Not sure if there is a specific chicken pox immune globulin or just this one.

Mosby's GenRx®, 10th ed.

Copyright © 2000 Mosby, Inc.

Immune Serum Globulin Human (001527)

CATEGORIES:

Indications: Agammaglobulinemia; Hepatitis A, prophylaxis;

Hypogammaglobulinemia; Immunization, rubeola; Immunoglobulin deficiency;

Varicella, passive immunity

Pregnancy Category C

Orphan Drugs; WHO Formulary

FDA Pre 1938 Drugs

FDA DRUG CLASS: Blood Components/Substitutes; Immune Serums; Immunomodulators; Vaccines/Antisera

BRAND NAMES: Allerglobuline (Benin, Burkina-Faso, Ethiopia, Gambia, Ghana, Guinea, Ivory-Coast, Kenya, Liberia, Malawi, Mali, Mauritania, Mauritius, Morocco, Niger, Nigeria, Senegal, Seychelles, Sierra-Leone, Sudan, Tanzania, Tunia, Uganda, Zambia, Zimbabwe); Aunativ (Bahrain, Cyprus, Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Oman, Qatar, Republic-of-Yemen, Saudi-Arabia, Syria, United-Arab-Emirates); Beriglobin (Bahrain, Cyprus, Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Oman, Qatar, Republic-of-Yemen, Saudi-Arabia, Syria, United-Arab-Emirates, Sweden, Austria, Germany); Beriglobin P (Taiwan); Beriglobin-P (South-Africa); Beriglobina (Spain, Ecuador); Beriglobina P (Colombia); Citax F (Mexico); Endobulin (England, Finland, Czech-Republic, South-Africa); Gamafine (India); Gamastan (US); Gamastan Immune Globulin (Israel); Gamimune-N (US); Gamma 16 (Israel); Gammabulin (Hong-Kong); Gamma Globulin (US); Gammagard (US); Gammagard S D (Hong-Kong, Israel); Gammar (US); Gammonativ (Bahrain, Cyprus, Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Oman, Qatar, Republic-of-Yemen, Saudi-Arabia, Syria, United-Arab-Emirates, Norway, Denmark, Sweden, Germany); Globuman Berna (Peru, Hong-Kong, Malaysia, Philippines, Thailand, Taiwan, South-Africa); IG (US); IG Gamma (Philippines, Israel); Immune Globulin (US); IGIM (US); IGIV (US); Intraglobin (Italy, Switzerland, Germany, Taiwan); Intraglobin F (Thailand); Iveegam (US); Pentaglobin (Austria, Germany, Thailand); Sandoglobulin (US); Sandoglobulina (Italy, Colombia, Mexico); Sandoglobuline (Belgium, France); Venoglobulin (US); Venoglobulin-I (Malaysia); WinRho SD (US);

(International brand names outside U.S. in italics)

HCFA JCODES: J1460 1 cc IM; J1470 2 cc IM; J1480 3 cc IM; J1490 4 cc IM; J1500 5 cc IM; J1510 6 cc IM; J1520 7 cc IM; J1530 8 cc IM; J1540 9 cc IM; J1550 10 cc IM; J1560 over 10 cc IM; J1561 per 500 mg IV; J1562 per 500 mg IV

DESCRIPTION:

Gammar IV

Immune Globulin Intravenous (Human), Gammar-IV, is a sterile, lyophilized preparation of intact, unmodified, immunoglobulin, primarily lgG, stabilized with Albumin (Human) and Sucrose. The distribution of lgG sub-classes is similar to that present in normal human plasma. It is prepared by cold alcohol fractionation of pooled plasma and is not chemically altered or enzymatically degraded. When reconstituted with the appropriate volume of sterile water for injection, Gammar-IV contains 5% IgG, 3% Albumin (Human), 5% sucrose, and 0.5% sodium chloride. The pH of the solution has been adjusted to 6.8 ± 0.4 with citric acid and/or sodium carbonate. Gammar-IV contains no preservative. This product is intended for intravenous administration.

