Thymoglobulin IV Injection
Anti-human T-lymphocyte (Antithymocyte) immunoglobulin (rabbits)
25mg / 10ml
Synovia Pharma PLC
| Pack size | 25 mg vial |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 29800.00 AED |
Indications
Thymoglobulin IV Injection is used for:
Acute Renal Graft Rejection,
Prevention of acute transplant rejection in patients receiving allogeneic solid organ Transplants (SOT),
Therapy of acute corticosteroid-resistant rejection after allogeneic solid organ Transplantation
Prevention of graft-versus-host disease (GVHD) in adults after allogeneic stem cell transplantation (SCT)
Aplastic Anemia (Immunotherapy).
Adult Dose
IV infusion
Acute Renal Graft Rejection
Indicated for the prophylaxis and treatment of acute rejection in patients receiving a kidney transplant in conjunction with concomitant immunosuppression
Treatment: 1.5 mg/kg IV infusion qDay x 7-14 days
Prophylaxis: 1.5 mg/kg IV once daily with the first dose initiated prior to reperfusion of the donor kidney; usual duration is 4-7 days
Solid Organ Transplantation - (2.5-5 mg/kg/BW)
Stem cell Transplantation- (2.5-5 mg/kg/BW)
Aplastic Anemia - (3-5 mg/kg/BW)
Child Dose
Renal Dose
Administration
IV Preparation
Aseptically reconstitute required number of vials with 5 mL supplied diluent (SWI) immediately before use
Gently rotate vials to dissolve particulate matters if any; discard if particulate matters persist
Transfer all reconstituted drug into infusion bag containing saline or dextrose, invert bag to mix
Recommended volume: 50 mL of infusion solution per vial (total volume between 50-500 mL)
IV Administration
Premedicate recommended with corticosteroids, acetaminophen, and/or an antihistamine 1 hr before each infusion; may reduce the incidence and intensity of infusion-associated reactions
Infuse IV through 0.22 micron filter into high-flow vein
Infuse first dose over at least 6 hr and subsequent doses over at least 4 hr
Contra Indications
Hypersensitivity to the active substance or to any of the excipients.
This is contraindicated in solid organ transplant patients with severe thrombocytopenia.
This is contraindicated in patients with malignant tumors except in cases where stem cell transplantation is performed as part of the treatment.
Precautions
To prevent overimmunosuppression, physicians may decrease the dose of the maintenance immunosuppression regimen during the period of antithymocyte globulin rabbit use
Serious immune-mediated reactions, including anaphylaxis (including fatal anaphylaxis) or severe cytokine release syndrome (CRS), reported; if an anaphylactic reaction occurs, terminate the infusion immediately and implement emergency treatment (eg, 0.3-0.5 mL epinephrine (1 mg/mL) SC and other resuscitative measures including oxygen, IV fluids, antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated
CRS is reported with rapid infusion rates; CRS is attributed to the release of cytokines by activated monocytes and lymphocytes; severe acute CRS can cause serious cardiorespiratory events and/or death; close compliance with the recommended dosage and infusion time may reduce the incidence and severity of infusion-associated reactions; slowing the infusion rate may minimize many of this risk
Low counts of platelets and WBCs (including low counts of lymphocytes and neutrophils) have been identified and are reversible following dose adjustments
Routinely used in combination with other immunosuppressive agents; infections (bacterial, fungal, viral and protozoal), reactivation of infection (particularly CMV), and sepsis reported; these infections can be fatal; monitor carefully and administer appropriate anti-infective treatment when indicated
Immunosuppressives may increase the incidence of malignancies, including lymphoma or lymphoproliferative disorders
Safety of immunization with attenuated live vaccines following anti-thymocyte globulin rabbit therapy has not been studied, and therefore, is not recommended following recent therapy
May interfere with rabbit antibody-based immunoassays and with crossmatch or panel-reactive antibody cytotoxicity assays
Monitoring Parameters
Monitor patients for adverse reactions during and after infusion
Monitor total WBC and platelet counts during and after therapy
Monitor patients and administer anti-infective prophylaxis.
Pregnancy-Lactation
Pregnancy
Unknown whether antithymocyte globulin rabbit therapy can cause fetal harm; use only if benefit outweighs risk
Animal reproduction studies have not been conducted
Lactation
Has not been studied in breastfeeding women; unknown if excreted in human milk
Because other immunoglobulins are excreted in human milk, breastfeeding should be discontinued during antithymocyte globulin rabbit therapy
Interactions
No direct interaction between this product and corticosteroids, purlin antagonists, calcineurin inhibitors or mTOR inhibitors has been observed. However, the co-administration of these medicinal products may increase the risk of infection, thrombocytopenia, and anemia.
Thus, patients receiving combined immunosuppressive therapies are to be monitored carefully and an adequate adaptation of the regimen is recommended.
Vaccination For immunosuppressed patients’ live-attenuated virus vaccination is contraindicated. The antibody response to other vaccines may be diminished.
Adverse Effects
Side effects of Anti-human T-lymphocyte (Antithymocyte) immunoglobulin (rabbits) :
>10%
Abdominal pain (38%)
Asthenia (27%)
Chills (57%)
Diarrhea (37%)
Dyspnea (28%)
Fever (63%),
Headache (40%)
HTN (37%)
Hyperkalemia (27%)
Infection (37%)
Leukopenia (57%)
Malaise (13%)
Nausea (37%)
Pain (46%)
Peripheral edema (34%)
Tachycardia (27%)
Thrombocytopenia (37%)
1-10%
Dizziness
Digestive
Gastritis
Oral moniliasis
Herpes simplex infection
Mechanism of Action
Rabbit gamma-globulins that may cause immunosuppression by acting against human T cell surface antigens and depleting CD4 lymphocytes
Note
Thymoglobulin 25mg / 10ml IV Injection manufactured by Synovia Pharma PLC. Its generic name is Anti-human T-lymphocyte (Antithymocyte) immunoglobulin (rabbits). Thymoglobulin is availble in Bangladesh.
Farmaco BD drug index information on Thymoglobulin IV Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.