Afamitresgene autoleucel
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNING: CYTOKINE RELEASE SYNDROME Cytokine Release Syndrome (CRS), which may be severe or life-threatening, occurred in patients receiving TECELRA. At the first sign of CRS, immediately evaluate patient for hospitalization and institute treatment with supportive care. Ensure that healthcare providers administering TECELRA have immediate access to medications and resuscitative equipment to manage CRS [see Preparation and Administration (2.2) , and Warnings and Precautions (5.1) ] . WARNING: CYTOKINE RELEASE SYNDROME See full prescribing information for complete boxed warning. Cytokine Release Syndrome (CRS), which may be severe or life-threatening, occurred in patients receiving TECELRA.
At the first sign of CRS, immediately evaluate patient for hospitalization and institute treatment with supportive care. Ensure that healthcare providers administering TECELRA have immediate access to medications and resuscitative equipment to manage CRS ( 2.2 , 5.1 ).
Dosing in kidney impairment
Administer a lymphodepleting chemotherapy regimen of fludarabine 30 mg/m 2 /day intravenously for 4 days starting on the seventh day before TECELRA infusion (Day-7 to Day -4) and cyclophosphamide 600 mg/m 2 /day intravenously for 3 days starting the seventh day before TECELRA infusion (Day -7 to Day -5). Refer to fludarabine prescribing for information on fludarabine dosage in patients with renal impairment.
Preparation and administration
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Preparation and Administration Receipt of TECELRA Plan for TECELRA to arrive prior to beginning lymphodepleting chemotherapy. Ensure storage conditions in vapor phase of liquid nitrogen (≤ -130°C). TECELRA is shipped directly to the healthcare facility in the vapor phase of a liquid nitrogen shipper. Upon receipt of TECELRA confirm the patient's identifiers on the metal cassette and product bag.
Inspect the product for obvious signs of damage and contact 1-855-246-9232 if any anomalies are identified at the time of receipt. Transfer TECELRA in the original packaging, containing the cassette(s) protecting the infusion bag(s), to onsite storage at ≤ -130°C before the shipper expires. Store TECELRA in a manner that is consistent with How Supplied/Storage and Handling .
If unforeseen circumstances prevent proper storage of TECELRA consistent with How Supplied/Storage and Handling , contact 1-855-246-9232 to arrange for return shipment. Preparing Patient for TECELRA Administration Pretreatment Confirm availability of TECELRA at the healthcare facility prior to starting the lymphodepleting chemotherapy regimen.
Match the patient's identity with the patient identifiers on the TECELRA cassette(s) and infusion bag(s). Do not infuse TECELRA if the information on the patient-specific label(s) does not match the intended patient. Administer a lymphodepleting chemotherapy regimen of fludarabine 30 mg/m 2 /day intravenously for 4 days starting on the seventh day before TECELRA infusion (Day-7 to Day -4) and cyclophosphamide 600 mg/m 2 /day intravenously for 3 days starting the seventh day before TECELRA infusion (Day -7 to Day -5).
Refer to fludarabine prescribing for information on fludarabine dosage in patients with renal impairment. Short-acting or pegylated granulocyte-colony stimulating factor (G-CSF) may be administered at the discretion of the physician, and according with institutional standards, from 24 hours after last day of lymphodepleting chemotherapy (from Day -3) until resolution of neutropenia.
Premedication Premedicate with an H1-antihistamine and acetaminophen according to institutional standard practice, approximately 30-60 minutes prior to TECELRA infusion. Avoid prophylactic systemic corticosteroids, as it may interfere with the activity of TECELRA. Preparation of TECELRA for Administration Do not thaw the product until it is ready to be used.
Coordinate the timing of TECELRA thaw and infusion. Confirm infusion time in advance and adjust the start time of TECELRA thaw such that it will be available for infusion when the patient is ready. A TECELRA dose may be contained in one or more infusion bag(s). Verify the number of bags received for the indicated dose prior to preparation of TECELRA for infusion.
If more than one bag will be infused for the treatment dose, thaw and administer the contents of each infusion bag completely before proceeding to thaw and infuse the contents of the next infusion bag. 1. Confirm patient identity. Prior to TECELRA preparation, match the patient's identity with the patient identifiers on each TECELRA cassette.
Do not remove the TECELRA infusion bag(s) from the cassette(s) if the information on the patient-specific label does not match the patient's identity. Contact 1-855-246-9232 if there are any discrepancies between the labels and the patient identifiers. 2. Once patient identity is confirmed, remove TECELRA infusion bag(s) from the cassette(s) and check that the patient identifiers on the cassette label match the patient identifiers on the bag label.
Contact 1-855-246-9232 if there are any discrepancies between the patient identifiers on the cassette and bag labels. 3. Inspect the infusion bag for any breaches of container integrity such as breaks or cracks before thawing. If the bag is compromised, do not infuse the contents and call 1-855-246-9232. 4. Place the infusion bag inside a second sealable, preferably sterile bag per institutional standard practice. 5.
Thaw the infusion bag at approximately 37°C using a water bath or dry thaw method, until there is no visible ice in the infusion bag. 6. Gently mix the contents of the bag by massaging, to disperse visible cell clumps. Small clumps of cellular material should disperse with gentle manual massaging. Do not infuse TECELRA if clumps are not dispersed.
Call 1-855-246-9232. 7. Keep TECELRA at ambient temperature (20°C to 25°C) once thawed. Do not pre-filter into a different container, wash, spin down, or resuspend TECELRA in new media prior to infusion. 8. Administer within one hour. TECELRA Administration 9. Do not use a leukodepleting filter. 10. Follow universal precautions and local biosafety guidelines for handling and disposal of TECELRA to avoid potential transmission of infectious diseases, due to the presence of human blood cells that are genetically modified with replication incompetent, self-inactivating lentiviral vector. 11.
Confirm patient identity with the patient identifiers on the infusion bag(s). Do not infuse TECELRA if the information on the patient-specific label does not match the intended patient. Call 1-855-246-9232. Prime the tubing of the infusion set with 0.9% sodium chloride solution prior to infusion. 12. Administer the TECELRA infusion bag via intravenous infusion within one hour.
Administer the entire contents of the TECELRA infusion bag. 13. After the entire contents of the TECELRA infusion bag are infused, rinse the infusion bag with approximately 50mL 0.9% sodium chloride solution to ensure all product is delivered. 14. If more than one infusion bag has been received, administer the content of each infusion bag completely before proceeding to thaw and infuse the content of the next infusion bag, following steps 1-14 for all subsequent infusion bags.
Drug interactions
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None
Contraindications
4 CONTRAINDICATIONS DO NOT use TECELRA in patients who are heterozygous or homozygous for HLA-A*02:05P. DO NOT use TECELRA in patients who are heterozygous or homozygous for HLA-A*02:05P ( 4 ).
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are limited available data with TECELRA use in pregnant women. In the SPEARHEAD-1 clinical trial, there were two pregnancies in patients treated with TECELRA. One patient became pregnant 6 months following treatment with TECELRA and the outcome of this pregnancy was premature birth (30 weeks gestation) with healthy infant. A second patient was found to be pregnant two months following treatment with TECELRA and the pregnancy was electively terminated. No animal reproductive and developmental toxicity studies have been conducted with TECELRA to assess whether it can cause fetal harm when administered to a pregnant woman.
It is not known if TECELRA has the potential to be transferred to the fetus and cause fetal toxicity. Therefore, TECELRA is not recommended for women who are pregnant, and pregnancy after TECELRA administration should be discussed with the treating physician. Report all pregnancies following treatment with TECELRA to 1-855-246-9232. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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