Gammar IM

Immune Globulin (Human) (IG) Gammar is a sterile solution of immunoglobulin G (IgG), containing 16.5=1.5% protein. It is prepared by cold alcohol fractionation of pooled plasma. Immune Globulin (Human)-Gammar contains the mercurial preservative thimerosal, at a concentration of 100 mg per liter and is stabilized with 0.3 M glycine. The pH of the solution has been adjusted to 6.8=0.4 with sodium bicarbonate. The product is intended for the intramuscular route of administration

CLINICAL PHARMACOLOGY:

Gammar IV

Immune Globulin Intravenous (Human), Gammar-IV provides a broad range of antibodies, capable of opsonization and neutralization of microbes and toxins, against bacterial and viral antigens for prevention or attenuation of infectious diseases. The half-life of Gammar-IV, as reflected in circulating lgG levels, is approximately three weeks, although individual variations have occurred.

Gammar-IV is a native, non-chemically modified lgG fractionated from pooled human donor plasma. The distribution of lgG sub-classes (lgG1, lgG2, lgG3, lgG4) is similar to that present in Cohn Fraction II. Since the lgG concentrate is prepared from a large pool of at least 1000 donors, it represents the expected diversity of antibodies in that population. The processing steps used in the manufacture of this product have been shown capable of eliminating at least 6.75 logs of added HIV.

Albumin (human) and sucrose are added to the formulation in order to provide adequate stabilization of the lgG molecules and the reconstituted product. Because sucrose, when given intravenously, is excreted unchanged in the urine, Immune Globulin Intravenous (Human), Gammar-IV, may be given to diabetics without compensatory changes in insulin dosage regimen.

Gammar IM

Peak blood levels of immunoglobulin G are obtained approximately 2 days after intramuscular injection of IG. The half-life of IgG in the circulation of individuals with normal IgG levels is 23 days.

Passive immunization with IG modifies hepatitis A, prevents or modifies measles, and provides replacement therapy in persons with hypo- or agammaglobulinemia. IG is not standardized with respect to antibody titers against hepatitis B surface antigen and should not be used for prophylaxis of viral hepatitis type B. Prophylactic treatment to prevent hepatitis B can best be accomplished with the use of Hepatitis B Immune Globulin, often in combination with Hepatitis B Vaccine.

IG may be of benefit in women who have been exposed to rubella in the first trimester of pregnancy and who would not consider a therapeutic abortion. IG may also be considered for use in immunocompromised patients for passive immunization against varicella-Zoster Immune Globulin (Human) is not available.

IG is not indicated for routine prophylaxis or treatment of rubella, poliomyelitis, mumps, or varicella. It is not indicated for allergy or asthma in patients who have normal levels of immunoglobulin.

INDICATIONS AND USAGE:

Gammar IV

Indicated for patients with primary defective antibody synthesis such as agammaglobulinemia or hypogammaglobulinemia, who are at increased risk of infection. When high levels or rapid elevation of circulating gamma globulins are desired, intravenous administration is more desirable than intramuscular therapy.

Gammar IM

Hepatis A: The Prophylactic value of IG is greatest when given before or soon after exposure to Hepatitis A. IG is not indicated in persons with clinical manifestations of hepatitis A or in those exposed more than two weeks previously.

Measles (Rubeola): IG should be given to prevent or modify measles in a susceptible person exposed less than 6 days previously. (A susceptible person is one who has not been vaccinated and has not had measles previously). IG may be especially indicated for susceptible household contacts under one year of age, for whom the risk of complications is highest. IG and measles vaccine should not be given at the same time . If a child is older than 12 months and has received IG, he should be given measles vaccines about 3 months later, when the measles antibody titer will have disappeared.

If a susceptible child exposed to measles is immunocompromised, IG should be given immediately. Children who are immunocompromised should not receive measles vaccine or any other live viral vaccine.

Immunoglobulin Deficiency: In patients with immunoglobulin deficiencies, IG may prevent serious infection. However, IG may not prevent chronic infections of the external secretory tissues such as the respiratory and gastrointestinal tract.

