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CERTICAN is a brand name for Everolimus, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ...........................................................................3 CONTRAINDICATIONS .................................................................................................3 WARNINGS AND PRECAU TIONS ..............................................................................4…
Verbatim from this product's HC label. Tap a section to expand.
SERIOUS WARNINGS AND PRECAUTIONS Increased susceptibility to infection and the possible development of malignancies such as lymphoma and skin cancer may result from immunosuppression ( See Warnings and Precautions) Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should use Certican.
Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.
(see Warnings and Precautions) Increased nephrotoxicity can occur with standard doses of cyclosporine in combination with everolimus. Therefore reduced doses of cyclosporine should be used in combination with everolimus in order to reduce renal dysfunction.
It is important to) monitor the cyclosporine and everolimus whole blood trough concentrations (see Dosage and Administration, Warnings and Precautions and Clinical Pharmacology) A risk of kidney arterial and venous thrombosis resulting in graft loss, was reported mostly within the first 30 days post-transplantation (see Warnings and Precautions) General Certican is intended for oral administration only.
Regular monitoring of renal function is recommended in all patients. Appropriate adjustment of the immunosuppressive regimen, in particular reduction of the cyclosporine dose should be considered in patients with elevated serum creatinine levels.
Caution should be exercised when co-administering other medicinal products that are known to have a deleterious effect on renal function. Certican has not been studied in patients with severe hepatic impairment. Close monitoring of everolimus whole blood trough levels (C0) in patients with impaired hepatic function is therefore recommended.
Patients administered Certican with an HMG-CoA reductase inhibitor and/or fibrate should be monitored for the possible development of adverse effects as described in the Dosage and Administration section (see also Drug-Drug Interactions).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Certican, as this may result in diarrhea and malabsorption. Carcinogenesis and Mutagenesis Patients receiving immunosuppressants, including everolimus, are at increased risk of developing lymphomas and other malignancies, particularly of the skin (See Warnings and Precautions, Product Monograph Certican Page 5 of 50 Boxed Warning).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Everolimus in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent. As usual for patients with increased risk for skin cancer, exposure to sunlight and ultraviolet light should be limited by wearing protective clothing and using a sunscreen with a high protection factor (see Adverse Reactions).
Serious Infections Patients receiving immunosuppressants, including everolimus, are at increased risk of developing bacterial, viral, fungal, and protozoal infections, including opportunistic infections. These infections may lead to serious, including fatal, outcomes.
Because of the danger of over immunosuppression of the immune system which can cause increased susceptibility to infection, combination immunosuppressant therapy should be used with caution. Endocrine and Metabolism Hyperlipidemia Increased serum cholesterol and triglycerides, requiring the need for anti-lipid therapy, have been reported to occur following initiation of everolimus and the risk of hyperlipidemia is increased with higher everolimus whole blood trough concentrations (see Adverse Events).
Use of anti- lipid therapy may not normalize lipid levels in patients receiving Certican. Any patient who is administered everolimus should be monitored for hyperlipidemia. If detected, interventions, such as diet, exercise, and lipid-lowering agents should be initiated as outlined by the National Cholesterol Education Program guidelines.
The risk/benefit should be considered in patients with established hyperlipidemia before initiating an immunosuppressive regimen containing everolimus. Similarly, the risk/benefit of continued everolimus therapy should be re- evaluated in patients with severe refractory hyperlipidemia.
Everolimus has not been studied in patients with baseline cholesterol levels >350 mg/dL. Due to an interaction with cyclosporine, clinical trials of everolimus and cyclosporine in kidney transplant patients strongly discouraged patients from receiving the HMG-CoA reductase inhibitors simvastatin and lovastatin.
During everolimus therapy with cyclosporine, patients administered an HMG-CoA reductase inhibitor and/or fibrate should be monitored for the possible development of rhabdomyolysis and other adverse effects, as described in the respective labeling for these agents (See Drug-Drug Interactions).
New onset diabetes mellitus Certican has been shown to increase the risk of new onset diabetes mellitus after transplant. Blood glucose concentrations should be monitored closely in patients treated with Certican. Hematologic Product Monograph Certican Page 6 of 50 Increased Risk of Hemolytic Uremic Syndrome/Thrombotic Thrombocytopenic Purpura/ Thrombotic Microangiopathy (HUS/TTP/TMA): The concomitant use of Certican with a calcineurin inhibitor (CNI) may increase the risk of CNI- induced hemolytic uremic syndrome, thrombotic thrombocytopenic purpura and thrombotic microangiopathy (see Adverse Reactions).
Hepatic/Biliary/Pancreatic Liver function impairment Everolimus whole blood trough levels (C0) are increased in patients with moderate impaired hepatic function. Therefore, the blood level should be closely monitored and everolimus dose should be adjusted based on blood concentration in the patients.
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