allogeneic processed thymus tissue (Rx)

Brand and Other Names:Rethymic, allogeneic processed thymus tissue-agdc

Dosing & Uses

AdultPediatric

See Pediatric Dosing

Dosage Forms & Strengths

Supplied as a single-dose unit, ready for use as slices of processed thymus tissue, in sterile, polystyrene dishes (drug product dishes)

Each drug product dish contains up to 4 slices, adhered to circular filter membranes on top of surgical sponges in 5 mL of medium containing fetal bovine serum

Up to 42 slices are supplied according to the dosage calculated in advance by the manufacturer for the specific patient

Congenital Athymia

Indicated for immune reconstitution in pediatric patients with congenital athymia

Dosage determined by the surface area of the allogeneic processed thymus tissue slices and the recipient’s body surface area (BSA)

The dose is calculated in advance by the manufacturer for the specific patient

Recommended dose range: 5,000-22,000 mm2 of allogeneic processed thymus tissue surface area/m2 recipient BSA

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 elevated response to phytohemagglutinin (PHA) should also receive immunosuppressive medications

Dosing Considerations

Limitations of use

  • Not indicated for severe combined immunodeficiency

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Interactions

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                    Adverse Effects

                    >10%

                    Hypertension (19%)

                    Cytokine release syndrome (18%)

                    Hypomagnesemia (16%)

                    Rash (15%)

                    Renal impairment/failure (12%)

                    Thrombocytopenia (12%)

                    1-10%

                    Graft versus host disease (GVHD) (10%)

                    Neutropenia (9%)

                    Respiratory distress (8%)

                    Proteinuria (7%)

                    Pyrexia (6%)

                    Acidosis (6%)

                    Diarrhea (5%)

                    Seizure (5%)

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                    Warnings

                    Contraindications

                    None

                    Cautions

                    Preexisting renal impairment is a risk factor for death

                    Preexisting CMV infection may result in death before development of thymic function; benefits/risks of treatment should be considered prior to treating patients with preexisting CMV infection

                    Because of underlying immune deficiency, patients may be at risk of posttreatment lymphoproliferative disorder

                    Monitoring

                    • Monitor for development of autoimmune disorders, including complete blood cell counts with differential, liver enzymes, serum creatinine, urinalysis, and thyroid function
                    • Monitor complete blood counts with differential weekly for first 2 months post-treatment and then monthly through 12 months post-treatment
                    • Liver enzymes including aspartate aminotransferase and alanine aminotransferase, serum creatinine levels, and urinalysis should be performed monthly for 3 months and then every 3 months through 12 months post-treatment
                    • Thyroid function studies should be performed prior to treatment and then at 6 months and 12 months post-treatment; after 12 months, testing should be performed annually
                    • Patients should be tested for EBV and CMV using PCR prior to and 3 months following treatment, or after any exposure to or suspected infection with CMV or EBV
                    • If fever develops, assess patient by blood and other cultures and treat with antimicrobials as clinically indicated

                    Graft versus host disease

                    • Monitor and treat patients at risk of developing graft versus host disease (GVHD); risk factors include atypical complete DiGeorge anomaly phenotype, prior hematopoietic cell transplant, and maternal engraftment
                    • Patients with elevated baseline T-cell proliferative response to phytohemagglutinin (PHA) >5,000 cpm or >20-fold over background should receive immunosuppressive therapies to decrease risk of GVHD; development of GVHD symptoms should be closely monitored and promptly treated
                    • GVHD may manifest as fever, rash, lymphadenopathy, elevated bilirubin and liver enzymes, enteritis, and/or diarrhea

