CytoGam 50 mg/mL intravenous solution

Generic name:
Cmv immune globulin - intravenous

Pronunciation
(CMV ih-MYOON GLOB-you-lin)

Brand name(s)
Cytogam

This medication may rarely cause serious problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs). You may be at increased risk for blood clots if you are an older adult, are severely dehydrated, have a catheter in a vein close to your heart for administering medications, or have a history of blood clots, heart/blood vessel disease, heart failure, stroke, or if you are immobile (such as very long plane flights or bedridden). If you use estrogen-containing products, these may also increase your risk. Before using this medication, discuss the risks and benefits and if you have any of these conditions, report them to your doctor or pharmacist.

The risk of blood clots may be decreased by infusing this medication more slowly or by using a less concentrated form of this medication if available. Being adequately hydrated before receiving this medication may also help reduce this risk.

Get medical help right away if any of these side effects occur: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, trouble speaking, weakness on one side of the body, sudden vision changes, or confusion.

This medication is used to prevent a certain serious viral infection (cytomegalovirus-CMV) in persons having an organ transplant (kidney, heart, liver, lung, pancreas). During the transplant process, the body's defense system (immune system) is weakened to prevent the body from attacking (rejecting) the new organ. A weakened immune system increases the risk of a serious, possibly fatal infection with CMV. This medication is made from healthy human blood that has a high level of certain defensive substances (antibodies) that help fight CMV. This medication is often used with the antiviral medication ganciclovir.

This medication is given by slow infusion into a vein. It is given as directed by your doctor, usually every 2 to 4 weeks, with the first dose given within 3 days of the transplant. The dosage and frequency depends on your medical condition, weight, and response to treatment.

Your health care professional will start the medication slowly while monitoring you closely. If you have few or no side effects, the medication will be given faster. Tell your health care professional right away if you experience any side effects such as flushing, chills, muscle cramps, back/joint pain, fever, nausea, vomiting, or shortness of breath. The infusion may need to be stopped or given more slowly.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

Use this medication regularly in order to get the most benefit from it. Keep all your medical/lab appointments.

See also Warning section.

Flushing, chills, muscle cramps, back/joint pain, fever, nausea/vomiting may occur. Tell your doctor or health care professional right away if any of these effects occur, last, or get worse. Pain, redness, and swelling at the injection site may also occur. If these effects continue or become bothersome, tell your doctor.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• easy bleeding/bruising
• fast/irregular heartbeat
• unusual tiredness
• signs of kidney problems (such as change in the amount of urine, pink/bloody/frothy urine)
• sudden weight gain

Treatment with this medication may rarely cause an inflammation of the brain (aseptic meningitis syndrome) several hours to 2 days after your treatment. Get medical help right away if you develop severe headache, stiff neck, drowsiness, high fever, sensitivity to light, eye pain, or severe nausea/vomiting.

Lung problems may occur 1 to 6 hours after your treatment. You will be monitored closely for any lung problems after your treatment.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or to other immunoglobulin products (such as IgG); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• certain immune system problems (immunoglobulin A deficiency, monoclonal gammopathies)
• diabetes
• high blood pressure
• high blood fats (triglycerides)
• migraines
• current blood infection (sepsis)
• kidney disease
• severe loss of body fluids (dehydration)

Tell your doctor of any recent or planned immunizations/vaccinations. This medication may prevent a good response to certain live viral vaccines (such as measles, mumps, rubella, varicella). If you have recently received any of these vaccines, your doctor may have you tested for a response or have you vaccinated again later. If you plan on getting any of these vaccines, your doctor will instruct you about the best time to receive them so you get a good response.

This medication is made from human blood. Even though the blood is carefully tested, and this medication goes through a special manufacturing process, there is an extremely small chance that you may get infections from the medication (for example, viruses such as hepatitis). Consult your doctor or pharmacist for more information.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• drugs that may harm the kidney (for example, aminoglycosides such as gentamicin)
• "water pills" (diuretics such as furosemide)

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as kidney function, urine volume) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Store in the refrigerator. Once the vial is opened, this medication expires after 6 hours. Discard any unused portion. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.