Epkinly

Generic name: Epcoritamab-bysp
Dosage form: injection, for subcutaneous use
Drug class: CD20 monoclonal antibodies

Usage of Epkinly

Epkinly is a prescription medicine used to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL).

Epkinly contains epcoritamab-bysp, a new type of cancer treatment called a bispecific CD20-directed CD3 T-cell engager. It is designed to work by directing cytotoxic T-cells selectively to tumors to elicit an immune response towards the malignant cells.

Epcoritamab-bysp works in the treatment of DLBCL by binding to CD3 on T-cells and CD20 on B-cells to induce T-cell mediated killing of lymphoma B cells.

Epkinly side effects

Epkinly can cause serious side effects, including:

See Important information.

Infections. Epkinly can cause serious infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment with Epkinly. Tell your healthcare provider right away if you develop any signs or symptoms of infection during treatment, including:

fever of 100.4°F (38°C) or higher

cough

chest pain

tiredness

shortness of breath

painful rash

sore throat

pain during urination

feeling weak or generally unwell

Low blood cell counts. Low blood cell counts are common during treatment, and can also be serious or severe. Your healthcare provider will check your blood cell counts during treatment. Epkinly may cause the following low blood cell counts:

low white blood cell counts (neutropenia). Low white blood cells can increase your risk for infection.

low red blood cell counts (anemia). Low red blood cells can cause tiredness and shortness of breath.

low platelet counts (thrombocytopenia). Low platelet counts can cause bruising or bleeding problems.

Your healthcare provider may temporarily stop or completely stop treatment if you develop certain side effects.

The most common side effects of Epkinly include:

tiredness

muscle and bone pain

injection site reactions

fever

stomach-area (abdominal) pain

nausea

diarrhea

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Epkinly

Before you receive treatment, tell your healthcare provider about all of your medical conditions, including if you:

have an infection.

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant. This medicine may cause harm your unborn baby. Females who are able to become pregnant:

Your healthcare provider should do a pregnancy test before you start treatment.

You should use effective birth control (contraception) during treatment, and for 4 months after your last dose.

Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed.

It is not known if this medicine passes into your breast milk. Do not breastfeed during treatment and for 4 months after your last dose.

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How to use Epkinly

Usual Adult Dose for Diffuse Large B-cell Lymphoma (DLBCL)

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 and 3 1, 8, 15 and 22 48 mg Cycles 4 to 9 1 and 15 48 mg Cycle 10 and beyond 1 48 mg

* Cycle = 28 days

Comments: - patients should be hospitalized for 24 hours after administration of the Cycle 1 Day 15 dosage of 48 mg. - administer premedications and prophylaxis as recommended. Premedications for the first cycle include prednisolone or Dexamethasone or equivalent, diphenhydramine or equivalent, and acetaminophen. Premedications for the remaining cycles include prednisolone or dexamethasone or equivalent. - dosages of 0.16 mg and 0.8 mg require dilution prior to administration.

Use: - 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Warnings

Epkinly can cause serious side effects, including:

Cytokine Release Syndrome (CRS). CRS is common during treatment 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 treatment on a "step-up dosing schedule".

The step-up dosing schedule is when you receive smaller "step-up" doses on Day 1 and Day 8 of your first cycle of treatment (Cycle 1).

You will receive your first full dose on Day 15 of Cycle 1.

If your dose 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 this medicine.

Neurologic Problems (Immune Effector Cell-Associated Neurotoxicity Syndrome or ICANS). 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 this medicine. 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 speaking or writing

confusion and disorientation

drowsiness

tiredness or lack of energy

muscle weakness

shaking (tremors)

seizures

memory loss

Due to the risk of CRS and neurologic problems, you should be hospitalized for 24 hours after receiving your first full dose on Day 15 of Cycle 1. Your healthcare provider will monitor you for signs and symptoms of CRS and neurologic problems during treatment, as well as other side effects and treat you if needed. Your healthcare provider may temporarily stop or completely stop your treatment if you develop CRS, neurologic problems, or any other side effects that are severe.

See Epkinly side effects for more information about side effects.

What other drugs will affect Epkinly

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

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