Dacogen Dosage/Direction for Use

Dacogen administration must be initiated under the supervision of physicians experienced in the use of chemotherapeutic medicinal products.
Posology: In a treatment cycle, Dacogen is administered at a dose of 20 mg/m² body surface area by intravenous infusion over 1 hour repeated daily for 5 consecutive days (i.e., a total of 5 doses per treatment cycle). The total daily dose must not exceed 20 mg/m² and the total dose per treatment cycle must not exceed 100 mg/m². If a dose is missed, treatment should be resumed as soon as possible. The cycle should be repeated every 4 weeks depending on the patient's clinical response and observed toxicity. It is recommended that patients be treated for a minimum of 4 cycles; however, a complete or partial remission may take longer than 4 cycles to be obtained. Treatment may be continued as long as the patient shows response, continues to benefit or exhibits stable disease, i.e., in the absence of overt progression.
If after 4 cycles, the patient's haematological values (e.g., platelet counts or absolute neutrophil count), have not returned to pre-treatment levels or if disease progression occurs (peripheral blast counts are increasing or bone marrow blast counts are worsening), the patient may be considered to be a non-responder and alternative therapeutic options to Dacogen should be considered.
Pre-medication for the prevention of nausea and vomiting is not routinely recommended but may be administered if required.
Management of myelosuppression and associated complications: Myelosuppression and adverse events related to myelosuppression (thrombocytopaenia, anaemia, neutropaenia, and febrile neutropaenia) are common in both treated and untreated patients with AML.
Complications of myelosuppression include infections and bleeding. Treatment may be delayed at the discretion of the treating physician, if the patient experiences myelosuppression-associated complications, such as those described as follows: Febrile neutropaenia (temperature ≥ 38.5°C and absolute neutrophil count < 1,000/μL); Active viral, bacterial or fungal infection (i.e., requiring intravenous anti-infectives or extensive supportive care); Haemorrhage (gastrointestinal, genito-urinary, pulmonary with platelets < 25,000/μL or any central nervous system haemorrhage).
Treatment with Dacogen may be resumed once these conditions have improved or have been stabilised with adequate treatment (anti-infective therapy, transfusions, or growth factors).
In clinical studies, approximately one-third of patients receiving Dacogen required a dose-delay. Dose reduction is not recommended.
Paediatric population: Dacogen should not be used in children with AML aged < 18 years, because efficacy was not established. Currently available data are described in Adverse Reactions and Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions.
Hepatic impairment: Studies in patients with hepatic impairment have not been conducted. The need for dose adjustment in patients with hepatic impairment has not been evaluated. If worsening hepatic function occurs, patients should be carefully monitored (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Renal impairment: Studies in patients with renal impairment have not been conducted. The need for dose adjustment in patients with renal impairment has not been evaluated (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Method of administration: Dacogen is administered by intravenous infusion. A central venous catheter is not required.
For instructions on reconstitution and dilution of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage.