Administer ELREXFIO subcutaneously according to the step-up dosing schedule to reduce the incidence and severity of cytokine release syndrome (CRS).
Administer pre-treatment medications prior to each dose in the ELREXFIO step-up dosing schedule, which includes step-up dose 1, step-up dose 2, and the first treatment dose as recommended [see Dosage and Administration (2.2, 2.3)].
ELREXFIO should only be administered by a qualified healthcare professional with appropriate medical support to manage severe reactions such as CRS and neurologic toxicity, including ICANS [see Warnings and Precautions (5.1, 5.2)].
Due to the risk of CRS, patients should be hospitalized for 48 hours after administration of the first step-up dose, and for 24 hours after administration of the second step-up dose.
For subcutaneous injection only.
The recommended dosing schedule for ELREXFIO is provided in Table 1. The recommended dosages of ELREXFIO subcutaneous injection are: step-up dose 1 of 12 mg on Day 1, step-up dose 2 of 32 mg on Day 4, followed by the first treatment dose of 76 mg on Day 8, and then 76 mg weekly thereafter through week 24.
For patients who have received at least 24 weeks of treatment with ELREXFIO and have achieved a response [partial response (PR) or better] and maintained this response for at least 2 months, the dose interval should transition to an every two-week schedule.
Continue treatment with ELREXFIO until disease progression or unacceptable toxicity.
Administer pre-treatment medications prior to each dose in the ELREXFIO step-up dosing schedule, which includes step-up dose 1, step-up dose 2, and the first treatment dose as recommended [see Dosage and Administration (2.3)].
Step-up Dosing Schedule
Step-up dose 1
Step-up dose 2
First treatment dose
Weekly Dosing Schedule
One week after first treatment dose and weekly thereafter§ through week 24
Subsequent treatment doses
Biweekly (Every 2 Weeks) Dosing Schedule
*Responders only week 25 onward
Week 25 and every 2 weeks thereafter§
Administer the following pre-treatment medications approximately 1 hour before the first three doses of ELREXFIO in the step-up dosing schedule, which includes step-up dose 1, step-up dose 2, and the first treatment dose as described in Table 1 to reduce the risk of CRS [see Warnings and Precautions (5.1)]:
If a dose of ELREXFIO is delayed, restart therapy based on the recommendations listed in Table 2 and resume the dosing schedule accordingly [see Dosage and Administration (2.2)]. Administer pre-treatment medications as indicated in Table 2.
Last Dose Administered
Time Since the Last Dose Administered
Action for Next Dose
Step-up dose 1 (12 mg)
2 weeks or less (≤14 days)
Restart ELREXFIO at step-up dose 2 (32 mg).* If tolerated, increase to 76 mg 4 days later.
Greater than 2 weeks (>14 days)
Restart ELREXFIO step-up dosing schedule at step-up dose 1 (12 mg).*
Step-up dose 2 (32 mg)
Restart ELREXFIO at 76 mg.*
Greater than 2 weeks to less than or equal to 4 weeks (15 days to ≤28 days)
Restart ELREXFIO at step-up dose 2 (32 mg).* If tolerated, increase to 76 mg 1 week later.
Greater than 4 weeks (>28 days)
Any treatment dose (76 mg)
6 weeks or less (≤42 days)
Restart ELREXFIO at 76 mg.
Greater than 6 weeks to less or equal to 12 weeks (43 days to ≤84 days)†
Restart ELREXFIO at step-up dose 2 (32 mg).* If tolerated, increase to 76 mg 1 week later.
Greater than 12 weeks (>84 days)†
Dosage reductions of ELREXFIO are not recommended.
Dosage delays may be required to manage toxicities related to ELREXFIO [see Warnings and Precautions (5)]. Recommendations on restarting ELREXFIO after a dose delay are provided in Table 2.
See Table 3 and Table 4 for recommended actions for adverse reactions of CRS and ICANS, respectively. See Table 5 for recommended actions for neurologic toxicity excluding ICANS and Table 6 for recommended actions for other adverse reactions following administration of ELREXFIO. Consider further management per current practice guidelines.
Management of CRS, Neurologic Toxicity Including ICANS
Cytokine Release Syndrome (CRS)
Management recommendations for CRS are summarized in Table 3.
