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Rethymic (allogeneic processed thymus tissue-agdc) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to help restore immune function in children with congenital athymia. Congenital athymia is a rare condition in which a child is born without a working thymus gland.
Rethymic is processed thymus tissue. It helps rebuild immune function in children who are born without a working thymus.
The thymus helps the body make T cells. T cells are white blood cells that help fight infections. After Rethymic is implanted, early immune cells can move into the Rethymic tissue and develop into new T cells.
Doctors prescribe Rethymic when children with congenital athymia need immune reconstitution. This means rebuilding the body’s immune defenses.
Rethymic is given during surgery. A qualified surgical team implants it into the quadriceps muscle, which is the large muscle in the front of the thigh. This is usually done in one surgery at a qualified hospital.
The recommended dose of Rethymic is 5,000 to 22,000 square millimeters of tissue surface area for each square meter of the child’s body surface area.
The manufacturer calculates the dose before surgery for each child. Up to 42 Rethymic tissue slices may be provided. During surgery, the surgeon implants as many slices as possible within the recommended dose range.
This information is based on the prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.
In clinical studies of Rethymic for immune reconstitution in children with congenital athymia, the most common side effects occurred in about 10 percent to 19 percent of children treated. These include:
Rethymic can cause serious side effects that may require immediate medical attention. These include:
Get medical help right away if you think your child is having a serious reaction.
Sumitomo Pharma America, the manufacturer of Rethymic, offers the Rethymic Connect Commercial Co-Pay Program. Eligible individuals with commercial insurance may receive assistance with medication-related out-of-pocket costs for Rethymic.
The Rethymic Connect program also provides personalized support from a dedicated Support Liaison and Access Specialist. Support includes educational resources, help understanding insurance coverage and potential out-of-pocket costs, and connections to additional patient assistance resources that may offer financial support.
To learn more, visit Rethymic Connect or call 877-738-4962.
Before treatment with Rethymic, your child’s doctor will check for anti-HLA antibodies. These are immune proteins that may react to donor tissue.
Your child’s doctor will also test for Epstein-Barr virus (EBV) and CMV using PCR. PCR is a lab test that looks for signs of certain viruses.
Vaccines should not be given after Rethymic until the doctor confirms that certain immune-function criteria have been met.
Tell your child’s doctor if your child has any allergies to Rethymic or any of its ingredients.
Tell your child’s doctor about all medicines your child uses, especially medicines that affect the immune system.
Tell your child’s doctor about any infections, including CMV infection. The doctor will consider the risks and benefits before treatment.
These answers are fact-checked by our editorial staff.
How effective is Rethymic for congenital athymia?
In studies, Rethymic was evaluated in 95 children with congenital athymia. Estimated survival was 77 percent at one year and 76 percent at two years after treatment.
Among children who were alive one year after treatment, survival was 94 percent at a median follow-up of 10.7 years.
Infections decreased over time after treatment. In the first year, the number of children with an infection event from six to 12 months after treatment was 38 percent lower than in the first six months.
Naïve T cells also increased over the first year and stayed higher through year 2.
How long does Rethymic take to work for congenital athymia?
Rethymic does not work right away. Immune function strong enough to help protect against infection is unlikely before six to 12 months after treatment.
For some children, higher naïve T cell counts are not seen until two years after treatment.
What tests or monitoring are needed with Rethymic for congenital athymia?
Doctors monitor children after Rethymic to see if immune function has developed. This includes a blood test called flow cytometry.
Complete blood counts with a differential are checked weekly for the first two months after treatment. Then they are checked monthly through 12 months.
Liver enzymes, serum creatinine, and urinalysis are checked monthly for three months. Then they are checked every three months through 12 months. These tests help check the liver, kidneys, and urine.
Thyroid testing is done before treatment, at six months, at 12 months, and then once a year after that.
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