Immunoglobulins, Normal Human, For Intravascular Adm.

Immunoglobulins, Normal Human, For Intravascular Adm. Overview

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Immunoglobulins is a prescription medication that contains immunoglobulin G (IgG) antibodies that come from human plasma. It is used to treat disorders of the immune system or to boost immune response to serious illness, and to treat bone marrow recipients who have suppressed immune systems.

Exactly how immunoglobulins work within the body is unknown. For patients who are unable to produce their own antibodies, this medication temporarily provides the antibodies they need to prevent infection. In patients with autoimmune diseases, or other conditions where the body's immune system is not functioning properly, it can help regulate an overactive immune system by signaling it to slow down or stop inflammatory processes.

Immunoglobulins are given by injection into a vein (IV), usually in a medical setting (infusion center, hospital, doctor's office). Some immunoglobulins are also formulated to be injected just under the skin (subcutaneously) using an infusion pump.

Regular infusions are necessary to maintain immune globulin levels within the desired range. How often you’ll receive infusions is something your healthcare professional will determine. Typically, an intravenous infusion takes place every 3–4 weeks and a subcutaneous infusion takes place once a week.

Common side effects include redness, swelling and itching at injection site, headache and nausea.

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Immunoglobulins, Normal Human, For Intravascular Adm. Cautionary Labels

precautionsprecautionsprecautionsprecautionsprecautions

Uses of Immunoglobulins, Normal Human, For Intravascular Adm.

Immunoglobulins is a prescription medication that contains immunoglobulin G (IgG) antibodies. It is used to treat disorders of the immune system or to boost immune response to serious illness, and to treat bone marrow recipients who have suppressed immune systems. Specifically, this medication is approved to treat:

  • Primary Humoral Immunodeficiency (PI)
  • Chronic Immune Thrombocytopenic Purpura (ITP)
  • Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Immunoglobulins, Normal Human, For Intravascular Adm. Brand Names

Immunoglobulins, Normal Human, For Intravascular Adm. may be found in some form under the following brand names:

Immunoglobulins, Normal Human, For Intravascular Adm. Drug Class

Immunoglobulins, Normal Human, For Intravascular Adm. is part of the drug class:

Side Effects of Immunoglobulins, Normal Human, For Intravascular Adm.

Serious side effects have been reported. See "Precautions" section.

Side effects are generally mild and tolerable and may include:

  • Redness, swelling and itching at injection site
  • Headache
  • Blood pressure changes 
  • Nausea
  • Vomiting
  • Dizziness
  • Fever
  • Fatigue
  • Chills 
  • Pain in the back, joints, arms and legs

Tell your healthcare provider if any side effect is bothersome or does not go away. These are not all the possible side effects of this medication. 

You may report side effects to the FDA at 1-800-FDA-1088.

 

Immunoglobulins, Normal Human, For Intravascular Adm. Interactions

Tell your healthcare provider about the medications you take including prescription and non-prescription medications, vitamins, and herbal supplements.

Especially tell your healthcare provider if you have recently received a live vaccine as this medication may interefere with your body's response to live vaccines.

Also, medications that contain the hormone estrogen (for example, birth control pills), may increase your risk of developing a blood clot. Be sure to tell your healthcare provider if you are taking one of these medications.

Immunoglobulins, Normal Human, For Intravascular Adm. Precautions

Serious side effects have been reported including:

  • Anaphylaxis (a life-threatening allergic reaction)
  • Serious Kidney Disease
  • Pulmonary Embolism (blood clot to the lung)
  • Aseptic Meningitis Syndrome (a type of brain inflammation)
  • Hemolytic Anemia (a serious blood problem)
  • Serious lung problems

Tell your doctor right away or go to the emergency room if you have hives, trouble breathing, wheezing, dizziness, or fainting. These could be signs of a bad allergic reaction.

Tell your doctor right away if you have any of the following symptoms. They could be signs of a rare, but serious problem.

