CERTICAN. 0.5 mg. 60 tablets
CERTICAN. 0.5 mg. 60 tablets
Certican is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving allogeneic kidney or heart . Certican should be administered in combination with ciclosporin microemulsion and corticosteroids.
Dosage and administration :
Certican therapy should begin and be carried out only by physicians experienced in immunosuppressive therapy after organ transplantation , able to trace levels of everolimus in whole blood.
The initial dose of 0.75 mg twice daily is recommended for the general population of patients with transplanted kidney or heart , as applicable in the shortest possible time after transplantation. Always Certican daily dose should be administered orally in two divided doses , with or without food and at the same ciclosporin microemulsion .
Certican is for oral use .
Certican tablets should be swallowed whole with a glass of water and must be crushed before use. For patients who can not swallow tablets whole , are created dispersible tablets Certican.
Host Certican patients may need a dosage adjustment according to blood levels achieved , tolerability , individual response , change in concomitant medications and clinical status . Dosage adjustment may be made at intervals of 4-5 days.
Black patients :
The incidence of biopsy-proven acute rejection of organs in Black patients was significantly higher than patients of other races . There is a limited amount of data , which indicate that Black patients may require larger doses Certican, in order to achieve efficacy comparable to that of patients with other races . Currently, the efficacy and safety are too small to be able to make specific recommendations on the use of everolimus in Black patients .
Use in children and adolescents:
Not enough experience to make recommendations for the use of Certican in children. There is only limited information on pediatric renal transplant patients.
Clinical experience in patients under 65 years is limited.
Patients with impaired renal function:
It is not necessary to adjust the dosage.
Patients with impaired hepatic function:
Concentrations of everolimus blood levels should be monitored carefully. In patients with mild to moderate hepatic impairment , dosage should be reduced to half the normal
Certican is contraindicated in patients with known hypersensitivity to everolimus, sirolimus or any of the excipients .
Pregnancy and lactation
There are no adequate data from the use of everolimus, in pregnant women. Studies in animals have shown reproductive toxicity effects including embryo / fetal toxicity . The potential risk for humans is unknown. Certican should not be taken by pregnant women unless the potential benefit outweighs the potential risk to the fetus . Women of childbearing potential must not exceed the potential risk to the fetus. Women of childbearing potential should be advised to use effective contraception while taking Certican and 8 weeks after cessation of treatment.
It is not known whether everolimus, is excreted in human milk . In animal studies, everolimus and / or its metabolites are rapidly and easily pass into the milk of lactating rats. Therefore host Certican women should not breastfeed.
SIDE EFFECTS :
Infections and infestations:
Common - viral, bacterial and fungal infections , sepsis
Uncommon - wound infections
Blood and lymphatic system disorders:
Common - thrombocytopenia , anemia, coagulopathy , thrombotic trombotsitopichna purpura / hemolytic uremic syndrome
Uncommon - hemolysis
Uncommon - male hypogonadism / low testosterone , elevated LH
Metabolism and nutrition disorders :
Very common - hypercholesterolemia , hyperlipidemia
Common - hypertriglyceridemia
Common - hypertension, lymphocele , venous thromboembolism
Respiratory, thoracic and mediastinal disorders:
Common - pneumonia
Uncommon - pneumonitis
Common - abdominal pain, diarrhea , nausea, vomiting
Uncommon - Hepatitis, liver disorders , jaundice, liver function tests
Skin and subcutaneous tissue disorders:
Uncommon - rash
Violation of the musculoskeletal system :
Uncommon - myalgia
Renal and urinary disorders:
Common - UTI
Uncommon - tubular necrosis of the kidney
General disorders and administration site conditions :
Common - swelling , pain