Haematological Malignancies|Elrexfio®▼ Support & Resources

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Elrexfio®^▼(elranatamab) support & resources

Pfizer is committed to supporting physicians, patients and the Multiple Myeloma community through initiatives to advance science and innovation in the management of Multiple Myeloma, as well as appropriate patient education resources.

Elrexfio®▼(elranatamab) Patient Booklet

A patient information booklet intended for patients who receive Elranatamab.

Click here to access prescribing information for Elrexfio®▼(elranatamab)

PP-E1A-IRL-0013. Apr-24

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Elrexfio®▼(elranatamab) Pharmacy Guide

A shorter summary of the SmPC for pharmacy staff containing information around dosing, adverse events and storage.

Click here to access prescribing information for Elrexfio®▼(elranatamab)

PP-E1A-IRL-0014. Apr-24

Haemoassist®2 is an innovative haemophilia therapy management tool supporting patients with an intuitive smartphone app and website.
As well as providing patients with an electronic patient diary, Haemoassist®2 provides automatic documentation and analysis of patient treatment.

Download

HemMobile®

The HemMobile® App uses innovative tools and technologies to help your patients track their bleeds and infusions, and share consolidated reports with their healthcare team.

Find out more

Hemocraft™

Haemophilia meets Minecraft™! Introducing Hemocraft™, a virtual world for haemophilia patients that lets players craft infusion kits to stay prepared, get tips and resources, and share what they've learned.

Haemophilia meets Minecraft! Introducing Hemocraft™, a virtual world for haemophilia patients that lets you craft infusion kits to stay prepared, get tips and resources, and share what you've learned.

Find out more

Elrexfio®▼(elranatamab)Dosing & Administration Video

A shorter video summary of the SmPC information around dosing & administration.

Click here to access prescribing information for Elrexfio®▼(elranatamab)

PP-E1A-IRL-0015. Apr-24

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Elrexfio Safety Information

ELREXFIO®▼ (elranatamab) 40 mg/mL solution for injection - (IRELAND)
Please refer to the Summary of Product Characteristics (SmPC) before prescribing ELREXFIO.

