Most antibodies, whether produced by their own immune system or given in the form of Ig replacement, are used up or metabolized by the body and must be constantly replenished.
Approximately half of the infused antibodies are metabolized over three to four weeks, so repeat doses of Ig are required at regular intervals. Ig replacement therapy reduces the susceptibility to infections, can optimize health, and improve quality of life. As with any treatment, however, individual risks and benefits should be discussed with a healthcare provider. People who do not have antibody disorders normally make antibody during and after natural infections and in response to immunization with vaccines.
Blood is drawn before giving the vaccine to measure the vaccine specific antibody levels. After vaccination, a second blood sample is drawn four to six weeks later to determine how well specific antibodies are made to these vaccines. It is important that the individual completes this second blood draw to determine the response to the vaccine within this four to six-week timeframe. Once Ig replacement therapy is started, it is not possible to get accurate results for these important tests without stopping Ig treatment for a few months.
Gamma globulin derived from human plasma was first introduced as a treatment option in when gamma globulin was injected intramuscularly IM to treat people with recurrent infections who had antibody immune deficiencies 1. Dosing was very difficult because only small amounts of gamma globulin could be given in each painful shot. Much scientific investigation in the s and s finally led to a suitable gamma globulin product that could be used intravenously in the early s.
People with antibody disorders have been successfully treated with intravenous immunoglobulin replacement therapy IVIG for over 30 years. With the discovery of well-tolerated preparations of IVIG in the s, the suboptimal, painful IM administration was no longer used 2.
In primary or secondary hypogammaglobulinemia low IgG , Ig replacement therapy protects against infections by providing an adequate amount of IgG in the blood 3. Human immunoglobulin plays an important role in the treatment of many diseases, including diseases for which there is no other alternative treatment 3,4.
Currently, more than inflammatory and autoimmune disorders are also treated with IVIG. SCIG can be given in two ways: conventional or facilitated. The facilitated method uses an additional enzyme medication to increase the amount of Ig that can be delivered during each subcutaneous infusion. The individual with PI or caregiver and the prescriber should have a discussion about which route of administration is most appropriate. There are advantages and disadvantages for each route of administration Table IVIG has allowed infusion of higher doses over a short time and historically has been the standard route of administration.
It must be administered by a healthcare professional. This therapy does not require venous access and is associated with the slow release of Ig from the subcutaneous tissues into the blood, which enables IgG levels to remain consistent and steadier between infusions 6. Currently, among those receiving Ig replacement therapy in the U. The individual with PI or caregiver and the prescriber need to make a decision on the route of therapy that is best for the individual person.
All options are clinically effective. There are more than 25 different Ig preparations available worldwide. The preparations vary in a number of ways, including the distribution of IgG subclasses, stabilizers, and infusion details.
All Ig products are made from human source plasma. Source plasma is different than recovered plasma, which is collected through whole blood donation where plasma is separated from its cellular components. This source plasma is pooled from thousands of plasma donations by a process called plasmapheresis in which the liquid part plasma is separated from the red and white cells.
The red and white cells are then returned to the patient. This allows a specific donor to return to the plasmapheresis center monthly. Usually a pool or lot of Ig product is derived from approximately 10, donors. This ensures that a pool or lot of Ig contains a broad spectrum of specific antibodies that are found in the general population which then provide protection to people with PI.
All Ig products licensed in the U. There are multiple safety steps in the production of Ig: donor screening, viral removal, and inactivation of viruses. All plasma donors undergo a very rigorous screening process that includes a detailed history of infections and risk behaviors, and testing of their plasma for certain viruses using very sensitive techniques. Donors cannot give their plasma unless they pass this screening.
Donors are asked specific questions about risk factors that could affect the safety of the donation and are excluded from donation if risk factors are identified. Plasma centers can look at the donation history for each donor.
The FDA also requires blood centers to maintain lists of unsuitable donors to prevent further donations from these rejected donors. As an added protection, donors must return to donate within a set timeframe for rescreening.
If a donor does not return within that timeframe, their prior plasma donation is discarded. After donation, the individually donated plasma is tested for infectious agents before being pooled with plasma from other donors.
The pooled plasma is then divided up and different methods of fractionation and filtration help to separate out the IgG molecules. At multiple times throughout this process, the pool is tested for viral safety before additional safety measures are implemented. This prompted the addition of an extra viral inactivation step in the manufacturing process.
Now multiple safety measures, including pasteurization, low pH, low pH with pepsin, and solvent detergent help dissolve the lipid enveloped viruses, including hepatitis C. An additional safety step is chromatography, a technique widely used to obtain pure ingredients from mixtures. More recently, a final ultrafiltration or depth filtration step has been added to remove the possibility of transmission of prion related diseases mad cow disease. Transmission of HIV, which is destroyed in the first ethanol fractionation step in the production of Ig, has never been documented with the use of any Ig replacement therapy.
