Tepkinly:
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      • This website is for Israeli Healthcare Professionals only.

       

      The first‑and‑only subcutaneous T‑Cell therapy

       

      The first‑and‑only subcutaneous T‑Cell therapy

      TEPKINLY DOSING AND ADMINISTRATION

      The potential for ongoing tumour suppression and surveillance with a monthly maintenance dosing schedule

      0.16 mg is a priming dose, 0.8 mg is an intermediate dose, and 48 mg is a full dose 

      • TEPKINLY should be administered until disease progression or unacceptable toxicity 
      • TEPKINLY should be administered to adequately hydrated patients
      • At least 1 dose of tocilizumab for use in the event of CRS should be available prior to TEPKINLY for cycle 1. Access to an additional dose of tocilizumab within 8 hours of use of the previous tocilizumab dose should be available

       

      Patients should be monitored for signs and symptoms of CRS and/or immune effector cell-associated neurotoxicity syndrome (ICANS) following epcoritamab administration. Patients should be hospitalised for 24 hours after administration of the Cycle 1 Day 15 dose of 48 mg to monitor for signs and symptoms of CRS and/or ICANS. Patients should be counselled on the signs and symptoms associated with CRS and ICANS and on seeking immediate medical attention should signs or symptoms occur at any time.

       

      A 1-mL SC injection*

      • Dosing every 2 weeks after cycle 3 (28-day cycle)
      • Dosing every 4 weeks after cycle 10

      *“Quick” is corroborated by the significantly faster administration with subcutaneous dosing as compared with IV alternatives.

      The TEPKINLY EPCORE™ NHL-1 clinical trial was designed to mitigate T-cell engager–induced cytokine release
      • TEPKINLY should be administered to adequately hydrated patients
      • Patients should be monitored for signs and symptoms of CRS and/or ICANS following TEPKINLY administration
      • Patients should be hospitalised for 24 hours after administration of the cycle 1, day 15 dose of 48 mg to monitor for signs and symptoms of CRS and/or ICANS
      • Patients should be counselled on the signs and symptoms associated with CRS and ICANS and on seeking immediate medical attention should signs or symptoms occur at any time

       

      Premedication can be taken at home orally prior to weekly TEPKINLY administration

       

      CyclePatient requiring premedicationPremedicationAdministration
      Cycle 1All patientsDexamethasone 15 mg† or prednisolone 100 mg† or equivalent
      • 30-120 minutes prior to each weekly administration of TEPKINLY
      • And for 3 consecutive days following each weekly administration of TEPKINLY in cycle 1
       
      		 
      • Diphenhydramine 50 mg† or
      • Paracetamol 650 to 1000 mg†
      • 30-120 minutes prior to each weekly administration of TEPKINLY

      Cycle 2 and beyond

      		Patients who experienced grade 2 or 3a CRS with previous doseDexamethasone 15 mg† or prednisolone 100 mg† or equivalent
      • 30-120 minutes prior to next administration of TEPKINLY after a grade 2 or 3a CRS event
      • And for 3 consecutive days following the next administration of TEPKINLY until TEPKINLY is given without subsequent CRS of grade 2 or higher

       

      At least 1 dose of tocilizumab for use in the event of CRS should be available prior to TEPKINLY for cycle 1.
      Access to an additional dose of tocilizumab within 8 hours of use of the previous tocilizumab dose should be available.

      Patients will be permanently discontinued from Tepkinly after a grade 4 CRS event

      For guidance on monitoring and management of CRS, ICANS, and serious infections, please refer to https://israeldrugs.health.gov.il.

      *Patients who experienced grade 2 or 3 CRS with previous dose.

      †Oral or intravenous.

      CRS=cytokine release syndrome; ICANS=immune effector cell-associated neurotoxicity syndrome; NHL=non-Hodgkin lymphoma.

      Guidance following a missed or delayed dose

      A re-priming cycle (identical to cycle 1 with standard CRS prophylaxis) is required: 

      • If there are more than 8 days between the priming dose (0.16 mg) and intermediate dose (0.8 mg), or 
      • If there are more than 14 days between the intermediate dose (0.8 mg) and first full dose (48 mg), or 
      • If there are more than 6 weeks between full doses (48 mg).

      After the re-priming cycle, the patient should resume treatment with day 1 of the next planned treatment cycle (subsequent to the cycle during which the dose was delayed).

       

      CyclePatient requiring premedicationPremedication
      Cycle 1All patientsPrednisolone 100 mg or dexamethasone 15 mg or equivalent†
       
      		 
      • Diphenhydramine 50 mg† or
      • Paracetamol 650 to 1000 mg†

      Cycle 2 and beyond

      		Patients who experienced grade 2 or 3a CRS with previous dosePrednisolone 100 mg† or dexamethasone 15 mg† or equivalent

       

      CyclePatient requiring premedicationAdministration
      Cycle 1All patients
      • 30-120 minutes prior to each weekly administration of TEPKINLY
      • And for 3 consecutive days following each weekly administration of TEPKINLY in cycle 1
       
      		 
      • 30-120 minutes prior to each weekly administration of TEPKINLY

      Cycle 2 and beyond

      		Patients who experienced grade 2 or 3a CRS with previous dose
      • 30-120 minutes prior to next administration of TEPKINLY after a grade 2 or 3a CRS event
      • And for 3 consecutive days following the next administration of TEPKINLY until TEPKINLY is given without subsequent CRS of grade 2 or higher

       

      At least 1 dose of tocilizumab for use in the event of CRS should be available prior to TEPKINLY for cycle 1.
      Access to an additional dose of tocilizumab within 8 hours of use of the previous tocilizumab dose should be available.

      Patients will be permanently discontinued after a grade 4 CRS event.

      For guidance on monitoring and management of CRS, ICANS, and serious infections, please refer to the full Prescribing Information.

      *Patients who experienced grade 2 or 3 CRS with previous dose.

      †Oral or intravenous.

      CRS=cytokine release syndrome; ICANS=immune effector cell-associated neurotoxicity syndrome; NHL=non-Hodgkin lymphoma.

      Guidance following a missed or delayed dose

      A re-priming cycle (identical to cycle 1 with standard CRS prophylaxis) is required:

      • If there are more than 8 days between the priming dose (0.16 mg) and intermediate dose (0.8 mg), or
      • If there are more than 14 days between the intermediate dose (0.8 mg) and first full dose (48 mg), or
      • If there are more than 6 weeks between full doses (48 mg).

      After the re-priming cycle, the patient should resume treatment with day 1 of the next planned treatment cycle (subsequent to the cycle during which the dose was delayed).

       

      Download the Dosing and Administration Guide for more information on how TEPKINLY is administered.

      DOWNLOAD HERE

      References:

      1. Tepkinly prescribing information 

       

       

      IL-EPCOR-240017. Date of preparation: July 2024.

       

       

      SCHEDULING TOOL

       

       

      Tepkinly PI – 4mg/0.8ml
      Tepkinly PI – 48 mg