Immune Globulin Subcutaneous

Pronunciation: i-MUNE GLOB-ue-lin
Class: Immune globulin

Trade Names

Hizentra
- Injection 200 mg/mL

Vivaglobin
- Injection 160 mg/mL

Pharmacology

Replaces normal human immunoglobulin G (IgG) antibodies.

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Pharmacokinetics

Absorption

Bioavailability of Vivaglobin is approximately 73% compared with immune globulin IV. Peak serum IgG levels are lower with subcutaneous compared with IV administration. Mean peak and trough IgG levels following Hizentra administration are 1,616 and 1,448 mg/dL, respectively; following Vivaglobin administration, mean peak and trough IgG levels are 1,163 and 1,064 mg/dL, respectively. Steady-state serum IgG levels are relatively stable with weekly subcutaneous administration.

Indications and Usage

Treatment of primary immune deficiency.

Contraindications

History of anaphylactic or severe systemic response to immune globulin preparations or to components of the preparation ( Hizentra only); patients with selective immunoglobulin A (IgA) deficiency who have known antibody against IgA and/or a history of hypersensitivity; patients with hyperprolinemia ( Hizentra only).

Dosage and Administration

Hizentra
Adults and Children 1 y of age and older

Subcutaneous Calculate the initial weekly dose by multiplying the previous immune globulin IV dose by 1.53, then divide this dose into weekly doses based on the previous immune globulin IV treatment interval. Doses may be adjusted over time to achieve the desired clinical response and serum IgG levels. To adjust the dose based on IgG trough levels, calculate the difference in (mg/dL) of the patient's serum IgG trough level from the target IgG trough level (1.3 times the last immune globulin IV trough level). Then find this difference in the following table and the corresponding amount (in mL) by which to increase or decrease the weekly dose based on the patient's body weight.

Adjustment (± mL) of the Weekly Hizentra Dose Based on the Difference (± mg/dL) From the Target Serum IgG Trough Level Difference from the target serum IgG trough level Body weight 10 kg 15 kg 20 kg 30 kg 40 kg 50 kg 60 kg 70 kg 80 kg 90 kg 100 kg 110 kg 120 kg Dose adjustment (mL/wk) 50 mg/dL 0 1 1 1 2 2 3 3 4 4 5 5 6 100 mg/dL 1 1 2 3 4 5 6 7 8 8 9 10 11 150 mg/dL 1 2 3 4 6 7 8 10 11 13 14 15 17 200 mg/dL 2 3 4 6 8 9 11 13 15 17 19 21 23 250 mg/dL 2 4 5 7 9 12 14 16 19 21 23 26 28 300 mg/dL 3 4 6 8 11 14 17 20 23 25 28 31 34 350 mg/dL 3 5 7 10 13 16 20 23 26 30 33 36 39 400 mg/dL 4 6 8 11 15 19 23 26 30 34 38 41 45 450 mg/dL 4 6 8 13 17 21 25 30 34 38 42 46 51 500 mg/dL 5 7 9 14 19 23 28 33 38 42 47 52 56

Dose adjustment in mL is based on the slope of the serum IgG trough level response to Hizentra dose increments (5.3 mg/dL per increment of 1 mg/kg/wk).

Vivaglobin
Adults and Children 2 y of age and older

Subcutaneous Recommended weekly dosage is 100 to 200 mg/kg. Calculate the initial weekly dose by multiplying the previous immune globulin IV dose by 1.37, then divide this dose into weekly doses based on the previous immune globulin IV treatment interval. Doses may be adjusted over time to achieve the desired clinical response and serum IgG levels.

General Advice

  • For subcutaneous administration only. Do not inject IV or into a blood vessel.
  • Inject into abdomen, thigh, upper arm, and/or lateral hip.
  • Prior to use, allow solution to reach ambient room temperature.
  • Do not shake.
  • Do not administer if particulate matter or cloudiness noted.
  • Divide doses larger than 15 mL into several muscle sites to reduce local pain and discomfort. Injection sites should be at least 2 inches apart. For Hizentra , not more than 4 sites should be infused simultaneously, and the volume infused per site may be increased to 20 mL per site after the fourth infusion and to a max of 25 mL per site as tolerated.
  • For the first infusion of Hizentra , the max recommended flow rate is 15 mL/h per site, and may be increased for subsequent infusions to a max of 25 mL/h per site as tolerated. However, the max flow rate should not exceed a total of 50 mL/h for all sites combined at any time.
  • For Vivaglobin , a rate of 20 mL/h per site was not exceeded in clinical trials.
  • Do not mix with other medicinal products.

