Dacogen Application Scope

Dacogen (decitabine) is indicated for the treatment of adult patients with:
- Myelodysplastic Syndromes (MDS), including previously treated and untreated, de novo and secondary MDS of all French-American-British (FAB) subtypes and Intermediate-1, Intermediate-2, and High-Risk International Prognostic Scoring System (IPSS) groups.
- Acute Myeloid Leukemia (AML) in adults aged 65 years and older who are not candidates for intensive induction chemotherapy.
  dacogen decitabine

Dacogen Characteristics

Ingredients: Decitabine
Properties: Lyophilized (freeze‑dried) sterile powder
Packaging Specification: Supplied as a single‑dose glass vial containing 50 mg decitabine (in 20 mL vial)
Storage: Store the vials at controlled room temperature: 20°C to 25°C (allowed excursions 15°C–30°C)
Expiry Date: As per manufacturer’s approved labelling
Executive Standard: As per the regulatory / pharmacopeia standard in the country where marketed
Approval Number: U.S. FDA NDA: 021790
Date of Revision: Please refer to the latest official prescribing information for the most recent revision date
Manufacturer: Otsuka America Pharmaceutical, Inc.

Guidelines for the Use of Dacogen

Dosage and Administration:
- Recommended Dose:
  - For MDS:
    - Option 1: 15 mg/m² administered by continuous intravenous infusion over 3 hours, repeated every 8 hours for 3 days. This cycle should be repeated every 6 weeks.
    - Option 2: 20 mg/m² administered by continuous intravenous infusion over 1 hour, repeated daily for 5 days. This cycle should be repeated every 4 weeks.
  - For AML: The 5-day dosing regimen (20 mg/m² daily for 5 days) is commonly used.
- Administration: Dacogen is for intravenous infusion only. It must be reconstituted and then diluted in a compatible solution (e.g., 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or Lactated Ringer’s Injection) before use.
- Missed Dose: This is a clinic/hospital-administered drug. The healthcare team will manage the schedule. If a treatment is delayed, the physician will determine the best course of action, which may involve rescheduling the dose or modifying the treatment cycle.
Adverse Reactions:
- Common Adverse Reactions:
  - Blood and Lymphatic System: Neutropenia, thrombocytopenia, anemia, leukopenia, and febrile neutropenia.
  - Gastrointestinal: Nausea, constipation, diarrhea, vomiting, abdominal pain, mucositis.
  - General: Fatigue, pyrexia (fever), edema, rigors.
  - Other: Cough, headache, petechiae, rash, arthralgia, insomnia, decreased appetite.
- Serious Adverse Reactions:
  - Severe myelosuppression (neutropenia, thrombocytopenia) leading to life-threatening infections (sepsis, pneumonia) and hemorrhage.
  - Febrile neutropenia.
  - Drug-induced hepatic toxicity (rare).
  - Progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection, has been reported.
Contraindications: According to the official prescribing information, there are no formal contraindications listed for Dacogen.
Precautions:
- Myelosuppression: Dacogen causes severe neutropenia and thrombocytopenia. Monitor complete blood counts frequently. Therapy may need to be delayed or dose-reduced based on blood counts and the presence of infection or bleeding.
- Pregnancy and Lactation: May cause fetal harm. Advise women of the potential risk to a fetus and to avoid pregnancy during treatment. It is not known if decitabine is excreted in human milk; a decision should be made to discontinue nursing or discontinue the drug.
- Use in Geriatric Patients: No significant differences in safety were observed relative to younger patients, but elderly patients are more likely to have decreased renal function, which may require caution.
- Renal/Hepatic Impairment: Use with caution in patients with pre-existing renal or hepatic impairment, as these populations have not been extensively studied.

Dacogen Interactions

No strong drug-drug interaction section is highlighted in the core prescribing information—but because decitabine is a cytotoxic/hypomethylating agent with marrow suppression, concurrent myelosuppressive therapies or bone marrow-toxic agents must be used with caution or avoided.
Because of potential fetal toxicity, interactions with other teratogenic agents need careful consideration (as with any cytotoxic chemotherapy).

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.