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How to administer Thymogam

Dosage:

Aplastic Anemia:

30-40 mg/kg per day for 4 days, These patients are to be monitored continuously for thrombocytopenia. When administered with a regime of supportive care it may induce partial to complete haematological remission.

Kidney Transplant:

Induction Therapy:

25 mg/kg of body weight one day before transplant. It is given to prevent acute rejection in early post transplantation period by providing optimum immunosuppression.

Treatment of Acute Rejection:

10 to 15mg/kg daily for 14 days (14 doses) followed by alternate day therapy for further 14 days (7 doses) bringing the total doses to 21 in 28 days.In children, doses in the range of 5 to 25mg/kg daily have been administered and in adult renal allograft recipients doses of 10 to 30mg/kg daily have been administered. Thymogam can also be used concomitantly with azathioprine and corticosteriods which are also used to suppress the immune response

Administration :

Thymogam should be diluted before use in 0.9% Sodium Chloride Injection, 5% Dextrose and 0.225% Sodium Chloride, or 5% Dextrose and 0.45% Sodium Chloride Injection to a concentration not to exceed 4mg of Antithymocyte Globulin per ml. The diluted solution should be gently rotated or swirled to effect thorough mixing and allowed to reach room temperature before infusion. Thymogam is appropriately administered into a vascular shunt, arterial venous fistula, or a high-flow central vein through an in-line filter with a pore size of 0.2 to 1.0 micron. Thymogam once diluted has been shown to be physically and chemically stable for up to 24 hours at concentrations of upto 4mg/ml in the diluents recommended. Adding Thymogam only to dextrose injection is not recommended, as a low salt concentrations can cause precipitation. Highly acidic infusion solutions can also contribute to physical instability over time. It is recommended that diluted Thymogam be stored in a refrigerator and be used within 24 hours.

Contraindications :

Thymogam should not be administered to a patient who has previous history of severe systemic reaction to this preparation or any other equine globulin preparations.

Warnings and Precautions :

Only physicians experienced in immunosuppressive therapy should use Thymogam. Use Thymogam only in facilities equipped and staffed with adequate laboratory and supportive medical resources. Discontinue therapy if anaphylaxis or severe and unremitting thrombocytopenia or leucopenia occurs. As observed with products derived from or purified with human blood components, the possibility of transmission of some infectious disseases should be borne in mind. Monitor patients carefully for concurrent infection. Several studies have suggested and increase in the incidence of cytomegalovirus infection in patients receiving Thymogam.

To identify those at greatest risk of systemic anaphylaxis, physician should strongly recommend skin testing before commencing treatment. A conservative, conventional approach would first employ epicutaneous (prick) testing with undiluted Thymogam. If the subject does not show a wheal ten minutes after pricking, proceed to intradermal testing with 0.02mL of a 1:1000 dilution of Thymogam in Sodium chloride injection with a separate Sodium chloride injection control of similar volume. Observe the results every 10 minutes over the first hour after intradermal injection. A wheal of 3mm or greater in diameter at the site of Thymogam injection than that at the Sodium chloride injection control site (or a positive prick test) shows clinical sensitivity and an increased possibility of systemic allergic reactions.

intradermal testing with 0.02mL of a 1:1000 dilution of Thymogam in Sodium chloride injection with a separate Sodium chloride injection control of similar volume. Observe the results every 10 minutes over the first hour after intradermal injection. A wheal of 3mm or greater in diameter at the site of Thymogam injection than that at the Sodium chloride injection control site (or a positive prick test) shows clinical sensitivity and an increased possibility of systemic allergic reactions.

Note :

The predictive value of this test has not been proved clinically. Allergic reactions such as anaphylaxis have occurred in patients whose skin test is negative. In the presence of a locally positive skin test to Thymogam, serious consideration to alternative forms of therapy should be given. A systemic reaction such as a generalized rash, tachycardia, dyspnea, hypotension, or anaphylaxis precludes any additional administration of Thymogam.

Use during pregnancy and lactation :

Thymogam has not been evaluated in either pregnant or lactating women. Animal reproduction studies have not been conducted with Thymogam. It is also not known whether Thymogam can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity. Thymogam administration to pregnant women is not recommended and should be considered only under exceptional circumstances. It is not known whether Thymogam is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Thymogam, caution should be exercised when Thymogam is administered to a nursing woman.

Adverse Effects :

Renal Transplantation : The primary clinical experience with Thymogam has been in renal allograft patients receiving concurrent standard immunosuppressive treatment. In these patients, investigators have most frequently reported fever, chills, leucopenia, thrombocytopenia, arthralgia and dermatologic reactions such as rash, urticaria, wheal, flare and pruritis.

Aplastic Anaemia :

The incidence of adverse reaction has been found more in patients being treated foraplastic anaemia. Frequently reported adverse reactions among patients enrolled in aplastic anaemia studies were fever, chills, skin rashes, arthralgia and thrombocytopenia. In patients with aplastic anaemia and other haematologic abnormalities who have received Thymogam, abnormal tests of liver function (SGOT, SGPT, alkaline phosphatase) and renal function (serum creatinine) have been observed. In some trials, clinical and laboratory findings of serum sickness have been in majority of patients.

Other Reactions :

Other reactions reported are : headache, nausea, vomiting, diarrhoea, dyspnoea, hypotension, night sweats, stomatitis, chest pain, back pain, pain at the infusion site, clotted A/V fistula and peripheral thrombophlebitis.

Reactions reported rarely are :

periorbital oedema, agitation, dizziness, weakness or faintness, malaise, epigastric pain or hiccoughs, laryngospasm, paraesthesia, lymphadenopathy, infection, possible encephalitis, herpes simplex reactivation, wound dehiscence, hyperglycaemia, hypertension, oedema, pulmonary oedema, pleural effusions, tachycardia, seizure, anaphylaxis, iliac vein obstruction, renal artery thrombosis, proteinuria and toxic epidermal necrosis.

Interactions :

When the dose of corticosteroids and other immunosuppressants is being reduced, some previously masked reactions toThymogam may appear. Under these circumstances, observe patients especially carefully during therapy with Thymogam.

Overdosage :

Because of its mode of action and because it is a biological substance, the maximal tolerated dose of Thymogam would be expected to vary from patient to patient. To date, the largest single daily dose administered to a patient, a renal transplant recipient, was 7000mg administered at a concentration of approximately 10mg/ml diluted with Sodium Chloride Injection, USP, approximately 7 times the recommended total dose and infusion concentration. The maximum number of doses (10 to 20 mg/kg/dose) that can be administered ot a single patient has not yet been determined. Some renal transplant patients have received up to 50 doses in 4 months, and others have received 28-day courses of 21 doses followed by as many as 3 more courses for the treatment of acute rejection. The incidence of toxicological manifestations did not increase with any of these regimens.

Storage condition :

2-8 degree Celsius (use sign of Celsius), Do Not Freeze

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