Storage/Stability

Store Hizentra at up to 77°F; store Vivaglobin in refrigerator at 36° to 46°F. Do not freeze.

Drug Interactions

Live vaccines (eg, measles, mumps, rubella)

Efficacy of live attenuated virus vaccines, such as measles, mumps, and rubella, may be transiently impaired. Be aware of recent therapy with immune globulin subcutaneous so that appropriate precautions can be taken.

Laboratory Test Interactions

After injection of immunoglobulins, the transitory increase of the various passively transferred antibodies in the patient's blood may yield positive serological testing, with the potential for misleading interpretation. Passive transmission of antibodies to erythrocyte antigens (eg, A, B, D) may cause a positive direct or indirect antiglobulin (Coombs') test.

Adverse Reactions

Cardiovascular

Tachycardia (3%).

CNS

Headache (48%); fatigue (12%); migraine (8%); asthenia (5%).

Dermatologic

Rash (17%); contusion (4%); skin disorder (3%).

EENT

Sore throat (17%); epistaxis, pharyngolaryngeal pain (8%).

GI

GI disorder (37%); nausea (18%); diarrhea (14%); upper abdominal pain (10%); vomiting (6%).

Genitourinary

Urine abnormality (3%).

Hypersensitivity

Allergic reaction (11%).

Local

Local reactions, including injection-site reactions, as well as bruising, cysts, eczema, irritation, nodules, pain, and scabbing at the injection site (100%).

Musculoskeletal

Back pain (10%); arthralgia, pain in extremity (8%).

Respiratory

Cough (16%).

Miscellaneous

Fever (25%); pain (10%).

Precautions

Monitor

When initiating therapy, monitor patients for any adverse reactions during and after infusion. Assess renal function, including BUN and serum creatinine, before the initial infusion and at appropriate intervals thereafter. Periodic monitoring of renal function and urine output is particularly important in patients judged to have a potential increased risk of developing acute renal failure. Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity. Monitor recipients for clinical signs and symptoms of hemolysis and pulmonary adverse reactions.


Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established in children younger than 1 y of age ( Hizentra ) or 2 y of age ( Vivaglobin ).

Hypersensitivity

Hypersensitivity, including anaphylactic reactions, may occur.

Renal Function

Patients with preexisting renal insufficiency may be at increased risk of developing renal dysfunction; infuse immune globulin subcutaneous at the minimum acceptable rate.

Special Risk Patients

Patients receiving immune globulin therapy for the first time, switching from another brand of immune globulin, or who have not received immune globulin within the preceding 8 wk may be at risk for developing reactions, including chills, fever, nausea, vomiting, and, rarely, shock.

Blood-borne virus transmission

Immune globulin subcutaneous is made from human blood and may carry a risk of transmitting infectious agents (eg, Creutzfeldt-Jakob disease, viruses).

Reactions associated with other immune globulin therapy

The following reactions have been reported with immune globulin IV treatment and may occur with immune globulin subcutaneous: aseptic meningitis syndrome, hemolysis, renal dysfunction/failure, thrombotic events, and transfusion-related lung injury.

Overdosage

Symptoms

No data available.

Patient Information

  • Provide home-treatment patients with instructions on subcutaneous infusion, including type of equipment and its maintenance, proper infusion techniques, selection of appropriate sites, maintenance of treatment diary, and measures to take if adverse reactions occur.
  • Inform patients of the early signs of hypersensitivity reactions (eg, anaphylaxis, generalized urticaria, hives, hypotension, tightness of the chest, wheezing) and advise them to notify their health care provider if they experience any of these symptoms.
  • Inform patients that the administration of immune globulin may interfere with the response to live virus vaccines and to inform their immunizing health care provider of recent therapy with immune globulin subcutaneous.
  • Advise patients to be aware of and immediately report to their health care provider any of the following symptoms: change in mental status, chest pain, dark-colored urine, drop in blood pressure, drowsiness, fatigue, fever, increased heart rate, light-headedness, nausea, neck stiffness, painful eye movements, sensitivity to light, severe breathing problems, severe headache, shortness of breath, vomiting, yellowing of the skin or eyes.
  • Inform patients that immune globulin subcutaneous is made from human plasma and may contain infectious agents that can cause disease (eg, viruses). Explain that the risk has been reduced by donor screening, testing the donated plasma for certain viruses, and inactivating and/or removing certain viruses during manufacturing.

Copyright © 2009 Wolters Kluwer Health.

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