Gamimune N 10%

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IMMUNE GLOBULIN 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 IGIV and IVIG .

Category

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

Description

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

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

  • 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 will do. This is a decision you and your doctor will make. For immune globulin intravenous (IGIV), the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to intramuscular or intravenous immune globulins. Also tell your 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 done in either humans or animals. Before receiving this immune globulin, make sure your doctor knows if you are pregnant or if you may become pregnant.

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

Children—Although there is no specific information comparing use of IGIV in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of IGIV in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When receiving IGIV it is especially important that your health care professional know if you are taking any of the following:

  • Live virus vaccines—IGIV may affect the degree of protection provided by live virus vaccines. Also, live virus vaccines may interfere with the therapeutic effects of IGIV
  • Nephrotoxic drugs (drugs that may damage the kidney)—IGIV has been shown to have a connection with kidney damage. Your doctor may need to lower your dose of IGIV if you are taking any nephrotoxic drugs

Other medical problems—The presence of other medical problems may affect the use of IGIV. Make sure you tell your doctor if you have 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 conditions worse
  • Kidney problems or
  • Conditions that make a person susceptible or more likely to have kidney problems such as:
    • Abnormal kidney function
    • Being older than 65 years of age
    • Diabetes mellitus (sugar diabetes)
    • Paraproteinemia (having abnormal proteins called paraproteins in the 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 certain your health care professional knows if you are on any special diet, such as a low-sodium or low-sugar diet.

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

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

Dosing—The dose of IGIV will be different for different patients. Doses are based on body weight and the condition for which you are being treated. If you are receiving IGIV at home, follow your doctor"s orders or the directions on the label. If you have any questions about the proper dose of IGIV, ask your doctor.

Side Effects of This Medicine

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

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

More common

Fast or pounding heartbeat; troubled breathing

Less common

Bluish coloring of lips or nailbeds; burning sensation in head; faintness or lightheadedness; unusual tiredness or weakness; wheezing

Rare

Difficulty in breathing or swallowing; hives or welts; itching, especially of feet or hands; reddening of skin, especially around ears; swelling of eyes, face, or inside of nose; unusual tiredness or weakness (sudden and severe)

Incidence not determined

Blistering, peeling, loosening of skin; bloody, black, or tarry stools; change in consciousness; loudy urine; convulsions; coughing that sometimes produces a pink frothy sputum; dark urine; decrease in urine output or decrease in urine-concentrating ability; diarrhea; difficult, fast, noisy breathing, sometimes with wheezing; feeling unusually cold; high fever; increased sweating; loss of bladder control; loss of consciousness; muscle spasm or jerking of all extremities; no blood pressure or pulse; noisy breathing; not breathing; painful or difficult urination; pains in chest, groin, or legs, especially calves of legs; pale skin; red, irritated eyes; red skin lesions, often with a purple center; severe headaches that occur suddenly; shakiness in legs, arms, hands, feet; shivering; shortness of breath; shortness of breath that occurs suddenly for no apparent reason; skin blisters; slurred speech that occurs suddenly; sore throat; sores, ulcers, or white spots in mouth or on lips; stomach pain; stopping of heart; sudden loss of consciousness; sudden loss of coordination; sudden vision changes; swelling in legs and ankles; swollen glands; tightness in chest; tiredness; trembling or shaking of hands or feet; unconsciousness; unexplained or unusual bleeding or bruising; yellow eyes or skin

Other side effects may occur that usually do not need medical attention. These side 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 continue or are bothersome:

More common

Backache or pain; general feeling of discomfort 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 lightheadedness when 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, arms and occasionally, upper chest; skin rash; sweating

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

Additional Information

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

  • Chronic parvovirus B19 infection (treatment)
  • Chronic inflammatory demyelinating polyneuropathies (treatment)
  • Dermatomyositis (treatment)
  • Guillain-Barré syndrome (treatment)
  • Hyperimmunoglobulinemia E syndrome (treatment)
  • Infections in low-birth-weight preterm high-risk neonates (prophylaxis and 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 relating to proper use, precautions, or side effects for its use.

Revised: 09/22/2005

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