and
It is not known if RYTELO is safe and effective in children.
Anemia happens when your body doesn’t have enough healthy red blood cells (RBCs), which are the cells that carry oxygen all over your body. If you have lower-risk MDS and anemia, your body is making RBCs that aren’t doing their job well enough.
People with anemia often have hemoglobin levels that are too low. Hemoglobin is the substance in RBCs responsible for moving oxygen throughout the body.
People with lower-risk MDS and anemia may experience:
Feeling tired
Physical weakness
Shortness of breath
To increase the number of healthy RBCs in the body, people with lower-risk MDS and anemia will often receive blood transfusions. Unfortunately, getting transfusions too often or needing more blood transfusions than normal can lead to transfusion burden. This may cause other problems, such as an overload of iron in your body, which is not good for your health.
RYTELO (imetelstat) is a prescription medicine used to treat a condition called low- to intermediate-1 risk myelodysplastic syndromes (MDS) in adults:
and
who have not responded to, have stopped responding to, or cannot be treated with medicines called erythropoiesis-stimulating agents (ESAs).
It is not known if RYTELO is safe and effective in children.
Before you receive RYTELO (imetelstat), tell your healthcare provider about all of your medical conditions, including if you:
are pregnant or plan to become pregnant. RYTELO may harm your unborn baby and may cause loss of pregnancy (miscarriage). Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with RYTELO.
Females who are able to become pregnant:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
RYTELO may cause serious side effects, including:
Low platelet counts (thrombocytopenia). Low platelet counts are common during treatment with RYTELO and can also be severe. Low platelet counts can increase your risk for bleeding. Your healthcare provider may give you platelet transfusions to reduce the risk of bleeding if you develop a low platelet count during treatment with RYTELO. Tell your healthcare provider right away if you develop any signs or symptoms of bleeding, including:
Low neutrophil counts (neutropenia). Low counts of a type of white blood cell called neutrophils are common during treatment with RYTELO and can also be severe. Low neutrophil counts can increase your risk for infections, including serious infections and sepsis. Your healthcare provider may give you medicines before you start treatment to help prevent neutropenia and infections and may treat you with medicines if you develop these problems during treatment with RYTELO. Tell your healthcare provider right away if you develop any signs or symptoms of infection during treatment with RYTELO, including:
Your healthcare provider will do blood tests to check your platelet and neutrophil counts before starting treatment with RYTELO, weekly for the first 2 cycles of treatment, before you receive each additional cycle, and as needed during your treatment.
Your healthcare provider may delay your next treatment, decrease your dose, or stop treatment with RYTELO if you develop thrombocytopenia or neutropenia during treatment.
RYTELO may cause serious side effects, including:
Infusion-related reactions. RYTELO can cause infusion-related reactions during or after your infusion that can be severe, including a severe sudden increase in blood pressure called hypertensive crisis. Your healthcare provider will give you medicines before each RYTELO infusion to help prevent or lessen infusion-related reactions and will watch you for at least 1 hour after your infusion. If you develop infusion-related reactions, your healthcare provider may infuse RYTELO more slowly, temporarily stop, or permanently stop your treatment. Tell your healthcare provider if you develop any signs or symptoms of infusion-related reactions, including:
The most common side effects of RYTELO include:
These are not all of the possible side effects of RYTELO. Call your doctor for more information and medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.
Please see RYTELO (imetelstat) full Prescribing Information, including Medication Guide.
Before you receive RYTELO (imetelstat), tell your healthcare provider about all of your medical conditions, including if you:
are pregnant or plan to become pregnant. RYTELO may harm your unborn baby and may cause loss of pregnancy (miscarriage). Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with RYTELO.
Females who are able to become pregnant:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
RYTELO may cause serious side effects, including:
Low platelet counts (thrombocytopenia). Low platelet counts are common during treatment with RYTELO and can also be severe. Low platelet counts can increase your risk for bleeding. Your healthcare provider may give you platelet transfusions to reduce the risk of bleeding if you develop a low platelet count during treatment with RYTELO. Tell your healthcare provider right away if you develop any signs or symptoms of bleeding, including:
Low neutrophil counts (neutropenia). Low counts of a type of white blood cell called neutrophils are common during treatment with RYTELO and can also be severe. Low neutrophil counts can increase your risk for infections, including serious infections and sepsis. Your healthcare provider may give you medicines before you start treatment to help prevent neutropenia and infections and may treat you with medicines if you develop these problems during treatment with RYTELO. Tell your healthcare provider right away if you develop any signs or symptoms of infection during treatment with RYTELO, including:
Your healthcare provider will do blood tests to check your platelet and neutrophil counts before starting treatment with RYTELO, weekly for the first 2 cycles of treatment, before you receive each additional cycle, and as needed during your treatment.
Your healthcare provider may delay your next treatment, decrease your dose, or stop treatment with RYTELO if you develop thrombocytopenia or neutropenia during treatment.
RYTELO may cause serious side effects, including:
Infusion-related reactions. RYTELO can cause infusion-related reactions during or after your infusion that can be severe, including a severe sudden increase in blood pressure called hypertensive crisis. Your healthcare provider will give you medicines before each RYTELO infusion to help prevent or lessen infusion-related reactions and will watch you for at least 1 hour after your infusion. If you develop infusion-related reactions, your healthcare provider may infuse RYTELO more slowly, temporarily stop, or permanently stop your treatment. Tell your healthcare provider if you develop any signs or symptoms of infusion-related reactions, including:
The most common side effects of RYTELO include:
These are not all of the possible side effects of RYTELO. Call your doctor for more information and medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.
Please see RYTELO (imetelstat) full Prescribing Information, including Medication Guide.
RYTELO (imetelstat) is a prescription medicine used to treat a condition called low- to intermediate-1 risk myelodysplastic syndromes (MDS) in adults:
and
who have not responded to, have stopped responding to, or cannot be treated with medicines called erythropoiesis-stimulating agents (ESAs).
It is not known if RYTELO is safe and effective in children.