Dosing

BREYANZI dosing¹

Jump to section:

For autologous use only as a single infusion product
Provided as a single-dose, one-time treatment
A single dose of BREYANZI contains 60 x 10⁶ to 120 × 10⁶CAR-positive viable T cells (consisting of CD4 and CD8 components at a ratio range from 0.8 to 1.2), with each component supplied separately in one to four single-dose vials
See the respective Certificate of Release for Infusion (RFI Certificate) for each component, for the actual cell counts and volumes to be infused

Dosing considerations¹

Do NOT infuse BREYANZI if the
information on the patient-specific
label does not match the intended
patient.

For intravenous use only; do NOT use a leukodepleting filter.

Do NOT irradiate BREYANZI.

Delay the infusion of BREYANZI if the patient has
unresolved serious events (including pulmonary events,
cardiac events, or hypotension), including those after
preceding chemotherapies, active uncontrolled infection
or inflammatory disorder, or active graft-versus-host
disease (GVHD).

Ensure that 2 doses of tocilizumab for use in the event of
cytokine release syndrome (CRS) and emergency
equipment are available per patient prior to infusion of
BREYANZI.

For complete dosing and administration information, please refer to the BREYANZI Product Monograph.

Back to top

PATIENT PREPARATION

Preparing patients for BREYANZI infusion¹

Confirm the availability of BREYANZI before starting lymphodepleting chemotherapy

Pre-treatment conditioning (lymphodepleting chemotherapy)

Administer the lymphodepleting chemotherapy regimen before infusion of BREYANZI: fludarabine 30 mg/m2/day and cyclophosphamide 300 mg/m2/day IV for 3 days
- See the Product Monographs for fludarabine and cyclophosphamide for information on dose adjustment in renal impairment
BREYANZI is to be administered 2 to 7 days after completion of lymphodepleting chemotherapy
Delay the infusion of BREYANZI if the patient has unresolved serious events (including pulmonary events, cardiac events, or hypotension), including those after preceding chemotherapies, active uncontrolled infection or inflammatory disorder, or active graft-versus-host disease (GVHD)

Pre-medication

To minimize the risk of infusion reactions, pre-medicate the patient with acetaminophen (650 mg orally) and diphenhydramine (25-50 mg, IV or orally), or another H1-antihistamine, approximately 30 to 60 minutes prior to treatment with BREYANZI
Avoid prophylactic use of systemic corticosteroids, as they may interfere with the activity of BREYANZI

For complete dosing and administration information, please refer to the BREYANZI Product Monograph.

IV: intravenous.

Back to top

RECEIPT OF BREYANZI

Receipt of BREYANZI shipment¹

BREYANZI is shipped directly to the cell associated lab or clinical pharmacy associated with the infusion centre in the vapour phase of a liquid nitrogen shipper
Confirm the patient’s identity with the patient identifiers on the shipper

If the patient is not expected to be ready for administration before the shipper expires:

And the infusion site is qualified for onsite storage, transfer BREYANZI to onsite vapour phase of liquid nitrogen storage prior to preparation.
And the infusion site is not qualified for onsite storage, contact Cell Therapy 360 at 1-855-999-0170 to arrange for return shipment.

For complete dosing and administration information, please refer to the BREYANZI Product Monograph.

Back to top