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Certican, combined with tacrolimus, was studied in one trial which included 719 liver transplant recipients (ITT population, see Pharmacology: PHARMACODYNAMICS under Actions). The overall safety profile was not distinct from previous experiences with Certican and expectations in a liver transplant population up to 36 months.
The occurrence of the adverse events may depend on the degree and duration of the immunosuppressive regimen. In the studies combining Certican with full dose ciclosporin for microemulsion elevated serum creatinine was observed more frequently than in control patients. The elevation of serum creatinine was less frequent and mean and median serum creatinine values were lower in the trials in which Certican was administered with reduced-dose ciclosporin.
With the exception of elevation of serum creatinine, the safety profile of Certican in the trials in which it was administered with reduced-dose ciclosporin was similar to that described in the three pivotal studies in which full dose of ciclosporin was administered, although the overall incidence of adverse events was lower with reduced dose ciclosporin (see Pharmacology: Pharmacodynamics: CLINICAL STUDIES under Actions). In controlled clinical trials in which a total of 3,256 patients receiving Certican in combination with other immunosuppressants were monitored for at least 1 year, a total of 3.1% developed malignancies, with 1.0% developing skin malignancies and 0.6% developing lymphoma or lymphoproliferative disorder.
Tabulated summary of adverse drug reactions from clinical trials: The frequencies of adverse reactions listed as follows are derived from analysis of the 12-month incidences of events reported in multicenter, randomized, controlled trials investigating Certican in combination with calcineurin inhibitors (CNI) and corticosteroids in transplant recipients. All of the trials included non-Certican, CNI-based standard-therapy arms.
Table 16 contains adverse drug reactions possibly or probably related to Certican seen in phase III clinical trials. Unless noted as otherwise, these disorders have been identified by an increased incidence in the phase III studies comparing Certican-treated patients with patients on a non-Certican, standard-therapy regimens, or the same incidence in case the event is known as an ADR of the comparator (MPA in renal and heart transplant studies) (see PHARMACOLOGY: PHARMACODYNAMICS under Actions). Except where noted otherwise, the adverse reaction profile is relatively consistent across all transplant indications.
Adverse drug reactions from clinical trials are listed by MedDRA system organ class. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000). (See Table 16.)
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Click on icon to see table/diagram/imageAdverse drug reactions from post-marketing spontaneous reports: The following adverse drug reactions (Table 17) have been derived from post-marketing experience with Certican via spontaneous case reports and literature cases. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorized as not known. Adverse drug reactions are listed according to system organ classes in MedDRA. Within each system organ class, ADRs are presented in order of decreasing seriousness. (See Table 17.)
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