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.

See also:

Further information

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

Medical Disclaimer