Frequently Asked Questions about Dacogen® (Decitabine)
Generic Name: Decitabine, (day-SIGH-tuh-been)
Trade Name: Dacogen®
For which conditions is Dacogen approved for? Dacogen is FDA approved for the treatment of myelodysplastic syndromes (MDS). It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than for which it is approved may wish to discuss this issue with their physician.
What is the mechanism of action? Dacogen belongs to a group of drugs called hypomethylating agents. Dacogen produces its anticancer effects by causing a chemical reaction that damages the DNA in a cell. The DNA damage caused by Dacogen inhibits protein synthesis and results in cellular death.
How is Dacogen typically given (administered)? Dacogen is administered intravenously (into a vein). The dose depends on several factors, including the condition being treated, the size of the patient, the particular treatment regimen being used, and the overall health of the patient. Although patients will be closely monitored during administration, they should report any burning, redness, or swelling near the administration site to a healthcare provider.
How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Dacogen. Typically, blood will be drawn to monitor levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver. Patients may also undergo physical examinations, scans, or other measures to assess side effects and response to therapy.
What are the common (occur in 30% or more of patients) side effects of treatment with Dacogen?
- Low white blood cell levels (increases risk of infection)
- Low red blood cell levels (increases risk of anemia and blood transfusions)
- Pain during drug administration
- Low platelet levels (increases risk of bleeding)
- Nausea and vomiting
- Small red spots on skin and in mouth
What are the less common (occur in 10% to 29% of patients) side effects of treatment with Dacogen?
- Inflammation of the lining of the mouth
- Abdominal pain
- Fluid retention
- Elevated levels of sugar in the blood
- Changes in heart rhythm
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
- Pay careful attention to the physician’s instructions and inform the physician of any side effects.
- Maintain adequate rest and nutrition.
- Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
- If possible, avoid large crowds or people who are sick or not feeling well, as this drug may leave some patients susceptible to infection.
- Wash hands often to reduce the risk of infection.
- Avoid activities that may cause injury or bruising.
- Use a soft toothbrush and an electric razor to prevent cuts on the mouth or skin.
- Eat small meals frequently to help alleviate nausea.
- If patients have been prescribed an anti-nausea medication, they should be sure to take the prescribed doses.
- Patients need to protect themselves from exposure to sunlight. Wear light clothing, hats, sunglasses, and sunscreen when outdoors.
Are there any special precautions patients should be aware of before starting chemotherapy?
- Patients should inform their physician if they are pregnant, breastfeeding, or planning a family in the near future. This drug may cause birth defects. It is important to use some form of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future since some drugs may cause fertility problems.
- It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
- Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
- Patients should check with their physician before starting any new drug or nutritional supplement.
- Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
When should patients notify their physician?
If they experience:
- Sore throat
- Flu or cold-like symptoms
- Excessive fatigue
- Numbness or tingling of hands or feet
- Pain, redness, or swelling at the site of administration
- Prolonged or severe nausea or vomiting
- Severe or persistent fatigue
- Unexplained bleeding (nosebleeds, bruises, blood in urine, black tarry stools, etc.)
- Change in color of urine or stool
- Yellowing of skin or eyes
- Severe weight loss
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics, and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Important Limitations of Use
The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.
As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.
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The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.