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
The copay program
For eligible, commercially insured patients, the REACH4RYTELO Copay Program offers savings up to $10,650 per calendar year.* 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.
*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, including requirements related to the diagnosis for which the patient is receiving treatment and the patient’s insurance status. To enroll in the Copay Program, patients must first enroll in REACH4RYTELO. If eligible for the Copay Program, the patient may pay as little as $0 out-of-pocket for RYTELO with a maximum benefit of $9450 per year for the cost of the drug and a maximum benefit of $1200 per year for the cost of administration (up to $100 per infusion). An itemized EOB must be provided with a separate line for the out-of-pocket cost of administration fee. Residents of MA, MI, MN, and RI are not eligible to receive copay assistance for product administration and are therefore only eligible for a maximum benefit of $9450 per year for the cost of the drug. For Copay Program eligibility questions, contact a representative from REACH4RYTELO at 1-844-479-8356.
How the copay program works
If your patient would like to be assessed for copay program eligibility, the first step is for them to enroll in REACH4RYTELO. You can 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: Support@REACH4RYTELO.com
Once the patient has been enrolled in REACH4RYTELO, a Case Manager will evaluate their Copay Program eligibility.
All programs provided through REACH4RYTELO are subject to eligibility requirements. Geron reserves the right to modify or discontinue REACH4RYTELO at any time without notice.
These copay benefits are subject to change for any reason at any time without notice.
Call us at 1-844-4RYTELO for patient support resources.
Monday to Friday 8:00 AM-8:00 PM ET
(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 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.