Afamitresgene Autoleucel Dosage

Medically reviewed by Drugs.com. Last updated on Sep 17, 2024.

Usual Adult Dose for Soft Tissue Sarcoma

2.68 x 10(9) to 10 x 10(9) melanoma-associated antigen A4 (MAGE-A4) T cell receptor positive T cells

Comments:

• This drug is provided as a single dose for infusion in one or more infusion bag(s). Verify the number of bags received for the indicated dose prior to preparation for infusion.
• Prior to infusion:
• Patient's identity should be verified
• A lymphodepleting regimen of cyclophosphamide and fludarabine should be administered
• Premedicate with acetaminophen and an H1-antihistamine

Use: For the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNING(S):
Cytokine Release Syndrome (CRS):
CRS, which may be severe or life-threatening, has been reported following administration of this drug. At the first sign of CRS, immediately evaluate patients for hospitalization and institute treatment with supportive care. Ensure that medications and resuscitative equipment is available on site prior to infusion of this drug to manage potential CRS.

CONTRAINDICATIONS:

• Adults who are heterozygous or homozygous for HLA-A*02:05P

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For autologous and intravenous use only.
• Verify the number of bags received for the indicated dose prior to preparation for infusion.
• Inspect the product for obvious signs of damage and contact Adaptimmune at 1-855-24MYADAP (1-855-246-9232) if any anomalies are identified at the time of receipt.
• Premedicate with an H1-antihistamine and acetaminophen according to institutional standard practice, approximately 30 to 60 minutes before administering infusion.
• Administer the product via intravenous infusion within one hour of thawing. Do not use a leukodepleting filter.
• Do not use prophylactic systemic corticosteroids, as it may interfere with the activity of this drug.
• Refer to the manufacturer product information for more information.

Storage requirements:

• This drug is supplied as a frozen suspension in infusion bag in the vapor phase of liquid nitrogen (minus 130 C or less).
• Store in the original packaging, in the vapor phase of liquid nitrogen at less than or equal to minus 130 C.
• May store this drug at room temperature (20 to 25 degrees Celsius) once it has been thawed.

Reconstitution/preparation techniques:

• Refer to the manufacturer product information for thawing and drug infusion preparation instructions.
• Employ universal precautions to avoid potential transmission of infectious diseases when handling this drug.

General:

• This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.
• Report suspected adverse reactions to Adaptimmune at 1-855-24MYADAP (1-855-246-9232) or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Monitoring:

• Hematologic: Blood counts (before and after)
• Hepatic: Screening for Epstein-Barr Virus, Cytomegalovirus, HBV, HCV, HIV any other infectious agents
• Hypersensitivity: Hypersensitivity reactions during infusion
• Immunologic: Signs/symptoms of cytokine release syndrome (at least 4 weeks after treatment)
• Infections/infestations: Signs/symptoms of infection
• Nervous system: Neurological events; Immune effector cell-associated neurotoxicity syndrome (ICANS) after treatment
• Oncologic: Secondary malignancies

Patient advice:

• Read the US FDA-approved patient labeling (Medication Guide).
• There is a risk of manufacturing or delivery failure, which may necessitate a second attempt to produce this product.
• Additional treatments beyond lymphodepletion might be required before this product is manufactured.
• After the infusion, daily monitoring of CRS will be needed for at least 7 days. Also, patients are advised to stay close to a healthcare facility for at least 4 weeks post-infusion.
• Seek immediate medical attention if symptoms of CRS, ICANS, bone marrow suppression, prolonged severe cytopenia, or Infections develop.
• If secondary malignancy occurs, contact Adaptimmune at 1-855-24MYADAP (1-855-246-9232).
• Refrain from driving or operating heavy or potentially dangerous machines for at least 4 weeks.

See also:

Further information

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

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