Understanding
supportive care

Protecting a child with congenital athymia from infection requires constant care and attention

Children with congenital athymia need special care to minimize the risk of life-threatening infections. One of the most important things that your child’s healthcare provider will discuss with you is isolation—both in the hospital and in the home.

Always talk to your child’s healthcare provider to create a plan that is right for you and your family. Some steps they may recommend are:

Limiting or restricting visitors in the home

Showering and changing clothes any time you leave and return home

Frequent handwashing

Working with healthcare providers to prevent exposure to sick people at medical appointments

Obtaining protective supplies like masks, gloves, and gowns

If possible, homeschooling other children in your family

It may not be possible for every family member to isolate.

Talk to your child’s immunologist about recommended practices to minimize the risk of infection outside the home. These may include:

Having a “sick plan” in place for when a member of your household feels ill. Make sure they have a place to go (such as staying with a friend or relative) until they are no longer contagious. Work with your child’s healthcare provider to come up with a plan if the primary caregiver becomes sick.

Educating everyone you know about congenital athymia. Make sure they understand the severity of the diagnosis and that special precautions and isolation are needed to protect your child.

Child with congenital athymia

A child with congenital athymia may be cared for by a team of healthcare providers

Your child’s team of pediatric clinicians and specialists may include but are not limited to:

  • Immunologists (for immune system disorders)
  • Endocrinologists (for thyroid and parathyroid functions)
  • Cardiologists (for heart conditions)
  • Otolaryngologists (for ear, nose, and throat conditions)
  • Geneticists (for genetic screenings)
  • Infectious disease specialists (for infections)
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RETHYMIC is the first and only FDA-approved tissue-based treatment for congenital athymia engineered to help children develop an immune system sufficient to fight infections.

Learn about RETHYMIC
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Find out how your child’s healthcare provider can begin the referral process.

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RETHYMIC Connect™ provides support and resources to children with congenital athymia and their caregivers.

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Indication and Important Safety Information
Important Safety Information

Infection Control: Immune reconstitution sufficient to protect from infection usually develops between 6-12 months after treatment with RETHYMIC. For some children, it may take up to 2 years. Taking medications that prevent infection and other infection control measures, such as hand washing and isolation, should be continued until your child’s doctor confirms that immune function has been reconstituted through immune tests and the criteria for discontinuing certain medications have been met. Immediately report signs and symptoms of infection, such as fever, to your child’s doctor.

Graft versus Host Disease (GVHD): RETHYMIC may cause or make pre-existing GVHD worse. Your child will be monitored for GVHD and treated if needed. Symptoms of GVHD may include fever, rash, swollen lymph nodes, inflammation of the digestive system, and/or diarrhea.

Autoimmune Disorders: Autoimmune-related side effects (when your immune system attacks healthy cells by mistake) occurred in patients treated with RETHYMIC. These included low platelets, white blood cells, or red blood cells; protein in the urine; hair loss; poor thyroid function; inflammation of the liver, joints, or spinal cord; loss of pigment in the skin, eyes and hair; overactive thyroid function; and loss of function of the ovaries. Your doctor will monitor your child regularly.

Kidney Disease: Children with kidney disease have a higher risk of death when treated with RETHYMIC.

Cytomegalovirus (CMV) Infection: In clinical studies, 4 out of 4 patients with CMV infection prior to treatment with RETHYMIC died.

Cancer: Due to your child’s weakened immune system, there is an increased risk of developing blood cancer. Your child’s doctor will monitor your child through testing for Epstein-Barr virus and CMV, which are two viruses that can cause cancer.

Transmission of Serious Infections and Transmissible Infectious Diseases: Because RETHYMIC is made from human tissue, and animal products are used in the manufacturing process, transmission of infectious diseases may occur.

Vaccine Administration: Notify your child’s doctor to evaluate your child’s immune status before receiving vaccinations. Live virus vaccines should not be given until the doctor determines that your child has met criteria for and received inactivated vaccines.

Anti-HLA Antibodies: Before receiving RETHYMIC, your child will be tested for HLA antibodies, which are proteins that may be present in your child’s blood. If your child has these antibodies, your child should receive RETHYMIC from a specific donor, which will be determined by your child’s doctor.

HLA Typing: If your child received a hematopoietic cell transplantation (HCT) or a solid organ transplant, testing to match your child with RETHYMIC from a compatible donor is required. Children who have received an HCT are at an increased risk of developing GVHD after RETHYMIC if the HCT donor does not fully match with RETHYMIC.

Deaths: Of the 105 children who participated in the clinical studies, 29 patients died, including 23 in the first year after implantation of RETHYMIC.

The most common side effects are high blood pressure, cytokine release syndrome, rash, low magnesium, decrease in kidney function, low platelets, and GVHD.

These are not all the possible side effects of RETHYMIC. Talk to your child’s doctor about any side effect that bothers your child or does not go away.

You are encouraged to report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch.

Indication

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

RETHYMIC is not for use in patients who have been diagnosed with severe combined immunodeficiency (SCID).

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Sumitomo Pharma 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 trademarks of Sumitomo Pharma Switzerland GmbH. © 2024 Sumitomo Pharma Switzerland GmbH. All rights reserved. RET-US-0380-24    11/2024