Prescription medicine
Imetelstat Brand names: Rytelo
Imetelstat (Rytelo) is a prescription medicine with an FDA approval on record since 2024. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the imetelstat FDA label on DailyMed (effective April 22, 2026, Geron Corporation); the NDA 217779 record on Drugs@FDA; every imetelstat label on DailyMed.
Highlights of the record
FDA label of April 22, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageINDICATIONS AND USAGE RYTELO is indicated for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring 4 or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA).
Forms and strengths
- 47 mg
- 188 mg
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- June 6, 2024 Rytelo, Geron; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- June 16, 2039 Rytelo injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 176 through July 30, 2026
What is imetelstat used for?
From the label: indications and usageINDICATIONS AND USAGE RYTELO is indicated for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring 4 or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA). […]
Conditions named in the indications of imetelstat's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Oligonucleotide Telomerase Inhibitor.
Source: FDA drug label (RYTELO), Geron Corporation, effective April 22, 2026 (SPL set b0fab7ca-e578-43c5-9df6-bdaff4182257), via openFDA; the full label on DailyMed
What does the patient leaflet for imetelstat say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about RYTELO?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: unusual bleeding or bruising bleeding that lasts a long time nosebleeds vomiting blood blood in your stool or black tarry stool 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: fever shortness of breath or trouble breathing cough chills pain or burning when you urinate 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. […]
Source: FDA drug label (RYTELO), Geron Corporation, effective April 22, 2026 (SPL set b0fab7ca-e578-43c5-9df6-bdaff4182257), via openFDA; the full label on DailyMed
Is there a generic for imetelstat (Rytelo)?
No generic imetelstat is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 6 patents for Rytelo injection: the compound patent runs to December 27, 2026, and the last listed entry to June 16, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2024 earliest approval on file
- 2039 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the imetelstat label say about other medicines?
The imetelstat label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Diphenhydramine | warnings and precautions | Premedicate patients at least 30 minutes prior to infusion with diphenhydramine and hydrocortisone as recommended and monitor patients for at least one hour following the infusion as recommended [see Dosage and Administration (2.2) ]. |
| Hydrocortisone | warnings and precautions | Premedicate patients at least 30 minutes prior to infusion with diphenhydramine and hydrocortisone as recommended and monitor patients for at least one hour following the infusion as recommended [see Dosage and Administration (2.2) ]. |
Source: FDA drug label (RYTELO), Geron Corporation, effective April 22, 2026 (SPL set b0fab7ca-e578-43c5-9df6-bdaff4182257), via openFDA; the full label on DailyMed
What do FAERS reports show for imetelstat?
The FDA Adverse Event Reporting System holds 176 reports that list imetelstat among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 11 are coded as a death and 35 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as imetelstat?
8 other medicines are given the same way (intravenous) and in the same FDA class as imetelstat or labeled mainly for the same use (anemia), the same class first. Anemia lists all 25 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Epoetin | Anemia | none listed | $32.27 per mL 2,000 units/mL vial | No current entry |
| Darbepoetin alfa | Anemia | none listed | $446.58 per mL 25 mcg/0.42 mL syring | No current entry |
| Iron sucrose | Anemia | 3 labelers | n/a | A presentation being discontinued |
| Methoxy polyethylene glycol-epoetin beta | Anemia | none listed | n/a | No current entry |
| Ferumoxytol | Anemia | 1 labeler | n/a | No current entry |
| Sodium ferric gluconate complex | Anemia | 1 labeler | n/a | No current entry |
| Ferric derisomaltose | Anemia | none listed | n/a | No current entry |
| Nipocalimab | Anemia | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Imetelstat side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other