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Frequently asked questions

If you have more questions, please call 877-RETHYMC (877-738-4962). We're available Monday–Friday, 8:00 AM to 8:00 PM ET.

What is RETHYMIC Connect™?

RETHYMIC Connect is a program that helps children with congenital athymia and their caregivers by providing personalized support throughout the treatment journey. The RETHYMIC Connect care team consists of a Support Liaison and an Access Specialist, who can:
  • Provide you with educational resources about congenital athymia and treatment
  • Determine insurance coverage and out-of-pocket costs if your patients have a commercial plan, Medicare, or Medicaid
  • Insurance coverage and costs will be annually reverified
  • Identify and put caregivers in touch with other patient assistance resources that may provide financial support
Enrolling in RETHYMIC Connect will also give your patients and their caregivers access to kits containing a document organizer, a storybook written specifically with your patients in mind, activities for their whole family, and more! They will also receive informative digital newsletters and access to a webinar series.

How do patients and their caregivers enroll in RETHYMIC Connect?

To begin the enrollment process for RETHYMIC Connect, you can fill out the enrollment form. Follow the instructions on the form to complete it and send it back to RETHYMIC Connect.

Alternatively, caregivers can call 877-RETHYMC (877-738-4962) or complete the enrollment form with your help.

How do you protect the personal information that is submitted on the Patient Enrollment Form?

Privacy is important to us. To effectively work with your office on issues such as verifying insurance benefits and other needs, RETHYMIC Connect will need to access some of your patients' personal health information, information about their parent or guardian, insurance coverage, and other confidential information. RETHYMIC Connect handles personal health information in compliance with applicable laws and regulations, including HIPAA, and only for the purposes stated on the Patient Enrollment Form.

Once my patients are enrolled in RETHYMIC Connect, does this mean they're next for treatment?

Sumitomo Pharma America, Inc. does not make treatment decisions and enrollment does not have any impact on when your patients will be treated. The team at Duke Children's Hospital and you will determine if your patients are eligible for treatment and potential timing for treatment.

Once enrolled in RETHYMIC Connect, what support and assistance programs are available to patients and caregivers?

The RETHYMIC Connect care team consists of a Support Liaison and an Access Specialist, who can:
  • Provide caregivers with educational resources about congenital athymia and treatment
  • Determine insurance coverage and out-of-pocket costs if your patients have a commercial plan, Medicare, or Medicaid
  • Insurance coverage and costs will be annually reverified
  • Identify and put caregivers in touch with other patient assistance resources that may provide financial support
Enrolling in RETHYMIC Connect will also give your patients and their caregivers access to kits containing a document organizer, a storybook written specifically with your patients in mind, activities for their whole family, and more! They will also receive informative digital newsletters and access to a webinar series.

Is treatment available to uninsured or underinsured patients?

An Access Specialist can connect caregivers with financial assistance programs and charitable organizations that may help uninsured or underinsured patients.

Does income impact my patients' ability to receive treatment?

No, income has no bearing on treatment decisions. The decision for treatment is made with you and the team at the treatment center.
Indication and Important Safety Information
Important Safety Information

Infection Control and Immunoprophylaxis: Immune reconstitution sufficient to protect from infection is unlikely to develop prior to 6-12 months after treatment with RETHYMIC. Follow infection control measures until the development of thymic function is established as measured by flow cytometry. Closely monitor patients for signs of infection. If fever develops, assess the patient via lab results and treat as clinically indicated. Patients should be maintained on immunoglobulin replacement therapy (IgG) and Pneumocystis jirovecii pneumonia prophylaxis until specified criteria are met. IgG trough level should be checked 2 months after stopping IgG to determine whether the patient may remain off IgG.

Graft versus Host Disease (GVHD): RETHYMIC may cause or exacerbate pre-existing GVHD, for which patients should be closely monitored and treated. Risk factors include atypical complete DiGeorge anomaly phenotype, prior hematopoietic cell transplantation (HCT), and maternal engraftment. Patients with specified elevated baseline T cell proliferative response to PHA should receive immunosuppressants to decrease this risk. GVHD may manifest as fever, rash, lymphadenopathy, elevated bilirubin and liver enzymes, enteritis, and/or diarrhea.

Autoimmune Disorders: Autoimmune-related adverse events occurred in patients treated with RETHYMIC. These events included thrombocytopenia, neutropenia, proteinuria, hemolytic anemia, alopecia, hypothyroidism, autoimmune hepatitis, autoimmune arthritis, transverse myelitis, albinism, hyperthyroidism, and ovarian failure. Monitor complete blood counts with differential, liver enzymes, serum creatinine, urinalysis, and thyroid function.

Renal Impairment: Pre-existing renal impairment is a risk factor for death.

Cytomegalovirus Infection (CMV): In the clinical studies, 4 out of 4 patients with pre-existing CMV infection died.

Malignancy: Due to underlying immune deficiency, patients who receive RETHYMIC may be at risk of developing post-treatment lymphoproliferative disorder. Patients should be tested for Epstein-Barr virus and CMV prior to and 3 months after treatment or after any suspected exposure.

Transmission of Serious Infections and Transmissible Infectious Diseases: Transmission of infectious disease may occur because RETHYMIC is derived from human tissue, and product manufacturing includes porcine- and bovine-derived reagents.

Vaccine Administration: Immunizations should not be given in patients treated with RETHYMIC until immune-function criteria have been met. Live virus vaccines should not be given until patients have met the criteria for and received inactivated vaccines.

Anti-HLA Antibodies: All patients should be screened for anti-HLA antibodies prior to receiving RETHYMIC. Patients testing positive should receive RETHYMIC from a donor who does not express those HLA alleles.

HLA Typing: HLA matching is required in patients who have received a prior HCT or a solid organ transplant. Patients who have received a HCT are at increased risk of developing GVHD after RETHYMIC if the HCT donor does not fully match with RETHYMIC.

Deaths: Of the 105 patients in clinical studies, 29 patients died, including 23 deaths in the first year (<365 days) after implantation.

Adverse Reactions: The most common (>10%) adverse events included hypertension, cytokine release syndrome, rash, hypomagnesemia, renal impairment/failure, thrombocytopenia, and GVHD.

Indication

RETHYMIC® is indicated for immune reconstitution in pediatric patients with congenital athymia.

Limitations of Use: RETHYMIC is not indicated for the treatment of patients with severe combined immunodeficiency (SCID).

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Sumitomo Pharma icon is a trademark of Sumitomo Pharma Co., Ltd., used under license. SUMITOMO PHARMA is a trademark of Sumitomo Pharma Co., Ltd., used under license. SUMITOMO is a registered trademark of Sumitomo Chemical Co., Ltd., used under license. Sumitomo Pharma America, Inc. is a U.S. subsidiary of Sumitomo Pharma Co., Ltd. RETHYMIC®, RETHYMIC Connect™, and its logos are registered trademarks of Sumitomo Pharma Co., Ltd., used under license. © 2025 Sumitomo Pharma America, Inc. All rights reserved. RET-US-0052-25    10/2025