IMMUNEGLOBULIN INTRAVENOUS (HUMAN) (Systemic)

Some commonly used brand names are:

In the U.S.?

• Gamimune N 5%
• Gamimune N 10%
• Gamimune N 5% S/D
• Gamimune N 10% S/D
• Gammagard Liquid
• Gammagard S/D
• Gammagard S/D 0.5 g
• Gammar-P IV
• Iveegam
• Panglobulin
• Polygam S/D
• Sandoglobulin
• Venoglobulin-I
• Venoglobulin-S

In Canada?

• Gamimune N 5%
• Gamimune N 10%
• Gamimune N 5% S/D
• Gamimune N 10% S/D
• Iveegam

Other commonly used names are IGIVand IVIG.

Category

• Antibacterial, systemic
• anti-Kawasaki disease, systemic
• antipolyneuropathyagent
• antiviral, systemic
• immunizing agent, passive
• platelet count stimulator,systemic

Description

Immune globulin intravenous (IGIV) belongs to a group of medicinesknown as immunizing agents. IGIV is used to prevent or treat some illnessesthat can occur when your body does not produce enough of its own immunityto prevent those diseases.

IGIV should be administered only by or under the supervision of your doctoror other health care professional. IGIV is available in the following dosageform:

Parenteral
• Injection (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For immune globulinintravenous (IGIV), the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to intramuscular or intravenous immune globulins. Also tellyour health care professional if you are allergic to any other substances,such as foods, preservatives, or dyes.

Pregnancy?Studies on effects in pregnancy have not been donein either humans or animals. Before receiving this immune globulin, make sureyour doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding?It is not known whether IGIV passes into the breastmilk. Although most medicines pass into breast milk in small amounts, manyof them may be used safely while breast-feeding. Mothers who are using thismedicine and who wish to breast-feed should discuss this with their doctor.

Children?Although there is no specific information comparinguse of IGIV in children with use in other age groups, this medicine is notexpected to cause different side effects or problems in children than it doesin adults.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults. Although there is no specific informationcomparing use of IGIV in the elderly with use in other age groups, this medicineis not expected to cause different side effects or problems in older peoplethan it does in younger adults.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When receiving IGIVit is especially important that your health care professional know if youare taking any of the following:

• Live virus vaccines?IGIV may affect the degree of protectionprovided by live virus vaccines. Also, live virus vaccines may interfere withthe therapeutic effects of IGIV
• Nephrotoxic drugs (drugs that may damage the kidney)?IGIV hasbeen shown to have a connection with kidney damage. Your doctor may need tolower your dose of IGIV if you are taking any nephrotoxic drugs

Other medical problems?The presence of other medicalproblems may affect the use of IGIV. Make sure you tell your doctor if youhave any other medical problems, especially:

• Allergy to maltose or sucrose?May be in some IGIV products

• Blood clotting problems (or history of) or
• Diabetes mellitus (sugar diabetes) or
• Heart disease (or history of) or
• Heart problems or
• Immunoglobulin A (IgA) deficiencies or
• Kidney problems or
• Severe allergic reaction to IGIV?IGIV may make these conditionsworse

• Kidney problems or
• Conditions that make a person susceptible or more likely to havekidney problems such as:
  • Abnormal kidney function
  • Being older than 65 years of age
  • Diabetes mellitus (sugar diabetes)
  • Paraproteinemia (having abnormal proteins called paraproteins inthe blood)
  • Sepsis (serious infection in the body)
  • Volume depletion (loss of body fluids)
  ?May cause kidney dysfunction, failure, and can be fatal.

Proper Use of This Medicine

Make certainyour health care professional knows if you are on any special diet, such asa low-sodium or low-sugar diet.

Waiting at least 2 to 3 weeks after receiving live virus vaccines beforereceiving IGIV, depending on the vaccine received.

Waiting at least 5 to 11 months after receiving IGIV before receiving livevirus vaccines, depending on the vaccine to be received.

Dosing?The dose of IGIV will be different for differentpatients. Doses are based on body weight and the condition for which you arebeing treated. If you are receiving IGIV at home, followyour doctor's orders or the directions on the label. If you have anyquestions about the proper dose of IGIV, ask your doctor.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwantedeffects. Although not all of these side effects may occur, if they do occurthey may need medical attention.

Check with your doctor as soon as possibleif any of the following side effects occur:

More common

Fast or pounding heartbeat; troubledbreathing

Less common

Rare

Incidence not determined

Other side effects may occur that usually do not need medical attention. Theseside effects may go away during treatment as your body adjusts to the medicine.However, check with your doctor if any of the following side effects continueor are bothersome:

More common

Backache or pain; general feeling ofdiscomfort or illness; headache; joint pain; muscle pain; nausea; vomiting

Less common

Chest or hip pain; leg cramps; redness, rash, or pain at place of injection

Incidence not determined

Blurred vision, confusion, dizziness, faintness, or lightheadednesswhen getting up from a lying or sitting position suddenly; chills; confusion; dizziness; fever; feeling of warmth; high blood pressure; lightheadedness; redness of the face, neck, armsand occasionally, upper chest; skin rash; sweating

Other side effects not listed above may also occur in some patients. If younotice any other effects, check with your doctor.

Additional Information

Once a medicine has been approved for marketingfor a certain use, experience may show that it is also useful for other medicalproblems. Although these uses are not included in product labeling, IGIV isused in certain patients with the following medical conditions:

• Chronic parvovirus B19 infection (treatment)
• Chronic inflammatory demyelinating polyneuropathies (treatment)
• Dermatomyositis (treatment)
• Guillain-Barr? syndrome (treatment)
• Hyperimmunoglobulinemia E syndrome (treatment)
• Infections in low-birth-weight preterm high-risk neonates (prophylaxisand treatment adjunct)
• Lambert-Eaton myasthenic syndrome (treatment)
• Multifocal motor neuropathy (treatment)
• Relapsing-remitting multiple sclerosis (treatment)

Other than the above information, there is no additional information relatingto proper use, precautions, or side effects for its use.