Decitabine is a chemotherapy (anticancer) drug available under the brand name “Dacogen.” This anticancer drug is typically prescribed for adult patients suffering from myelodysplastic syndromes (MDS). Each year, around 10,000 people are diagnosed with myelodysplastic syndromes (MDS) in the United States. Due to the small number of individuals diagnosed with MDS, the condition is categorized as rare. As a result, Dacogen was granted the status of an orphan drug in 2006 by the FDA, which means it is a medication specifically designed to treat rare diseases.
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This anticancer medication belongs to the DNA methylation inhibitor drug class. Dacogen is available as a sterile powder for reconstitution and injection and is only given under the supervision of a qualified healthcare professional.
What Is Dacogen Used To Treat?
The FDA has approved Dacogen as a first-line treatment in adult patients with MDS. MDS is a group of blood disorders that occur when the bone marrow (which is responsible for producing blood cells) does not function properly. In MDS patients, the bone marrow produces abnormal blood cells that do not mature properly and do not function normally.
Subsequently, these abnormal blood cells occupy the bone marrow and replace healthy blood cells leading to low blood counts and an increased risk of infections, abnormal bleeding, and other complications. Although the exact cause of MDS is not fully understood, it is believed to occur as a result of changes or mutations in the DNA of the bone marrow cells. These mutations can lead to the abnormal growth and development of blood cells.
By restoring normal cell function, Dacogen can help to improve blood counts and reduce the need for blood transfusions in patients with MDS.
How Does Dacogen Work?
The active drug in Dacogen, decitabine, is a natural analog of cytidine deoxynucleoside, which is a component of the DNA structure. After Dacogen administration, this prodrug becomes active and exerts its antineoplastic (anti-tumor) effects by incorporating itself into the DNA structure. Dacogen interferes with the DNA methylation process by inhibiting the activity of an enzyme called DNA methyltransferases (DNMTs), which are essential for cancer cell development and progression.
By blocking the activity of this enzyme, Dacogen promotes the production of normal blood cells by reactivating certain genes important for their development. This reactivation can help boost the production of normal blood cells in the bone marrow, leading to improved blood counts and a reduced need for blood transfusions.
In addition to its effects on DNA methylation, Dacogen can also induce apoptosis, or programmed cell death, in cancer cells. This may contribute to its anti-tumor effects and its ability to slow the progression of myelodysplastic syndromes (MDS).
How Long Does It Take To Work?
The time it takes for Dacogen to work can vary from person to person and may depend on several factors, including the individual’s age, overall health, the severity of their myelodysplastic syndrome (MDS), and other medical conditions they may have.
In general, it may take several weeks or even months for Dacogen to improve blood counts and other symptoms of MDS significantly. It’s important to note that Dacogen is not a cure for MDS, but rather a treatment option that can help to manage the disease and improve quality of life.
Dosage Form and Strength
Dacogen is usually supplied in single-dose vials containing 50 mg of decitabine as a lyophilized powder. The powder is reconstituted with 10 ml of sterile water before infusion. Each milliliter contains 5 mg of decitabine.
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Dosing Information
Dacogen is given to patients in either a 3-day or 5-day regimen.
- In the 3-day regimen, patients receive Dacogen through continuous intravenous infusion dosed at 15 mg/m2 dose over 3 hours, repeated every 8 hours for 3 days. After the 3-day period, patients rest for 6 weeks before starting the next cycle.
- On the other hand, in the 5-day regimen, patients receive Dacogen through continuous intravenous infusion at a 20 mg/m2 dose over 1 hour, repeated daily for 5 days. After the 5-day period, patients rest for 4 weeks before starting the next cycle.
Overdose
An overdose of Dacogen may increase myelosuppression, including prolonged thrombocytopenia and neutropenia.
How Is Dacogen Given?
Dacogen is administered by injection into a vein over a period of several hours, typically for 5 consecutive days, followed by a period of rest. It is only available by prescription and should only be used under the supervision of a qualified healthcare professional.
Is Dacogen a Form of Chemotherapy?
Yes, Dacogen is a form of chemotherapy that stops or slows the growth of cancer cells and helps to improve symptoms and increase survival rates for patients with MDS.
As a form of chemotherapy, Dacogen is typically administered via injection into the bloodstream, either in a hospital or clinic setting. However, it is usually used at lower doses than traditional chemotherapy drugs, which may help reduce some side effects commonly associated with chemotherapy, such as nausea, hair loss, and fatigue.
Possible Side Effects
Dacogen also has some common and severe side effects, like other medications. The most common side effects are:
- Fever
- Injection site reactions
- Anemia (low RBC count)
- Thrombocytopenia (low blood platelets count)
- Neutropenia (low white blood cell count)
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Precautions
If you have certain medical conditions, Dacogen may not be suitable for you. Therefore, it is recommended to consult your healthcare provider in the following cases before taking Dacogen:
- If you are pregnant or intend to become pregnant, avoid receiving Dacogen infusion as it may cause fetal-born toxicity and harm the baby.
- If you are breastfeeding or planning to breastfeed, avoid receiving Dacogen during breastfeeding, or if you are already taking Dacogen, then do not breastfeed the child for at least 1 week after the last dose.
- If you are a fertile man or woman, use effective contraceptives to avoid pregnancy while receiving treatment with Dacogen. This medication can cause congenital disabilities and may harm the fetus. Fertile women should use birth control for at least 6 months after the last dose, and men for 3 months after the last dose.
- If you have an allergy to any component of Dacogen, do not take this medication.
- If you have liver or kidney disease, consult your doctor.
- If you are taking multivitamins, herbal supplements, or over-the-counter medicines, talk to your doctor before taking Dacogen.
Cost
The cost of Dacogen intravenous powder of 50 mg is around $1,901. The cost of this medication can vary and may depend on the pharmacy you visit. Contact us if you would like help finding financial assistance.
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REFERENCES:
- US Food and Drug Administration (FDA). Dacogen Prescribing Information: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021790s021lbl.pdf
- Nieto, M. J., Demolis, P., Béhanzin, E., Moreau, A., Hudson, I., Flores, B. R., Stemplewski, H., Salmonson, T., Gisselbrecht, C., Bowen, D. G., & Pignatti, F. (2016). The European Medicines Agency Review of Decitabine (Dacogen) for the Treatment of Adult Patients With Acute Myeloid Leukemia: Summary of the Scientific Assessment of the Committee for Medicinal Products for Human Use. Oncologist, 21(6), 692–700. https://doi.org/10.1634/theoncologist.2015-0298
- Jabbour, E., Issa, J. P. J., Garcia-Manero, G., & Kantarjian, H. M. (2008). Evolution of decitabine development. Cancer, 112(11), 2341–2351. https://doi.org/10.1002/cncr.23463
- Aronson, J. K. (2015). Meyler’s Side Effects of Drugs: The International Encyclopedia of Adverse Drug Reactions and Interactions. Elsevier.
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Dr. Christine Leduc, PharmD, was born and raised in Irvine, CA. She attended college at Midwestern University, where she graduated cum laude. The most rewarding part of her job is suggesting lifestyle changes, educating patients on how their medication works, and precepting future pharmacists. Her areas of expertise are customer service and knowledge of specialty medication. Having worked in the service industry in the past, she has gained the customer service skills necessary to understand the needs of her patients. Dr. Leduc is currently precepting students from Marshall B. Ketchum University, University of Kansas, and Midwestern University. In her free time, she enjoys traveling, baking, and gardening.