Lunsumio

4). It is important to check the product labels to ensure that the correct formulation (intravenous or subcutaneous fixed dose) is being administered to the patient, as prescribed. Lunsumio intravenous formulation is not intended for subcutaneous administration and should be administered via intravenous infusion only.

3 Posology Prophylaxis and premedication Lunsumio should be administered to well-hydrated patients. Table 1 provides details on recommended premedication for CRS and infusion related reactions. Table 1 Premedication to be administered to patients prior to Lunsumio infusion Patients requiring premedication Premedication Administration Cycles 1 and 2: all patients Cycles 3 and beyond: patients who experienced any grade CRS with previous dose Intravenous corticosteroids: dexamethasone 20 mg (preferred) or methylprednisolone 80 mg Complete at least 1 hour prior to Lunsumio infusion Anti-histamine: 50-100 mg diphenhydramine hydrochloride or equivalent oral or intravenous anti-histamine At least 30 minutes prior to Lunsumio infusion Anti-pyretic: 500-1000 mg paracetamol The recommended dose of Lunsumio for each 21 day-cycle is detailed in Table 2.

Day 8 2 mg Day 15 60 mg Cycle 2 Day 1 60 mg If the infusions were well-tolerated in Cycle 1, subsequent infusions of Lunsumio may be administered over 2 hours. Cycles 3 and beyond Day 1 30 mg Duration of treatment Lunsumio should be administered for 8 cycles, unless a patient experiences unacceptable toxicity or disease progression.

For patients who achieve a complete response, no further treatment beyond 8 cycles is required. For patients who achieve a partial response or have stable disease in response to treatment with Lunsumio after 8 cycles, an additional 9 cycles of treatment (17 cycles total) should be administered, unless a patient experiences unacceptable toxicity or disease progression.

Delayed or missed dose Table 3:

Recommendations for restarting therapy with Lunsumio intravenous infusion after dose delay Last dose administered Time since the last dose administered Action for next dose(s) 1 mg Cycle 1 Day 1 1 to 2 weeks Administer 2 mg (Cycle 1 Day 8), then resume the planned treatment schedule.

Greater than 2 weeks Repeat 1 mg (Cycle 1 Day 1), then administer 2 mg (Cycle 1 Day 8) and resume the planned treatment schedule. 4 Last dose administered Time since the last dose administered Action for next dose(s) 2 mg Cycle 1 Day 8 1 to 2 weeks Administer 60 mg (Cycle 1 Day 15), then resume the planned treatment schedule.

Summary of safety profile The adverse reactions described in this section were identified from the pivotal clinical trial GO29781 in patients treated at the recommended intravenous dose (n=218) and the recommended subcutaneous dose (n=139).

3%). The median number of cycles of Lunsumio intravenously received was 8 (range 1 -17), 37% of patients received 8 cycles, and 15% received more than 8 cycles up to 17 cycles. Patients who received the recommended intravenous dose (n=218) and subcutaneous (n=139) dose are pooled (n=357) for this safety population.

In this pooled safety population, the most common adverse reactions (≥ 20%) observed were cytokine release syndrome, neutropenia, rash and upper respiratory tract infection. The most common serious adverse reactions (≥ 2%) observed included cytokine release syndrome (CRS) (17% by ASTCT grading system), pyrexia (3%), sepsis (3%), upper respiratory tract infection (3%) and pneumonia (5%).

8% (21/357) of patients. 9%]). Tabulated list of adverse reactions The adverse reactions are listed below by MedDRA system organ class (SOC) and categories of frequency. Frequency categories are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 3%, and grade […]

Traceability In order to improve traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded. 8). Signs and symptoms included pyrexia, chills, hypotension, tachycardia, hypoxia, and headache.

Infusion related reactions may be clinically indistinguishable from manifestations of CRS. CRS events occurred predominantly in cycle 1 and were mainly associated with Day 1 and Day 15 dose administrations. 9 Patients should be premedicated with corticosteroids, antipyretics and antihistamines at least through cycle 2.

Patients must receive adequate hydration prior to the administration of Lunsumio. Patients should be monitored for signs or symptoms of CRS. Patients should be counselled to seek immediate medical attention should signs or symptoms of CRS occur at any time.

Physicians should institute treatment with supportive care, tocilizumab and/or corticosteroids as indicated. 2). 8). Febrile neutropenia was observed in patients after receiving Lunsumio infusion. Lunsumio should not be administered in the presence of active infections.

, chronic, active Epstein-Barr Virus), with underlying conditions that may predispose to infections or who have had significant prior immunosuppressive treatment. Patients should be administered prophylactic antibacterial, antiviral and/or antifungal medicinal products, as appropriate.

Patients should be monitored for signs and symptoms of infection, before and after Lunsumio administration, and treated appropriately. In the event of febrile neutropenia, patients should be evaluated for infection and managed with antibiotics, fluids and other supportive care, according to local guidelines.

Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) ICANS have occurred in patients receiving Lunsumio, including serious and life threatening reactions. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS.

1.