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All price changes →Indications & Uses
Anti-human T-lymphocyte immunoglobulin is used together with other immunosuppressive medicines to suppress the immune competent cells that cause acute rejection or graft versus host disease. Grafalon is indicated in the same way. It is usually given for the following purposes. Prevention of acute transplant rejection in patients receiving allogeneic solid organ transplants: Anti-human T-lymphocyte immunoglobulin is used in combination with other immunosuppressive medicines (e.g. glucocorticosteroids, purin antagonists, calcineurin inhibitors or mTOR inhibitors) to enhance immunosuppression after allogeneic solid organ transplantation. Therapy of acute corticosteroid-resistant rejection after allogeneic solid organ transplantation: It is indicated for treating acute corticosteroid-resistant rejection episodes after allogeneic solid organ transplantation, if treatment with methyl-prednisolone has not worked well enough. Prevention of graft-versus-host disease (GVHD) in adults after allogeneic stem cell transplantation (SCT): Anti-human T-lymphocyte immunoglobulin is indicated to prevent graft-versus-host disease (GVHD) in adults with haematological malignancies after stem cell transplantation from matched unrelated donors. It is given in combination with standard Cyclosporin A/methotrexate prophylaxis.
Pharmacology
Anti-human T-lymphocyte immunoglobulin is a polyclonal anti-T-lymphocyte immunoglobulin made from rabbits that have been immunized with Jurkat cells, a lymphoblastoid cell line. Jurkat cells carry T-cell markers, and this fits with the effects the immunoglobulin has on lymphocytes. It has also been found to contain antibodies against other surface antigens of Jurkat cells. When lymphocyte subsets were analysed in patients who received Anti-human T-lymphocyte immunoglobulin, those carrying surface proteins expressed by the Jurkat cell line were reduced.
The immunoglobulin is cytotoxic against human lymphocytes, and the data show that activated lymphocytes are more susceptible. It did not activate T-cells (via CD3) or lymphocytes, but it did inhibit activation of T-cells by an anti-CD3 antibody. It also reduced migration of human melanoma cells by binding to adhesion molecules.
Its anti-adhesive properties (anti-LFA-1 and anti-ICAM-1 activity) might explain a finding in porcine kidneys. These kidneys were perfused with human lymphocytes that had been incubated with or without the immunoglobulin. Where it was added, the vascular resistance of the kidney vessels was lower and fewer lymphocytes were retained in the kidney.
In rhesus monkeys, Anti-human T-lymphocyte immunoglobulin prolonged skin graft survival. Immunosuppression was clear in this model, and leukopenia and lymphopenia were observed. In cynomolgus monkeys, it had a beneficial effect on ischemia/reperfusion injury by inhibiting the adhesion of lymphocytes and neutrophils.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
The dose of Anti-human T-lymphocyte immunoglobulin depends on the indication, and it is worked out from body weight.
Prevention of acute transplant rejection in patients receiving allogeneic solid organ transplants: the recommended dose range is 2 to 5 mg/kg/d. Most often the dose falls between 3 and 4 mg/kg/d. Therapy should start on the day of transplantation, either before, during or immediately after the operation. How long it continues depends on the patient's condition, the daily dose chosen and the other immunosuppressive medicines being given. The recommended duration of therapy is 5 to 14 days.
Therapy of acute corticosteroid-resistant rejection after allogeneic solid organ transplantation: the recommended dose range is 3 to 5 mg/kg/d. The most common dosages are 3 to 4 mg/kg/d. Duration of therapy varies with the condition of the grafted organ and the clinical response, and it is usually between 5 and 14 days.
Prevention of graft-versus-host disease (GVHD) in adults after allogeneic stem cell transplantation (SCT): this is given as part of myeloablative conditioning regimens for stem cell transplantation. The recommended dose is 20 mg/kg/d, usually starting from day -3 to day -1 before SCT.
