EPKINLY- epcoritamab-bysp injection, solution EPKINLY- epcoritamab-bysp injection, solution, concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

epcoritamab (UNII: D6OMY2L0WA) (epcoritamab - UNII:D6OMY2L0WA)

Available from:

Genmab US, Inc.

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

EPKINLY is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). None. Risk Summary Based on the mechanism of action, EPKINLY may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . There are no available data on the use of EPKINLY in pregnant women to evaluate for a drug-associated risk. No animal reproductive or developmental toxicity studies have been conducted with epcoritamab-bysp. Epcoritamab-bysp causes T-cell activation and cytokine release; immune activation may compromise pregnancy maint

Product summary:

How Supplied EPKINLY (epcoritamab-bysp) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution, free of visible particles, supplied in glass vials as follows: The vial stopper is not made with natural rubber latex. Storage and Handling Store refrigerated at 2°C to 8°C (36°F to 46°F). Keep in the original carton to protect from light. Do not freeze. Do not shake.

Authorization status:

Biologic Licensing Application

Patient Information leaflet

EPKINLY- EPCORITAMAB-BYSP INJECTION, SOLUTION, CONCENTRATE
Genmab US, Inc.
----------
MEDICATION GUIDE
EPKINLY™ (EP-KIN-LEE)
(EPCORITAMAB-BYSP)
INJECTION, FOR SUBCUTANEOUS USE
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Issued: May 2023
What is the most important information I should know about EPKINLY?
EPKINLY can cause serious side effects, including:
•
Cytokine Release Syndrome (CRS). CRS is common during treatment with
EPKINLY and can
also be serious or life-threatening. Tell your healthcare provider or
get medical help right away if
you develop any signs or symptoms of CRS, including:
•
fever of 100.4°F (38°C) or higher
•
dizziness or light-headedness
•
trouble breathing
•
chills
•
fast heartbeat
•
feeling anxious
•
headache
•
confusion
•
shaking (tremors)
•
problems with balance and
movement, such as trouble
walking
Due to the risk of CRS, you will receive EPKINLY on a "step-up dosing
schedule".
•
The step-up dosing schedule is when you receive smaller "step-up"
doses of
EPKINLY on Day 1 and Day 8 of your first cycle of treatment (Cycle 1).
•
You will receive your first full dose of EPKINLY on Day 15 of Cycle 1.
•
If your dose of EPKINLY is delayed for any reason, you may need to
repeat the
"step-up dosing schedule".
•
Before each dose in Cycle 1, you will receive medicines to help reduce
your
risk of CRS. Your healthcare provider will decide if you need to
receive
medicine to help reduce your risk of CRS with future cycles.
•
See "How will I receive EPKINLY?" for more information about how you
will
receive EPKINLY.
•
Neurologic problems. EPKINLY can cause serious neurologic problems
that can be life-
threatening and lead to death. Neurologic problems may happen days or
weeks after you receive
EPKINLY. Your healthcare provider may refer you to a healthcare
provider who specializes in
neurologic problems. Tell your healthcare provider right away if you
develop any signs or
symptoms of neurologic problems, including:
•
trouble speak

Summary of Product characteristics

EPKINLY- EPCORITAMAB-BYSP INJECTION, SOLUTION
EPKINLY- EPCORITAMAB-BYSP INJECTION, SOLUTION, CONCENTRATE
GENMAB US, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EPKINLY SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EPKINLY.
EPKINLY™ (EPCORITAMAB-BYSP) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2023
WARNING: CYTOKINE RELEASE SYNDROME AND IMMUNE EFFECTOR CELL-ASSOCIATED
NEUROTOXICITY SYNDROME
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
CYTOKINE RELEASE SYNDROME (CRS), INCLUDING SERIOUS OR LIFE-THREATENING
REACTIONS, CAN
OCCUR IN PATIENTS RECEIVING EPKINLY. INITIATE TREATMENT WITH THE
EPKINLY STEP-UP
DOSING SCHEDULE TO REDUCE THE INCIDENCE AND SEVERITY OF CRS. WITHHOLD
EPKINLY UNTIL
CRS RESOLVES OR PERMANENTLY DISCONTINUE BASED ON SEVERITY. (2.1, 2.2,
2.6, 5.1)
IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME (ICANS),
INCLUDING LIFE-
THREATENING AND FATAL REACTIONS, CAN OCCUR WITH EPKINLY. MONITOR
PATIENTS FOR
NEUROLOGICAL SIGNS OR SYMPTOMS OF ICANS DURING TREATMENT. WITHHOLD
EPKINLY UNTIL
ICANS RESOLVES OR PERMANENTLY DISCONTINUE BASED ON SEVERITY. (2.1,
2.2, 2.6, 5.2)
INDICATIONS AND USAGE
EPKINLY is a bispecific CD20-directed CD3 T-cell engager indicated for
the treatment of adult patients with
relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not
otherwise specified, including DLBCL
arising from indolent lymphoma, and high-grade B-cell lymphoma after
two or more lines of systemic
therapy. (1)
This indication is approved under accelerated approval based on
response rate and durability of response.
Continued approval for this indication may be contingent upon
verification and description of clinical
benefit in a confirmatory trial(s).
DOSAGE AND ADMINISTRATION
For subcutaneous injection only. (2.2)
Recommended Dosage: (2.2)
CYCLE OF TREATMENT
DAY OF
TREATMENT
DOSE OF EPKINLY
*
Cycle 1
1
Step-up dose 1
0.16 mg
8
Step-up dose 2
0.8 mg
15
First full dose
48 mg
22
48 mg
Cycles 2