Treatment with IMDYLLTRA should be initiated and supervised by physicians experienced in the treatment of small cell lung cancer. 4). Posology Pre-treatment medicinal products should be administered prior to each dose of IMDYLLTRA on Day 1 and Day 8 of the dosing schedule (see below).
Recommended dosing Schedule The recommended dosage and schedule of IMDYLLTRA is an initial dose of 1 mg on Day 1 followed by 10 mg on Days 8, 15, and every 2 weeks thereafter as shown in Table 1. Table 1. IMDYLLTRA recommended dosage and schedule.
Dose of IMDYLLTRA Day 1 1 mg Day 8 10 mg Day 15 and every 2 weeks thereafter 10 mg Administer IMDYLLTRA as a 1-hour intravenous infusion in an appropriate healthcare setting. Ensure patients are well hydrated prior to administration of IMDYLLTRA.
Premedicate with dexamethasone 8 mg IV 1 hour prior to first two doses (Day 1 and Day 8). Consider IV fluids for patients after infusion of IMDYLLTRA (Day 1 and Day 8). Monitor patients during the infusion and for at least 16 hours after the first infusion (Day 1).
On Day 8, monitor patients for 6-8 hours post infusion and at subsequent infusions monitor patients for 2-4 hours post infusion at the discretion of the healthcare professional. On Day 1 and Day 8, recommend patients to remain within 1 hour of an appropriate healthcare setting, such as the treatment hospital, for 24 hours starting from each IMDYLLTRA infusion, accompanied by a caregiver.
Inform both the patient and the caregiver on the signs and symptoms of Cytokine Release Syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) prior to discharge. Duration of treatment Administer IMDYLLTRA until disease progression or unacceptable toxicity.
Dose modifications and Adverse Reaction Management If a dose of IMDYLLTRA is delayed because of an adverse event, therapy will be restarted based on the recommendations listed in Table 6. See Table 2 and Table 3 for recommended actions for the management of CRS and ICANS respectively and Table 4 for neutropenia and other adverse reactions.
Cytokine Release Syndrome (CRS) Diagnose CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. If CRS is suspected, manage according to the recommendations in Table 2. , hypotension not responsive to fluids, or hypoxia requiring supplemental oxygen) should be monitored for signs and symptoms of CRS including fever, hypotension and hypoxia using pulse oximetry or cardiac telemetry as indicated.
For severe or life- threatening CRS, recommend anti-IL-6 therapy, for example, tocilizumab and admission in an intensive-care unit (ICU) for supportive therapy. Table 2 provides the guidelines for grading and dosage modification and management of cytokine release syndrome.
Table 2. , fever ≥ 38°C without hypotension or hypoxia). Withhold IMDYLLTRA until event resolves, then resume IMDYLLTRA at the next scheduled doseb. , paracetamol) for fever. • Consider dexamethasonec 4 mg (or equivalent) to 10 mg PO or IV.
Grade 2 Symptoms require and respond to moderate intervention. Fever ≥38°C, Hypote Withhold IMDYLLTRA until event resolves, then resume IMDYLLTRA at the next scheduled • Recommend hospitalisation with monitoring for fever, hypotension and hypoxia using pulse oximetry or cardiac telemetry as indicated.
• Administer symptomatic CRS Grade Defining Symptoms IMDYLLTRA Dosage Modification Management nsion responsive to fluids not requiring vasopressors, and/or Hypoxi a requiring low flow nasal cannula or blow-by. doseb. , paracetamol) for fever.
• Administer supplemental oxygen and intravenous fluids when indicated. i • Consider tocilizumab (or equivalent). When resuming treatment at the next planned dose, monitor patients at the physician’s discretion in an appropriate healthcare settingb.
Grade 3 Severe symptoms defined as temperature ≥ 38°C with:
Haemo dynamic instability requiring a vasopressor (with or without vasopressin) or Worsen ing hypoxia or respiratory distress requiring high flow nasal canula (> 6 L/min oxygen) or face mask. Withhold IMDYLLTRA until the event resolves, then resume IMDYLLTRA at the next scheduled doseb.
For recurrent Grade 3 events, permanently discontinue IMDYLLTRA. , ICU care. • Administer dexamethasonec (or equivalent) 8 mg IV every 8 hours up to 3 doses. • Vasopressor support as needed. • High flow oxygen support as needed. • Recommend tocilizumab (or equivalent) • Prior to the next dose, administer concomitant medications as recommended for Day 1 and Day 8 (see Table 1).
When resuming treatment at the next planned dose, monitor patients at the physician’s discretion in an appropriate healthcare settingb. CRS Grade Defining Symptoms IMDYLLTRA Dosage Modification Management Grade 4 Life- threatening symptoms defined as temperature ≥38°C with: Haemo dynamic instability requiring multiple vasopressors (excluding vasopressin).
Worsen ing hypoxia or respiratory distress despite oxygen administration requiring positive pressure. Permanently discontinue IMDYLLTRA. • ICU care. • Grade 3 treatment. a CRS based on American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading (2019).
2, Table 5 for recommendations on restarting IMDYLLTRA after dose delays. c Taper […]