Gammagard

GAMMAGARD S/D, Immune Globulin Intravenous (Human), contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins.

Peak levels of IgG are reached immediately after infusion of GAMMAGARD S/D (immune globulin) . It has been shown that, after infusion, exogenous IgG is distributed relatively rapidly between plasma and extravascular fluid until approximately half is partitioned in the extravascular space. Therefore, a rapid initial drop in serum IgG levels is to be expected.4 As a class, IgG survives longer in vivo than other serum proteins.4,5 Studies show that the half-life of GAMMAGARD S/D (immune globulin) is approximately 37.7 ± 15 days.3 Previous studies reported IgG half-life values of 21 to 25 days.4,5 using radiolabeled IgG or 17.7 to 37.6 days measuring IgG levels during administration of IGIV to immunodeficient patients.6 The half-life of IgG can vary considerably from person to person, however. In particular, high concentrations of IgG and hypermetabolism associated with fever and infection have been seen to coincide with a shortened half-life of IgG. 4-7

REFERENCES

3. Unpublished data in the files of Baxter Healthcare Corporation.

4. Waldmann TA, Storber W. Metabolism of immunoglobulins. Prog Allergy. 1969;13:1-110.

5. Morell A, Riesen W. Structure, function and catabolism of immunoglobulins. In: Nydegger UE, ed. Immunotherapy. London: Academic Press; 1981;17-26.

6. Mankarious S, Lee M, Fischer S, Pyun KH, Ochs HD, Oxelius VA, Wedgwood RJ. The half-lifes of IgG subclasses and specific antibodies in patients with primary immunodeficiency who are receiving intravenously administered immunoglobulin. J Lab Clin Med. 1988; 112:634-40.

7. Buckley RH. Immunoglobulin replacement therapy: Indications and contraindications for use and variable IgG levels achieved In: Alving BM, Finlayson JS eds. Immunoglobulins: characteristics and use of intravenous preparations. Washington, D.C.: US Department of Health and Human Services; 1979;3-8.

Increases in creatinine and blood urea nitrogen (BUN) have been observed as soon as one to two days following infusion. Progression to oliguria and anuria requiring dialysis has been observed, although some patients have improved spontaneously following cessation of treatment.35

Types of severe renal adverse reactions that have been seen following IGIV therapy include:

• acute renal failure
• acute tubular necrosis36
• proximal tubular nephropathy
• osmotic nephrosis18 (see also 37-39)

In general, reported adverse reactions to GAMMAGARD (immune globulin) , in patients with either congenital or acquired immunodeficiencies are similar in kind and frequency. Various minor reactions, such as mild to moderate hypotension, headache, fatigue, chills, backache, leg cramps, lightheadedness, fever, urticaria, flushing, slight elevation of blood pressure, nausea and vomiting may occasionally occur. Slowing or stopping the infusion usually allows the symptoms to disappear promptly.

Immediate anaphylactic and hypersensitivity reactions are a remote possibility. Epinephrine and antihistamines should be available for treatment of any acute anaphylactoid reaction (See WARNINGS).

Primary Immunodeficiency Diseases

Twenty-one adverse reactions occurred in 341 infusions (6%), when using GAMMAGARD (immune globulin) (5% solution), in a clinical trial of 17 patients with primary immunodeficiency.40 Of the 17 patients, 12 (71%) were adults, and 5 (29%) were children (16 years or younger).

In a cross-over study comparing GAMMAGARD and GAMMAGARD S/D (immune globulin) (5% solutions) conducted in a small number (n=10) of primary immunodeficient patients, no unusual or unexpected adverse reactions were observed in the GAMMAGARD S/D (immune globulin) group. The adverse reactions experienced in the GAMMAGARD S/D (immune globulin) group were similar in frequency and nature to those observed in the control group consisting of patients receiving GAMMAGARD (immune globulin) .

GAMMAGARD (immune globulin) , reconstituted to a concentration of 10%, was administered intravenously at rates varying from 2 to 11 mL/kg/Hr. Systemic reactions occurred in 23 (10.5%) of 219 infusions. This compares with an adverse reaction incidence of 6% (only systemic reactions reported) for primary immunodeficient patients previously treated with a 5% solution at infusion rates varying between 2 and 8 mL/kg/Hr, as described above (see reference 40). Local pain or irritation was experienced during 35 (16%) of 219 infusions. Application of a warm compress to the infusion site alleviated local symptoms. These local reactions tended to be associated with hand vein infusions and their incidence may be reduced by infusions via the antecubital vein.

B-cell Chronic Lymphocytic Leukemia (CLL)

In the study of patients with B-cell Chronic Lymphocytic Leukemia, the incidence of adverse reactions associated with GAMMAGARD (immune globulin) infusions was approximately 1.3% while that associated with placebo (normal saline) infusions was 0.6%.9

Idiopathic Thrombocytopenic Purpura (ITP)

During the clinical study of GAMMAGARD (immune globulin) for the treatment of Idiopathic Thrombocytopenic Purpura, the only adverse reaction reported was headache which occurred in 12 of 16 patients (75%). Of these 12 patients, 11 had chronic ITP (9 adults, 2 children), and one child had acute ITP. Oral antihistamines and analgesics alleviated the symptoms and were used as pretreatment for those patients requiring additional IGIV therapy. The remaining 4 patients did not report any side effects and did not require pretreatment.

