Click on the following topics for answers to frequently asked questions about VIDAZA:
Understanding VIDAZA
What is VIDAZA?
VIDAZA is the first drug approved by the US Food and Drug Administration (FDA) for
the treatment of all 5 FAB subtypes of myelodysplastic syndromes
(MDS).
Why was VIDAZA prescribed?
Your doctor may have prescribed VIDAZA to help reduce your need for RBC
transfusions. Your doctor may prescribe VIDAZA for as long as you continue to benefit from it
and side effects don't require that you stop treatment. Always follow your doctor's
recommendations about continuing your treatment plan.
There are different ways of classifying MDS. One system (French-American-British or FAB) divides MDS into 5 groups called subtypes. VIDAZA is used to treat patients with all 5 FAB subtypes. Your doctor can explain which subtype of MDS you have.
The 5 FAB MDS subtypes that VIDAZA treats are:
- RA,
refractory anemia, or RARS,
refractory anemia
with ringed sideroblasts—With RA or RARS, you have less than 5%
blasts
or immature cells in the
bone marrow
and at least 1
cytopenia
(abnormally low blood cell count [usually RBCs]). About 40% of patients with MDS
have RA or RARS
- RAEB,
refractory anemia
with excess
blasts—With RAEB, you have 5% to 20%
blasts
in the
bone marrow
and at least 2
cytopenias (low counts of at least 2 types of blood cells [for example, RBCs and
platelets]). About 30% of patients with MDS have RAEB
- RAEB-T,
refractory anemia
with excess
blasts
in transformation—With RAEB-T, you have between 21% and 30%
blasts
in the
bone marrow
and at least 2
cytopenias. This form of MDS may turn into a type of cancer of the blood and
bone marrow
called acute myeloid leukemia
(AML). About 20% of patients with MDS have RAEB-T
- CMMoL,
chronic myelomonocytic leukemia—With CMMoL, you have between 5% and 20%
blasts
in the
bone marrow
and an increased number of
monocytes, a type of WBC. About 10% of patients with MDS have CMMoL
Another system (International Prognostic Scoring System or IPSS) uses cell type and blood counts of patients with MDS to predict the course of their disease. This system separates patients into lower-risk and higher-risk categories. This helps doctors determine a treatment plan for each patient.
Treatment Information for VIDAZA
How is VIDAZA given?
VIDAZA can be given as a
subcutaneous
injection. It can also be given as an
intravenous
or IV infusion. Click here to learn more about
subcutaneous
injection and IV infusion.
Can I give myself VIDAZA at home?
No. It should be given by a trained nurse or doctor in a doctor's office, clinic,
or hospital. The doctor or nurse will monitor you before treatment and watch for
any reaction you may have to the treatment.
How often will I receive VIDAZA?
You will visit your doctor's office daily for 7 days to receive VIDAZA through a
subcutaneous
injection or an IV infusion. An injection can be given in a few minutes each day.
An IV infusion can take from 10 to 40 minutes each day. Then you will have 21 days
without treatment. Each 28-day period (the 7 days you receive VIDAZA plus the 21
days you do not) is called a "cycle" of treatment. Your doctor will look at your
blood counts and other factors as you receive treatment with VIDAZA. If your doctor
decides it is necessary, he or she may extend your
treatment cycle
to longer than 28 days.
As you receive treatment with VIDAZA, remember:
- Routine blood tests—Before each cycle of treatment, you will need to have a blood test. Blood tests help your doctor understand how you are responding to treatment. They will also help your doctor address any side effects of treatment
- Pregnancy and nursing—Women should not become pregnant or breastfeed while receiving VIDAZA. Men should avoid fathering a child while receiving VIDAZA
- Liver problems—Tell your doctor if you have liver problems before receiving VIDAZA
- Kidney problems—Tell your doctor if you have kidney problems before receiving VIDAZA
Understanding Side Effects
What are the most common side effects by subcutaneous injection?
What are the most common side effects for an IV infusion?
- Nausea
-
Anemia
-
Thrombocytopenia
- Vomiting
- Fever
- Diarrhea
- Redness of the skin at the injection site
- Constipation
-
Neutropenia
- Bruising of the skin at the injection site
- Small reddish-purple spots on the body
- Chills
- Weakness
- Low potassium in the blood
What are other side effects that may occur?
Myelosuppression
In some patients, treatment with VIDAZA may cause
myelosuppression. This common condition causes
bone marrow
to make fewer blood cells than normal.
Myelosuppression
can cause any or all of the following:
- Reduced RBC counts, also called
anemia—This may make you feel tired
- Reduced WBC counts, also called
neutropenia—This may make you more likely to get an infection
- Reduced platelet counts, also called
thrombocytopenia—This may cause bleeding for no reason (such as nosebleeds or bleeding gums)
Be sure to ask your doctor or nurse about any symptoms you may have or other side
effects that may occur. It is important to tell your doctor or nurse about any side
effects you may have so that you can discuss your treatment plan.
What Else You Need to Know
How long will I be on VIDAZA?
VIDAZA is not a one-time treatment. Treatment cycles are given every 28 days for as long as your doctor recommends them. It may take several cycles (about 4 to 6 months) for your doctor to notice a difference. If you stop receiving treatment, your symptoms may return. Therefore, your doctor may want to keep you on it for as long as you continue to benefit from it and side effects don’t require you to stop it.
While you’re on VIDAZA your blood cell counts may fall during your first few cycles of treatment. This may cause you to feel tired or have a fever. Always follow your doctor’s recommendations about continuing your treatment plan. By cycle 3 or 4, VIDAZA may be helping your bone marrow make healthy blood cells. As a result, your blood cell counts may begin to rise. By cycles 4-6, your need for transfusions may be decreased. That means you may feel less tired and have fewer fevers.
As you receive treatment with VIDAZA, remember:
- Routine blood tests—Before each cycle of treatment, you will need to have a blood test. Blood tests help your doctor understand how you are responding to treatment. They will also help your doctor address any side effects of treatment
- Pregnancy and nursing—Women should not become pregnant or breastfeed while receiving VIDAZA. Men should avoid fathering a child while receiving VIDAZA
- Liver problems—Tell your doctor if you have liver problems before receiving VIDAZA
- Kidney problems—Tell your doctor if you have kidney problems before receiving VIDAZA