Side Effects
Very common side effects of Anti-human T-lymphocyte immunoglobulin are likely to affect more than 1 in every 10 patients. They are fever, chills, headache, tremor, vomiting, nausea, diarrhea, abdominal pain, breathing difficulties, flushing, an increased rate of infections (CMV infection, urinary tract infection), and a low count of red blood cells (anemia). Common side effects are likely to affect less than 1 in every 10 patients. These are thrombocytopenia, leukopenia, pancytopenia (blood disorders), inflammation of mucosa, peripheral swelling, feeling tired, chest pain, joint and muscle pain, back pain, muscle stiffness, low or high blood pressure, a sensation of tingling, pricking, or numbness in the skin, fast beating of the heart, light sensitivity (photophobia), elevation of laboratory parameters, increased bilirubin in the blood, blood in urine, cough, nose bleeding, reddening of skin, itching, rash, anaphylactic shock, anaphylactic reaction, hypersensitivity, kidney function failure, lymphoproliferative disorder (a type of cancer that originates from certain white blood cells), venoocclusive disease (blocked small veins in the liver), bacterial sepsis, pneumonia, pyelonephritis, herpes infection, Influenza, Candidiasis, bronchitis, rhinitis, sinusitis, nasopharyngitis, and skin infection.
Cautions & Contraindications
Warnings & Precautions
Patients who receive Anti-human T-lymphocyte immunoglobulin must be managed in a facility that has enough laboratory and supportive medical resources, and enough trained staff, to give emergency treatment if it's needed. The medicine must be given and monitored under qualified medical supervision. Hypersensitivity reactions have been reported with Anti-human T-lymphocyte immunoglobulin. Before the first dose, it is recommended to find out whether the patient has a history of allergic tendency, in particular to rabbit proteins. If the patient is exposed again, either by repeating the course or by treatment with rabbit immunoglobulin preparations from other manufacturers, the risk of an anaphylactic reaction is higher. This is because the earlier therapy may have caused sensitisation. Severe thrombocytopenia needs a separate decision. In solid organ transplant patients who develop it (less than 50,000 platelets/μl), treatment with Anti-human T-lymphocyte immunoglobulin should be interrupted or stopped, as the medicine may worsen thrombocytopenia and so raise the risk of haemorrhage. Clinical staff should be ready with suitable emergency measures. Anti-human T-lymphocyte immunoglobulin has to be given with special caution in patients with hepatic diseases. Clotting disorders that are already present may get worse, so careful monitoring of thrombocytes and coagulation parameters is recommended. The same special caution applies to patients with known or suspected cardiovascular disorders. If a patient has hypotension, or cardiac decompensation with orthostatic symptoms (e.g. unconsciousness, weakness, vomiting, nausea), slowing or interrupting the infusion should be considered.
Pregnancy & Breastfeeding
We don't know what risk anti-human T-lymphocyte immunoglobulin may carry for the fetus, so doctors should be careful when prescribing it to pregnant women. Human immunoglobulin, at the very least, can potentially cross the placental barrier and pass into human breast milk. For this reason, the treating physician should decide whether to treat a pregnant or breastfeeding woman, based on an assessment of the risk against the benefit.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Storage
Store anti-human T-lymphocyte immunoglobulin in a refrigerator at 2°C-8°C. Keep the vial in its outer carton so the light can't reach it.
Common questions about Grafalon 100 mg/5 ml
What is Grafalon 100 mg/5 ml IV Infusion?
Grafalon 100 mg/5 ml IV Infusion is a medicine that contains Anti-human T-lymphocyte immunoglobulin. It is made by ZAS Corporation. It belongs to the Vaccines group of medicines.
What is Grafalon used for?
Anti-human T-lymphocyte immunoglobulin is used together with other immunosuppressive medicines to suppress the immune competent cells that cause acute rejection or graft versus host disease. Grafalon is indicated in the same way.
What are the side effects of Grafalon?
Very common side effects of Anti-human T-lymphocyte immunoglobulin are likely to affect more than 1 in every 10 patients. They are fever, chills, headache, tremor, vomiting, nausea, diarrhea, abdominal pain, breathing difficulties, flushing, an increased rate of infections (CMV infection, urinary tract infection), and a low count of red blood cells (anemia).
Can I take Grafalon during pregnancy or while breastfeeding?
We don't know what risk anti-human T-lymphocyte immunoglobulin may carry for the fetus, so doctors should be careful when prescribing it to pregnant women. Human immunoglobulin, at the very least, can potentially cross the placental barrier and pass into human breast milk. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Grafalon?
Store anti-human T-lymphocyte immunoglobulin in a refrigerator at 2°C-8°C. Keep the vial in its outer carton so the light can't reach it.
Do I need a prescription for Grafalon?
Grafalon is a prescription (Rx) medicine. Take it as your doctor advises.