Oral decitabine, known by the brand name Inqovi, represents an advancement in the treatment of certain blood cancers. It is a medication that combines decitabine with cedazuridine to allow for oral administration. This oral formulation offers a different approach to delivering a well-established anti-cancer agent, aiming to provide a more convenient option for patients.
What Oral Decitabine Is
Decitabine belongs to a class of drugs called hypomethylating agents, which work by influencing gene expression in cancer cells. At a cellular level, decitabine incorporates into DNA and inhibits DNA methyltransferase, an enzyme involved in regulating gene activity. This inhibition leads to decreased methylation of genetic material, which can alter gene expression and promote the differentiation or programmed cell death of abnormal cells. Cedazuridine is included to protect decitabine from being broken down too quickly in the body, allowing it to be effectively absorbed when taken by mouth.
Conditions It Treats
Oral decitabine is approved for treating adults with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML). Myelodysplastic syndromes are a group of cancers where immature blood cells in the bone marrow do not fully mature into healthy blood cells, leading to low blood cell counts. These conditions can range in severity, from lower-risk types primarily causing symptoms like anemia to higher-risk types that may progress to acute myeloid leukemia. Chronic myelomonocytic leukemia is a specific type of MDS that also involves an overproduction of monocytes, a type of white blood cell. Oral decitabine addresses these conditions by targeting the abnormal blood cell production in the bone marrow.
How Oral Decitabine is Administered
Oral decitabine, typically in the form of a tablet containing 35 milligrams (mg) of decitabine and 100 mg of cedazuridine, is taken by mouth. The usual dosage schedule involves taking one tablet once daily for five consecutive days within a 28-day cycle. This regimen is typically repeated for at least four cycles, or as directed by a healthcare provider.
It is generally recommended to take this medication on an empty stomach, specifically avoiding food for at least two hours before and two hours after taking the dose. Patients should swallow the tablet whole, without cutting, crushing, or chewing it. Taking the medication at the same time each day is advisable. Healthcare providers may also prescribe other medications to help manage potential side effects like nausea and vomiting.
Potential Side Effects and Management
Common side effects often include fatigue, nausea, vomiting, constipation, and diarrhea. Patients might manage nausea and vomiting with anti-nausea medications, while dietary adjustments can help with constipation or diarrhea.
More serious side effects primarily involve blood cell counts, such as decreases in white blood cells (leading to increased infection risk), red blood cells (causing anemia), and platelets (increasing bleeding risk). Fever, especially with a low white blood cell count (febrile neutropenia), and infections like sepsis require immediate medical attention. Patients should report any signs of infection, unusual bruising or bleeding, or severe fatigue to their doctor promptly. Regular blood tests are performed to monitor these changes, allowing healthcare providers to adjust treatment or provide supportive care as needed.
Oral vs. Intravenous Decitabine
The development of oral decitabine offers a significant alternative to its intravenous (IV) counterpart. The most apparent difference lies in the method of administration: IV decitabine requires infusions, typically administered in a hospital or clinic setting, often over several hours. In contrast, oral decitabine can be taken at home, offering greater convenience and potentially reducing the need for frequent hospital visits.
This shift to oral administration can improve patient compliance, as it eliminates the logistical challenges associated with IV infusions. Clinical studies have shown that the oral combination achieves similar drug exposure to IV decitabine, indicating comparable therapeutic potential. The overall safety profile of oral decitabine has also been observed to be similar to that of IV decitabine.