Rethymic Generic Name & Formulations
Thymus tissue–agdc (allogeneic processed); 4 slices in 5mL medium (fetal bovine serum).
Single-dose unit—up to 42
Immune reconstitution in children with congenital athymia.
Limitations of Use
Not for treating those with severe combined immunodeficiency.
Rethymic Dosage and Administration
See full labeling. Administered by surgical implantation into the quadriceps muscle. Dose is determined by total surface area of Rethymic slices, recipient BSA, and calculated by manufacturer. Dose range: 5000–22000mm2 of Rethymic/m2 recipient BSA. Max slices provided: 42 per patient.
Rethymic Boxed Warnings
Follow infection control measures, immunoprophylaxis, and monitor closely for fever; see full labeling. Graft vs host disease. Autoimmune disorders. Monitor CBCs with differential, liver enzymes, serum creatinine, urinalysis, thyroid function as indicated. Preexisting renal impairment or cytomegalovirus (CMV) infection. May develop post-treatment lymphoproliferative disorder; test for Epstein-Barr virus and CMV prior to and after treatment. Risk of transmitting serious infectious diseases and disease agents. Delay immunizations until immune-function criteria have been met; see full labeling. Screen for anti-HLA antibodies prior to initiation. Prior hematopoietic cell or solid organ transplantation; obtain HLA typing. Pregnancy. Nursing mothers.
Avoid concomitant prolonged immunosuppressives (eg, high-dose corticosteroids).
Rethymic Adverse Reactions
Hypertension, cytokine release syndrome, rash, hypomagnesemia, renal impairment/failure, thrombocytopenia, graft vs host disease.
Rethymic Clinical Trials
Rethymic Patient Counseling