GRAFALON 20 MG/ML [SIN05994P]

Product Info

GRAFALON 20 MG/ML

[SIN05994P]

4.1 Therapeutic indications

Grafalon is indicated in combination with other immunosuppressive medicinal products for the suppression of immune competent cells, which are the cause for acute rejection. It is usually administered for the following indications:

Prevention of acute transplant rejection in patients receiving allogeneic solid organ transplants
Grafalon is indicated in combination with other immunosuppressive medicinal products (e.g. glucocorticosteroids, purine antagonists, calcineurin inhibitors or mTOR inhibitors) to enhance immunosuppression following allogeneic solid organ transplantation.

Therapy of acute corticosteroid-resistant rejection after allogeneic solid organ transplantation
Grafalon is indicated for the treatment of acute corticosteroid-resistant rejection episodes after allogeneic solid organ transplantation if the therapeutic effect of methylprednisolone treatment has proven unsatisfactory.

4.2 Posology and method of administration

Grafalon should be prescribed only by physicians who are experienced in the use of immunosuppressive therapies. Grafalon must be administered under qualified medical supervision.

Posology
The dose of Grafalon is dependent on the indication. Dose recommendations are based on body weight (BW).

Prevention of acute transplant rejection in patients receiving allogeneic solid organ transplants
The recommended dose range is 2 to 5 mg/kg BW/d Grafalon. The most common doses are in the range of 3 to 4 mg/kg BW/d. Therapy should commence on the day of transplantation pre-, intra-, or immediately post-operatively. Depending on the patient's condition, selected daily dose and the concomitant immunosuppressive regimen, the recommended duration of therapy is in the range of 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 BW/d Grafalon. The most common dosages are in the range of 3 to 4 mg/kg BW/d. Duration of therapy will vary according to the condition of the grafted organ and clinical response, usually between 5 to 14 days.

Method of administration
Intravenous use (after dilution)
Grafalon is a hypotonic concentrate for solution for infusion with pH 3.7 ± 0.3 and is not for direct injection. It has to be diluted in sodium chloride 9 mg/ml (0.9%) solution before intravenous administration to the patient. A dilution ratio of 1:7 is recommended (per 1 ml Grafalon 6 ml sodium chloride solution should be added) to maintain the required level of osmolality. Higher dilution ratios, with attendant higher pH levels of the infusion solution, may result in particle formation. Solutions containing visible particles must not be used.

The standard infusion time in organ transplantation is 4 hours. In case of intra-operative administration, infusion time of 0.5 to 2 hours has been usually used.

During administration, the patient shall be closely monitored for symptoms of hypersensitivity or anaphylaxis. The first dose of Grafalon should be administered at a reduced infusion rate for the first 30 minutes. If no symptoms of intolerance occur, the infusion rate may be increased. In case of anaphylactic or anaphylactoid reactions, the responsible physician must be prepared to deal promptly with such an event and appropriate medical treatment has to be implemented.

Alternatively to infusion via central venous catheter, a peripheral vein with high flow rate and large diameter can be chosen. The administration of methylprednisolone and/or antihistamines prior to infusion is recommended in order to improve systemic and local tolerance. Apart from standard hygienic precautions at the injection site, reduction of the infusion speed and/or change of the venous access site are to be considered.

Sodium heparin must not be added to the Grafalon infusion solution or administered via the same infusion set, see section 6.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Grafalon is contraindicated in patients with bacterial, viral, parasitic or mycotic infections which are not under adequate therapeutic control.

Grafalon is contraindicated in solid organ transplant patients with severe thrombocytopenia, i.e. less than 50,000 platelets/microlitre because Grafalon may enhance thrombocytopenia and thus increase the risk of hemorrhage.

Grafalon is contraindicated in patients with malignant tumours except in cases where stem cell transplantation is performed as part of the treatment.