Many factors, however, are considered when the medication is prescribed. Doses are adjusted for clinical efficacy, with the expectation of minimizing the frequency and severity of recurrent infections while minimizing side effects of the medication. IgG levels are usually monitored over time and correlated with the response to therapy. With SCIG, there is a steady level of IgG present in the bloodstream due to the more frequent dosing regimens Figure and slower rate of absorption.
The goal is to keep the levels of Ig in the blood stream above a certain level even when the level is at its lowest the trough level right before the next infusion is due. Uses: IVIG is given through a vein. Most immunologists strongly discourage the use of central catheters to administer IVIG due to the increased risk of serious blood infections and the development of blood clots.
Placing a central venous catheter, also known as a port, due to poor venous access increases the risk of infections and blood clots, and it should be strongly discouraged. Given the very serious risk involved with the use of implantable ports, individuals should instead consider switching to the subcutaneous route of administration SCIG if there is a vein access problem.
IVIG is typically given every three-four weeks at a dose determined by the prescriber. Infusions can be given in various settings including an inpatient or outpatient infusion suite, physician office, or in the home. IVIG is administered by a healthcare professional, and the procedure is scheduled in advance.
In special extenuating circumstances, individuals can be instructed to self-infuse this therapy after they are stable on the treatment as long as IV access can be established. The medical professional should, however, stay with the individual for the length of the infusion because of the risk of serious side effects, such as anaphylaxis.
Individuals may be at increased risk for developing an adverse reaction if they have never received IVIG, have active infections or pre-existing conditions such as pneumonia or bronchiectasis , or are switching products. Individuals with a history of migraine headache may be at risk for a postinfusion headache reaction.
The prescriber of the therapy can modify IVIG dosing by decreasing the rate of infusion or adding other medications to the prescription. Medications such as acetaminophen, diphenhydramine, non-steroidal anti-inflammatory drugs, or corticosteroids can help prevent side effects during and after an infusion.
It is important to know, however, that repeated use of corticosteroids used to manage IVIG side effects may lead to longterm problems associated with repeated steroid use. While IVIG brands differ by manufacturer, the listed side effects are virtually identical on each package insert. Some common infusion reactions are headache, nausea, fever, chills, flushing, wheezing, vomiting, backache, muscle aches, joint aches, or chest tightness.
Side effects experienced during an infusion of Ig are almost always related to the rate of the infusion, such as infusing too fast, or relate to the temperature of the product. Stopping or slowing the infusion is usually the only intervention needed to alleviate these symptoms.
Sometimes a switch in product is successful in alleviating these side effects as some may simply tolerate one brand better than another. Some side effects can happen up to 72 hours after an infusion of Ig. 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. This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Rarely, this product may contain substances that could cause infections because it is made from human blood. Though the risk is very low due to careful screening of blood donors, discuss the risks and benefits with your doctor. Treatment with this medication may rarely cause a serious inflammation of the brain aseptic meningitis syndrome several hours to 2 days after your treatment.
Lung problems may rarely 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:. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. Call your doctor for medical advice about side effects. In Canada - Call your doctor for medical advice about side effects.
You may report side effects to Health Canada at Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other immunoglobulin products such as CMV 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:. This drug may make you dizzy. Alcohol or marijuana cannabis can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely.
Limit alcoholic beverages. Talk to your doctor if you are using marijuana cannabis. Ask your doctor for more details. Some immune globulin products are made with maltose. This substance can cause false high blood sugar levels when your blood sugar is normal or even low. If you have diabetes, check with your pharmacist whether the product you are using contains maltose and whether your blood sugar testing supplies will work with this product.
Rarely, serious problems have occurred when too much insulin was given because of false high sugar readings or when low blood sugar went untreated. 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.
Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially the effects on the kidneys. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Ask your doctor before receiving a "live" vaccine while using IGIV.
The vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella MMR , rotavirus, typhoid, yellow fever, varicella chickenpox , zoster shingles , and nasal flu influenza vaccine. Get emergency medical help if you have signs of an allergic reaction : hives; difficult breathing; swelling of your face, lips, tongue, or throat. Some side effects may occur during the injection. Tell your caregiver if you feel dizzy, nauseated, light-headed, sweaty, or have a headache, pounding in your neck or ears, fever, chills, chest tightness, or warmth or redness in your face.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. IGIV can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, or pain or arthritis including aspirin, Tylenol, Advil, and Aleve.
Other drugs may affect IGIV, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. Every effort has been made to ensure that the information provided by Cerner Multum, Inc. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise.
Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient.
Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.
If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist. This information does not replace the advice of a doctor. Healthwise, Incorporated, disclaims any warranty or liability for your use of this information.
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