Prophylactic therapy, especially against infections due to encapsulated bacteria, is effective in Bruton-type, sex linked congenital agammaglobulinemia, agammaglobulinemia and severe combined immunodeficiency.

Varicella: passive immunization against varicella in immunosuppressed patients is best accomplished by use of Varicella-Zoster Immune Globulin (Human) (VZIG). If VZIG is unavailable, IG, promptly given, may also modify varicella.

Rubella: The routine use of IG for prophylaxis of rubella in early pregnancy is of dubious value and cannot be justified. Some studies suggest that the use of IG in exposed susceptible women can lessen the likelihood of infection and fetal damage. IG may benefit those women who will not consider a therapeutic abortion.

CONTRAINDICATIONS:

These products are contraindicated in individuals with a history of anaphylactic or severe systemic response to immune globulin intramuscular or intravenous preparations.

Gammar-IV: should not be given to persons with isolated immunoglobulin A (lgA) deficiency. Such persons have the potential for developing antibodies to lgA and could have anaphylactic reactions to subsequent administration of blood products that contain lgA.

Gammar IM: IG should not be administered to patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.

WARNINGS:

Gammar IV

If anaphylactic or severe anaphylactoid reactions occur, discontinue infusion immediately. Epinephrine should be available for the treatment of any acute anaphylactoid reactions.

Patients with agammaglobulinemia or extreme hypogammaglobulinemia who have not received immunoglobulin therapy within the preceding 8 weeks may be at risk of developing inflammatory reactions upon the infusion of human immunoglobulins. These reactions are manifested by a rise in temperature, chills, nausea and vomiting, and appear to be related to the rate of infusion.

Infusion rates and the patient's clinical state should be monitored closely during infusion. (See DOSAGE AND ADMINISTRATION.)

Gammar IM

IG should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations.

IG is for intramuscular injection only.

PRECAUTIONS:

General

Gammar IV: Epinephrine should be available for treatment of acute allergic reactions. See DOSAGE AND ADMINISTRATION section for product compatibility information.

Gammar IM: IG should not be administered intravenously because of the potential for serious reactions. Injections should be made intramuscularly and care should be taken to draw back on the plunger of the syringe before the injection in order to be certain that the needle is not in the blood vessel.

Although systemic reactions to intramuscularly administered immunoglobulin preparations are rare, epinephrine should be available for the treatment of acute symptoms.

Pregnancy Category C: Animal reproduction studies have not been performed with Immune Globulin Intravenous (Human), Gammar-IV. It is also not known whether Gammar-IV can cause fetal harm when administered to a pregnant women or can affect reproduction capacity. Gammar-IV should be given to a pregnant women only if clearly needed.

Pediatric Use: See DOSAGE AND ADMINISTRATION section.

DRUG INTERACTIONS:

Gammar IV

It is reported that antibodies in immune globulin preparations may interfere with the response by pediatric patients to live viral vaccines such as measles, mumps and rubella. Immunizing physicians should be informed of recent therapy with Immune Globulin Intravenous (Human) so that appropriate precautions may be taken.

Gammar IM

Antibodies in the globulin preparation may interfere with the response to live viral vaccines such as measles, mumps, and rubella. Therefore, use of such vaccines should be deferred until approximately three months after IG administration.

ADVERSE REACTIONS:

Gammar IV

Adverse reactions which may occur include headache, backache, myalgia, pyrexia, hypotension, chills, flushing and nausea, usually beginning within one hour of the start of the infusion. Symptoms subside in most cases within 30 minutes. The incidence of adverse reactions reported for a twelve month multi-center, repeated administration crossover study was shown to be 16% for Immune Globulin Intravenous (Human), Gammar-IV and 11% for another manufacturer's Immune Globulin Intravenous (Human). Data from this clinical evaluation indicated that the numbers of patients experiencing adverse reactions to each preparation were comparable, and that similar reactions were involved regardless of preparation.

