Our Therapies

RYTELO™ Infusion Therapy

Next-generation infusion care - Violet Health Infusion Care

About RYTELO™ Infusion Therapy

RYTELO™ (imetelstat) is a first-in-class telomerase inhibitor given as an intravenous (IV) infusion, and it is the only medicine of its kind approved in the United States. Telomerase is an enzyme that the abnormal bone marrow cells in myelodysplastic syndromes rely on to keep dividing. By blocking that enzyme, RYTELO™ is intended to give your healthier blood-forming cells room to recover, so that over time you need fewer red blood cell transfusions, or none at all.

This is a different approach from the immunotherapy and antibody medicines described on our other pages. RYTELO™ does not work through your immune system, and it is not chemotherapy. Instead, it acts directly on the enzyme that the abnormal cells depend on to keep growing.

Your dose is based on your weight at 7.1 mg/kg, infused over about two hours once every four weeks, and each four-week interval is called a cycle. At least 30 minutes before every infusion, you receive an antihistamine such as diphenhydramine 25 to 50 mg or an equivalent, along with a corticosteroid such as hydrocortisone 100 to 200 mg or an equivalent, to prevent or reduce infusion-related reactions. After the infusion finishes, your nurse monitors you for at least one hour before you head home.

Lab work keeps your treatment on track. You have a complete blood count before starting, weekly through the first two cycles, and then before every cycle and any time it is needed, plus liver function tests before starting, weekly during the first cycle, and before each cycle after that. Low blood counts are common with RYTELO™ and usually mean a short delay or a reduced dose rather than stopping treatment altogether. If your transfusion needs have not decreased after 24 weeks, which is six doses, your care team will stop RYTELO™ and talk with you about other options.

Conditions treated by this therapy

RYTELO™ is FDA-approved for the treatment of adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring four or more red blood cell units over eight weeks, who have not responded to, have lost response to, or are ineligible for erythropoiesis-stimulating agents. Your care team may consider this therapy if you are:

An adult with low-risk or intermediate-1 risk myelodysplastic syndromes
Living with anemia that requires regular red blood cell transfusions, four or more units over eight weeks
Someone who did not respond to an erythropoiesis-stimulating agent, such as epoetin or darbepoetin
Someone who lost their response to an erythropoiesis-stimulating agent
Not eligible for erythropoiesis-stimulating agents
A patient with or without ring sideroblasts
An adult, since RYTELO™ is approved for adults only and has not been studied in children
Hoping for fewer transfusions: in the phase III MDS3001 trial, 39.8% of patients on RYTELO™ went at least eight weeks without a red blood cell transfusion compared with 15.0% on placebo, and 28.0% went at least 24 weeks compared with 3.3%, with responders staying transfusion free for a median of about 51.6 weeks
Ready for your hematologist to rule out other causes of anemia, such as iron, B12, or folate deficiency, kidney disease, or ongoing bleeding, before you start treatment

Your hematologist will confirm whether RYTELO™ is right for you before treatment begins.

RYTELO™ Price

The cost of prescription medications can vary depending on your insurance coverage. If you're concerned about the price of your medication:

Contact your insurance provider to understand your coverage
Ask your doctor or pharmacist about lower-cost alternatives
Check with the drug manufacturer about financial assistance programs
Explore patient assistance options if you're uninsured or underinsured

Remember, many resources exist to help patients access necessary medications. Don't hesitate to ask for help if you're struggling with medication costs. No patient should go without necessary treatment due to financial limitations. If you have questions about financial assistance opportunities, contact a member of our Violet Health team.

What to Expect During RYTELO™ Infusion Therapy

When you arrive at a Violet Health location, our team will greet you by name and help you settle into a private, welcoming space designed for comfort during your infusion. Here is what a typical visit looks like. Your care team will:

Review your current health and any symptoms you have noticed, with close attention to bruising, bleeding, fever, or signs of infection
Check your vital signs
Review your most recent blood counts and liver function tests, which must meet certain thresholds before each cycle
Give your premedication, an antihistamine and a corticosteroid, at least 30 minutes before the infusion begins
Place your IV using gentle, practiced technique
Administer your RYTELO™ infusion over about two hours with a nurse at your side
Monitor you for at least one hour after the infusion ends, since infusion reactions usually happen during the infusion or shortly after it finishes
Coordinate any supportive care you need between cycles, such as platelet transfusions, growth factor injections, or antibiotics
Protect your privacy and comfort throughout the visit

Plan on roughly four hours for a treatment day once you add up the premedication, the two-hour infusion, and the hour of monitoring afterward. Visits repeat every four weeks, and you will have blood work in between so your care team can see how your counts are responding.

Many patients still need red blood cell transfusions early in treatment, and that is expected. Your transfusion needs are tracked cycle by cycle, because the number of units you require over time is how we measure whether the medicine is working for you.

RYTELO™ Side Effects

With RYTELO™, low blood counts are the defining feature of treatment rather than an uncommon complication. In the clinical trial, new or worsening grade 3 or 4 low platelet counts occurred in 65% of patients and grade 3 or 4 low neutrophil counts occurred in 72%, most often during the first three cycles, and each episode typically resolved in about one to two weeks. Knowing this ahead of time helps you recognize what is expected, what to watch for, and when to call your care team. Common side effects include:

Low platelet counts (thrombocytopenia)
Low white blood cell and neutrophil counts
Fatigue
Elevated liver enzymes such as AST, ALT, and alkaline phosphatase
Headache
Joint and muscle pain
Bone pain. Fractures were reported more often with RYTELO™ than with placebo, so tell your care team about any falls, new bone pain, or a history of osteoporosis.
Prolonged partial thromboplastin time. This is a clotting test result that often changes on lab reports without causing any bleeding.
COVID-19 and other infections
Fever
Nausea
Swelling in the arms or legs
Infusion-related reactions. These occurred in 8% of patients and were severe in fewer than 2%, and headache was the most common one.

Although rare, serious side effects can occur. Please alert our clinical staff or seek medical attention immediately if you experience any of the following symptoms:

Severe thrombocytopenia with bleeding (unusual bruising, nosebleeds that will not stop, blood in urine or stool, bleeding gums, tiny red spots on the skin)
Severe neutropenia with infection (fever of 100.4 degrees Fahrenheit or higher, chills, sore throat, cough, burning with urination)
Sepsis, the most common serious reaction at 4.2% of patients. Treat this as a medical emergency and call 911 or go to the nearest emergency room.
Serious infusion-related reactions (difficulty breathing, wheezing, chest tightness, flushing, severe drop in blood pressure)
Heart failure symptoms such as new shortness of breath, swelling, or rapid weight gain, which were reported in 2.5% of patients.
Liver problems (yellowing of skin or eyes, dark urine, severe fatigue, right-sided abdominal pain)

Please note: your blood counts are monitored weekly during the first two cycles, before each cycle thereafter, and as needed. Your treatment may be delayed or your dose reduced based on these results.

Good to know: RYTELO™ carries no boxed warning, unlike the anti-CD20 and HER2 medicines described on our other infusion pages.

Pregnancy warning: RYTELO™ may harm an unborn baby. Use effective contraception during treatment and for one week after the last dose, and do not breastfeed during treatment or for one week after. That one-week window is the shortest of any medicine on our infusion pages, where three to twelve months is typical.

RYTELO™ Infusion Therapy at Violet Health

Your comfort during RYTELO™ infusion therapy at Violet Health is our priority. Our patients enjoy walk-up parking, complimentary entertainment and snacks, and a team of highly trained providers during each treatment. Plus, Violet Health's evening and weekend hours and convenient city and rural locations make it easier to schedule your appointments.