                    Infection control and immunoprophylaxis

                    • Immune reconstitution sufficient to protect from infection is unlikely to develop until 6-12 months after implantation; given the immunocompromised condition of athymic patients, follow infection control measures until the development of thymic function can be established
                    • Maintain on immunoglobulin until all following criteria met
                      • No longer on immunosuppression (≥10% of CD3+ T-cells are naïve in phenotype)
                      • ≥9 months posttreatment
                      • PHA response within normal limits
                      • Normal serum IgA is desirable but not required
                    • 2 months after stopping immunoglobulin, IgG trough level should be checked
                      • If IgG trough level is normal range for age, patient can remain off immunoglobulin replacement
                      • If IgG trough level is lower than normal range for age, restart immunoglobulin replacement therapy and continue for a year before being retested using the above guidelines
                    • Before and after treatment, maintain patient on Pneumocystis jirovecii pneumonia prophylaxis until all following criteria met
                      • No longer on immunosuppression (≥10% of CD3+ T-cells are naïve in phenotype)
                      • ≥9 months posttreatment
                      • PHA response within normal limits
                      • CD4+ T-cell count >200 cells/mm3

                    Transmission of serious infections and transmissible infections

                    • Transmission of infectious disease may occur because the implants are derived from human tissue
                    • Screen donors for increased risk of infection with HIV, human T-cell lymphotropic virus, HBV, HCV, Treponema pallidum, Trypanosoma cruzi, West Nile virus, transmissible spongiform encephalopathy agents, vaccinia, and Zika virus
                    • Screen donors screened for clinical evidence of sepsis and communicable disease risks associated with xenotransplantation (eg, CMV)

                    HLA

                    • Anti-HLA antibodies
                      • Screen for anti-HLA antibodies before treatment
                      • Patients testing positive for anti-HLA antibodies should receive allogeneic processed thymus tissue from a donor who does not express those HLA alleles
                    • HLA typing
                      • HLA matching required in patients who have received a prior hematopoietic cell transplantation (HCT) or a solid organ transplant
                      • Patients who have received a prior HCT are at increased risk of developing GVHD after allogeneic processed thymus tissue if the HCT donor did not fully match the recipient
                      • Minimize this risk by HLA matching to recipient alleles that were not expressed in the HCT donor

                    Immunizations

                    • Do no administer immunizations after implantation until immune-function criteria have been met
                    • Inactivated vaccines: May administer once all of the criteria are met
                      • Immunosuppressive therapies have been discontinued
                      • IgG replacement therapy has been discontinued
                      • Total CD4+ T-cell count >200 cells/mm3 and there are more CD4+ T cells than CD8+ T cells (CD4+ > CD8+)
                      • Limit inactivated vaccines to 2 vaccines/month
                    • Live vaccines
                      • Live virus vaccines should not be administered until patients have met the criteria for inactivated vaccines and received vaccinations with inactivated agents (eg, tetanus toxoid)
                      • No additional vaccines (live or inactivated), except the inactivated influenza vaccine, should be given within 6 months after vaccination with a measles-containing vaccine or within 2 months after the varicella vaccine
                      • Consider verifying response to vaccination with appropriate testing, in particular varicella and measles
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                    Pharmacology

                    Mechanism of Action

                    Allogeneic processed thymic tissue is intended to reconstitute immunity in patients who are athymic

                    Proposed mechanism of action involves migration of recipient T-cell progenitors from the bone marrow to the surgically implanted allogeneic thymic tissue slices, where they develop into naïve immunocompetent recipient T cells

                    The thymus is responsible for T-cell selection to fight infections; evidence of thymic function can be observed with the development of naïve T-cells in the peripheral blood; this is unlikely to be observed until 6-12 months after treatment surgical implantation

                    Congenital athymia is an ultra-rare condition in which children are born without a thymus, causing profound immunodeficiency, vulnerability to potentially fatal infections, and life-threatening immune dysregulation

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                    Administration

                    Implant Preparation

                    A manufacturing team assists the surgical team for the implantation procedure within the sterile field

                    Surgical Implantation

                    A qualified surgical team performs the surgical implantation in a single surgical session at a qualified hospital

                    Slices providing the prespecified dose are implanted in the quadriceps muscle in accordance with the instructions provided in prescribing information

                    Implantation into the quadriceps requires a healthy bed of muscle tissue

                    Storage

                    Store at room temperature in the polycarbonate container in the insulated shipping box until ready for use

                    Do not refrigerate, freeze, agitate, or sterilize

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                    Patient Handout

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                    Formulary

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                    Tier Description
                    1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                    2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
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                    4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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                    NC NOT COVERED – Drugs that are not covered by the plan.
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                    Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.