J0870

Permanent J-Code for RYTELOTM (imetelstat)

Effective January 1, 2025 for all sites of care.

It is the sole responsibility of the provider to select and enter proper codes in seeking coverage and reimbursement for an individual patient. Geron makes no guarantee regarding reimbursement.

Reference: Centers for Medicare & Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS) application summaries and coding recommendations. Centers for Medicare & Medicaid Services. Updated October 7, 2024. Accessed October 8, 2024. https://www.cms.gov/files/document/2024-hcpcs-application-summary-quarter-3-2024-drugs-and-biologicals.pdf

INDICATION

RYTELO™ (imetelstat) 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). See more

Most patients who experienced adverse reactions were managed with dose delay and/or reductions1

Recommended RYTELO dose reductions for Grade 3 and Grade 4 adverse reactions1

Table of recommended dose reductions for RYTELO.
Table of recommended dose reductions for RYTELO.

NOTE: RYTELO (imetelstat) should be permanently discontinued if the patient cannot tolerate the lowest dose level of 4.4 mg/kg.1

Dose modifications for patients with hematologic adverse reactions1,*

Thrombocytopenia

Grade 3†
1st Occurrence
Delay RYTELO until recovery of platelets to
50 x 109/L; restart at same dose level

2nd Occurrence
Delay RYTELO until recovery of platelets to
50 x 109/L; restart at one dose level lower

3rd Occurrence
Delay RYTELO until recovery of platelets to
50 x 109/L; restart at one dose level lower

4th Occurrence
Discontinue RYTELO

Grade 4‡
1st Occurrence
Delay RYTELO until recovery of platelets to
50 x 109/L; restart at one dose level lower

2nd Occurrence
Delay RYTELO until recovery of platelets to
50 x 109/L; restart at one dose level lower

3rd Occurrence
Discontinue RYTELO

Neutropenia

Grade 3§
1st Occurrence
Delay RYTELO until recovery of ANC to
1 x 109/L; restart at same dose level

2nd Occurrence
Delay RYTELO until recovery of ANC to
1 x 109/L; restart at one dose level lower

3rd Occurrence
Delay RYTELO until recovery of ANC to
1 x 109/L; restart at one dose level lower

4th Occurrence
Discontinue RYTELO

Grade 4||
1st Occurrence
Delay RYTELO until recovery of ANC to
1 x 109/L; restart at one dose level lower

2nd Occurrence
Delay RYTELO until recovery of ANC to
1 x 109/L; restart at one dose level lower

3rd Occurrence
Discontinue RYTELO

ANC, absolute neutrophil count; AR, adverse reaction; CTCAE, Common Terminology Criteria for Adverse Events.

*Severity based on National Cancer Institute CTCAE Version 4.03.

†Grade 3 thrombocytopenia defined as platelet counts <50-25 x 109/L.2

‡Grade 4 thrombocytopenia defined as platelet counts <25 x 109/L.2

§Grade 3 neutropenia defined as neutrophil counts <1-0.5 x 109/L.2

||Grade 4 neutropenia defined as neutrophil counts <0.5 x 109/L.2

Dose modifications for patients with non-hematologic adverse reactions1,*

Other adverse reactions including elevated LFTs

Grade 3
1st Occurrence
Delay RYTELO until recovery of adverse reactions to Grade 1 or baseline;
restart at one dose level lower

2nd Occurrence
Delay RYTELO until recovery of adverse reactions to Grade 1 or baseline;
restart at one dose level lower

3rd Occurrence
Permanently discontinue RYTELO

Grade 4
1st Occurrence
Delay RYTELO until recovery of adverse reactions to Grade 1 or baseline;
restart at one dose level lower

2nd Occurrence
Delay RYTELO until recovery of adverse reactions to Grade 1 or baseline;
restart at one dose level lower

3rd Occurrence
Permanently discontinue RYTELO

Infusion-related reactions

Grade 2 or Grade 3
1st Occurrence
Interrupt the RYTELO infusion until resolution of the adverse reaction or until the intensity of the reaction decreases to Grade 1; restart infusion at 50% of the infusion rate administered prior to the adverse reaction

2nd Occurrence
Interrupt the RYTELO infusion until resolution of the adverse reaction or until the intensity of the reaction decreases to Grade 1; restart infusion at 50% of the infusion rate administered prior to the adverse reaction

3rd Occurrence
For Grade 2, stop infusion. May restart at next cycle
For Grade 3, permanently discontinue RYTELO

Grade 4#
1st Occurrence
Stop infusion, administer supportive care as appropriate, and permanently discontinue RYTELO

LFT, liver function test.

Grade 3 infusion-related reactions defined as prolonged recurrence of symptoms following initial improvement.2

#Grade 4 infusion-related reactions defined as having life-threatening consequences with urgent intervention indicated.2

Management of Grade 3-4 adverse reactions may require temporary dose delay, dose reduction, or treatment discontinuation1

Icon of an orange clock

Dose delay

  • 68.6% (n=81) of patients receiving RYTELO had a dose delay due to Grade ≥3 adverse reactions vs 23.7% (n=14) on placebo3

NOTE: Length of dose delay is patient dependent and may vary.

Icon of a vial with a down facing arrow

Dose reduction

  • 49.2% (n=58) of patients receiving RYTELO had a dose reduction due to Grade ≥3 adverse reactions vs 6.8% (n=4) on placebo3
  • 15% (n=17) of patients receiving RYTELO discontinued treatment due to adverse reactions1
    • 7.6% (n=9) of RYTELO patients discontinued due to cytopenias vs 0% on placebo3
  • Administer growth factors and anti-infective therapies or platelet transfusions for treatment or prophylaxis as appropriate1



Download a guide for managing adverse reactions with RYTELO
View our HCP resources

References: 1. RYTELO. Prescribing information. Geron Corp.; 2024. 2. US Department of Health and Human Services. National Institutes of Health. CTCAE v4.03. June 14, 2010. 3. Data on file. Geron Corporation. Foster City, CA.

INDICATION

RYTELO™ (imetelstat) 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).

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Thrombocytopenia

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

You are encouraged to report adverse events related to Geron products by calling 1-855-437-6664 (1-855-GERON-MI) (US only). If you prefer, you may contact the US Food and Drug Administration (FDA) directly. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.