EPKINLY CONCENTRATE FOR SOLUTION FOR INJECTION 4MG/0.8ML [SIN17105P]

Product Info

EPKINLY CONCENTRATE FOR SOLUTION FOR INJECTION 4MG/0.8ML

[SIN17105P]

2. INDICATION

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.

3. DOSAGE AND ADMINISTRATION

3.1 Recommended dosage and premedications

Epcoritamab is for subcutaneous (SC) injection only. Epcoritamab should be administered by a licensed healthcare professional.

Administered epcoritamab according to the following schedule in 28-day cycles.

Administer epcoritamab until disease progression or unacceptable toxicity.

Premedications and Prophylaxis

Epcoritamab should be administered to adequately hydrated patients.

Details on recommended premedication for CRS is shown in Table 2.

Prophylaxis against Pneumocystis jirovecii pneumonia (PCP) and herpes virus infections is strongly recommended especially during concurrent use of steroids.

Monitor patients for potential CRS and immune effector cell-associated neurotoxicity syndrome (ICANS) following EPKINLY administrations during Cycle 1 and in subsequent cycles as needed at the physician’s discretion. Following administration of the first full dose, patients should remain within close proximity to a healthcare facility that can assess and manage potential CRS and /or ICANS for at least 24 hours. Counsel patients on the signs and symptoms associated with CRS and ICANS and on seeking immediate medical attention should signs or symptoms occur at any time (see Warnings and Precautions (5.1 and 5.2) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

3.2 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).

3.3 Dosage Modifications and Management of Adverse Reactions

Cytokine Release Syndrome (CRS)

Patients treated with EPKINLY may develop CRS.
Evaluate for and treat other causes of fever, hypoxia, and hypotension. If CRS is suspected, manage according to the recommendations in Table 3. Patients who experience CRS should be monitored more frequently during next scheduled EPKINLY administrations.

Immune Effector Cell Associated Neurotoxicity Syndrome (ICANS)
Monitor patients for signs and symptoms of ICANS. Rule out other causes of neurologic symptoms. If ICANS is suspected, manage according to the recommendations in Table 4.

3.4 Preparation and Administration

Epcoritamab should be prepared and administered by a healthcare provider as subcutaneous injection (SC). Each vial of epcoritamab is intended for single dose only.

The administration of EPKINLY takes place over the course of 28-day cycles, following the dosing scheduled in Section 3.1.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Dose Preparation
Use aseptic technique to prepare EPKINLY. Filtration of the diluted solution is not required.

Preparation instructions for 0.16 mg and 0.8 mg doses of EPKINLY

0.16 mg Priming Dose Preparation Instructions – (2 dilutions required)
Use an appropriately sized syringe, vial, and needle for each transfer step.

Discard the vial and any unused portion of EPKINLY in accordance with local requirements.

0.8 mg Intermediate Dose Preparation Instructions – (1 dilution required)
Use an appropriately sized syringe, vial, and needle for each transfer step.

Discard the vial and any unused portion of EPKINLY in accordance with local requirements.

48 mg Full Dose Preparation Instructions (No dilution required)
EPKINLY 48mg/0.8mL vial is supplied as ready-to-use solution that does not need dilution prior to administration.

Discard the vial and any unused portion of EPKINLY in accordance with local requirements.

Storage for Diluted and Prepared EPKINLY
Use immediately or store EPKINLY solution in a refrigerator and protect from light up to 24 hours at 2°C to 8 °C (36 F° to 46F°) from the time of preparation. Within these 24 hours, the EPKINLY solution can be stored for 12 hours at room temperature from the start of dose preparation to administration. Minimize exposure to daylight. Allow EPKINLY solution to equilibrate to room temperature before administration. Discard unused EPKINLY solution beyond the allowable storage time.

Site Administration
The injection site should be preferably in the lower part of abdomen or the thigh. Change of injection site from left or right side or vice versa is recommended especially during the weekly administration (Cycles 1–3).

3.5 Dosing in Special Populations

3.5.1 Pediatrics
The safety and efficacy of epcoritamab in children aged less than 18 years of age have not yet been established.

3.5.2 Geriatric
In patients with LBCL in EPCORE NHL-1, 48 (31%) were ≥65 to <75 years of age and 29 (18%) were ≥75 years of age. No clinically meaningful differences in safety or efficacy were observed between patients ≥65 years of age compared with younger adult patients.

3.5.3 Renal impairment
Dose adjustments are not considered necessary in patients with mild to moderate renal impairment. No dose recommendations can be made for patients with severe renal impairment to end-stage renal disease.

3.5.4 Hepatic impairment
Dose adjustments are not considered necessary in patients with mild hepatic impairment. No dose recommendations can be made for patients with moderate to severe hepatic impairment.

4. CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients listed in section 15.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.