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

RYTELO safety profile from the IMerge phase 3 trial

Adverse reactions commonly reported in IMerge phase 3 trial1

Table showing common adverse reactions for RYTELO vs placebo in the IMerge phase 3 trial.
Table showing common adverse reactions for RYTELO vs placebo in the IMerge phase 3 trial.

Data presented may differ from Prescribing Information due to differences in cutoff dates.

Graded according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03.

MDS, myelodysplastic syndromes;

SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.

*Fatigue: asthenia, fatigue, and malaise.1

†Arthralgia/myalgia: arthralgia, back pain, bone pain, musculoskeletal pain, myalgia, neck pain, non-cardiac chest pain, pain, pain in extremity, pain in jaw, and pelvic pain.1

‡COVID-19: asymptomatic COVID-19, COVID-19, COVID-19 pneumonia, and SARS-CoV-2 antibody test positive.1

§Urinary tract infection: cystitis, Escherichia urinary tract infection, renal abscess, and urinary tract infection.1

||Syncope: fall, pre-syncope, and syncope.1

Infusion-related reactions: abdominal pain, arthralgia, asthenia, back pain, bone pain, diarrhea, erythema, headache, hypertensive crisis, malaise, non-cardiac chest pain, pruritus, and urticaria. Only events considered related to infusion-related reactions are included.1

#Atrial arrhythmia: atrial fibrillation and atrial flutter.1

**Fractures: femur fracture, hand fracture, hip fracture, humerus fracture, lumbar vertebral fracture, and thoracic vertebral fracture.1

  • Clinically relevant adverse reactions in <5% of patients who received RYTELO included febrile neutropenia, sepsis, gastrointestinal hemorrhage, and hypertension1

Select laboratory abnormalities observed with RYTELO (imetelstat)2

Table showing All Grades, Grade 3, and Grade 4 laboratory abnormalities for RYTELO and placebo in the IMerge phase 3 trial.
Table showing All Grades, Grade 3, and Grade 4 laboratory abnormalities for RYTELO and placebo in the IMerge phase 3 trial.
Data presented may differ from Prescribing Information due to differences in cutoff dates.
Graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.

ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; PTT, partial thromboplastin time.

  • In IMerge phase 3 trial, treatment was discontinued due to adverse reactions in 15% (n=17) of patients receiving RYTELO1
    • 7.6% (n=9) of RYTELO patients discontinued treatment due to cytopenias vs 0% on placebo2

Clinical consequences of cytopenias across IMerge trial2

Table showing the clinical consequences of cytopenias for RYTELO and placebo by All Grades and Grade 3 or Grade 4 in the IMerge phase 3 trial.
Table showing the clinical consequences of cytopenias for RYTELO and placebo by All Grades and Grade 3 or Grade 4 in the IMerge phase 3 trial.
  • Clinical consequences of Grade ≥3 cytopenias were comparable to placebo2

Supportive care:

  • 17.8% (n=21) of RYTELO-treated patients received a median of 1 platelet transfusion vs 1.7% (n=1) on placebo2
  • 34.7% (n=41) of RYTELO-treated patients received growth factor support vs 3.3% (n=2) on placebo2

TI, transfusion independence.

††No patients with Grade 3 or higher bleeding events received platelet transfusions.2

‡‡Three patients in the RYTELO group had Grades 3-4 infections concurrent with Grades 3-4 neutropenia.2

§§Occurred day 33, lasted 8 days; assessed by investigator as possibly related to RYTELO; patient subsequently achieved TI >40 weeks and remains on treatment at data cutoff.3

Table showing the incidence rates of cytopenias for RYTELO and placebo in the IMerge phase 3 trial.
Table showing the incidence rates of cytopenias for RYTELO and placebo in the IMerge phase 3 trial.
  • The median time to onset of cytopenias occurred during the first 4.6-6 weeks1
  • In >80% of patients, platelets recovered to ≥50,000/mm3 and neutrophils recovered to ≥1000/mm3 within 4 weeks3,4,¶¶

¶¶Recovery occurred due to dose delays or reductions. All data presented indicate CTCAE Grade ≥2.

References: 1. RYTELO. Prescribing information. Geron Corp.; 2024. 2. Data on file. Geron Corporation. Foster City, CA. 3. Platzbecker U, Santini V, Fenaux P, et al. Imetelstat in patients with lower-risk myelodysplastic syndromes who have relapsed or are refractory to erythropoiesis-stimulating agents (IMerge): a multinational, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024;(Supplement)403(10423): published online Dec 1. https://doi.org/10.1016/S0140-6736(23)01724-5 4. Platzbecker U, Santini V, Fenaux P, et al. Imetelstat in patients with lower-risk myelodysplastic syndromes who have relapsed or are refractory to erythropoiesis-stimulating agents (IMerge): a multinational, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024;403(10423):249-260.

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 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.