Where is Dacogen approved?
DACOGEN® is a DNA hypomethylating agent currently approved for the treatment of myelodysplastic syndromes (MDS) in more than 35 countries worldwide including key markets such as the United States, Brazil, China, India, Korea, Russia and Turkey.
Who manufactures Dacogen?
See full prescribing information for DACOGEN. To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA- 1088 or www.fda.gov/medwatch.
What is dacogen drug used for?
This medication is used to treat a group of blood/bone marrow disorders (myelodysplastic syndromes-MDS) in which the bone marrow does not produce enough healthy blood cells. People with MDS may have problems such as infections, anemia, and easy bleeding/bruising. Decitabine is a chemotherapy drug.
What is the cost of dacogen?
The cost for Dacogen intravenous powder for injection 50 mg is around $1,885 for a supply of 1 powder for injection, depending on the pharmacy you visit. Prices are for cash paying customers only and are not valid with insurance plans.
When was dacogen approved?
Approval Date: 02/02/2006.
Is decitabine FDA approved?
FDA approves oral combination of decitabine and cedazuridine for myelodysplastic syndromes. On July 7, 2020, the Food and Drug Administration approved an oral combination of decitabine and cedazuridine (INQOVI, Astex Pharmaceuticals, Inc.)
Is dacogen a chemotherapy drug?
Dacogen is the trade name for decitabine. In some cases, health care professionals may use the trade name Dacogen when referring to the generic drug name decitabine. Drug type: Decitibine is an anti-cancer (“antineoplastic” or “cytotoxic”) chemotherapy drug.
Is dacogen chemo?
How long can you take dacogen?
Decitabine is given through an intravenous (IV, into a vein) infusion either once a day, for 5 days OR once every 8 hours, for 3 days. The dosage and schedule is determined by the person’s size and the type of cancer being treated.
How long is dacogen infusion?
Administer DACOGEN at a dose of 20 mg/m2 by continuous intravenous infusion over 1 hour daily for 5 days. Delay and reduce dose for hematologic toxicity (see Dose Modifications for Toxicity).
What is the cost of decitabine?
The cost for decitabine intravenous powder for injection 50 mg is around $275 for a supply of 1 powder for injection, depending on the pharmacy you visit. Prices are for cash paying customers only and are not valid with insurance plans.
When was decitabine approved?
When was Dacogen approved for use in Europe?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dacogen have been included in the summary of product characteristics and the package leaflet. The European Commission granted a marketing authorisation valid throughout the European Union for Dacogen on 20 September 2012.
What kind of cancer is Dacogen used for?
Dacogen is used to treat adults with newly diagnosed acute myeloid leukaemia (AML), a type of cancer affecting the white blood cells. It is used in patients who are not eligible for standard induction chemotherapy (initial treatment with cancer medicines).
How often should I take Dacogen for AML?
In a 4-week treatment cycle, Dacogen is given daily for the first 5 days. At least 4 treatment cycles are recommended but they can be continued for as long as the AML remains under control. If a patient develops certain severe side effects, the doctor may decide to delay or stop Dacogen treatment.
How long do Dacogen patients live on average?
Patients receiving Dacogen lived for an average of 7.7 months compared with 5.0 months for patients receiving supportive care or treatment with cytarabine. What is the risk associated with Dacogen?