Dacogen Adverse Reactions




Zuellig Pharma
Full Prescribing Info
Adverse Reactions
Clinical Study Data: Throughout this section, adverse reactions are presented. Adverse reactions are adverse events that were considered to be reasonably associated with the use of DACOGEN based on the comprehensive assessment of the available adverse event information. A causal relationship with DACOGEN cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The most important and frequently occurring adverse reactions in both the 5-Day and 3-Day regimens are myelosuppression and those occurring as a consequence of myelosuppression.
Adverse Reactions: The safety of DACOGEN was evaluated in 682 subjects from AML and MDS clinical studies (D-0007, DACO-016, DACO-017, DACO-020, EORTC-06011 and ID03-0180). In these clinical studies, DACOGEN was administered with the 5-Day or 3-Day dosing regimen. Adverse reactions reported during these clinical studies are summarized as follows in Table 5. The adverse reactions are listed by frequency category. Frequency categories are defined as follows: Very common (≥1/10), Common (≥1/100 to <1/10) and Uncommon (≥1/1,000 to <1/100).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See Table 5.)

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Description of selected adverse reactions: Hematologic adverse reactions: The most commonly reported hematologic adverse reactions associated with DACOGEN treatment included febrile neutropenia, thrombocytopenia, neutropenia, anemia and leucopenia.
Serious infection-related adverse reactions such as septic shock, sepsis, and pneumonia were reported in patients receiving DACOGEN.
Serious bleeding-related adverse reactions such as CNS hemorrhage (1%) and gastrointestinal hemorrhage (2%), in the context of severe thrombocytopenia, were reported in patients receiving DACOGEN.
Hematological adverse reactions should be managed by routine monitoring of complete blood counts and supportive treatments as required. Supportive treatments include, administration of prophylactic antibiotics and/or growth factor support (e.g. G-CSF) for neutropenia and transfusions for anaemia or thrombocytopenia according to institutional guidelines. For situations where decitabine administration should be delayed, see Dosage & Administration.
Postmarketing Data: In addition to the adverse reactions reported during clinical studies and listed previously, the following adverse reactions have been reported during postmarketing experience. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. In the table, the frequencies are provided according to the following convention: Very common ≥ 1/10, Common ≥ 1/100 and < 1/10, Uncommon ≥ 1/ 1000 and < 1/100, Rare ≥ 1/10000 and < 1/1000, Very rare < 1/10000, including isolated reports. (See Table 6.)

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