Epkinly™

Read the CMI leaflet (Opens in new tab) 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).

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.

Source: ARTG

• Shelf lifetime is 24 Months
• Store at 2 to 8 degrees Celsius
• Do not Freeze; Do not Shake

Source: ARTG

Non-composite pack

This medicine contains one component only.

Component

• Injection, concentrated
• Subcutaneous
• Sterile, preservative free, clear to slightly opalescent, colourless to slightly yellow solution, practically free of visible particles.

Source: ARTG

These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4: Prescription Only Medicine.?What is the medicines and poisons schedule?

All medicines and poisons in Australia are categorised by how they are made available to the public. Medicines with a low safety risk are usually less tightly controlled than medicines with a higher safety risk. This system is called ‘scheduling’. You can read more about the scheduling of medicines as well as the different scheduling categories on our Scheduling of medicines and poisons information page.

• 1 vial

Source: ARTG

This medicine was verified as available on the Pharmaceutical Benefits Scheme (PBS) on 1 August 2026, under PBS item codes 14792M (Opens in new tab) and 14803D (Opens in new tab). Ask your pharmacist or doctor about your eligibility

Source: PBS

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.

Source: AHT

Healthdirect medicines information is not intended for use in an emergency. If you are suffering an acute illness, overdose, or emergency condition, call triple zero (000) and ask for an ambulance.

Reasonable care has been taken to provide accurate information at the time of creation. This information is not intended to substitute medical advice, diagnosis or treatment and should not be exclusively relied on to manage or diagnose a medical condition. Please refer to our terms and conditions (Opens in new tab).