RETHYMIC 22000 mm/1
allogenic thymocyte-depleted thymus tissue-agdc · IMPLANT · Sumitomo Pharma America, Inc.
RETHYMIC is a implant containing allogenic thymocyte-depleted thymus tissue-agdc at 22000 mm/1, taken intramuscular. Manufactured by Sumitomo Pharma America, Inc..
Key Facts
- Brand Name
- RETHYMIC
- Generic Name
- allogenic thymocyte-depleted thymus tissue-agdc
- NDC Code (Product)
72359-001- Manufacturer
- Sumitomo Pharma America, Inc.
- Strength
- 22000 mm/1
- Dosage Form
- IMPLANT
- Route
- INTRAMUSCULAR
- Marketing Status
- Application #
- BLA125685
- Marketing Start
- 10/08/2021
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE RETHYMIC ® is indicated for immune reconstitution in pediatric patients with congenital athymia. 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). Limitations of Use RETHYMIC is not indicated for the treatment of patients with severe combined immunodeficiency (SCID).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION RETHYMIC is administered by a surgical procedure. The recommended dose range is 5,000 to 22,000 mm 2 of RETHYMIC/m 2 recipient body surface area (BSA). (2) Immunosuppressive therapy is recommended for patients receiving RETHYMIC based on disease phenotype and PHA levels. ( 14 ) 2.1 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 mm 2 of RETHYMIC surface area/m 2 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 …
Contraindications
4 CONTRAINDICATIONS None. None.
Drug Interactions
7 DRUG INTERACTIONS No drug interaction studies have been conducted with RETHYMIC. If possible, prolonged use of immunosuppressive therapies, including high-dose corticosteroids, should be avoided.
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions (incidence in at least 10% of patients) reported following administration of RETHYMIC were hypertension (high blood pressure), cytokine release syndrome, rash, hypomagnesemia (low magnesium), renal impairment / failure (decrease of kidney function), thrombocytopenia (low platelets), and graft versus host disease. The most common (>10%) adverse events related to RETHYMIC included: hypertension (high blood pressure, 19%), cytokine release syndrome (18%), rash (15%), hypomagnesemia (low magnesium, 16%), renal impairment / failure (decrease of kidney function, 12%), thrombocytopenia (low platelets, 12%), and graft versus host disease, (10%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sumitomo Pharma America at 833-369-9868 or FDA at 1-800-FDA-1088 or https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed…
Frequently Asked Questions
What is RETHYMIC used for?
RETHYMIC contains allogenic thymocyte-depleted thymus tissue-agdc. It is a implant taken intramuscular. Consult your doctor for specific uses.
Is RETHYMIC a controlled substance?
RETHYMIC is not classified as a controlled substance by the DEA.
What is the generic name for RETHYMIC?
The generic name for RETHYMIC is allogenic thymocyte-depleted thymus tissue-agdc. There are no other listed brand versions of allogenic thymocyte-depleted thymus tissue-agdc.
What is the NDC code for RETHYMIC 22000 mm/1?
The NDC (National Drug Code) for RETHYMIC 22000 mm/1 is 72359-001, listed by Sumitomo Pharma America, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)