Cytogam (injection)

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

CMV IG is used to help prevent infection by cytomegalovirus 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.

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 Cytogam 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 ensure 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 containing infectious agents, but there is still a small chance 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.

Cytogam may cause serious side effects. Stop using Cytogam and call your doctor immediately if you have:

• blue lips, pale or blue color in your fingers or toes;
• 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, coughing with foamy mucus, fast or uneven heart rate; or
• signs of a new infection--high fever, flu 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 Cytogam 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.

CMV IG is injected into a vein through an IV. A healthcare provider will give you this injection.

CMV IG is usually given within 72 hours after your transplant. You will then receive several more doses every 2 to 4 weeks afterward.

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

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

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

Do not receive a "live" vaccine while using CMV IG. The vaccine may not work as well 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 begin or stop using.