True anaphylactic reactions may occur in patients with a history of prior systemic allergic reactions or seizure following administration of human immunoglobulin preparations. Very rarely an anaphylactoid reaction may occur in patients with no prior history of severe allergic reactions to human immunoglobulin preparations. Patients previously sensitized to certain antigens, most commonly lgA, may be at risk of immediate anaphylactoid and hypersensitivity reactions. Epinephrine should be available for the treatment of any acute anaphylactoid reaction. (See WARNINGS and

CONTRAINDICATIONS.)

Infusion rates and clinical state should be monitored closely during infusion. If an adverse reaction occurs, the infusion rate should be reduced or the infusion stopped until the symptoms have subsided. (See DOSAGE AND ADMINISTRATION.)

Gammar IM

Local pain and tenderness at the injection site, urticaria, and angioedema may occur. Anaphylactic reactions, although rare, have been reported following the injection of human immune globulin preparations. Anaphylaxis is more likely to occur if IG is given intravenously; therefore IG must be administered intramuscularly.

DOSAGE AND ADMINISTRATION:

Gammar IV

The usual dose of Immune Globulin Intravenous (Human) is directed toward restoration of the immune deficient patient's circulating lgG level to near-normal levels. Use of 100-200 mg/kg body weight every three to four weeks is recommended. An initial loading dose of at least 200 mg/kg at more frequent intervals, proceeding to 100-200 mg/kg at three week intervals once a therapeutic plasma level has been established can be used. However, treatment must be individualized for each patient due to variation among patients in catabolic rate of lgG.

Product Compatibility: It is recommended that Gammar IV be administered by a separate infusion line without admixture with other drugs or medications which the patient may be receiving. However, based upon compatibility studies, Gammar IV may be infused sequentially into a primary iv line containing either 0.9% sodium chloride injection or 5% dextrose injection or flushed with 0.9% sodium chloride injection or 5% dextrose injection. Do not mix Immune Globulin Intravenous (Human) products of differing formulations. If several doses of Immune Globulin Intravenous (Human), Gammar IV, are to be administered, several reconstituted vials of identical formulation and diluent may be pooled, using proper aseptic technique. As described under "Reconstitution," below, do not shake or cause excessive foaming. Swirl gently to mix. Filtration is acceptable but not required; pore sizes of greater than equal or equal to 15 microns will be less likely to slow infusion.

Reconstitution: Directions must be followed exactly.

1. Bring diluent and lyophilized product vials to room temperature prior to reconstitution.

2. Remove plastic flip-off caps from both vials.

3. Treat rubber stoppers with antiseptic solution and allow to dry.

4. Remove the clear guard from the plastic piercing pin (with double orifice). Insert plastic piercing pin of the transfer spike into the upright diluent via first.

5. Remove the blue guard from the plastic needle (with single orifice). Invert the diluent vial with the attached transfer spike and insert plastic needle into the upright product vial.

6. The vacuum in the product vial will pull the diluent into the product vial. As soon as all diluent has been transferred the transfer spike will automatically admit filtered air to the product. An additional venting of the product vial after diluent addition is not necessary. Withdraw and discard transfer spike.

7. Do not shake product vial. Solubilize the product by gently swirling it in an upright position. Avoid the formation of foam. NOTE: If the product cake is badly broken prior to addition of diluent, allow product vial to remain undisturbed for 2-3 minutes after addition of diluent before gently swirling to mix product.

8. Examine solution. Any small particles will dissolve with gentle swirling of vial. The solution should be clear and ready to administer in less than 20 minutes.

9. Product contains no preservative. Use within 3 hours of reconstitution.

Note: If several doses of Immune Globulin Intravenous (Human), Gammar IV, are to be pooled aseptically for administration, avoid excessive formation of foam in the pooling container and gently swirl the pooling container to mix. DO NOT SHAKE THE POOLING CONTAINER.

Administration

Caution: When entering the product stopper with an IV set spike for administration, care should be taken to follow the path made by the plastic needle of the transfer spike (see Reconstitution).