Identify CRS based on clinical presentation [see Warnings and Precautions (5.1)]. Evaluate and treat other causes of fever, hypoxia, and hypotension.
If CRS is suspected, withhold ELREXFIO until CRS resolves. Manage CRS according to the recommendations in Table 3 and consider further management per current practice guidelines. Administer supportive therapy for CRS, which may include intensive care for severe or life-threatening CRS. Consider laboratory testing to monitor for disseminated intravascular coagulation (DIC), hematology parameters, as well as pulmonary, cardiac, renal, and hepatic function.
Temperature ≥100.4 °F (38 °C)†
Temperature ≥100.4 °F (38 °C) with either:
Grade 3 (Recurrent)
Neurologic Toxicity Including ICANS
Management recommendations for ICANS and neurologic toxicity are summarized in Table 4 and Table 5.
At the first sign of neurologic toxicity, including ICANS, withhold ELREXFIO and consider neurology evaluation. Rule out other causes of neurologic symptoms. Provide supportive therapy, which may include intensive care, for severe or life-threatening neurologic toxicities, including ICANS [see Warnings and Precautions (5.2)]. Manage ICANS according to the recommendations in Table 4 and consider further management per current practice guidelines.
ICE score 7-9‡Or depressed level of consciousness§: awakens spontaneously.
ICE score 3-6‡Or depressed level of consciousness§: awakens to voice.
ICE score 0-2‡or depressed level of consciousness§: awakens only to tactile stimulus, or seizures§, either:
or raised intracranial pressure: focal/local edema on neuroimaging§
Grade 3 (recurrent)
ICE score 0‡Or, depressed level of consciousness§ either:
or seizures§, either:
or motor findings§:
or raised intracranial pressure/cerebral edema§, with signs/symptoms such as:
Neurologic Toxicity (excluding ICANS)
Grade 3 (First occurrence)
Hematologic Adverse Reactions
[see Warnings and Precautions (5.5)]
Absolute neutrophil count less than 0.5 x 109/L
Hemoglobin less than 8 g/dL
Platelet count less than 25,000/mcL
Platelet count between 25,000/mcL and 50,000/mcL with bleeding
Infections and Other Non-hematologic Adverse Reactions†
[see Warnings and Precautions (5.4, 5.6) and Adverse Reactions (6.1)]
ELREXFIO is intended for subcutaneous use by a healthcare provider only.
ELREXFIO should be administered by a healthcare provider with adequate medical personnel and appropriate medical equipment to manage severe reactions, including CRS and neurologic toxicity, including ICANS [see Warnings and Precautions (5.1, 5.2)].
ELREXFIO 76 mg/1.9 mL (40 mg/mL) vial and 44 mg/1.1 mL (40 mg/mL) vial are supplied as ready-to-use solution that do not need dilution prior to administration.
ELREXFIO is a clear to slightly opalescent, and colorless to pale brown liquid solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer if solution is discolored or contains particulate matter.
Use aseptic technique to prepare and administer ELREXFIO.
ELREXFIO vials are for one-time use in a single patient and do not contain any preservatives.
Prepare ELREXFIO following the instructions below (see Table 7) depending on the required dose. Use a 44 mg/1.1 mL (40 mg/mL) single-dose vial for step-up dose 1 or step-up dose 2.
Total Dose (mg)
Volume of Injection
Remove the appropriate strength ELREXFIO vial from refrigerated storage 2 °C to 8 °C (36 °F to 46 °F)]. Once removed from refrigerated storage, equilibrate ELREXFIO to ambient temperature [15 °C to 30 °C (59 °F to 86 °F)]. Do not warm ELREXFIO in any other way.
Withdraw the required injection volume of ELREXFIO from the vial into an appropriately sized syringe with stainless steel injection needles (30G or wider) and polypropylene or polycarbonate syringe material. Discard unused portion.
Inject the required volume of ELREXFIO into the subcutaneous tissue of the abdomen (preferred injection site). Alternatively, ELREXFIO may be injected into the subcutaneous tissue at other sites (e.g., thigh).
Do not inject into tattoos or scars or areas where the skin is red, bruised, tender, hard or not intact.
Storage of Prepared Syringe
If the prepared dosing syringe is not used immediately, store syringe between 2 °C (36 °F) to 30 °C (86 °F) for a maximum of 4 hours.
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