Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: Neovii Biotech GmbH, Am Haag 6+7, 82166 Graefelfing, Germany
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:
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.
Grafalon is indicated for the treatment of acute corticosteroid-resistant rejection episodes after allogeneic solid organ transplantation if the therapeutic effect of methyl-prednisolone treatment has proven unsatisfactory.
Grafalon should be prescribed only by physicians who are experienced in the use of immunosuppressive therapies. Grafalon must be administered under qualified medical supervision.
The dose of Grafalon is dependent on the indication. Dose recommendations are based on body weight (BW).
Unless otherwise prescribed, the recommended daily dose of Grafalon is:
0.1-0.25 ml (=2-5 mg) Grafalon/kg BW. The most common daily dosages are in the range of 3-4 mg/kg BW.
Depending on the patient’s condition, dosage, and concomitant medication, the required duration of therapy will be in the range of 5-14 days, starting with the day of transplantation.
0.15-0.25 ml (=3-5 mg) Grafalon/kg BW. The most common daily dosages are in the range of 3-4 mg/kg BW.
Duration of therapy will vary according to the condition of the graft organ and therapy plan. The treatment will usually last 5-14 days, starting with the day of rejection crisis.
Currently available data are described in section 4.8 and 5.1 but no recommendation on a posology can be made. Available information indicates that paediatric patients do not require a different dosage than adult patients.
The experience in elderly patients (≥65 years) is limited, but there is no evidence that these patients require a different dosage than other age groups.
Grafalon is a hypotonic concentrate for solution for infusion with pH 3.7 +/- 0.3 and is not for direct injection. It should 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 (i.e., dilute 1 ml of Grafalon with 6 ml of sodium chloride solution) to maintain the required level of osmolality. Higher dilution ratios, with attendant higher pH levels, may result in particle formation. Solutions containing visible particles must not be used. Grafalon should be infused intravenously over a period of at least 4 hours.
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 large high flow vein can be chosen. The administration of methylprednisolone and/or antihistamines prior to infusion is recommended in order to improve systemic and local tolerance. 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 route see section 6.2.
In case of overdose, immediate use of broad-spectrum antibiotics, antimycotic and antiviral therapy is recommended.
Grafalon therapy must be discontinued, and any other concurrent immunosuppressive treatment must be adjusted according to the hemogram (in particular, leukocytes and lymphocytes).
The platelet count must be monitored closely, and substitution therapy initiated as appropriate.
3 years.
Chemical and physical in-use stability of the diluted solution has been demonstrated for 24 hours at room temperature.
However, from a microbiological point of view, the diluted product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are at the responsibility of the user.
Store in a refrigerator (2°C-8°C). Keep the vial in the outer carton in order to protect from light.
For storage conditions after dilution of the medicinal product, see section 6.3.
For instruction on preparation and administration of the medicinal product, see section 4.2.
Pack with 1 or 10 vials containing 5 ml solution.
Pack with 1 or 10 vials containing 10 ml solution.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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