform each of your health care providers about all medicines you are currently using and any medicine you start or stop using.