Immune globulin intravenous and subcutaneous

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 immunodeficiency (PI), idiopathic thrombocytopenic purpura (ITP), or chronic inflammatory demyelinating polyneuropathy (CIDP). This medication is also used to improve muscle strength in adults with multifocal motor neuropathy.

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

This medicine can cause blood clots. A blood clot may be more likely if you have risk factors such as heart disease, blood circulation problems, estrogen use, a history of blood clots, if you are 65 years or older, if you have been bed-ridden, or if you are using a catheter.

Stop using immune globulin and call your doctor at once if you have:

• signs of a blood clot in the brain--sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance;
• signs of a blood clot in the heart or lung--chest pain, rapid heart rate, sudden cough, wheezing, rapid breathing, coughing up blood; or
• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

Immune globulin can also harm your kidneys, especially if you already have kidney disease or if you also use certain other medicines. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

Call your doctor at once if you have signs of a kidney problem, such as swelling, rapid weight gain, and little or no urinating.

Drink plenty of liquids while you are using this medicine to help improve your blood flow and keep your kidneys working properly.

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.

Immune globulin can harm your kidneys or cause blood clots. To make sure this medicine is safe for you, tell your doctor if you have:

• heart disease, blood circulation problems or a blood vessel disorder;
• a history of stroke or blood clot;
• if you use estrogens (birth control pills or hormone replacement therapy);
• kidney disease;
• diabetes;
• a serious infection called sepsis;
• hyperproteinemia (too much protein in the blood);
• paraproteinemia (abnormal proteins in the blood);
• if you are dehydrated;
• if you are 65 years or older;
• if you have been bed-ridden due to severe illness; or
• if you are using a catheter.

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. Tell 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.

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), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Immune globulin can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, injectable osteoporosis medication, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

Other drugs may interact with immune globulin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

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 immunodeficiency (PI), idiopathic thrombocytopenic purpura (ITP), or chronic inflammatory demyelinating polyneuropathy (CIDP). This medication is also used to improve muscle strength in adults with multifocal motor neuropathy.

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

This medicine can cause blood clots. A blood clot may be more likely if you have risk factors such as heart disease, blood circulation problems, estrogen use, a history of blood clots, if you are 65 years or older, if you have been bed-ridden, or if you are using a catheter.

Stop using immune globulin and call your doctor at once if you have:

• signs of a blood clot in the brain--sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance;

• signs of a blood clot in the heart or lung--chest pain, rapid heart rate, sudden cough, wheezing, rapid breathing, coughing up blood; or

• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

Immune globulin can also harm your kidneys, especially if you already have kidney disease or if you also use certain other medicines. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

Call your doctor at once if you have signs of a kidney problem, such as swelling, rapid weight gain, and little or no urinating.

Drink plenty of liquids while you are using this medicine to help improve your blood flow and keep your kidneys working properly.

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 an injection. Do not mix immune globulin with other medications in the same infusion. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine. Check the expiration date on the medicine container before using.

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.

While using immune globulin, you may need frequent blood tests.

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.

Usual Adult Dose for Primary Immunodeficiency Syndrome:

Intravenously:
300 to 600 mg/kg, IV, every 3 to 4 weeks
-Initial infusion rate: 1 mg/kg/min
-Maximum infusion rate (if tolerated): 8 mg/kg/min

Subcutaneously:
1.37 x current IV dose in grams / number of weeks between IV doses; administer weekly
-Infuse subcutaneously at 20 mL/hr/site
-Use up to 8 infusion sites simultaneously
-Ensure infusion sites are at least 2 inches (5 cm) apart

Comments:
-Begin subcutaneous dosing one week after the patient's last IV infusion.
-For subcutaneous administration: convert the previous IV dose (in grams) by multiplying by 1.37, then dividing this dose into weekly doses based on the previous IV interval.

Use: Treatment of primary humoral immunodeficiency including, but not limited to, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Usual Adult Dose for Idiopathic (Immune) Thrombocytopenic Purpura:

1 g/kg, IV, on two consecutive days (high dose regimen)
or
0.4 g/kg, IV, on five consecutive days
(total dose 2 g/kg)
-Initial infusion rate: 1 mg/kg/min; increase gradually if tolerated
-Maximum infusion rate: 8 mg/kg/min

Comments:
-If after administration of the first 1 g/kg (high dose regimen), an adequate increase in platelet count is seen at 24 hours, the second dose may be withheld.
-High dose regimen is not recommended if expanded fluid volumes exist or if fluid volume may be a concern.
-Do not administer subcutaneously in idiopathic thrombocytopenic purpura (ITP) patients.

Use: Treatment of patients with idiopathic thrombocytopenic purpura to raise platelet counts to prevent bleeding or allow surgery to be performed.

Usual Adult Dose for Chronic Inflammatory Demyelinating Polyradiculoneuropathy:

Loading dose: 2 g/kg, IV, in divided doses, over 2 to 4 consecutive days
Maintenance dose: 1 g/kg, IV, over 1 day; OR 0.5 g/kg, IV, given on 2 consecutive days
-Initial infusion rate: 2 mg/kg/min
-Maintenance infusion rate (if tolerated): 8 mg/kg/min every 3 weeks

Comments:
-Patients at risk of renal dysfunction or thrombosis: administer at the minimum infusion rate practicable.

Uses: Treatment of chronic inflammatory demyelinating polyneuropathy to improve neuromuscular disability and impairment, and for maintenance therapy to prevent relapse.

Usual Adult Dose for Multifocal Motor Neuropathy:

Gammagard (R):

IV administration:
Dose range 0.5 to 2.4 grams/kg/month based on clinical response
Initial infusion rate: 0.5 mL/kg/hr (0.8 mg/kg/min)
Maintenance infusion rate: Infusion rate may be advanced if tolerated to 5.4 mL/kg/hr (9 mg/kg/min)

Subcutaneous administration:
Initial Dose is 1.37 x previous intravenous dose divided by # of weeks between intravenous doses.
Maintenance dose is based on clinical response and target IgG trough level.
Initial infusion rate:
40 kg body weight (BW) and greater:
30 mL/site at 20 mL/hr/site.
Under 40 kg BW:
20 mL/site at 15 mL/hr/site
Maintenance infusion rate:
40 kg BW and greater:
30 mL/site at 20 to 30 mL/hr/site.
Under 40 kg BW:
20 mL/site at 15 to 20 mL/hr/site

Usual Pediatric Dose for Primary Immunodeficiency Syndrome:

Intravenously:
300 to 600 mg/kg, IV
-Initial infusion rate: 1 mg/kg/min
-Maintenance infusion rate (if tolerated): 8 mg/kg/min every 3 to 4 weeks

Subcutaneously:
1.37 x current IV dose in grams / number of weeks between IV doses; administer weekly
-Initial infusion rate: 10 mL/hr/site
-Maintenance infusion rate; patients under 25 kg: 10 mL/hr/site
-Maintenance infusion rate; patients 25 kg and over: 20 mL/hr/site
-Use up to 6 infusion sites simultaneously
-Ensure infusion sites are at least 2 inches (5 cm) apart

Comments:
-Begin subcutaneous dosing one week after the patient's last IV infusion.
-Convert the previous IV dose (in grams) by multiplying by 1.37, then dividing this dose into weekly doses based on the previous IV interval.

Use: Treatment of primary humoral immunodeficiency including, but not limited to, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.