Pronunciation:

im-MYOON GLOB-yoo-lin

Brand Names:

• Baygam
• Carimune
• Flebogamma 5%
• Gamastan S/D
• Gamimune N
• Gammagard
• Gammagard S/D
• Gammar-P
• Gamunex
• Iveegam EN
• Octagam
• Panglobulin NF
• Polygam S/D
• Privigen
• Sandoglobulin
• Venoglobulin-S
• Iveegam
• Iveegam Immuno

Dosage Forms:

• Powder for Solution
• Solution
• Injectable

Warnings:

Immune globulin intravenous (human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number .

• GAMMAGARD S/D
  • GAMMAGARD S/D does not contain sucrose .

Immune globulin intravenous (IGIV) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Use caution in patients predisposed to acute renal failure and administer at the minimum concentration available and the minimum rate of infusion practicable in such patients. Higher rates of renal failure were associated with IGIV products containing sucrose. GAMMAGARD S/D and PREVIGEN do not contain sucrose .

Classifications:

Therapeutic—

Immune Serum

Uses of This Medicine:

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.

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)

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

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.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. 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 or
  • Being older than 65 years of age or
  • Diabetes mellitus (sugar diabetes) or
  • Paraproteinemia (having abnormal proteins called paraproteins in the blood) or
  • Sepsis (serious infection in the body) or
  • 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 this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

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

cloudy 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

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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 may also occur in some patients. If you notice any other effects, check with your healthcare professional.