CytoGam IV Warnings
This medication may rarely cause serious blood clots (such as pulmonary embolism, stroke, heart attack, deep vein thrombosis). 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 arm/leg, sudden/severe headache, slurred speech, weakness on one side of the body, sudden vision changes, or confusion.
CytoGam IV Uses
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.How to use CytoGam IV
This medication is given by slow infusion into a vein as directed by your doctor.
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 immediately 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.
The first dose is usually given within 3 days of the transplant, followed by more doses every 2 to 4 weeks or as directed by your doctor. The dosage and frequency depends on your medical condition, weight, and response to treatment.
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 visually 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.
CytoGam IV Side Effects
See also Warning section.
Flushing, chills, muscle cramps, back/joint pain, fever, nausea/vomiting may occur. Tell your doctor or health care professional immediately if any of these effects occur, persist, or worsen. Pain, redness, and swelling at the injection site may also occur. If these effects continue or become bothersome, tell your doctor.
Remember that your doctor has prescribed this medication because he or she 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 if you experience any of these unlikely but serious side effects: easy bleeding/bruising, fast/irregular heartbeat, unusual tiredness, change in the amount of urine, pink/bloody/frothy urine, sudden weight gain.
Rarely, this product may contain substances that could cause infections because it is made from human blood. Discuss the risks and benefits with your doctor. Tell your doctor immediately if you develop any signs of infection such as persistent sore throat/fever, yellowing eyes/skin, or dark urine.
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.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
CytoGam IV Precautions
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.
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 not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
CytoGam IV Interactions
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 (e.g., aminoglycosides such as gentamicin), "water pills" (diuretics such as furosemide).
CytoGam IV Overdose
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.NOTES:
Laboratory and/or medical tests (e.g., kidney function test, urine volume) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.MISSED DOSE:
For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule. Do not double the dose to catch up.STORAGE:
Store in the refrigerator between 36-46 degrees F (2-8 degrees C). Use opened vials within 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.
Information last revised June 2013. Copyright(c) 2013 First Databank, Inc.
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