Cytogam

DRUG DESCRIPTION

Cytogam® , Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV), is an immunoglobulin G (IgG) containing a standardized amount of antibody to Cytomegalovirus (CMV). CMV-IGIV is formulated in final vial as a sterile liquid. The globulin is stabilized with 5% sucrose and 1% Albumin (Human). Cytogam® contains no preservative. The purified immunoglobulin is derived from pooled adult human plasma selected for high titers of antibody for Cytomegalovirus (CMV) (1). Source material for fractionation may be obtained from another U.S. licensed manufacturer. Pooled plasma was fractionated by ethanol precipitation of the proteins according to Cohn Methods 6 and 9, modified to yield a product suitable for intravenous administration. A widely utilized solvent-detergent viral inactivation process is also used (2). Certain manufacturing operations may be performed by other firms. Each milliliter contains: 50 ± 10 mg of immunoglobulin, primarily IgG, and trace amounts of IgA and IgM; 50 mg of sucrose; 10 mg of Albumin (Human). The sodium content is 20-30 mEq per liter, i.e., 0.4-0.6 mEq per 20 mL or 1.0-1.5 mEq per 50 mL The solution should appear colorless and translucent.

What are the possible side effects of CMV IG (Cytogam)?

CMV IG is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although CMV IG is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using CMV IG.

Treatment with immune globulin products such as CMV IG has been associated with the development of kidney problems, sometimes resulting in kidney failure and/or death. Notify your doctor immediately if you...

Read All Potential Side Effects and See Pictures of Cytogam »

What are the precautions when taking cytomegalovirus immune globulin intravenous human (Cytogam)?

See Side Effects section.

Before receiving this medication, tell your doctor or pharmacist if you have had a bad reaction or an allergic reaction to it; or to other immunoglobulin products (e.g., 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/planned...

Read All Potential Precautions of Cytogam »

What are the possible side effects of CMV IG (Cytogam)?

CMV IG is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although CMV IG is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using CMV IG.

Treatment with immune globulin products such as CMV IG has been associated with the development of kidney problems, sometimes resulting in kidney failure and/or death. Notify your doctor immediately if you...

Read All Potential Side Effects and See Pictures of Cytogam »

What are the precautions when taking cytomegalovirus immune globulin intravenous human (Cytogam)?

See Side Effects section.

Before receiving this medication, tell your doctor or pharmacist if you have had a bad reaction or an allergic reaction to it; or to other immunoglobulin products (e.g., 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/planned...

Read All Potential Precautions of Cytogam »

What are the possible side effects of CMV IG (Cytogam)?

CMV IG is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although CMV IG is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using CMV IG.

Treatment with immune globulin products such as CMV IG has been associated with the development of kidney problems, sometimes resulting in kidney failure and/or death. Notify your doctor immediately if you...

Read All Potential Side Effects and See Pictures of Cytogam »

What are the precautions when taking cytomegalovirus immune globulin intravenous human (Cytogam)?

See Side Effects section.

Before receiving this medication, tell your doctor or pharmacist if you have had a bad reaction or an allergic reaction to it; or to other immunoglobulin products (e.g., 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/planned...

Read All Potential Precautions of Cytogam »

What are the possible side effects of CMV IG (Cytogam)?

CMV IG is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although CMV IG is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using CMV IG.

Treatment with immune globulin products such as CMV IG has been associated with the development of kidney problems, sometimes resulting in kidney failure and/or death. Notify your doctor immediately if you...

Read All Potential Side Effects and See Pictures of Cytogam »

What are the precautions when taking cytomegalovirus immune globulin intravenous human (Cytogam)?

See Side Effects section.

Before receiving this medication, tell your doctor or pharmacist if you have had a bad reaction or an allergic reaction to it; or to other immunoglobulin products (e.g., 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/planned...

Read All Potential Precautions of Cytogam »


Cytogam Consumer (continued)

SIDE EFFECTS: 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.