Immune Globulin Intravenous (Human) Gammar-IV is to be administered by intravenous infusion. The infusion should begin at a rate of 0.01 ml/kg/minute, increasing to 0.02 ml/kg/minute after 15 to 30 minutes. Most patients tolerate a gradual increase to 0.03-0.06 ml/kg/minute. For the average 70 kg person this is equivalent to 2 to 4 ml/minute. If adverse reactions develop, slowing the infusion rate will usually eliminate the reaction. Discard any unused solution.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Gammar IM

Dosage

Hepatitis A: IG in a dose of 0.01 ml/lb (0.02 ml/kg) is recommended for household and institutional hepatitis A contacts.

The doses of IG shown inTABLE 1 are recommended for persons who plan to travel in areas where hepatitis A is common.

TABLE 1

Length of Stay

Dose Volume

Less than three months

0.02 ml/kg

3 Months or longer

0.06 ml/kg

(repeat every 4-6 months)

Measles (Rubeola): IG should be given in a dose of 0.11 ml/lb (0.25 ml/kg) to prevent or modify measles in a susceptible person exposed less than 6 days previously.

If a susceptible child who is also immunocompromised is exposed, IG in a dose of 0.5 ml/kg (maximum 15 ml) should be given immediately.

Immunoglobulin Deficiency: IG may prevent serious infection in patients with immunoglobulin deficiencies if circulating IgG levels are appear 200 mg/100 ml plasma are maintained. The recommended dosage is 0.66 ml/kg (at least 100 mg/kg) given every 3 to 4 weeks. A double dose is given at onset of therapy: some patients may require more frequent injections.

Varicella: If Varicella-Zoster Immune Globulin (Human) is unavailable, IG at a dose of 0.6 to 1.2 ml/kg given promptly, is the recommended dose.

Rubella: The recommended dose of 0.55 ml/kg IG may benefit women who will not consider a therapeutic abortion.

Administration

IG is administered intramuscularly (see PRECAUTIONS), preferably in the gluteal region. Doses over 10 ml should be divided and injected into several muscular sites to reduce local pain and discomfort.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

REFERENCES:

1. Fudenberg HH. Sensitization to immunoglobulins and hazards of gamma globulin therapy. Immunoglobulins, Biologic Aspects and Clinical Uses. 1970; 211-220. Edited by Merler E. National Academy of Sciences, Washington, D.C. 2. Steele RW, Augustine RA, Tannenbaum AS, Marmer DJ. Intravenous Immune Globulin for Hypogammaglobulinemia: A Comparison of Opsonizing Capacity in Recipient Sera. Clin. Immunol. Immunopathol. 1985; 34:275-283. 3. Martindale. The Extra Pharmacopoeia 27th ed. Edited by Wade A. London: The Pharmaceutical Press. 1979;65. 4. Polley MJ, Fischetti VA, Landaburu PH. Native Intravenous IgG Exhibits Greater Biological Activity than Modified IgG. From the XX Cong. Int. Soc. of Hematology; 1984.

HOW SUPPLIED:

Gammar IV

Individual Vial Packages: Immune Globulin Intravenous (Human), Gammar IV, is supplied in single dose vials, with diluent and sterile, vented transfer spike for reconstitution. The 10 g dosage form package also contains an administration set.

Bulk Package: Immune Globulin Intravenous (Human), Gammar IV, 5.0 g immune globulin/vial is supplied in a bulk pack of six (6) single dose vials with six (6) sterile vented transfer spikes for reconstitution. Each single dose vial should be reconstituted with 100 ml Sterile Water for Injection, U.S.P. (not supplied).

Storage: When stored at temperatures not exceeding 30°C (86°F), Gammar-IV is stable for the period indicated by the expiration date on its label. Avoid freezing which may damage container for the diluent. For Gammar-IM, Vials should be stored at 2°-8° C (36°-46° F) Do not freeze. Do not use after expiration date.

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