Antithymocyte Globulin (Rabbit)
Pronunciation: (an-tee-THIGH-moe-site GLAH-byoo-lin)Class: Immune globulin
Trade Names:Thymoglobulin- Powder for injection 25 mg vials
Pharmacology
Mechanism of action is not fully understood. Possible mechanisms include the following: T-cell Cl from the circulation and modulation of T-cell activation, homing, and cytotoxic activities.
Pharmacokinetics
Elimination
The t ½ is 2 to 3 days.
Indications and Usage
Treatment of acute allograft rejection in renal transplantation.
Contraindications
Acute viral illness; hypersensitivity to leporine proteins; previous hypersensitivity to anti-thymocyte globulin.
Dosage and Administration
Acute Renal Graft RejectionAdultsIV 1.5 mg/kg/day for 7 to 14 days using a high-flow vein. Infuse over a minimum of 6 h for first infusion and over at least 4 h for subsequent doses.
Dosage AdjustmentAdultsIV Reduce 50% if the WBC is between 2,000 and 3,000 cells/mm 3 or if the platelet count is between 50,000 and 75,000 cells/mm 3 . Consider stopping treatment if the WBC falls below 2,000 cells/mm 3 or platelets below 50,000 cell/mm 3 .
General Advice
- Premedicate with corticosteroids, acetaminophen, and/or antihistamine 1 h before infusion of anti-thymocyte globulin as ordered.
- Allow vials to reach room temperature before reconstitution.
- Reconstitute each vial of powder for injection using 5 mL of supplied diluent (sterile water for injection) following manufacturer's guidelines. Do not shake vial during reconstitution. Gently rotate vial until powder is completely dissolved. Resulting solution provides 5 mg/mL of anti-thymocyte globulin.
- Transfer contents of appropriate number of reconstituted vials into bag of saline or dextrose infusion solution (recommended volume of 50 mL infusion solution per vial of anti-thymocyte globulin). Mix solution by gently inverting infusion bag once or twice.
- Do not administer if solution is discolored, cloudy, turbid, or if particulate matter is noted.
- Administer prescribed dose through a 0.22 micron filter into a high-flow vein.
- To reduce infusion-related adverse reactions (eg, fever, chills) infuse first dose over no less than 6 h and subsequent doses over no less than 4 h. Infusion rate may be further slowed if infusion-related reactions occur.
Storage/Stability
Store unopened vials in refrigerator (36° to 46°F). Protect from light and freezing. Use reconstituted vials within 4 h. Diluted infusion solution must be used immediately. Discard any unused solution. Do not save unused solution for future use.
Drug Interactions
Immunosuppressants (antineoplastic agents, corticosteroids, cyclosporines)Risk of infection may increase.
Laboratory Test Interactions
May interfere with rabbit antibody-based immunoassays and with cross-match or panel-reactive antibody cytotoxicity assays.
Adverse Reactions
Cardiovascular
Hypertension (37%); tachycardia (27%).
CNS
Headache (40%); asthenia (27%); malaise (13%); dizziness (9%).
GI
Abdominal pain (38%); diarrhea, nausea (37%).
Hematologic-Lymphatic
Leukopenia (57%); thrombocytopenia (37%).
Hypersensitivity
Anaphylaxis.
Lab Tests
Hyperkalemia (27%).
Respiratory
Dyspnea (28%).
Miscellaneous
Fever (63%); chills (57%); pain (46%); infection (37%); peripheral edema (34%).
Precautions
MonitorAllergic reactionMonitor patient for signs of anaphylaxis or severe allergic reaction. Discontinue therapy and immediately notify health care provider if noted. Be prepared to treat appropriately. CBCEnsure CBC and differential are determined at baseline and periodically during course of therapy. Lymphocyte countEnsure lymphocyte count (total lymphocyte and/or T-cell subsets) is monitored during treatment to assess degree of T-cell depletion. |
Pregnancy
Category C .
Lactation
Undetermined.
Children
Safety and efficacy not established.
Hypersensitivity
Anaphylaxis may occur.
Antibodies
Human anti-rabbit antibodies develop in 68% of patients.
Extravasation
Local irritation or phlebitis may occur. Refer to your institution specific protocol.
Prophylaxis
Ensure that potential value of antiviral, antibacterial, antiprotozoal, and/or antifungal prophylaxis has been evaluated.
Overdosage
Symptoms
Leukopenia, thrombocytopenia.
Patient Information
- Review the treatment regimen, including dosing schedule, duration of treatment, and monitoring that will be required.
- 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 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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