immune globulin

Generic Name: immune globulin (intravenous and subcutaneous) (im MYOON GLOB yoo lin)Brand names: Gamunex-C, Gammaked, Gammagard

 

What is immune globulin?

Immune globulin is a sterilized solution made from human plasma. It contains the antibodies to help your body protect itself against infection from various diseases.

Immune globulin intravenous and subcutaneous (for injection into a vein or under the skin) is used to treat primary immune deficiency, idiopathic thrombocytopenic purpura (ITP), or chronic inflammatory demyelinating polyneuropathy.

Immune globulin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about immune globulin?

You should not use this medication if you have ever had an allergic reaction to an immune globulin, or if you have immune globulin A (IgA) deficiency with antibody to IgA.

Before using this medication, tell your doctor if you have kidney disease, heart disease, diabetes, hyperproteinemia (high levels of protein in the blood), paraproteinemia (abnormal proteins in the blood), a serious infection called sepsis, blood circulation problems or a blood vessel disorder, a history of stroke or blood clot, if you are on a low-salt diet, if you take diuretics, if you are 65 or older, or if you have been bed-ridden due to severe illness.

Immune globulin can harm your kidneys, and this effect is increased when you also use certain other medicines harmful to the kidneys. Before using immune globulin, tell your doctor about all other medications you use. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys. You may need a dose adjustment if you are exposed to measles, or if you travel to an area where this disease is common.

What should I discuss with my healthcare provider before taking immune globulin?

You should not use this medication if you have ever had an allergic reaction to an immune globulin, or if you have immune globulin A (IgA) deficiency with antibody to IgA.

To make sure you can safely use immune globulin, tell your doctor if you have any of these other conditions:

  • kidney disease (or if you are on dialysis)-

  • heart disease-

  • diabetes-

  • a serious infection called sepsis-

  • hyperproteinemia (high level of a certain amino acid in the blood)-

  • a condition called paraproteinemia (abnormal proteins in the blood)-

  • blood circulation problems or a blood vessel disorder-

  • a history of stroke or blood clot-

  • if you are on a low salt diet or you take diuretics (water pills)-

  • if you have a prolonged illness that causes diarrhea or vomiting-

  • if you are 65 years or older- or

  • if you have been bed-ridden due to severe illness.

You may need a dose adjustment if you are exposed to measles, or if you travel to an area where this disease is common. FDA pregnancy category C. It is not known whether immune globulin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether immune globulin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Immune globulin is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How should I use immune globulin?

Immune globulin is injected into a vein through an IV, or injected under the skin using an infusion pump. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, tubing, and other items used to inject the medicine.

How you give this medication, how often you receive it, and the length of your infusion time will depend on the condition being treated. Follow your doctor's dosing instructions. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

Do not inject immune globulin into a vein if you have been instructed to give the medicine as a subcutaneous injection (under the skin).

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Immune globulin must be given slowly. You may need to use several catheters to inject this medicine into different body areas at the same time. Your care provider will show you the best places on your body to inject the medication. Follow your doctor's instructions. Keep a diary of the days and times you gave the injection and where you injected it on your body.

Do not shake the medication bottle or you may ruin the medicine. Prepare your dose only when you are ready to give yourself an injection. Do not mix immune globulin with other medications in the same infusion. Do not use the medication if it has changed colors, looks cloudy, or has particles in it. Call your doctor for a new prescription.

Use disposable injection items (needle, catheter, tubing) only once. Throw away the used items in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

To be sure this medication is helping your condition, your blood may need to be tested often. Visit your doctor regularly.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using immune globulin.

Each single use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Store this medicine in its original carton in the refrigerator. Do not freeze immune globulin, and throw away the medication if it has become frozen.

You may take the medicine out of the refrigerator and allow it to reach room temperature 1 hour before preparing your dose. Do not heat the medicine before using.

You may also store immune globulin for up to 6 months at room temperature. Keep away from moisture and heat.

Throw away any unused immune globulin after the expiration date on the label has passed.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of immune globulin.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using immune globulin?

