Allogeneic Processed Thymus Tissue Dosage

Usual Pediatric Dose for Congenital Athymia

Less than 18 years: 5,000 to 22,000 mm2 of tissue implant/m2 recipient body surface area (BSA) surgically implanted into the quadricep muscle.
Maximum dose: 22,000 mm2 of tissue implant/m2 recipient BSA.

Comments:

• Determine the dose based on the total surface area of this tissue implant and the recipient's BSA.
• Prior to surgical implantation, ensure that the tissue implant lot received is for the intended recipient.
• Involve a nephrologist in the care of patients with renal impairment.
• In patients with evidence of maternal engraftment or an elevated response to phytohemagglutinin (PHA), administer this tissue implant along with immunosuppressive medications.

Use: Immune reconstitution in pediatric patients with congenital athymia.

Renal Dose Adjustments

Dose adjustment may be required; however, no specific guidelines have been suggested. Caution recommended.

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS: None

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Administer the implant into the quadricep muscle in a single surgical session.
• Use the minimum number of tissue slices recommended by the manufacturer to achieve the minimum dose.
• Handle aseptically; do not use if there is evidence of contamination.
• In patients with an elevated T cell response, maternal engraftment or oligoclonal T cell expansion, as well as autoreactive T cells manifested by rash, lymphadenopathy, and/or diarrhea, immunosuppressants should be administered.
• The manufacturer's product information should be consulted.

Storage requirements:

• Store at room temperature. Do not refrigerate, freeze, agitate, or sterilize.
• Dispose of leftover tissues as biohazardous waste in accordance with local requirements.

Preparation technique:

• The manufacturer product information should be consulted.

General:

• This product is not indicated for the treatment of severe combined immunodeficiency (SCID).
• Patients using this product are at risk of developing graft versus host disease, autoimmune disorders, renal impairment, malignancy, cytomegalovirus infection, transmission of serious infections, and transmissible infectious diseases.

Monitoring:

• Hematologic: Monitor complete blood counts
• Renal: Serum creatinine

Patient advice:

• Exercise strict infection control measures until immune function has been reconstituted.
• Advise patients and caregivers to follow good handwashing practices, minimize contact with others, and report signs and symptoms of infection immediately.
• Notify healthcare professional to evaluate immune status prior to receiving vaccinations.
• Consult with a clinical geneticist prior to initiating therapy with this product.
• Risk of GVHD, autoimmune disorders, renal impairment, cytomegalovirus infection, malignancy, transmission of serious infections and transmissible infectious diseases have been reported with the use of this product.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer