Quest for the right Drug
לאנסומיו LUNSUMIO (MOSUNETUZUMAB)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
תוך-ורידי : I.V
צורת מינון:
תרכיז להכנת תמיסה לאינפוזיה : CONCENTRATE FOR SOLUTION FOR INFUSION
עלון לרופא
מינוניםPosology התוויות
Indications תופעות לוואי
Adverse reactions התוויות נגד
Contraindications אינטראקציות
Interactions מינון יתר
Overdose הריון/הנקה
Pregnancy & Lactation אוכלוסיות מיוחדות
Special populations תכונות פרמקולוגיות
Pharmacological properties מידע רוקחי
Pharmaceutical particulars אזהרת שימוש
Special Warning עלון לרופא
Physicians Leaflet
Posology : מינונים
4.2 Posology and method of administration Lunsumio must only be administered under the supervision of a healthcare professional qualified in the use of anti-cancer therapies, in a setting with appropriate medical support to manage severe reactions such as cytokine release syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) (see section 4.4). 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 Administration premedication Intravenous corticosteroids: Complete at least 1 hour dexamethasone 20 mg or prior to Lunsumio infusion Cycles 1 and 2: all patients methylprednisolone 80 mg Anti-histamine: 50-100 mg At least 30 minutes prior to Cycles 3 and beyond: patients diphenhydramine hydrochloride or Lunsumio infusion who experienced any grade CRS equivalent oral or intravenous with previous dose anti-histamine Anti-pyretic: 500-1000 mg paracetamol The recommended dose of Lunsumio for each 21 day-cycle is detailed in Table 2. Table 2 Dose of Lunsumio for patients with relapsed or refractory follicular lymphoma Day of treatment Dose of Lunsumio Rate of infusion Cycle 1 Day 1 1 mg Infusions of Lunsumio in Cycle 1 should be Day 8 2 mg administered over a minimum of 4 hours. Day 15 60 mg Cycle 2 Day 1 60 mg If the infusions were well-tolerated in Cycles 3 and Day 1 30 mg Cycle 1, subsequent infusions of Lunsumio beyond may be administered over 2 hours. 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 If any dose in cycle 1 is delayed for > 7 days, the previous tolerated dose should be repeated prior to resuming the planned treatment schedule. If a dose interruption occurs between Cycles 1 and 2 that results in a treatment-free interval of ≥ 6 weeks, Lunsumio should be administered at 1 mg on Day 1, 2 mg on Day 8, then resume the planned Cycle 2 treatment of 60 mg on Day 15. If a dose interruption occurs that results in a treatment-free interval of ≥ 6 weeks between any Cycles in Cycle 3 onwards, Lunsumio should be administered at 1 mg on Day 1, 2 mg on Day 8, then resume the planned treatment schedule of 30 mg on Day 15. Dose modification Patients who experience grade 3 or 4 reactions (e.g. serious infection, tumour flare, tumour lysis syndrome) should have treatment temporarily withheld until symptoms are resolved (see section 4.4). CRS should be identified based on clinical presentation (see section 4.4). Patients should be evaluated and treated for, other causes of fever, hypoxia, and hypotension, such as infections/sepsis. Infusion related reactions (IRR) may be clinically indistinguishable from manifestations of CRS. If CRS or IRR is suspected, patients should be managed according to the recommendations in Table 3. Table 3 CRS grading1 and management CRS grade CRS management2 Next scheduled infusion of Lunsumio Grade 1 If CRS occurs during infusion: The symptoms should be • The infusion should be interrupted and resolved for at least 72 hours Fever ≥ 38ºC symptoms treated prior to next infusion • The infusion should be re-started at the same rate once the symptoms resolve The patient should be monitored more frequently • If symptoms recur with re-administration, the current infusion should be discontinued If CRS occurs post-infusion: • The symptoms should be treated If CRS lasts > 48 hours after symptomatic management: • Dexamethasone3 and/or tocilizumab4,5 should be considered Grade 2 If CRS occurs during infusion: The symptoms should be • The infusion should be interrupted and resolved for at least 72 hours Fever ≥ 38ºC symptoms treated prior to next infusion and/or hypotension • The infusion should be re-started at not requiring 50% the rate once the symptoms Premedication should be vasopressors resolve maximized as appropriate7 and/or hypoxia • If symptoms recur with re- requiring Consideration should be administration, the current infusion low-flow oxygen6 given to administration of the should be discontinued by nasal cannula