Geron is pleased to inform you that RYTELO is now approved 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 provided as a lyophilized powder in a single-dose vial for intravenous infusion only and must be reconstituted and diluted prior to administration. Calculate the dose of RYTELO needed based on the patient’s body weight (kg). See Section 2 of US Prescribing Information. Determine the number of RYTELO vials needed to achieve the required dose (total mg). More than one vial may be needed to achieve a full dose. Below please find codes to consider when adding RYTELO to your organization’s system.

RYTELO Package Information:¹

Wholesale Acquisition Cost (WAC) is the list price from a manufacturer to a wholesaler or a direct purchaser before any discounts or rebates are applied. The WAC price listed may differ significantly from actual prices paid by customers and consumers.

Coding examples below are provided for informational purposes only. It is always the provider’s responsibility to determine details specific to individual patients and to submit true and correct claims for the products and services rendered. Providers should contact third-party payers for specific information on their coding, coverage, payment policies, and fee schedules. Geron and its agents make no guarantee regarding reimbursement for any service or item. This information is not intended as reimbursement advice, legal advice, medical advice, or a substitute for a provider’s independent professional judgment.

HCPCS Codes:

RYTELO is designated by a miscellaneous J-code/C-code until a permanent code is assigned.^2,3

Example ICD-10-CM Diagnosis Codes⁴

Diagnosis codes used in submission of claims should be chosen based on the individual patient's medical diagnosis.

NDC=National Drug Code, HCPCS= Healthcare Common Procedure Coding System, ICD-10-CM=International Classification of Diseases, Tenth Revision, Clinical Modification.

IMPORTANT SAFETY INFORMATION 

WARNINGS AND PRECAUTIONS 

Thrombocytopenia 

RYTELO can cause thrombocytopenia based on laboratory values. In the clinical trial, new or worsening Grade 3 or 4 decreased platelets occurred in 65% of patients with MDS treated with RYTELO. 

Monitor patients with thrombocytopenia for bleeding. Monitor complete blood cell counts prior to initiation of RYTELO, weekly for the first two cycles, prior to each cycle thereafter, and as clinically indicated. Administer platelet transfusions as appropriate. Delay the next cycle and resume at the same or reduced dose, or discontinue as recommended. 

Neutropenia 

RYTELO can cause neutropenia based on laboratory values. In the clinical trial, new or worsening Grade 3 or 4 decreased neutrophils occurred in 72% of patients with MDS treated with RYTELO. 

Monitor patients with Grade 3 or 4 neutropenia for infections, including sepsis. Monitor complete blood cell counts prior to initiation of RYTELO, weekly for the first two cycles, prior to each cycle thereafter, and as clinically indicated. Administer growth factors and anti-infective therapies for treatment or prophylaxis as appropriate. Delay the next cycle and resume at the same or reduced dose, or discontinue as recommended. 

Infusion-Related Reactions 

RYTELO can cause infusion-related reactions. In the clinical trial, infusion-related reactions occurred in 8% of patients with MDS treated with RYTELO; Grade 3 or 4 infusion-related reactions occurred in 1.7%, including hypertensive crisis (0.8%). The most common infusion-related reaction was headache (4.2%). Infusion-related reactions usually occur during or shortly after the end of the infusion. 

Premedicate patients at least 30 minutes prior to infusion with diphenhydramine and hydrocortisone as recommended and monitor patients for one hour following the infusion as recommended. Manage symptoms of infusion-related reactions with supportive care and infusion interruptions, decrease infusion rate, or permanently discontinue as recommended. 

Embryo-Fetal Toxicity 

RYTELO can cause embryo-fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with RYTELO and for 1 week after the last dose. 

ADVERSE REACTIONS 

Serious adverse reactions occurred in 32% of patients who received RYTELO. Serious adverse reactions in >2% of patients included sepsis (4.2%), fracture (3.4%), cardiac failure (2.5%), and hemorrhage (2.5%). Fatal adverse reactions occurred in 0.8% of patients who received RYTELO, including sepsis (0.8%).

Most common adverse reactions (≥10% with a difference between arms of >5% compared to placebo), including laboratory abnormalities, were 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. 

Please see RYTELO (imetelstat) full Prescribing Information, including Medication Guide. 

All Colorado prescribers and Connecticut prescribing practitioners and pharmacists click here for Wholesale Acquisition Cost for RYTELO.

References: 1. RYTELO (imetelstat) [prescribing information]. Foster City, CA. Geron Corp.; 2024. 2. HCPCS J-Codes. HCPCS.codes website. Accessed May 1, 2024. https://hcpcs.codes/j-codes/ 3. HCPCS Code C9399. HCPCS.codes website. Accessed May 1, 2024. https://hcpcs.codes/c-codes/C9399/. 4. Myelodysplastic syndromes D46. ICD10Data.com website. Accessed January 11, 2024. https://www.icd10data.com/ICD10CM/Codes/C00-D49/D37-D48/ D46

2024 Geron. All rights reserved. C-US-RYT-IM-0094. 06/24

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