Epkinly TM
You should seek medical advice in relation to medicines and use only as directed by a healthcare professional. Always read the label. If symptoms persist see your healthcare professional.
Active ingredients: epcoritamab
Brand name
(ARTG)
: EPKINLY epcoritamab 48mg/0.8mL solution for injection vialConsumer Medicine Information (CMI)
Read the CMI leaflet for facts you need to know before, during and after taking your medicine.
For more information about CMIs and how to read them, please visit How to read Consumer Medicine Information (CMI).
What this medicine is used for
(ARTG)
EPKINLY 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. EPKINLY is not indicated for the treatment of patients with primary central nervous system lymphoma. This medicine has provisional approval in Australia for the treatment of adult patients with relapsed or refractory DLBCL after two or more lines of systemic therapy. The decision to approve this indication has been made on the basis of overall response and duration of response from an uncontrolled, open label phase I/II study. Continued approval of this indication depends on verification and description of benefit in confirmatory trials.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Sterile, preservative free, clear to slightly opalescent, colourless to slightly yellow solution, practically free of visible particles.
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Do not Freeze
- Do not Shake
- Shelf lifetime is 24 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is
- 1 vial pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient epcoritamab
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
- You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme
