Uses of CytoGam:

• It is used to prevent cytomegalovirus (CMV) disease after organ transplant.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take CytoGam?

• If you have an allergy to cytomegalovirus immune globulin or any other part of CytoGam (cytomegalovirus immune globulin (intravenous-human)).
• If you are allergic to CytoGam (cytomegalovirus immune globulin (intravenous-human)); any part of CytoGam (cytomegalovirus immune globulin (intravenous-human)); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have IgA deficiency.
• If you have had a skin reaction to CytoGam (cytomegalovirus immune globulin (intravenous-human)) or another drug like it in the past.

This is not a list of all drugs or health problems that interact with CytoGam (cytomegalovirus immune globulin (intravenous-human)).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take CytoGam (cytomegalovirus immune globulin (intravenous-human)) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take CytoGam?

• Tell all of your health care providers that you take CytoGam (cytomegalovirus immune globulin (intravenous-human)). This includes your doctors, nurses, pharmacists, and dentists.
• Talk with your doctor before getting any vaccines. Use of some vaccines with CytoGam (cytomegalovirus immune globulin (intravenous-human)) may either raise the chance of an infection or make the vaccine not work as well.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Very bad and sometimes deadly kidney problems have happened with CytoGam (cytomegalovirus immune globulin (intravenous-human)). The chance may be higher if you have kidney problems, high blood sugar (diabetes), fluid loss (dehydrated) or low blood volume, a blood infection, or proteins in the blood that are not normal. The chance may also be higher if you are 65 or older, or if you take other drugs that may harm the kidneys. Talk with your doctor.
• This medicine is made from human plasma (part of the blood) and may have viruses that may cause disease. This medicine is screened, tested, and treated to lower the chance that it carries an infection. Talk with the doctor.
• If you are 65 or older, use CytoGam (cytomegalovirus immune globulin (intravenous-human)) with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using CytoGam (cytomegalovirus immune globulin (intravenous-human)) while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (CytoGam) best taken?

Use CytoGam (cytomegalovirus immune globulin (intravenous-human)) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Very bad dizziness or passing out.
• This medicine may raise the chance of a very bad brain problem called aseptic meningitis. Call your doctor right away if you have a headache, fever, chills, very upset stomach or throwing up, stiff neck, rash, bright lights bother your eyes, feeling sleepy, or feeling confused.
• Lung problems have happened with CytoGam (cytomegalovirus immune globulin (intravenous-human)). Call your doctor right away if you have lung or breathing problems like trouble breathing, shortness of breath, or a cough that is new or worse.

What are some other side effects of CytoGam?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Flushing.
• Fever or chills.
• Joint pain.
• Back pain.
• Muscle pain or cramping.
• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out CytoGam?

• If you need to store CytoGam (cytomegalovirus immune globulin (intravenous-human)) at home, talk with your doctor, nurse, or pharmacist about how to store it.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about CytoGam (cytomegalovirus immune globulin (intravenous-human)), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.