Indications, posology and method of administration
THERAPEUTIC INDICATIONS
Mycophenolate mofetil is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with mycophenolate mofetil should be initiated and maintained by appropriately qualified transplant specialists.
Posology
Use in renal transplant:
Adults:
Oral mycophenolate mofetil should be initiated within 72 hours following transplantation. The recommended dose in renal transplant patients is 1 g administered twice daily (2 g daily dose).
Paediatric population aged 2 to 18 years:
The recommended dose of mycophenolate mofetil is 600 mg/m2 administered orally twice daily (up to a maximum of 2 g daily). Mycophenolate mofetil capsules should only be prescribed to patients with a body surface area of at least 1.25 m2. Patients with a body surface area of 1.25 to 1.5 m2 may be prescribed mycophenolate mofetil capsules at a dose of 750 mg twice daily (1.5 g daily dose). Patients with a body surface area greater than 1.5 m2 may be prescribed mycophenolate mofetil capsules at a dose of 1 g twice daily (2 g daily dose). As some adverse reactions occur with greater frequency in this age group compared with adults, temporary dose reduction or interruption may be required; these will need to take into account relevant clinical factors including severity of reaction.
Paediatric population < 2 years:
There are limited safety and efficacy data in children below the age of 2 years. These are insufficient to make dosage recommendations and therefore use in this age group is not recommended.
Use in cardiac transplant:
Adults:
Oral mycophenolate mofetil should be initiated within 5 days following transplantation. The recommended dose in cardiac transplant patients is 1.5 g administered twice daily (3 g daily dose).
Paediatric population:
No data are available for paediatric cardiac transplant patients.
Use in hepatic transplant:
Adults:
Intravenous mycophenolate mofetil should be administered for the first 4 days following hepatic transplant, with oral mycophenolate mofetil initiated as soon after this as it can be tolerated. The recommended oral dose in hepatic transplant patients is 1.5 g administered twice daily (3 g daily dose).
Paediatric population:
No data are available for paediatric hepatic transplant patients.
Use in special populations
Elderly:
The recommended dose of 1 g administered twice a day for renal transplant patients and 1.5 g twice a day for cardiac orhepatic transplant patients is appropriate for the elderly.
Renal impairment:
In renal transplant patients with severe chronic renal impairment (glomerular filtration rate < 25 mL/min/1.73 m2), outside the immediate post-transplant period, doses greater than 1 g administered twice a day should be avoided. These patients should also be carefully observed. No dose adjustments are needed in patients experiencing delayed renal graft function post-operatively. No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment.
Severe hepatic impairment:
No dose adjustments are needed for renal transplant patients with severe hepatic parenchymal disease. No data are available for cardiac transplant patients with severe hepatic parenchymal disease.
Treatment during rejection episodes:
Mycophenolic acid (MPA) is the active metabolite of mycophenolate mofetil. Renal transplant rejection does not lead to changes in MPA pharmacokinetics; dosage reduction or interruption of mycophenolate mofetil is not required. There is no basis for mycophenolate mofetil dose adjustment following cardiac transplant rejection. No pharmacokinetic data are available during hepatic transplant rejection.
Paediatric population:
No data are available for treatment of first or refractory rejection in paediatric transplant patients.
Method of administration
Oral administration.
Precautions to be taken before handling or administering the medicinal product
Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, mycophenolate mofetil capsules should not be opened or crushed to avoid inhalation or direct contact with skin or mucous membranes of the powder contained in mycophenolate mofetil capsules. If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water.
CONTRAINDICATIONS
- Mycophenolate mofetil should not be given to patients with hypersensitivity to mycophenolate mofetil, mycophenolic acid or to any of the excipients. Hypersensitivity reactions to mycophenolate mofetil have been observed.
- Mycophenolate mofetil should not be given to women of childbearing potential who are not using highly effective contraception.
- Mycophenolate mofetil treatment should not be initiated in women of child bearing potential without providing a pregnancy test result to rule out unintended use in pregnancy.
- Mycophenolate mofetil should not be used during pregnancy unless there is no suitable alternative treatment to prevent transplant rejection.
- Mycophenolate mofetil should not be given to women who are breastfeeding.
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