immune globulin for I.M. use

(redirected from Gamunex)

immune globulin for I.M. use (IGIM)


immune globulin for I.V. use, human (IGIV)

Carimune NF, Flebogamma, Gammagard S/D, Gammar-P IV, Gamunex, Octagam, Polygam S/D, Privigen, Sandoglobulin, Vivaglobulin

immune globulin for I.V. and subcutaneous use, human


immune globulin for subcutaneous use, human


Pharmacologic class: Immune serum

Therapeutic class: Antibody-production stimulator

Pregnancy risk category C

FDA Box Warning

• IGIV (human) products have been linked to renal dysfunction, acute renal failure (ARF), osmotic nephrosis, and death. Patients predisposed to ARF include those with preexisting renal insufficiency, diabetes mellitus, age older than 65, volume depletion, sepsis, or paraproteinemia and those receiving known nephrotoxic drugs. In these patients, give drug at minimum rate of infusion feasible. IGIV products containing sucrose accounted for disproportionate share of renal dysfunction and acute renal failure reports.


Improves immunity by binding to and neutralizing pathogens, thereby increasing antibodies against bacterial, viral, parasitic, and mycoplasmic antigens. Acts through antimicrobial and antitoxin neutralization.


Injection: 2- and 10-ml vials (IGIM)

Powder for injection: 1-, 2.5-, 3-, 5-, 6-, 10-, and 12-g vials (IGIV)

Solution (5%): 10-, 50-, 100-, 200-, and 250-ml vials (IGIV)

Solution (10%): 10-, 25-, 50-, 100-, and 200-ml vials (IGIV)

Indications and dosages

To prevent hepatitis A

Adults traveling to areas where hepatitis A is common: 0.02 ml/kg I.M. if staying less than 3 months; 0.06 ml/kg repeated q 4 to 6 months if staying 3 months or longer

Adults with household or institutional contacts: 0.02 ml/kg I.M.

To prevent or reduce severity of measles in susceptible persons

Adults and children: 0.2 ml/kg to 0.25 ml/kg I.M. within 6 days of exposure to measles

Exposure to measles in immuno-compromised children

Children: 0.5 ml/kg I.M. as soon as possible after exposure

Varicella in immunocompromised patients

Adults: 0.6 to 1.2 ml/kg I.M. as soon as possible if varicella-zoster immune globulin is unavailable

To reduce risk of infection and fetal damage in females exposed to rubella during early pregnancy

Adults: 0.55 ml/kg I.M.

Immunoglobulin deficiency

Adults: Initially, 1.3 ml/kg I.M., followed in 3 to 4 weeks by 0.66 ml/kg, up to 100 mg/kg q 3 to 4 weeks


Gamimune N-

Adults and children: 100 to 200 mg/kg I.V. or 2 to 4 ml/kg (10%) I.V. monthly

Gammagard S/D-

Adults and children: 200 to 400 mg/kg I.V., then monthly in doses based on response

Gammar-P IV-

Adults: 200 to 400 mg/kg I.V. q 3 to 4 weeks

Children and adolescents: 200 mg/kg I.V. q 3 to 4 weeks

Iveegam EN-

Adults and children: 200 mg/kg I.V. monthly; may increase up to 800 mg/kg/month based on response


Adults and children: 200 mg/kg I.V. monthly, increased to 300 mg/kg/month. In some patients, infusion frequency may be increased.

Panglobulin NF/Carimune NF-

Adults and children: 0.2 g/kg I.V. monthly. If response inadequate, dosage may be increased to 0.3 g/kg or infusion frequency may be increased.

Polygam S/D-

Adults and children: 100 to 400 mg/kg I.V. monthly


Adults and children: 100 to 400 mg/kg I.V. monthly. In patients with previously untreated agammaglobulinemia or hypogammaglobulinemia, first infusion may be increased to 300 mg/kg or infusion frequency may be increased.


Adults and children: 200 mg/kg I.V. monthly, increased up to 400 mg/kg/month. In some patients, infusion frequency may be increased.

Idiopathic thrombocytopenic purpura

Gamimune N-

Adults and children: 400 mg/kg I.V. for 5 consecutive days, or 1,000 mg/kg/day for 1 day or for 2 consecutive days

Gammagard S/D-

Adults and children: 1,000 mg/kg I.V. Up to three doses may be given on alternating days, dependent on platelet count.


Adults and children: Initially, 0.4 g/kg I.V. for 2 to 5 consecutive days

Polygam S/D-

Adults and children: 1 g/kg I.V. Depending on response, additional doses may be given.


Adults and children: 2,000 mg/kg I.V. over 5 days or less for induction therapy; then 1,000 mg/kg p.r.n. to maintain platelet count of 30,000/mm3 in children or 20,000/mm3 in adults or to prevent bleeding episodes between infusions

Kawasaki disease

Gammagard S/D-

Adults and adolescents: 1 g/kg I.V. as a single dose; alternatively, 400 mg/kg/day for 4 consecutive days with aspirin

Iveegam EN-

Adults and children: 400 mg/kg/day I.V. with aspirin

Polygam S/D-

Adults and children: 1 g/kg I.V. as a single dose, or 400 mg/kg I.V. for 4 consecutive days starting within 7 days of fever onset. Give with aspirin, as prescribed.


Adults and children: 400 mg/kg I.V. for 2 to 5 consecutive days. If platelet count falls below 30,000/mm3 or significant bleeding occurs, may give 0.4 g/kg as a single infusion, increased to 0.8 or 1 g/kg as a single infusion, depending on response.

