Epcoritamab

Epcoritamab is a prescription medication used for the treatment of B-cell lymphoma.

• Epcoritamab is available under the following different brand names: Epkinly, epcoritamab-bysp

Common side effects of Epcoritamab include:

• CRS
• tiredness
• muscle and bone pain
• injection site reactions
• fever
• stomach-area (abdominal) pain
• nausea, and diarrhea

Serious side effects of Epcoritamab include:

• cytokine release syndrome including fever of 100.4°F (38°C) or higher, dizziness or lightheadedness, trouble breathing, chills, fast heartbeat, feeling anxious, headache, confusion, shaking (tremors), or problems with balance and movement, such as trouble walking
• neurologic toxicity including aphasia (being unable to understand speech or speak normally), being more tired than usual, tremors, confusion, and seizures
• infection including a fever of 100.4°F (38°C) or higher, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, or feeling weak or generally unwell
• diarrhea
• low blood cell counts
• injection site reactions
• muscle or joint pain/aches
• nausea and/or vomiting
• fatigue

Rare side effects of Epcoritamab include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable solution, single-dose vial

• 4 mg/0.8 mL (dilute before use)
• 48 mg/0.8 mL

B-cell lymphoma

Adult dosage

• Each cycle is 28 days
• See Administration for recommended premedications
  • Cycle 1
    • Day 1 (step-up dose 1): 0.16 mg SC *1 dose
    • Day 8 (step-up dose 2): 0.8 mg SC *1 dose
    • Day 15 (first full dose): 48 mg SC *1 dose (hospitalize the patient for 24 hours during the first 48-mg dose)
    • Day 22: 48 mg SC *1 dose
  • Cycles 2 and 3
    • Days 1, 8, 15, and 22: 48 mg SC *1 dose
  • Cycles 4–9
    • Days 1 and 15: 48 mg SC *1 dose
  • Cycle 10 and thereafter
    • Day 1: 48 mg SC *1 dose
• Continue until disease progression or unacceptable toxicity
• Dosage Considerations – Should be Given as Follows: 
  • See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Epcoritamab has severe interactions with no other drugs
• Epcoritamab has serious interactions with the following drug:
  • ublituximab
• Epcoritamab has moderate interactions with no other drugs
• Epcoritamab has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Epcoritamab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Epcoritamab?”

Cautions

• Severe cytopenias, including neutropenia, anemia, and thrombocytopenia reported; based on the severity of cytopenias, temporarily withhold or permanently discontinue therapy; consider prophylactic granulocyte colony-stimulating factor administration as applicable
• Based on its mechanism of action, fetal harm may occur when administered to pregnant women
• Cytokine release syndrome
  • Can cause CRS, including serious or life-threatening reactions
  • Signs and symptoms include pyrexia, hypotension, hypoxia, dyspnea, chills, and tachycardia
  • Concurrent neurologic adverse reactions associated with CRS include headache, confusional state, tremors, dizziness, and ataxia
  • Initiate therapy according to the step-up dosing schedule
  • Administer premedications to reduce the risk of CRS and monitor for potential CRS following the dose
  • Following the administration of the first 48 mg dose, hospitalize the patient for 24 hours
  • At first signs or symptoms of CRS, immediately evaluate patients for hospitalization, manage per current practice guidelines, and administer supportive care as appropriate
  • Withhold or discontinue therapy based on the severity of CRS
• ICANS
  • May cause life-threatening and fatal ICANS
  • Clinical manifestations include a confusional state, lethargy, tremor, dysgraphia, aphasia, and nonconvulsive status epilepticus
  • The onset of ICANS can be concurrent with CRS, following the resolution of CRS, or in the absence of CRS
  • Monitor for potential ICANS following administration
  • At first signs or symptoms of ICANS, immediately evaluate the patient and provide supportive therapy based on the severity
  • Withhold or discontinue therapy per recommendations and consider further management per current practice guidelines
  • Advise patients of increased risk, and to refrain from driving and from operating heavy or potentially dangerous machinery until resolution
• Infections
  • Serious and fatal infections reported; monitor for signs and symptoms of infection before and during treatment and treat appropriately; avoid administration in patients with active infections
  • Provide pneumocystis jirovecii pneumonia and herpes virus prophylaxis before initiating
• Drug interaction overview
  • For certain cytochrome P450 (substrates, minimal changes in concentration may lead to serious adverse reactions
  • Monitor for toxicity or drug concentrations of such CYP substrates when co-administered
  • Epcoritamab causes the release of cytokines that may suppress the activity of CYP enzymes, resulting in increased exposure to CYP substrates
  • Increased exposure of CYP substrates is more likely to occur after the first dose (Cycle 1 Day 1) and up to 14 days after the first 48-mg dose on Cycle 1 Day 15, and during and after CRS

Pregnancy and Lactation

• Based on the mechanism of action, epcoritamab fetal harm when administered to pregnant women
• There are no available data on use in pregnant women to evaluate for a drug-associated risk
• No animal reproductive or developmental toxicity studies have been conducted with epcoritamab
• Epcoritamab causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance; based on the expression of CD20 on B-cells and the finding of B-cell depletion in nonpregnant animals, epcoritamab can cause B-cell lymphocytopenia in infants exposed to epcoritamab in utero
• Human immunoglobulin G is known to cross the placenta; therefore, epcoritamab may be transmitted from the mother to the developing fetus. Advise women of the potential
• Verify pregnancy status in women of reproductive potential before initiating
• Contraception
  • Advise women of reproductive potential to use effective contraception during treatment and for 4 months after the last dose
• Lactation
  • There is no information regarding the presence of epcoritamab in human milk, its effect on breastfed children, or milk production
  • Advise women not to breastfeed during treatment and for 4 months after the last dose