Starting on subcutaneous EPKINLY1

Dosing schedule

EPKINLY is administered in 4-week dosing cycles:

During cycle 1, EPKINLY is administered  weekly.
During cycles 2‐3, EPKINLY is administered  weekly.
During cycles 4‐9, EPKINLY is administered  every 2 weeks.
During cycles 10+, EPKINLY is administered  every 4 weeks.
  • Administer EPKINLY subcutaneously in 28-day cycles to well-hydrated patients until disease progression or unacceptable toxicity
  • Initiate treatment with the EPKINLY step-up dosing schedule and premedicate before each dose in cycle 1 to reduce the risk of CRS
  • EPKINLY should only be administered by a qualified HCP with appropriate medical support to manage severe reactions such as CRS and ICANS
  • Monitor patients for potential CRS and ICANS. Due to the risk of CRS and ICANS, patients should be hospitalized for 24 hours after administration of the cycle 1 day 15 dosage of 48 mg

Restarting EPKINLY after dose delays

If a dose of EPKINLY is delayed, restart therapy based on the recommendations made in Table 2 in Section 2.3 of the Prescribing Information and resume the treatment schedule accordingly.

Management of CRS or ICANS may require either temporary delay or discontinuation of EPKINLY based on the severity of CRS or ICANS.

See Dose Modification


Recommended premedications

Between 30 and 120 minutes prior to administration of EPKINLY, administer the following medications:

Cycle 1: Administered prior to each weekly administration of EPKINLY to all patients

  • Prednisolone (100 mg oral or IV) or dexamethasone (15 mg oral or IV) or equivalent (and for 3 consecutive days following each weekly administration)
  • Diphenhydramine (50 mg oral or IV) or equivalent
  • Acetaminophen (650-1000 mg oral)

Cycles 2+: Administered prior to next administration of EPKINLY to patients who experienced grade 2 or 3* CRS with previous dose, until EPKINLY is given without subsequent CRS of grade 2 or higher

  • Prednisolone (100 mg oral or IV) or dexamethasone (15 mg oral or IV) or equivalent (and for 3 consecutive days following administration of EPKINLY)

*Patients will be permanently discontinued from EPKINLY after a grade 4 CRS event.

Recommended prophylaxis

Provide Pneumocystis jirovecii pneumonia prophylaxis prior to starting treatment with EPKINLY.

Consider initiating prophylaxis against herpes virus prior to starting EPKINLY to prevent herpes zoster reactivation.


Preparation and administration

EPKINLY is available in 2 dosing strengths, 4 mg/0.8 mL and 48 mg/0.8 mL. The step-up doses (0.16 mg and 0.8 mg) require dilution prior to administration using the EPKINLY 4 mg/0.8 mL vial by an HCP using aseptic technique. The full dose (48 mg) is administered using a ready-to-use EPKINLY 48 mg/0.8 mL vial.

Administration

  • EPKINLY should be injected into the subcutaneous tissue preferably in the lower part of the abdomen or thigh
  • Change of injection site from the left or right side or vice versa is recommended, especially during the weekly administrations (cycles 1 to 3). Do not inject into tattoos or scars or areas where the skin is red, bruised, tender, hard or not intact

Dose preparation and handling for EPKINLY

Watch the following video for step-by-step instructions on how to properly store, handle, and prepare EPKINLY for administration.

Preparation and administration

EPKINLY is available in 2 dosing strengths, 4 mg/0.8 mL and 48 mg/0.8 mL. The step-up doses (0.16 mg and 0.8 mg) require dilution prior to administration using the EPKINLY 4 mg/0.8 mL vial by an HCP using aseptic technique. The full dose (48 mg) is administered using a ready-to-use EPKINLY 48 mg/0.8 mL vial.

Refer to Section 2.7 of the Prescribing Information for more detailed instructions on preparation and storage.

CRS=cytokine release syndrome; ICANS=immune effector cell-associated neurotoxicity syndrome; IV=intravenous; W1=week 1; W2=week 2; W3=week 3; W4=week 4.

Download the Dosing and Administration Guide for more information on how EPKINLY is administered

" "

Learn how to modify and manage dosing for adverse reactions