Frequently Asked Questions About Vidaza® (azacitadine)
Generic Name : azacitadine (aye-zuh-CYE-ta-deen)
Trade Name: Vidaza®
For which conditions is Vidaza approved for? Vidaza is indicated for the treatment of the following types of myelodysplastic syndromes: refractory anemia or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts, and refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia.
What is the mechanism of action? Vidaza belongs to a group of drugs called a nucleoside analogue. Vidaza produces its anti-cancer effects by inhibiting the ability of DNA replication. The suppression of DNA replication tends to affect faster replicating cells, such as cancer cells, ultimately causing cellular death.
How is Vidaza typically given (administered)? Vidaza is typically administered subcutaneously (injection under the skin). The dose and scheduling in which Vidaza is administered is dependent upon many factors, including the condition being treated, the particular treatment regimen being utilized, the patient’s height and weight, overall health, and the patient’s tolerance of therapy. Patients may also receive anti-nausea medication prior to treatment with Vidaza.
How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Vidaza. Typically, blood may be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver. Physical examinations, scans, or other measures may also be utilized to assess side effects and response to therapy.
What are the common (occur in 30% or more of patients) side effects of treatment with Vidaza?
- Redness or irritation at injection site
What are the less common (occur in 10% to 29% of patients) side effects of treatment with Vidaza?
- Low levels of platelets
- Low levels of white blood cells
- Shortness of breath
- Red spots on skin
- Areas of bruising
- Pain at injection site
- Joint pain
- Limb pain
- Significant decrease in weight or loss of appetite
- Inflammation of the throat
- Back pain
- Chest pain
- Low levels of white blood cells accompanied by fever
- Muscle pain
- Inflammation of the nasal area
- Bruising at injection site
- Injection site reaction
- Abdominal tenderness
What are the rare (occur in less than 10% of patients) side effects of treatment with Vidaza?
- Bleeding gums
- Enlarging of lymph nodes
- Runny nose
- Heart murmur
- Increased sweating
- Upper abdominal pain
- Crackles heard in the lungs
- Decreased appetite
- Skin abnormalities
- Water retention
- Bloody nose
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.
- 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.
- Eat small meals frequently to help alleviate nausea.
- Avoid activities that may cause injury or bruising.
- Use a soft toothbrush and an electric razor to prevent cuts on the mouth or skin.
- Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
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 kind 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?
- Sore throat
- Flu or cold-like symptoms
- Signs of infection – redness, swelling, pus, tenderness, painful or more frequent than usual urination
- Blistering or severe pain/redness/swelling at administration site
- Persistent and severe fatigue
- Unexplained bleeding (nosebleeds, bruises, black tarry stools, blood in the urine, etc.)
- Persistent or severe nausea and vomiting
- Persistent diarrhea or constipation
- Signs of an allergic reaction – wheezing, difficulty breathing, hives, rash, closing of throat
- Noticeable changes in heart rate or rhythm
- Chest pain
- Difficulty breathing
- Abdominal pain
- Yellowing of skin or eyes
- Swelling of ankles or feet
- Severe or persistent pain
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 kin 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.