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Rethymic Generic Name & Formulations
Legal Class
Rx
General Description
Thymus tissue–agdc (allogeneic processed); 4 slices in 5mL medium (fetal bovine serum).
How Supplied
Single-dose unit—up to 42
Manufacturer
Generic Availability
NO
Rethymic Indications
Indications
Immune reconstitution in children with congenital athymia.
Limitations of Use
Not for treating those with severe combined immunodeficiency.
Rethymic Dosage and Administration
Adult
Not applicable.
Children
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 Contraindications
Not Applicable
Rethymic Boxed Warnings
Not Applicable
Rethymic Warnings/Precautions
Warnings/Precautions
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.
Rethymic Pharmacokinetics
See Literature
Rethymic Interactions
Interactions
Avoid concomitant prolonged immunosuppressives (eg, high-dose corticosteroids).
Rethymic Adverse Reactions
Adverse Reactions
Hypertension, cytokine release syndrome, rash, hypomagnesemia, renal impairment/failure, thrombocytopenia, graft vs host disease.
Rethymic Clinical Trials
See Literature
Rethymic Note
Not Applicable
Rethymic Patient Counseling
See Literature
