allogeneic processed thymus tissue (Rx)

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

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

Next:

Interactions

Interaction Checker

and allogeneic processed thymus tissue

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (0)

                  Minor (0)

                    Previous
                    Next:

                    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%)

                    Previous
                    Next:

                    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
                    Previous
                    Next:

                    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

                    Previous
                    Next:

                    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

                    Previous
                    Next:

                    Images

                    No images available for this drug.
                    Previous
                    Next:

                    Patient Handout

                    A Patient Handout is not currently available for this monograph.
                    Previous
                    Next:

                    Formulary

                    FormularyPatient Discounts

                    Adding plans allows you to compare formulary status to other drugs in the same class.

                    To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                    Adding plans allows you to:

                    • View the formulary and any restrictions for each plan.
                    • Manage and view all your plans together – even plans in different states.
                    • Compare formulary status to other drugs in the same class.
                    • Access your plan list on any device – mobile or desktop.

                    The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                    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.
                    3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                    4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                    5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                    6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                    NC NOT COVERED – Drugs that are not covered by the plan.
                    Code Definition
                    PA Prior Authorization
                    Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                    QL Quantity Limits
                    Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                    ST Step Therapy
                    Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                    OR Other Restrictions
                    Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
                    Additional Offers
                    Email to Patient

                    From:

                    To:

                    The recipient will receive more details and instructions to access this offer.

                    By clicking send, you acknowledge that you have permission to email the recipient with this information.

                    Email Forms to Patient

                    From:

                    To:

                    The recipient will receive more details and instructions to access this offer.

                    By clicking send, you acknowledge that you have permission to email the recipient with this information.

                    Previous
                    Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.