  • Decreased urination, sudden weight gain, fluid retention/swelling in your legs, and/or shortness of breath. They could be signs of a serious kidney problem called renal failure.
  • Pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one side of the body. These could be signs of a blood clot in your body (thrombosis). Immediately report symptoms of thrombosis.
  • Severe headache, stiff neck, fatigue, fever, sensitivity to light, painful eye movements, nausea and vomiting. These could be signs of a type of brain inflammation called aseptic meningitis.
  • Increased heart rate, fatigue, yellow skin or eyes, and dark colored urine. These could be signs of a type of blood problem called hemolytic anemia.
  • Chest pains, trouble breathing, blue lips or extremities, and fever. These could be signs of a lung problem called TRALI (transfusion-related acute lung injury).
  • Fever over 100°F. This could be a sign of an infection. 

Do not take this medication if you have had a severe allergic reaction to immune globulins.

 

 

Immunoglobulins, Normal Human, For Intravascular Adm. Food Interactions

Medications can interact with certain foods. In some cases this may be harmful and your doctor may advise you to avoid certain foods. In the case of this medication there are no specific foods you must exclude from your diet.

Inform MD

Before receiving this medication, tell your healthcare provider if you:

  • have a history of hardening of the arteries (atherosclerosis), stroke, heart attack, or heart failure (low volume of blood pumped by the heart)
  • have a blood clotting disorder
  • are inactive for long periods of time (such as long bed rest)
  • if you use estrogens
  • if you have thickening of your blood
  • have a kidney problem
  • have Type II diabetes mellitus
  • are older than 65
  • are dehydrated
  • have a blood infection (sepsis)
  • have high protein content in your blood
  • are receiving other medicines that are harmful to your kidneys
  • have an allergy to immune globulin

Tell your healthcare provider about the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Immunoglobulins, Normal Human, For Intravascular Adm. and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. Animal reproduction studies have not been conducted. It is also not known whether this medication can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Immune globulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation. This medication should be given to a pregnant woman only if clearly indicated.

Immunoglobulins, Normal Human, For Intravascular Adm. and Lactation

Tell your healthcare provider if you are breastfeeding or planning to breastfeed.

It is not known whether this medication is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when it is administered to a nursing woman.

Immunoglobulins, Normal Human, For Intravascular Adm. Usage

Immunoglobulins are given by injection into a vein (IV), usually in a medical setting (infusion center, hospital, doctor's office). Some immunoglobulins are also formulated to be injected just under the skin (subcutaneously) using an infusion pump. 

Regular infusions are necessary to maintain immune globulin levels within the desired range. How often you’ll receive infusions is something your healthcare professional will determine. Typically, an intravenous infusion takes place every 3–4 weeks and a subcutaneous infusion takes place once a week.

If your healthcare provider feels it appropriate for you to give yourself subcutaneous injections using an infusion pump, clear instructions and training on subcutaneous infusion will be provided. This medication must be injected subcutaneously into the stomach, thighs, upper arms, or hips.

Immunoglobulins, Normal Human, For Intravascular Adm. Dosage

The dose your healthcare provider recommends may be based on several factors including:

  • the condition being treated
  • other medical conditions you have
  • your body's response to this medication

Over time, the dose may need to be adjusted to achieve the desired clinical response and serum IgG trough level. 

 

Immunoglobulins, Normal Human, For Intravascular Adm. Overdose

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

If you have injected too much medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

 

 

Other Requirements

Do not freeze. Refrigeration requirements vary depending on the brand product. If you are infusing this medication at home, be sure to know the storage requirements for the product you receive.

Keep this and all medications out of the reach of children.

Immunoglobulins, Normal Human, For Intravascular Adm. FDA Warning

WARNING: THROMBOSIS, RENAL DYSFUNCTION, and ACUTE RENAL FAILURE

  • Thrombosis may occur with immune globulin products. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. 

  • For patients at risk of thrombosis, administer at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. 

  • Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients. Patients predisposed to renal dysfunction include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs.

  • Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. 

  • For patients at risk of renal dysfunction or failure, administer at the minimum concentration available and the minimum infusion rate practicable.