Lymphocyte Immune Globulin

Pronunciation: lim-fo-site ih-MYOON GLAH-byoo-lin
Class: Immune globulin

Trade Names

Atgam
- Solution for injection 50 mg/mL

Pharmacology

Antilymphocytic effect is believed to reflect an alteration of the function of the T lymphocytes.

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Pharmacokinetics

Absorption

T _max is 5 days.

Elimination

Mean t _½ is 5.7 days (2.7 to 8.7 days).

Onset

Rapid.

Indications and Usage

Moderate to severe aplastic anemia; treatment of acute allograft rejection in renal transplantation.

Unlabeled Uses

Immunosuppressant in course of liver, bone-marrow, heart, and other organ transplants; treatment of multiple sclerosis, myasthenia gravis, pure red-cell aplasia, and scleroderma.

Contraindications

Hypersensitivity to lymphocyte immune globulin or any other equine gamma globulin preparation.

Dosage and Administration

IV 10 to 20 mg/kg/day for 8 to 14 days; additional doses may be given every other day for a total of 21 doses (inclusive).

IV 10 to 30 mg/kg/day.

IV 5 to 25 mg/kg/day.

IV Give a fixed dose of 15 mg/kg/day for 14 days, then every other day for 14 days, for a total of 21 doses in 28 days. Administer the first dose within 24 h before or after the transplant.

IV The first dose can be delayed until the diagnosis of the first rejection episode. The recommended dose is 10 to 15 mg/kg/day for 14 days. Additional alternate-day therapy up to a total of 21 doses can be given.

General Advice

• For administration by IV infusion only. Not for intradermal, subcutaneous, IM, IV bolus, or intra-arterial administration.
• Before administering lymphocyte immune globulin, test patient with an intradermal injection of 0.1 mL of a freshly prepared 1:1,000 dilution of lymphocyte immune globulin in normal saline and a contralateral sodium chloride injection control.
• Do not shake diluted or undiluted solution. Shaking may cause foaming and/or denaturation of the protein.
• Dilute solution in an inverted bottle of compatible, sterile, saline-containing diluent so the undiluted lymphocyte immune globulin does not contact the air inside the bottle. Gently rotate or swirl the diluted solution to thoroughly mix. Final concentration should not exceed 4 mg of lymphocyte immune globulin/mL.
• Do not dilute with dextrose injection. Low salt concentrations may result in precipitation.
• Do not administer if solution is discolored, cloudy, turbid, or if particulate matter is noted.
• Allow solution to reach room temperature before infusion.
• Infuse prescribed dose through inline filter with pore size of 0.2 to 1 micron into vascular shunt, arterial venous fistula, or high-flow central vein catheter, over a period of no less than 4 h.

Storage/Stability

Store ampules in refrigerator (36° to 46°F). Protect from freezing. If not administered immediately, store diluted solution in refrigerator for up to 24 h (including infusion time).

Drug Interactions

Risk of infection may increase.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Unless otherwise stated, the following adverse reactions occurred in less than 5% of patients.

Cardiovascular

Chest pain; hypotension; hypertension; tachycardia; edema; CHF, vasculitis (postmarketing).

CNS

Fever; chills; headache; malaise; confusion, disorientation, dizziness, faintness, abnormal involuntary movements, paresthesia, rigidity, seizures, tremor (postmarketing).

Dermatologic

Skin reactions common including rash, pruritus, wheal, flare, and urticaria; chemical phlebitis reported, along with pain, redness, or swelling at the injection site; rashes (27%), sweating (postmarketing).

EENT

Laryngospasm/edema, nosebleed (postmarketing).

GI

Stomatitis; diarrhea, nausea, vomiting (5% to 10%); abdominal, epigastric, and stomach pain, GI bleeding or perforation, sore mouth or throat (postmarketing).

Genitourinary

Renal failure; oliguria; elevated creatinine, BUN; abnormal renal function (5% to 10%); acute renal failure, enlarged or ruptured kidney, renal artery thrombosis (postmarketing).

Hematologic

Thrombocytopenia (30%); leukopenia (14%); anemia, aplasia or pancytopenia, deep vein thrombosis, eosinophilia, hemolysis, hemolytic anemia, neutropenia or granulocytopenia, thrombophlebitis (postmarketing).

Hepatic

Abnormal LFTs, viral hepatitis (postmarketing).

Hypersensitivity

Anaphylactoid reactions. Symptoms may include respiratory distress, chest pain, flank pain, back pain, or hypotension. Anaphylaxis in fewer than 5% of patients; serum sickness common in patients with aplastic anemia or other hematological diseases.

Metabolic

Hyperglycemia (postmarketing).

Musculoskeletal

Arthralgia, back or flank pain (5% to 10%); leg pain, myalgia (postmarketing).

Respiratory

Apnea, dyspnea (5% to 10%); cough, pulmonary edema (postmarketing).

Miscellaneous

Fever (51%); chills (16%); systemic infection (13%); serum sickness-like symptoms, chest pain (5% to 10%); lymphoproliferative disorders reported, including lymphomas (secondary malignancy); systemic infections; some studies have found an increased risk of cytomegalovirus infection; herpes simplex infection, pain, localized infection, lymphadenopathy (postmarketing).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Experience with children has been limited. It has been administered safely to a small number of pediatric renal allograft recipients and pediatric aplastic anemia patients at dosage levels comparable to those in adults.

Hypersensitivity

Hypersensitivity may occur at any time during therapy.

Special Risk Patients

Because an immunosuppressive agent and antimetabolites are usually coadministered with this product, monitor patients carefully for signs of leukopenia, thrombocytopenia, or concurrent infection.

Antibodies

Human antilymphocyte immune globulin antibodies develop in 78% of patients treated with lymphocyte immune globulin. It is unknown whether such antibodies alter the clinical efficacy of repeated courses of therapy.

Discontinuation

Discontinue treatment if symptoms of anaphylaxis or severe and unremitting thrombocytopenia or leukopenia occur in renal transplant patients.

Disease transmission

Because this product is made using equine and human blood components, there is a risk of transmitting infectious agents (eg, viruses) and theoretically, the Creutzfeld-Jacob disease.

Dosage adjustment for hematologic toxicity

Consider dosage reduction in patients with profound bone marrow suppression; no specific guidelines available.

Extravasation

Local irritation or phlebitis may occur. Refer to your institution-specific protocol.

Hemolysis

Clinically significant hemolysis has been reported.

Serum sickness

Serum sickness reactions typically occur within 6 to 18 days of starting therapy, although reactions have been reported after drug discontinuation.

Patient Information

• Explain name, actions, and potential side effects of the treatment regimen. Review the treatment regimen including dosing schedule, duration of treatment, and monitoring that will be required.
• Review benefits of therapy and risks, including potential to transmit disease and unknown infectious agents.
• Advise patient, family, or caregiver that medication will be prepared and administered by health care provider in a health care setting.
• Advise patient, family, or caregiver that medication will be used in combination with other agents to achieve max benefit possible.
• Advise patient, family, or caregiver that a skin test may be performed before the first dose is administered.
• Advise patient, family, or caregiver to immediately report any of the following to health care provider: rash; itching; hives; difficulty breathing; fever, chills, or other signs of infection; bleeding or unusual bruising; pain, redness, or swelling at injection site.

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