Presentations: ELREXFIO is available in packs of 1 vial. The 1.1 mL vial contains 44 mg elranatamab. The 1.9 mL vial contains 76 mg of elranatamab.
Indications: ELREXFIO is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
Posology and method of administration: Treatment should be initiated and supervised by physicians experienced in the treatment of multiple myeloma and administered via subcutaneous injection by a healthcare professional adequately trained and with appropriate medical equipment to manage severe reactions, including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) (see SmPC sections 4.2 and 4.4). Recommended dosing schedule Due to the risk of CRS and ICANS, patients should be monitored for signs and symptoms for 48 hours after administration of each of the 2 step-up doses and instructed to remain within proximity of a healthcare facility. 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 day 1 of week 2 to week 24. For patients who have received at least 24 weeks of treatment and have achieved a response, the dosing interval should transition to an every two‑week schedule. The following pre-treatment medicinal products should be administered approximately 1 hour prior to the first three doses of ELREXFIO, which includes step-up dose 1, step-up dose 2, and the first full treatment dose to reduce the risk of CRS: paracetamol 500 mg orally (or equivalent), dexamethasone 20 mg orally or intravenously (or equivalent), diphenhydramine 25 mg orally (or equivalent). Prophylactic antimicrobials and anti-virals should be considered according to local institutional guidelines (see SmPC section 4.2).
If a dose is missed, the dose should be administered as soon as possible, and the dosing schedule should be adjusted to maintain the dosing interval as needed (see SmPC section 4.2 Table 1). Duration of treatment Treatment should be continued until disease progression or unacceptable toxicity. Special populations Elderly No dose adjustment is necessary (see SmPC sections 5.1 and 5.2). Renal impairment No dose adjustment is recommended in patients with mild to moderate renal impairment (estimated glomerular filtration rate [eGFR] > 30 mL/min/1.73 m²). Limited data are available from patients with severe renal impairment, see SmPC section 5.2. Hepatic impairment No dose adjustments are required for mild hepatic impairment (total bilirubin > 1 to 1.5 × ULN and any AST, or total bilirubin ≤ ULN and AST > ULN, see SmPC section 5.2). Paediatric population There is no relevant use of ELREXFIO in the paediatric population for the treatment of multiple myeloma.
Contraindications: Hypersensitivity to the active substance or to any of the excipients listed in SmPC section 6.1.
Special warnings and precautions for use Cytokine release syndrome (CRS) CRS, including life-threatening or fatal reactions, may occur in patients receiving ELREXFIO. At the first sign of CRS, ELREXFIO should be withheld and patients should be immediately evaluated for hospitalisation. CRS should be managed according to the recommendations listed in SmPC section 4.2, and further management should be considered per local institutional guidelines. Neurologic toxicities, including ICANS Serious or life-threatening neurologic toxicities, including ICANS, may occur following treatment with ELREXFIO (see SmPC section 4.8). At the first sign of neurologic toxicity, including ICANS, ELREXFIO should be withheld and neurology evaluation should be considered. Patients should be counselled to seek urgent medical attention should signs or symptoms of CRS or ICANS occur. Infections Severe, life-threatening, or fatal infections have been reported in patients receiving ELREXFIO (see SmPC section 4.8). Treatment should not be initiated in patients with active infections. Patients should be monitored for signs and symptoms of infection prior to and during treatment with ELREXFIO and treated appropriately. ELREXFIO should be withheld based on the severity of the infection as indicated for other non-haematologic adverse reactions (see SmPC section 4.2 Table 4). Prophylactic antimicrobials (e.g., prevention of pneumocystis jirovecii pneumonia) and anti-virals (e.g., prevention of herpes zoster reactivation) should be administered according to local institutional guidelines. Neutropenia and febrile neutropenia have been reported in patients receiving ELREXFIO Complete blood cell counts should be monitored at baseline and periodically during treatment. Treatment with ELREXFIO should be withheld as indicated in the SmPC section 4.2 Table 4. Patients with neutropenia should be monitored for signs of infection. Supportive therapy should be provided according to local institutional guidelines. Hypogammaglobulinaemia has been reported in patients receiving ELREXFIO Immunoglobulin levels should be monitored during treatment. Treatment with subcutaneous or intravenous immunoglobulin (IVIG) should be considered if IgG levels fall below 400 mg/dL and patients should be treated according to local institutional guidelines, including infection precautions and antimicrobial prophylaxis. Concomitant use of live viral vaccines The safety of immunisation with live viral vaccines during or following treatment with ELREXFIO has not been studied. Vaccination with live virus vaccines is not recommended within the 4 weeks prior to the first dose, during treatment, and at least 4 weeks after treatment.
Interaction with other medicinal products and other forms of interaction: No interaction studies have been performed with ELREXFIO. The highest risk of interaction is expected to occur during and up to 14 days after the step-up dosing as well as during and up to 14 days after CRS. During this time period, toxicity or medicinal product concentrations should be monitored in patients who are receiving concomitant sensitive CYP450 substrates with a narrow therapeutic index (e.g., cyclosporine, phenytoin, sirolimus, and warfarin). The dose of the concomitant medicinal product should be adjusted as needed.
Fertility, pregnancy and lactation: Women of child-bearing potential/Contraception The pregnancy status of women of child-bearing potential should be verified prior to initiating treatment with ELREXFIO. Women of child-bearing potential should use effective contraception during treatment with ELREXFIO and for 6 months after the last dose. Pregnancy Based on the mechanism of action, elranatamab may cause foetal harm when administered to a pregnant woman and therefore ELREXFIO is not recommended for use during pregnancy. ELREXFIO is associated with hypogammaglobulinaemia, therefore, assessment of immunoglobulin levels in newborns of mothers treated with ELREXFIO should be considered. Breast-feeding It is not known whether elranatamab is excreted in human or animal milk, affects breastfed infants or affects milk production. Human IgGs are known to be excreted in breast milk. A risk to the breastfed child cannot be excluded and therefore breast-feeding is not recommended during treatment with ELREXFIO and for 6 months after the last dose. Fertility There are no data on the effect of elranatamab on human fertility. Effects of elranatamab on male and female fertility have not been evaluated in animal studies.
Effects on ability to drive and use machines: ELREXFIO has major influence on the ability to drive and use machines. Due to the potential for ICANS, patients receiving ELREXFIO are at risk of depressed level of consciousness (see section Undesirable effects). Patients should be instructed to refrain from driving or operating heavy or potential dangerous machinery during and for 48 hours after completing each of the 2 step-up doses and in the event of new onset of neurologic toxicity until resolution of any neurological symptoms (see sections Posology and method of administration and Special warnings and precautions for use).
Undesirable effects: See SmPC for full details including detailed description of CRS and ICANS. The most frequent adverse reactions are CRS (57.9%), anaemia (54.1%), neutropenia (44.8%), fatigue (44.3%), upper respiratory tract infection (38.8%), injection site reaction (38.3%), diarrhoea (37.7%), pneumonia (37.2%), thrombocytopenia (36.1%), lymphopenia (30.1%), decreased appetite (26.8%), pyrexia (27.3%), rash (26.2%), arthralgia (25.1%), hypokalaemia (23.0%), nausea (21.3%), and dry skin (21.3%). Serious adverse reactions are pneumonia (30.6%), sepsis (15.3%), CRS (12.6%), anaemia (5.5%), upper respiratory tract infection (4.9%), urinary tract infection (3.3%), febrile neutropenia (2.7%), dyspnoea (2.2%), and pyrexia (2.2%).
Legal Category: S1A. Marketing Authorisation Number: EU/1/23/1770/001-002. Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium. For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at [email protected]. For queries regarding product availability please contact: Pfizer Healthcare Ireland, Pfizer Building 9, Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24 + 353 1 4676500.

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Refer to section 4.8 of the SPC for how to report adverse reactions.

Last revised: 12/2023
Ref: EA 1_0 IE

Legal Category: S1A
Further information is available upon request

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PP-UNP-IRL-0784. June 2024

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PP-UNP-IRL-0784. June 2024