I
Tepkinly is now
licensed for 3L+ DLBCL
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.1
Tepkinly has a conditional marketing authorisation
- further data awaited.
You are advised to read the Prescribing Information and Summary of Product Characteristics, accessible via the links above, to evaluate patient suitability for Tepkinly.
Adverse event reporting information can be found at the bottom of this page.
Tepkinly is now licensed for 3L+ DLBCL
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.1
Tepkinly has a conditional marketing authorisation
- further data awaited.
You are advised to read the Prescribing Information and Summary of Product Characteristics, accessible via the links above, to evaluate patient suitability for Tepkinly.
Adverse event reporting information can be found at the bottom of this page.
Tepkinly Dosing and Administration
Tepkinly should be administered by subcutaneous injection according to the following step-up dosing schedule over the course of 28-day cycles using priming, intermediate, and full doses.1
For illustration purposes only.
- Tepkinly should be administered by subcutaneous injection, preferably in the lower part of the abdomen or the thigh. Change of injection site from left to right side or vice versa is recommended especially during the weekly administration schedule (i.e. Cycles 1-3)
- 0.16 mg is a priming dose, 0.8 mg is an intermediate dose, and 48 mg is a full dose
- The 0.16 mg and 0.8 mg doses need diluting prior to administration. For instructions on how to prepare the doses, please read Section 6.6 of the Summary of Product Characteristics, accessible via the link at the top of the page.
- Tepkinly should be administered until disease progression or unacceptable toxicity
- Tepkinly should be administered to adequately-hydrated patients
- Premedication and CRS prophylaxis are recommended for all patients in cycle 1 and for patients who experienced grade 2 or 3 CRS with previous dose in cycles 2 and beyond
A subcutaneous injection1
- Weekly dosing for cycles 1-3 (28-day cycle)
- Dosing every 2 weeks for cycles 4-9
- Dosing every 4 weeks after cycle 10
Tepkinly must only be administered under the supervision of a healthcare professional qualified in the use of anti-cancer therapy. At least 1 dose of tocilizumab for use in the event of CRS should be available prior to Tepkinly administration for Cycle 1. Access to an additional dose of tocilizumab within 8 hours of use of the previous tocilizumab dose should be available.
For guidance on management of CRS, ICANS, and serious infections, please refer to the SmPC and the safety section.
Tepkinly premedication and CRS prophylaxis1
*Patients will be permanently discontinued after a Grade 4 CRS event.1
Tepkinly dosing considerations1
Special populations
- Renal impairment: no dose adjustment is necessary in patients with mild/moderate renal impairment. No data are available in patients with severe renal impairment.
- Hepatic impairment: dose adjustments are not considered necessary in patients with mild hepatic impairment. Epcoritamab has not been studied in patients with severe hepatic impairment (defined as total bilirubin > 3 times ULN and any AST) and data are limited in patients with moderate hepatic impairment (defined as total bilirubin > 1.5 to 3 times ULN and any AST). No dose recommendations can be made for patients with moderate to severe hepatic impairment.
- Elderly: no dose adjustment is necessary in patients ≥65 years.
Pregnancy, breastfeeding and fertility
- Tepkinly is not recommended during pregnancy and in women of childbearing potential not using contraception. Women of childbearing potential should be advised to use effective contraception during treatment with Tepkinly and for at least 4 months after the last dose.
- Breastfeeding should be discontinued during treatment with Tepkinly and for at least 4 months after the last dose.
- No fertility studies have been conducted with Tepkinly and the effect of Tepkinly on male and female fertility is unknown.
Immunisation
Live and/or live-attenuated vaccines should not be given during treatment with Tepkinly. Studies have not been conducted in patients who received live vaccines.
Interactions
No interaction studies have been performed. Transient elevation of certain proinflammatory cytokines by Tepkinly may suppress CYP450 enzyme activities. On initiation of Tepkinly in patients being treated with CYP450 substrates with a narrow therapeutic index, therapeutic monitoring should be considered.
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed below:
- Sodium acetate trihydrate
- Acetic acid
- Sorbitol (E420)
- Polysorbate 80
- Water for injections
Excipients with known effect
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’. This medicinal product contains 21.9 mg of sorbitol per vial.
Effects on ability to drive and use machinery
Tepkinly has minor influence on the ability to drive and use machines. Due to the potential for ICANS, patients should be advised to exercise caution while (or avoid if symptomatic) driving, cycling or using heavy or potentially dangerous machines.
CRS, ICANS, serious infections, TLS and tumour flare have also occurred in patients receiving Tepkinly. For further information and management of these adverse reactions, see the Safety section.
Missed or delayed dose1
A re-priming cycle (identical to cycle 1 with standard CRS prophylaxis including D15 hospitalisation) 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)
Downloadable resource
Tepkinly dosing and administration guide
A digital guide to dosing and administration of Tepkinly. The guide also provides instructions on how to prepare and store Tepkinly, along with important safety information.
Abbreviations
AST=aspartate transaminase; CRS=cytokine release syndrome; ICANS=immune effector cell-associated neurotoxicity syndrome; IV=intravenous; ULN=upper limit normal.
References
- Tepkinly NI Summary of Product Characteristics.
- Thieblemont C et al. J Clin Oncol. 2022; 41(12): 2238-47.
- Hutchings M et al. Lancet 2021; 398(10306): 1157-69.
UK-EPCOR-230171. Date of preparation: March 2024.
Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk.
Adverse events should also be reported to AbbVie on [email protected]