Kawasaki Syndrome

In a study of patients (n=51) with Kawasaki syndrome, no hypersensitivity-type reactions (urticaria, bronchospasm or generalized anaphylaxis) were reported in patients receiving either a single 1g/kg dose of IGIV, GAMMAGARD (immune globulin) , or 400 mg/kg of IGIV, GAMMAGARD (immune globulin) , for four consecutive days.13 Mild adverse reactions, including chills, flushing, cramping, headache, hypotension, nausea, rash and wheezing, were reported with both dose regimens. These adverse reactions occurred in 7/51 (13.7%) patients and in association with 7/129 (5.4%) infusions. Of the 25 patients who received a single 1 g/kg dose, 4 patients experienced adverse reactions for an incidence of 16%. Of the 26 patients who received 400 mg/kg/day over 4 days, 3 experienced a single adverse reaction for an incidence of 11.5%.3

Postmarketing

The following list of adverse reaction have been identified and reported during the post-approval use of IGIV products:

Respiratory: cyanosis, hypoxemia, pulmonary edema, dyspnea, bronchospasm

Cardiovascular: thromboembolism, hypotension

Neurological: seizures, tremor

Hematologic: hemolysis, positive direct antiglobulin (Coombs) test

General/Body as a Whole: pyrexia, rigors

Musculoskeletal: back pain

Gastrointestinal:hepatic dysfunction, abdominal pain

Rare and Uncommon Adverse Events:

Respiratory: apnea, Acute Respiratory Distress Syndrome (ARDS), Transfusion Associated Lung Injury (TRALI)

Integumentary: bullous dermatitis, epidermolysis, erythema multiforme, Stevens- Johnson syndrome

Cardiovascular: cardiac arrest, vascular collapse

Neurological: coma, loss of consciousness

Hematologic: pancytopenia, leukopenia

Because postmarketing reporting of these reactions is voluntary and the at-risk populations are of uncertain size, it is not always possible to reliably estimate the frequency of the reaction or establish a causal relationship to exposure to the product. Such is also the case with literature reports authored independently.41 (See PRECAUTIONS)

Read the entire FDA prescribing information for Gammagard (Immune Globulin)

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© Gammagard Patient Information is supplied by Cerner Multum, Inc. and Gammagard Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Immune globulin injection is used to prevent or treat diseases that occur when your body has a weak immune system. Immune globulin contains antibodies that make your immune system stronger. It is used for patients who have primary humoral immunodeficiency (PI), idiopathic thrombocytopenic purpura (ITP), chronic immune thrombocytopenic purpura, or chronic inflammatory demyelinating polyneuropathy (CIDP). It is also used to improve muscle strength and disability in patients with multifocal motor neuropathy (MMN). Immune globulin injection belongs to a group of medicines known as immunizing agents.

This medicine is to be given only by or under the supervision of your doctor.

• It is used to stop or lower the harshness of other infections in people with a weak immune system.
• It is used to treat immune thrombocytopenia (ITP).
• It is used treat chronic inflammatory demyelinating polyneuropathy (CIDP).
• It is used to treat multifocal muscle neuropathy.
• It may be given to you for other reasons. Talk with the doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

All subcutaneous products:

• It is given as an infusion under the skin over a period of time.
• Your doctor may teach you how to use.
• Follow how to use carefully.
• Do not shake the solution.
• Wash your hands before and after use.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• Do not use if it has been frozen.
• Do not mix with any other liquid drugs.
• Do not give into skin that is irritated, bruised, red, infected, or scarred.
• Move the site where you give Gammagard as you were told by the doctor.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

Injection (I.V.):

• It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Fever or chills.
• Change in color of skin to a bluish color like on the lips, nail beds, fingers, or toes.
• Feeling very tired or weak.
• Seizures.
• Bloating.
• Feeling confused.
• Swelling.
• Very bad dizziness or passing out.
• A heartbeat that does not feel normal.
• Any unexplained bruising or bleeding.
• Mood changes.
• Muscle or joint pain.
• Change in speech.
• Change in eyesight.
• Blurred eyesight.
• Shakiness.
• Sweating a lot.
• Very bad belly pain.
• Dark urine or yellow skin or eyes.
• Very bad irritation where the shot was given.
• Lung problems have happened with this medicine. Call your doctor right away if you have lung or breathing problems like trouble breathing, shortness of breath, or a cough that is new or worse.
• This medicine may raise the chance of a very bad brain problem called aseptic meningitis. Call your doctor right away if you have a headache, fever, chills, very upset stomach or throwing up, stiff neck, rash, bright lights bother your eyes, feeling sleepy, or feeling confused.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where Gammagard is given.
• Headache.
• Loose stools (diarrhea).
• Feeling tired or weak.
• Back pain.
• Sore throat.
• Stuffy nose.
• Dizziness.
• Flushing.
• Cramps.
• Upset stomach or throwing up.
• Belly pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.