Rethymic

Generic name: allogenic thymocyte-depleted thymus tissue-agdc
Dosage form: implant

Medically reviewed by Drugs.com. Last updated on Oct 1, 2021.

Indications and Usage for Rethymic

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

Limitations of Use

• Rethymic is not indicated for the treatment of patients with severe combined immunodeficiency (SCID).

Rethymic Dosage and Administration

Dosage

Rethymic is administered by a surgical procedure. The dosage is determined by the total surface area of the Rethymic slices and recipient body surface area (BSA). A Rethymic slice is defined as the contents on a single filter membrane; the Rethymic slices are variable in size and shape. The recommended dose range is 5,000 to 22,000 mm2 of Rethymic surface area/m2 recipient BSA. The manufacturer calculates the dose in advance for the specific patient; the amount of product provided is adjusted at the manufacturing facility to ensure the maximum dose for the patient cannot be exceeded. Up to 42 cultured Rethymic slices will be provided for each patient. At the time of surgery, the manufacturing personnel communicate to the surgical team the portion of the product that represents the minimum dose. Patients with evidence of maternal engraftment or an elevated response to phytohemagglutinin (PHA) should receive Rethymic with immunosuppressive medications (Table 2).

Administration Instructions

Surgical implantation of Rethymic should be done by a qualified surgical team in a single surgical session at a qualified hospital. Rethymic should be implanted in the quadriceps muscle in accordance with the instructions provided below. Implantation of Rethymic into the quadriceps requires a healthy bed of muscle tissue.

Preparation for the Implantation Procedure:

1. Operating room culture dishes (sterile 100 mm tissue culture dishes) and saline for injection are supplied by the operating room; a sufficient supply of operating room culture dishes and saline mu...