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TEPKINLY DOSING AND ADMINISTRATION

The potential for ongoing tumour suppression and surveillance with a monthly maintenance dosing schedule1,2

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 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.2

 

A quick 1-mL SC injection1,2*

  • 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.3

The TEPKINLY EPCORE™ NHL-1 clinical trial was designed to mitigate T-cell engager–induced cytokine release4

  • TEPKINLY should be administered to adequately hydrated patients2
  • Patients should be monitored for signs and symptoms of CRS and/or ICANS following TEPKINLY administration2
  • 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 ICANS2
  • 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 time2

 

Premedication can be taken at home orally prior to weekly TEPKINLY administration2,4

 

CyclePatient requiring premedicationPremedicationAdministration
Cycle 1All patientsPrednisolone 100 mg or dexamethasone 15 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 dosePrednisolone 100 mg or dexamethasone 15 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.2

Patients will be permanently discontinued after a grade 4 CRS event.2

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.2

Oral or intravenous.

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

Guidance following a missed or delayed dose2

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.

In a 2017 study, patients preferred SC treatment over IV treatment5

77%-84% of patients preferred SC treatment based on results from a PPQ5a

The study found that the most commonly identified reasons for SC were:

 

 

aResults from an international, phase 3b, prospective, multicentre, open-label, crossover study of patients with DLBCL or follicular lymphoma (N=743). All patients were given 1 dose of rituximab IV treatment. Patients in Arm A then received 3 cycles of treatment via SC injection, followed by 4 cycles of IV treatment. Patients in Arm B received 3 cycles of IV treatment, followed by 4 cycles of SC treatment. The primary objective was assessing overall patient preference for rituximab SC or IV using a PPQ that recorded preference as “SC,” “IV,” or “no preference” after rituximab in cycles 6 and 8 and rated preference on a 3-point scale as “very strong,” “fairly strong,” or “not very strong.” At cycle 8, 591 patients completed the PPQ; 48 patients indicated no preference.

 


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Find additional resources about TEPKINLY that may be useful in your clinical practice.

 

DLBCL=diffuse large B-cell lymphoma; IV=intravenous; PPQ=Patient Preference Questionnaire; QoL=quality of life; SC=subcutaneous.

TEPKINLY as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.2

References: 1. Thieblemont C, Phillips T, Ghesquieres H, et al. Epcoritamab, a novel, subcutaneous CD3xCD20 bispecific T-cell-engaging antibody, in relapsed or refractory large B-cell lymphoma: dose expansion in a phase I/II trial. J Clin Oncol. Published online December 22, 2022. doi:10.1200/JCO.22.01725 2. TEPKINLY Summary of Product Characteristics. AbbVie Inc. 3. Stewart D, Aucoin, Crosbie T, et al. Update on the subcutaneous administration of rituximab in Canadian cancer centres. Curr Oncol. 2020;27(2):113-116. 4. Hutchings M, Mous R, Clausen MR, et al. Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2 study. Lancet. 2021;398(10306):1157-1169. doi:10.1016/S0140-6736(21)00889-8 5. Rummel M, Kim TM, Aversa F, et al. Preference for subcutaneous or intravenous administration of rituximab among patients with untreated CD20+ diffuse large B-cell lymphoma or follicular lymphoma: results from a prospective, randomized, open-label, crossover study (PrefMab). Ann Oncol. 2017;28(4):836-842. doi:10.1093/annonc/mdw685 6. van Hoogdalem LE, Siemes C, Lugtenburg PJ, et al. Patients’ decision-making, experiences and preferences regarding pixantrone treatment in relapsed or refractory diffuse large B-cell lymphoma: study protocol for a longitudinal mixed methods study. BMJ Open. 2019;9:e026505. doi:10.1136/bmjopen-2018-026505

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