RYTELO 47 mg/1
imetelstat sodium · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Geron Corporation
Rytelo (imetelstat sodium) is an intravenous injection used to treat certain blood disorders by targeting telomerase, an enzyme involved in cell growth. It is administered as an injection and requires a prescription from a healthcare provider.
Key Facts
- Brand Name
- RYTELO
- Generic Name
- imetelstat sodium
- NDC Code (Product)
82959-112- Manufacturer
- Geron Corporation
- Strength
- 47 mg/1
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA217779
- Marketing Start
- 06/06/2024
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1. INDICATIONS 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). RYTELO is an oligonucleotide telomerase inhibitor 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). ( 1 )
Dosage & Administration
2. DOSAGE AND ADMINISTRATION The recommended dosage of RYTELO is 7.1 mg/kg administered as an intravenous infusion over 2 hours every 4 weeks. ( 2.1 ) Premedicate prior to dosing with RYTELO for potential infusion-related reactions. ( 2.2 ) See full prescribing information for preparation and administration instructions. ( 2.4 ) 2.1. Recommended Dosage The recommended dosage of RYTELO is 7.1 mg/kg administered as an intravenous infusion over 2 hours every 4 weeks. Discontinue RYTELO if a patient does not experience a decrease in red blood cell (RBC) transfusion burden after 24 weeks of treatment (administration of 6 doses) or if unacceptable toxicity occurs at any time [see Dosage and Administration (2.3) ] . 2.2. Recommended Premedications Administer the following pre-treatment medications at least 30 minutes prior to dosing to prevent or reduce potential infusion-related reactions: diphenhydramine (or equivalent) 25 mg to 50 mg, intravenously or orally hydrocortisone (or equivalent) 100 mg to 200 mg, intravenously or orally Monitor patients for adverse reactions for at least one hour after the infusion has been completed [see Warnings and Precautions (5.3) and Adverse Reactions (…
Contraindications
4. CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
6. ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Thrombocytopenia [see Warnings and Precautions (5.1) ] Neutropenia [see Warnings and Precautions (5.2) ] Infusion-Related Reactions [see Warnings and Precautions (5.3) ] Most common adverse reactions (incidence ≥10% with a difference between arms of >5% compared to placebo), including laboratory abnormalities are decreased platelets, decreased white blood cells, decreased neutrophils, increased AST, increased alkaline phosphatase, increased ALT, fatigue, prolonged partial thromboplastin time, arthralgia/myalgia, COVID-19 infections, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Geron Corporation at 1-855-437-6664 (1-855-GERONMI) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Low- to Intermediate-Risk Myelodysplastic Syndromes The safety of RYTELO was…
Frequently Asked Questions
What is RYTELO used for?
Rytelo (imetelstat sodium) is an intravenous injection used to treat certain blood disorders by targeting telomerase, an enzyme involved in cell growth. It is administered as an injection and requires a prescription from a healthcare provider.
Is RYTELO a controlled substance?
RYTELO is not classified as a controlled substance by the DEA.
What is the generic name for RYTELO?
The generic name for RYTELO is imetelstat sodium. There are no other listed brand versions of imetelstat sodium.
What is the NDC code for RYTELO 47 mg/1?
The NDC (National Drug Code) for RYTELO 47 mg/1 is 82959-112, listed by Geron Corporation.
Other RYTELO Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)