ELREXFIO SOLUTION FOR INJECTION 76 MG/1.9 ML

Pharmacia & Upjohn Company LLC (UNITED STATES)🇸🇬 Health Sciences Authority

Approval Date: Dec 31, 2024
Approval ID: 29993a21fc162630
Company: Pharmacia & Upjohn Company LLC (UNITED STATES)
Type: Therapeutic

Approval Details

Approval Id: 29993a21fc162630
Drug Name: ELREXFIO SOLUTION FOR INJECTION 76 MG/1.9 ML
Product Name: ELREXFIO SOLUTION FOR INJECTION 76 MG/1.9 ML
Approval Number: SIN17156P
Approval Date: 2024-12-31
Registrant: PFIZER PRIVATE LIMITED
Licence Holder: PFIZER PRIVATE LIMITED
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: INJECTION, SOLUTION
Dosage: 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). <img src="/TGIF/Elrexfio-Table1.png" alt="Elrexfio Dosage Table 1" /> 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): <ul> <li>paracetamol 500 mg orally (or equivalent)</li> <li>dexamethasone 20 mg orally or intravenously (or equivalent)</li> <li>diphenhydramine 25 mg orally (or equivalent)</li> </ul> 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. <img src="/TGIF/Elrexfio-Table2_030625.png" alt="Elrexfio Dosage 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. Supportive therapy for CRS (including but not limited to anti-pyretic agents, intravenous fluid support, vasopressors, IL-6 or IL-6 receptor inhibitors, supplemental oxygen, etc.) should be administered as appropriate. 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. <img src="/TGIF/Elrexfio-Table3_030625.png" alt="Elrexfio Dosage Table 3" /> 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. <img src="/TGIF/Elrexfio-Table4_071125.png" alt="Elrexfio Dosage Table 4" /> <img src="/TGIF/Elrexfio-Table5.png" alt="Elrexfio Dosage Table 5" /> 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.
Route Of Administration: SUBCUTANEOUS
Indication Info: 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.
Contraindications: 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.
Atc Code: L01FX32
Pharma Manufacturer Name: PFIZER PRIVATE LIMITED

Active Ingredients

Elranatamab

76 mg/1.9 ml

Elranatamab

76 mg/1.9 ml

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Dec 31, 2024

Approval ID

29993a21fc162630

Type

Therapeutic

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