Do not receive a "live" vaccine while using immune globulin. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Gu rin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

Immune globulin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives- wheezing, difficulty breathing- dizziness, feeling like you might pass out- swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:
  • swelling, rapid weight gain, feeling short of breath, urinating less than usual or not at all-

  • pain, swelling, redness, warmth, or a lump in your arms or legs-

  • pale or yellowed skin, dark colored urine, fever, confusion or weakness-

  • fever, chills, headache, neck stiffness, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions)-

  • chest pain or tightness, trouble breathing- or

  • signs of new infection such as high fever, chills, body aches, flu symptoms, or sores in your mouth and throat.

Less serious side effects may include:

  • headache, tired feeling-

  • low fever, sore throat, cough-

  • redness, itching, and swelling of skin where the injection was given-

  • nausea, vomiting-

  • back pain, joint pain, pain in your arms or legs- or

  • mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Immune globulin Dosing Information

Usual Adult Dose for Primary Immunodeficiency Syndrome:

Because there are significant differences in the half-life or IgG among patients with PI, the frequency and amount of immunoglobulin therapy may vary from one patient to another. The proper amount can be determined by monitoring clinical response.IV: 300 to 600 mg/kg every 3 to 4 weeks adjusted over time to achieve desired trough levels and clinical response. The recommended initial infusion rate is 1 mg/kg/min and increased as tolerated to a maximum rate of 8 mg/kg/min.If a patient routinely receives a dose of less than 400 mg/kg IV every 3 to 4 weeks, and is at risk of measles exposure (i.e., traveling to a measles endemic area), a dose of at least 400 mg/kg IV should be administered just prior to the expected measles exposure.Subcutaneous: Begin treatment one week after receiving a regularly scheduled IGIV infusion. Initial dose: calculated by multiplying the previous IGIV dose (in grams) by 1.37, then dividing this dose into weekly doses based on the patient's previous IGIV treatment, administered subcutaneously- for example, if IGIV was administered every three weeks, divide by 3. Over time, the dose may need to be adjusted to achieve the desired clinical response and serum IgG trough level. To determine if a dose adjustment may be considered, the serum IgG trough level of the patient is measured on IGIV and as early as 5 weeks after switching from IGIV to subcutaneous. The target serum IgG trough level on weekly subcutaneous treatment is projected to be the last IGIV trough level plus 340 mg/dL. The IgG trough level should be monitored every 2 to 3 months to determine if further dose adjustments are necessary.

Usual Adult Dose for Idiopathic (Immune) Thrombocytopenic Purpura:

IV: 2 g/kg, divided into 2 doses of 1 g/kg given on 2 consecutive days or into 5 doses of 0.4 g/kg given on 5 consecutive days. If after administration of the first 2 daily 1 g/kg doses, an adequate increase in the platelet count is observed at 24 hours, the second dose of 1 gm/kg body weight may be withheld. The recommended initial infusion rate is 1 mg/kg/min and increased as tolerated to a maximum rate of 8 mg/kg/min.

Usual Adult Dose for Chronic Inflammatory Demyelinating Polyradiculoneuropathy:

Loading dose: 2 g/kg IV, given as an infusion, in divided doses over 2 to 4 consecutive days.Maintenance dose: 1 g/kg IV, given as an infusion, over 1 day or 0.5 g/kg IV infusion on 2 consecutive days, every 3 weeks.The recommended initial infusion rate is 1 mg/kg/min and increased as tolerated to a maximum rate of 8 mg/kg/min.

What other drugs will affect immune globulin?

Immune globulin can harm your kidneys. This effect is increased when you also use other drugs (including some over the counter medicines) harmful to the kidneys. You may need dose adjustments or special tests if you have recently used:

  • medicines to treat a bowel disorder-

  • medication to prevent organ transplant rejection-

  • antiviral medications-

  • chemotherapy-

  • pain or arthritis medicines, including aspirin (Anacin, Excedrin), acetaminophen (Tylenol), ibuprofen (Advil, Motrin), naproxen (Aleve), and others- or

  • any injected antibiotics.

This list is not complete and other drugs may interact with immune globulin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about immune globulin.
  • 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. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. 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. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. 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.

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