Decitex Special Precautions

Myelosuppression: Myelosuppression and complications of myelosuppression, including infections and bleeding that occur in patients with MDS or AML may be exacerbated with decitabine treatment. Myelosuppression caused by decitabine is reversible. Complete blood count and platelet counts should be performed regularly, as clinically indicated and prior to each treatment cycle. In the presence of myelosuppression or its complications, treatment with decitabine may be interrupted, the dose reduced or supportive measures instituted as recommended in RECOMMENDED DOSE under Dosage & Administration and ADVERSE REACTIONS.
Cardiac disease: Patients with a history of severe congestive heart failure or clinically unstable cardiac disease were excluded from reported clinical studies and therefore the safety and efficacy of decitabine in these patients has not been reported.
Effects on Ability to Drive and Use Machines: No reported studies of the effects on the ability to drive or use machines with decitabine have been performed. Patients should be advised that they may experience undesirable effects, such as anemia, during treatment. Therefore, caution should be recommended when driving a car or operating machines.
Hepatic impairment: The use of decitabine in patients with hepatic impairment has not been reported. Caution should be exercised in the administration of decitabine to patients with hepatic impairment or in patients who develop signs or symptoms of hepatic impairment. Patients should be monitored closely (see RECOMMENDED DOSE under Dosage & Administration and Pharmacology: Pharmacokinetics under Actions).
Renal impairment: The use of decitabine in patients with severe renal impairment has not been reported. Caution should be exercised in the administration of decitabine to patients with severe renal impairment (Creatinine Clearance [CrCl] <30 mL/min) and these patients should be monitored closely (see RECOMMENDED DOSE under Dosage & Administration).