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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
Copay program benefits
The REACH4RYTELO Copay Program
For eligible, commercially insured patients,* the REACH4RYTELO Copay Program offers savings up to $10,650 per calendar year subject to certain conditions. There are no income requirements to participate in the program.
Terms and conditions apply. See Patient Copay Program Brochure for full terms and conditions.
If eligible, patients may pay as little as $0 out-of-pocket (OOP) for RYTELO, which includes copay and coinsurance, up to $9450 annually.
If eligible, patients may save up to $100 per infusion, up to $1200 annually. Itemized explanation of benefits (EOB) must have separate line for OOP cost of administration.
How to apply for the REACH4RYTELO Copay Program
If you determine RYTELO is right for your patient, download the REACH4RYTELO Patient Enrollment Form or call 1-844-4RYTELO (1-844-479-8356).*
Complete the form with your patient and submit via fax or email.
Fax: 1-888-224-2518
Email: [email protected]
*The REACH4RYTELO Copay Program is not available to patients with any form of government insurance (such as Medicaid, Medicare, TRICARE, and VA). Patients must meet certain eligibility criteria to qualify for this program. Once enrolled, the patient may pay as low as $0 out-of-pocket for RYTELO with maximum benefit of $9450 per year for the cost of the drug and up to $100 per infusion cost of administration. An itemized explanation of benefits must be provided with a separate line for out-of-pocket cost of administration fee. Residents of MA, MI, MN, and RI are not eligible to receive copay assistance for product administration. If you have a question around your eligibility for the Copay Program, contact the patient support Hub at REACH4RYTELO at 1-844-479-8356.
All programs provided through REACH4RYTELO are subject to eligibility requirements. Geron reserves the right to modify or discontinue REACH4RYTELO at any time without notice.
View the Patient Copay Program Brochure
- Subject to the RYTELO Copay Program Terms and Conditions, this program provides the following financial assistance for the out-of-pocket (OOP) costs for eligible commercially insured patients with a Geron-determined valid prescription. The eligible patient pays as low as $0 OOP for up to $10,650 per calendar year, subject to the following detail:
- Up to a maximum of $9450 in cost-sharing assistance per calendar year with no monthly limit for the following product:
- RYTELO 47 mg and 188 mg for intravenous use
- Up to a maximum of $100 per infusion cost of administration per calendar year. An itemized explanation of benefits must be provided with a separate line for out-of-pocket cost of administration fee
- These copay benefits are subject to change for any reason at any time without notice
- Up to a maximum of $9450 in cost-sharing assistance per calendar year with no monthly limit for the following product:
Support for your patients to access RYTELO
1-844-4RYTELO Monday to Friday 8:00 AM-8:00 PMET
(Except major holidays)
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 at least 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
Based on animal findings, 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.