Decita Special Precautions

Myelosuppression and complications of myelosuppression, including infections and bleeding that occur in patients with MDS may be exacerbated with Decitabine treatment. Therefore patients are at increased risk for severe infections (due to any pathogen such as bacterial, fungal and viral), with potentially fatal outcome. Patients should be monitored for signs and symptoms of infection and treated promptly.
In clinical studies, the majority of patients had baseline Grade 3/4 myelosuppression. In patients with baseline Grade 2 abnormalities, worsening of myelosuppression was seen in most patients and more frequently than in patients with baseline Grade 1 or 0 abnormalities. Myelosuppression caused by Decitabine is reversible. Complete blood 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 and/or supportive measures instituted.
Respiratory, thoracic and mediastinal disorders: Cases of interstitial lung disease (ILD) (including pulmonary infiltrates, organising pneumonia and pulmonary fibrosis) without signs of infectious aetiology have been reported in patients receiving decitabine. Careful assessment of patients with an acute onset or unexplained worsening of pulmonary symptoms should be performed to exclude ILD. If ILD is confirmed, appropriate treatment should be initiated.
Cardiac disease: Patients with a history of severe congestive heart failure or clinically unstable cardiac disease were excluded from clinical studies and therefore the safety and efficacy of Decitabine in these patients has not been established.
Excipients: This medicine contains 0.5 mmol potassium per vial. After reconstitution and dilution of the solution for intravenous infusion, this medicine contains less than 1 mmol (39 mg) of potassium per dose, i.e. essentially 'potassium-free'.
This medicine contains 0.29 mmol sodium per vial. After reconstitution and dilution of the solution for intravenous infusion, this medicine contains between 0.6-6 mmol sodium per dose depending on the infusion fluid for dilution. To be taken into consideration by patients on a controlled sodium diet.
Hepatic impairment: Use in patients with hepatic impairment has not been established. Caution should be exercised in the administration of Decitabine to patients with hepatic impairment and patients should be monitored closely.
Renal impairment: Use in patients with severe renal impairment has not been studied. 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.