Venoglobulin S-

Adults and children: 2 g/kg I.V. infused over 10 to 12 hours with aspirin

To prevent bacterial infection in patients with hypogammaglobulinemia or recurrent bacterial infection associated with B-cell chronic lymphocytic leukemia

Adults and adolescents: 400 mg/kg I.V. (Gammagard S/D or Polygam S/D) q 3 to 4 weeks

To reduce risk of graft-versus-host disease, interstitial pneumonia, septicemia, and other infections during first 100 days after bone marrow transplantation

Adults ages 20 and older: 500 mg/kg I.V. (Gamimune N) 7 days before and 2 days before transplantation, then weekly through 90th day after transplantation

To prevent bacterial infection in children with human immunodeficiency virus

Children: 400 mg/kg I.V. (Gamimune N) q 28 days

Off-label uses

• Chronic inflammatory demyelinating polyneuropathy

• Guillain-Barré syndrome


• Hypersensitivity to drug or its components

• Selective immunoglobulin A deficiency


Use cautiously in:

• bleeding disorders, renal impairment

• pregnant patients.


Before giving, determine if patient has risk factors for acute renal failure (such as use of nephrotoxic drugs; history of diabetes mellitus, renal insufficiency, sepsis, volume depletion, or paraproteinemia; age 65 or older).

• For I.V. use, decrease infusion rate by 50% to 25% for patients at risk for renal dysfunction.

Give IGIM by I.M. route only; give IGIV by I.V. route only.

• If sterile laminar airflow conditions aren't available for drug reconstitution, administer immediately; discard unused portion.

• Don't shake vigorously, because foaming may occur. Know that cold drug or diluent may take up to 20 minutes to dissolve.

Adverse reactions

CNS: headache, malaise

CV: chest pain, tachycardia, thromboembolism

GI: nausea, vomiting, abdominal pain

Musculoskeletal: joint pain, back pain, myalgia

Respiratory: dyspnea

Skin: pruritus

Other: chills, lymphadenopathy, pain at injection site, anaphylaxis


Drug-drug. Live-virus vaccines: decreased antibody response to vaccine

Patient monitoring

Watch for acute inflammatory reaction in patients receiving drug for first time (usually appears within 30 to 60 minutes after infusion begins), in those whose last treatment was more than 8 weeks earlier, and when initial infusion rate exceeds 1 ml/minute.

• Monitor vital signs continuously during I.V. infusion. Stay alert for hypotension.

• Assess fluid volume status and blood urea nitrogen and creatinine levels.

• After infusion ends, monitor patient closely for nausea, vomiting, drowsiness, and severe headache.

Patient teaching

• Instruct patient to report symptoms occurring during or after therapy.

• Advise patient to avoid live-virus vaccines for 3 months after therapy; drug may delay or inhibit body's response to vaccine.

• As appropriate, review all significant and life-threatening adverse reactions and interactions, especially those related to the drugs mentioned above.

McGraw-Hill Nurse's Drug Handbook, 7th Ed. Copyright © 2013 by The McGraw-Hill Companies, Inc. All rights reserved
References in periodicals archive ?
PL- and FCS-cultured JPCs cultivated under undifferentiated and osteogenic conditions were detached from cell culture flasks and centrifuged (350g for 7min), and pellets were resuspended in 20 ml of 10% Gamunex (human immune globulin solution, Talecris Biotherapeutics, Frankfurt, Germany) and incubated for 15 min at 4[degrees]C.
Talecris further said that the difference between Gamunex and Gamunex-C is the labelling and packaging information.
Sales Rank Product 2009 dollar sales (bit.) 1 Oxycontin $2.90 2 Adderall XR 1.04 3 Proair HFA 0.91 4 Rebif 0.87 5 Metoprolol Succinate 0.81 6 Lovaza 0.76 7 Pantoprazole Sodium (Pfizer) 0.75 8 Androgel 1% 0.71 9 Amphetamin Salt ER 0.69 10 Pantoprazole Sodium (Teva) 0.56 11 Amlodipine Besylate/Benazepril 0.54 12 Solodyn 0.54 13 Fentanyl 0.49 14 Gamunex 0.43 15 Gammagard Liquid 0.43 16 Ocella 0.38 17 Divalproex Sodium ER 0.32 18 Carimune NF 0.28 19 Hydrocone APAP 0.28 20 Oxycodone HCI ER 0.27 Source: IMS Health
The current study enrolled 82 women and after 5 withdrawals, randomized 38 women to IVIG (Gamunex or Gamimune) 500 mg/kg and 39 women to an equivalent volume of normal saline infused prior to ovulation for a maximum of six cycles and continued every 4 weeks until 18-20 weeks of pregnancy.
Its lead product, Gamunex IGIV, helps in the treatment of immune deficiency conditions and leukemia, and with bone marrow transplant recovery.
Washington, Apr 25 (ANI): A new study has found that long-term treatment with Gamunex can significantly improve health-related quality of life in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
Gamunex is the first and only FDA-approved product for the treatment of CIDP.
During the initial 24-week treatment period, patients received IVIg (Gamunex) or placebo: a baseline loading dose of 2 g/kg over 2 to 4 days and then a maintenance infusion of 1 g/kg over 1 to 2 days every 3 weeks for up to 24 weeks.
(12) Patients were re-randomized to receive Gamunex or placebo every 3 weeks.
Three new IGIV products have been approved since FDA proposed the trial design: Bayer's Gamunex and Instituto Grifols' Flebogamma were approved in 2003, and Octapharma's Octagam was approved in 2004.