This medication may rarely cause blood clots (such as pulmonary embolism, stroke, heart attack, deep vein thrombosis). You may be at increased risk for blood clots if you are severely dehydrated, 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, if you have any of these conditions report them to your doctor or pharmacist. 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, slurred speech, weakness on one side of the body, sudden vision changes, confusion.

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.

PRECAUTIONS: See Side Effects section.

Before receiving this medication, tell your doctor or pharmacist if you have had a bad reaction or an allergic reaction to it; or to other immunoglobulin products (e.g., 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/planned vaccinations. This medication may prevent a good response to live viral vaccines (e.g., measles, mumps, German measles). If you are vaccinated less than 14 days before receiving this medication or in the 6 months after receiving this medication, you may need to be revaccinated or tested to see whether the vaccine was effective.

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 Patient Information Including Side Effects

Brand Names: Cytogam

Generic Name: cytomegalovirus immune globulin (CMV IG) (injectable) (Pronunciation: sye toe MEH gah loe vye rus ih MUNE GLAW byoo lin)

  • What is CMV IG (Cytogam)?
  • What are the possible side effects of CMV IG (Cytogam)?
  • What is the most important information I should know about CMV IG (Cytogam)?
  • What should I discuss with my healthcare provider before taking CMV IG (Cytogam)?
  • How should I take CMV IG (Cytogam)?
  • What happens if I miss a dose (Cytogam)?
  • What happens if I overdose (Cytogam)?
  • What should I avoid while taking CMV IG (Cytogam)?
  • What other drugs will affect CMV IG (Cytogam)?
  • Where can I get more information?

What is CMV IG (Cytogam)?

Cytomegalovirus immune globulin (CMV IG) is a sterilized solution obtained from pooled human blood. It contains the immunoglobulins (or antibodies) to protect against infection from cytomegalovirus. Antibodies are substances in the blood that fight infections.

CMV IG is used to help prevent infection by cytomegalovirus in people who receive an organ transplant.

CMV IG may also be used for purposes other than those listed here.

What are the possible side effects of CMV IG (Cytogam)?

CMV IG is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although CMV IG is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using CMV IG.

Treatment with immune globulin products such as CMV IG has been associated with the development of kidney problems, sometimes resulting in kidney failure and/or death. Notify your doctor immediately if you develop decreased urination, sudden weight gain, fluid retention or swelling, or shortness of breath. These may be signs of kidney problems.

Rare cases of aseptic meningitis syndrome (AMS) have been associated with the use of immune globulin products such as CMV IG. Notify your doctor immediately if you experience severe headache, neck stiffness, drowsiness, fever, eye sensitivity to light, painful eye movements, and nausea or vomiting. These may be signs of AMS. Stopping treatment with the immune globulin has resulted in resolution of AMS without any lasting problems.

Notify your doctor immediately if you experience a rare but serious allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) to CMV IG.

Other less serious side effects may also occur. Upon injection of the medication, some patients experience the following side effects:

  • flushing or sweating;
  • wheezing;
  • muscle cramps;
  • joint pain;
  • nausea or vomiting; or
  • fever or chills.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about CMV IG (Cytogam)?

CMV IG is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although CMV IG is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using CMV IG.

Treatment with immune globulin products such as CMV IG has been associated with the development of kidney problems, sometimes resulting in kidney failure and/or death. Notify your doctor immediately if you develop decreased urination, sudden weight gain, fluid retention or swelling, or shortness of breath. These may be signs of kidney problems.

Rare cases of aseptic meningitis syndrome (AMS) have been associated with the use of immune globulin products such as CMV IG. Notify your doctor immediately if you experience severe headache, neck stiffness, drowsiness, fever, eye sensitivity to light, painful eye movements, and nausea or vomiting. These may be signs of AMS. Stopping treatment with the immune globulin has resulted in resolution of AMS without any lasting problems.

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