Sandoglobulin

Action

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

Availability

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

➣ Immunodeficiency

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

Panglobulin-

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

Sandoglobulin-

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.

Venoglobulin-

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.

Panglobulin-

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.

Venoglobulin-S-

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.

Sandoglobulin-

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

Contraindications

• Hypersensitivity to drug or its components

• Selective immunoglobulin A deficiency

Precautions

Use cautiously in:

• bleeding disorders, renal impairment

• pregnant patients.

Administration

☞ 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

Interactions

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.