ELREXFIO SOLUTION FOR INJECTION 76 MG/1.9 ML [SIN17156P]

Product Info

ELREXFIO SOLUTION FOR INJECTION 76 MG/1.9 ML

[SIN17156P]

4.1. Therapeutic indications

ELREXFIO is a B-cell maturation antigen (BCMA)-directed and CD3-directed bispecific antibody indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

4.2. Posology and method of administration

Treatment with ELREXFIO should be initiated and supervised by physicians experienced in the treatment of multiple myeloma.

ELREXFIO should be administered by a healthcare provider with adequately trained medical personnel and appropriate medical equipment to manage severe reactions, including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Posology

Recommended dosing schedule
The recommended dosing schedule for ELREXFIO is provided in Table 1. The recommended doses of ELREXFIO subcutaneous (SC) injection are step-up doses of 12 mg on Day 1 and 32 mg on Day 4 followed by a full treatment dose of 76 mg weekly, from Week 2 to Week 24.

For patients who have received at least 24 weeks of treatment with ELREXFIO and have achieved a response, the dosing 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 the first three doses of ELREXFIO in the dosing schedule, which includes Step-up dose 1 (12 mg), Step-up dose 2 (32 mg), and the first full treatment dose (76 mg) as described in Table 1 (see below).

Administer ELREXFIO subcutaneously according to the step-up dosing schedule in Table 1 to reduce the incidence and severity of CRS and ICANS. Due to the risk of CRS and ICANS, monitor patients for signs and symptoms for 48 hours after administration of each of the 2 step-up doses within the ELREXFIO dosing schedule and instruct patients to remain within proximity of a healthcare facility (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Missed doses
If a dose of ELREXFIO is missed, administer the dose as soon as possible, and adjust the dosing schedule as needed to maintain the dosing interval (see Table 1).

Recommended pre-treatment medications
Administer the following pre-treatment medications approximately 1 hour before the first three doses of ELREXFIO in the dosing schedule, which includes Step-up dose 1, Step-up dose 2, and the first full treatment dose as described in Table 1 to reduce the risk of CRS (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information):

• paracetamol (or equivalent) 500 mg orally

• dexamethasone (or equivalent) 20 mg orally or intravenously

• diphenhydramine (or equivalent) 25 mg orally

Restarting ELREXFIO after dosage delay

If a dose of ELREXFIO is delayed, therapy should be restarted based on the recommendations listed in Table 2 and ELREXFIO resumed according to the dosing schedule (see Table 1). Pre-treatment medications should be administered as indicated in Table 2.

Dosage modifications for adverse reactions

Dosage reductions of ELREXFIO are not recommended.

Dosage delays may be required to manage toxicities related to ELREXFIO (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Recommendations on restarting ELREXFIO after a dose delay are provided in Table 2.

See Tables 3 and 4 for recommended actions for adverse reactions of CRS and ICANS, respectively.
See Table 5 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 summarised in Table 3.

Identify CRS based on clinical presentation (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 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), haematology parameters, as well as pulmonary, cardiac, renal, and hepatic function.

Neurologic toxicity, including ICANS
Management recommendations for ICANS are summarised in Table 4.

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 section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Manage ICANS according to the recommendations in Table 4 and consider further management per current practice guidelines.

Special populations

Elderly (65 years of age and older)
No dose adjustment is necessary (see sections 5.1 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment
No dose adjustment is recommended in patients with mild to moderate renal impairment. ELREXFIO has not been studied in patients with severe renal impairment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment
No dose adjustments are required for mild hepatic impairment. The effects of moderate to severe hepatic impairment on the pharmacokinetics of elranatamab have not been studied (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population
There is no relevant use of ELREXFIO in the paediatric population (below 18 years of age) for the treatment of multiple myeloma.

Method of administration

ELREXFIO is for subcutaneous injection only.

For instructions on handling of the medicinal product before administration, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.