immune globulin for subcutaneous use, human

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immune globulin for subcutaneous use, human

Hizentra

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.

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.

References in periodicals archive ?
M2 EQUITYBITES-July 20, 2017-CSL Behring submits supplemental BLA for Hizentra with the US FDA for treating Chronic Inflammatory Demyelinating Polyneuropathy
Biotherapeutics company CSL Behring said on Wednesday that it has filed its supplemental Biologics License Application (BLA) for Hizentra [Immune globulin subcutaneous (Human) 20% liquid] with the US Food and Drug Administration (FDA) for the treatment for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a rare immune-mediated disorder of the peripheral nerves and the effects can worsen over time.
M2 PHARMA-July 20, 2017-CSL Behring submits supplemental BLA for Hizentra with the US FDA for treating Chronic Inflammatory Demyelinating Polyneuropathy
Hizentra, the first and only 20 percent subcutaneous immunoglobulin (SCIg) approved in the U.
The ability to store Hizentra without refrigeration for up to two and a half years is a milestone that provides added convenience to busy and active patients, while serving as another example of CSL Behring's dedication to meeting customer needs.
M2 PHARMA-July 20, 2017-CSL Behring's Supplemental Biologics License Application for Hizentra for CIPD Accepted for Review by FDA
According to the company, the SCIg60 Infusion System is the only mechanical syringe infusion pump system cleared by the US FDA for use with subcutaneous immunoglobulin Hizentra, Gammagard and Shire's new Cuvitru.
The ability to store Hizentra without refrigeration for up to two years is an innovation that can positively impact busy and active patients managing their primary immunodeficiency at home or in any setting that is convenient for them.
CSL Behring, a plasma protein biotherapeutics company, specialising in the manufacture of therapies for the treatment of rare and serious diseases, has received approval for a new 10g vial size of Hizentra, an immune globulin subcutaneous (human) liquid drug, from the US Food and Drug Administration, it was reported on Thursday.
Hizentra is the only 20% subcutaneous immunoglobulin (SCIg) approved in the U.
Manufactured by CSL Behring, Hizentra is the first 20 percent subcutaneous immunoglobulin approved by the U.
A once weekly immunoglobulin (Ig) replacement therapy, Hizentra provides effective protection against infection by maintaining a steady and normal level of immunoglobulin in the body.