Miscellaneous immune disorders:
Indications for: RETHYMIC
Immune reconstitution in children with congenital athymia.
Limitations of Use:
Not for treating those with severe combined immunodeficiency.
Adult Dosage:
Not applicable.
Children Dosage:
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 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 Interactions:
Avoid concomitant prolonged immunosuppressives (eg, high-dose corticosteroids).
Adverse Reactions:
Hypertension, cytokine release syndrome, rash, hypomagnesemia, renal impairment/failure, thrombocytopenia, graft vs host disease.
Generic Drug Availability:
NO
How Supplied:
Single-dose unit—up to 42
