RETHYMIC- allogenic thymocyte-depleted thymus tissue-agdc implant

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALLOGENEIC THYMOCYTE-DEPLETED THYMUS TISSUE-AGDC (UNII: XD66YK3YY3) (ALLOGENEIC THYMOCYTE-DEPLETED THYMUS TISSUE-AGDC - UNII:XD66YK3YY3)

Available from:

Sumitomo Pharma America, Inc.

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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). None. Risk Summary There are no clinical data with RETHYMIC in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with RETHYMIC. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Risk Summary There is no information regarding the presence of cellular components of RETHYMIC in human milk, the effect breastfeeding may have on RETHYMIC, the effect of being breastfed from a mother who received RETHYMIC as a child, or the effects of RETHYMIC on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for RETHYMIC and potential adverse effects on the breastfed infant from RETHYMIC. No nonclinical or clinical studies were performed to evaluate the effects of RETHYMIC on fertility. The efficacy and safety of RETHYMIC have been established in pediatric patients with congenital athymia. The efficacy of RETHYMIC has been established in 95 pediatric patients (median age 9 months [range: 33 days to 3 years], including 65 patients age <1 year, 24 patients age 1 to <2 years, and 6 patients age 2 to <3 years at time of treatment) who were treated with RETHYMIC and included in the analysis of efficacy [see Clinical Studies (14) ]. The safety of RETHYMIC has been established in 105 pediatric patients (median age 9 months [range: 33 days to 16.9 years] at time of treatment) with congenital athymia who were evaluated for safety following RETHYMIC administration. The safety population included 65 patients age <1 year, 27 patients age 1 to <2 years, 9 patients age 2 to <3 years, 1 patient age 3 to <6 years, and 3 patients age 13 to 17 years at time of treatment. Within the safety population, survival was similar across age groups. Adverse reactions were reported at similar frequencies across the age groups and were generally of similar types and severities. In the clinical studies with RETHYMIC, 10 of 105 patients had impaired renal function at baseline based on elevated screening creatinine [see Warnings and Precautions (5.4)] . Baseline renal function should be considered when selecting immunosuppressants. Ensure appropriate involvement of a nephrologist in care of patients with renal impairment.

Product summary:

How Supplied Storage and Handling

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

RETHYMIC- ALLOGENIC THYMOCYTE-DEPLETED THYMUS TISSUE-AGDC IMPLANT
SUMITOMO PHARMA AMERICA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RETHYMIC SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RETHYMIC.
RETHYMIC (ALLOGENEIC PROCESSED THYMUS TISSUE–AGDC)
FOR SURGICAL IMPLANTATION
INITIAL U.S. APPROVAL: 2021
INDICATIONS AND USAGE
RETHYMIC is indicated for immune reconstitution in pediatric patients
with congenital athymia. (1)
Limitations of Use:
RETHYMIC is not indicated for the treatment of patients with severe
combined immunodeficiency
(SCID).
DOSAGE AND ADMINISTRATION
RETHYMIC is administered by a surgical procedure. The recommended dose
range is 5,000 to 22,000 mm
of RETHYMIC/m recipient body surface area (BSA). (2) Immunosuppressive
therapy is recommended for
patients receiving RETHYMIC based on disease phenotype and PHA levels.
(14)
DOSAGE FORMS AND STRENGTHS
RETHYMIC consists of yellow to brown slices of processed tissue with
varying thickness and shape. The
dosage is determined by the surface area of the RETHYMIC slices and
recipient BSA. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Immune reconstitution sufficient to protect from infection is unlikely
to develop prior to 6 to 12 months
after treatment with RETHYMIC. Given the immunocompromised condition
of athymic patients, infection
control measures should be followed until the development of thymic
function can be established. ( 5.1)
Monitor and treat patients at risk for the development of graft versus
host disease (GVHD). ( 5.2)
Monitor for the development of autoimmune disorders, including
complete blood counts with
differential, liver enzymes, serum creatinine, urinalysis, and thyroid
function. ( 5.3)
Pre-existing renal impairment is a risk factor for death. ( 5.4)
Pre-existing cytomegalovirus infection may result in death prior to
the development of thymic function.
( 5.5)
Monitor for the development of lymphoproliferative disorder (blood
cancer).