next infusion 50% rate, with or blow-by more frequent monitoring of If CRS occurs post-infusion: the patient • The symptoms should be treated If no improvement occurs after symptomatic management: • Dexamethasone3 and/or tocilizumab4,5 should be considered Grade 3 If CRS occurs during infusion: The symptoms should be • The current infusion should be resolved for at least 72 hours Fever ≥ 38ºC discontinued prior to next infusion and/or hypotension • The symptoms should be treated requiring a Patients should be vasopressor • Dexamethasone3 and tocilizumab4, 5 hospitalized for the next (with or without should be administered infusion vasopressin) and/or If CRS occurs post-infusion: Premedication should be hypoxia requiring • The symptoms should be treated maximized as appropriate7 high • Dexamethasone3 and tocilizumab4, 5 flow oxygen8 by The next infusion should be should be administered nasal cannula, face administered at a 50% rate mask, If CRS is refractory to dexamethasone and non-rebreather tocilizumab: mask, or Venturi mask • Alternative immunosuppressants9 and methylprednisolone 1 000 mg/day intravenously should be administered until clinical improvement Grade 4 If CRS occurs during or post-infusion: • Treatment with Lunsumio should be permanently discontinued Fever ≥ 38ºC • The symptoms should be treated and/or hypotension • Dexamethasone3 and tocilizumab4, 5 should be administered requiring multiple vasopressors If CRS is refractory to dexamethasone and tocilizumab: (excluding vasopressin) • Alternative immunosuppressants9 and methylprednisolone and/or 1 000 mg/day intravenously should be administered until clinical hypoxia requiring improvement oxygen by positive pressure (e.g., CPAP, BiPAP, intubation and mechanical ventilation) 1 ASTCT = American Society for Transplant and Cellular Therapy. Premedication may mask fever, therefore if clinical presentation is consistent with CRS, please follow these management guidelines. 2 If CRS is refractory to management, consider other causes including hemophagocytic lymphohistiocytosis 3 Dexamethasone should be administered at 10 mg intravenously every 6 hours (or equivalent) until clinical improvement 4 In study GO29781, tocilizumab was administered intravenously at a dose of 8 mg/kg (not to exceed 800 mg per infusion), as needed for CRS management 5 If no clinical improvement in the signs and symptoms of CRS occurs after the first dose, a second dose of intravenous tocilizumab 8 mg/kg may be administered at least 8 hours apart (maximum 2 doses per CRS event). Within each time period of 6 weeks of Lunsumio treatment, the total amount of tocilizumab doses should not exceed 3 doses 6 Low-flow oxygen is defined as oxygen delivered at < 6 L/minute. 7 Refer to Table 1 for additional information 8 High-flow oxygen is defined as oxygen delivered at ≥ 6 L/minute 9 Riegler L et al. (2019) Special populations Elderly No dose adjustment of Lunsumio is required in patients ≥ 65 years of age (see section 5.2). Renal impairment Lunsumio has not been studied in patients with severe renal impairment. Dose adjustments are not considered necessary in patients with mild to moderate renal impairment based on pharmacokinetics (see section 5.2). Hepatic impairment Lunsumio has not been studied in patients with hepatic impairment. Dose adjustments are not considered necessary based on pharmacokinetics (see section 5.2). Paediatric population The safety and efficacy of Lunsumio in children and adolescents below 18 years of age have not yet been established. Method of administration Lunsumio is for intravenous use only. Lunsumio must be diluted using aseptic technique under the supervision of a healthcare professional. It should be administered as an intravenous infusion through a dedicated infusion line. Do not use an in- line filter to administer Lunsumio. Drip chamber filters can be used to administer Lunsumio. The first cycle of Lunsumio should be administered over a minimum of 4 hours as intravenous infusion. If the infusions are well-tolerated in cycle 1, the subsequent cycles may be administered over a 2-hours infusion. Lunsumio must not be administered as intravenous push or bolus. For instructions on dilution of the medicinal product before administration, see section 6.6.
שימוש לפי פנקס קופ''ח כללית 1994
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GENENTECH INC., USAבעל רישום
ROCHE PHARMACEUTICALS (ISRAEL) LTDרישום
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