Epkinly Side Effects

Generic name: epcoritamab

Medically reviewed by Drugs.com. Last updated on Aug 31, 2024.

Note: This document provides detailed information about Epkinly Side Effects associated with epcoritamab. Some dosage forms listed on this page may not apply specifically to the brand name Epkinly.

Applies to epcoritamab: subcutaneous solution.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests are needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for 4 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause cytokine release syndrome (CRS) and nervous system problems, including immune effector cell-associated neurotoxicity syndrome (ICANS). These may be life-threatening and require immediate attention. Tell your doctor right away if you have agitation, back pain, blurred vision, burning, throbbing, or stabbing pain, coma, confusion, double vision, drowsiness, feeling restless, fever, chills, hallucinations, headache, hearing loss, irritability, jerking movements, mood or mental changes, muscle spasms, nausea, lightheadedness, dizziness, fainting, rigid muscles, seizures, skin rash, stiff neck, tremor, trouble breathing, trouble speaking, unusual tiredness or weakness, or vomiting.

This medicine may cause serious infections. Check with your doctor right away if you have fever or chills, confusion, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may cause dizziness, confusion, or tremors. Do not drive or do anything else that could be dangerous after receiving this medicine until you know how this medicine affects you.

Serious side effects of Epkinly

Along with its needed effects, epcoritamab (the active ingredient contained in Epkinly) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking epcoritamab:

Other side effects of Epkinly

Some side effects of epcoritamab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

See also:

For healthcare professionals

Applies to epcoritamab: subcutaneous solution.

General adverse events

The most common adverse reactions were cytokine release syndrome, fatigue, musculoskeletal pain, injection site reactions, pyrexia, abdominal pain, nausea, diarrhea, COVID-19, upper respiratory tract infection, rash, cough, viral infection, and headache. The most common grade 3 to 4 laboratory abnormalities were decreased lymphocyte count, decreased neutrophil count/neutropenia, decreased WBC count, decreased hemoglobin/anemia, and decreased platelets/thrombocytopenia.^[Ref]

Cardiovascular

• Common (1% to 10%): Cardiac arrhythmias
• Uncommon (0.1% to 1%): Myocardial infarction, cardiac failure

Cardiac arrhythmias (up to 10%) included bradycardia, sinus bradycardia, sinus tachycardia, supraventricular extrasystoles, supraventricular tachycardia, and tachycardia.

Dermatologic

• Very common (10% or more): Rash (up to 28%)
• Common (1% to 10%): Pruritus, cellulitis

Rash included bullous dermatitis, erythema, palmar erythema, penile erythema, rash, erythematous rash, macular rash, maculopapular rash, papular rash, pruritic rash, pustular rash, vesicular rash, recall phenomenon, seborrheic dermatitis, and skin exfoliation.

Gastrointestinal

• Very common (10% or more): Diarrhea (up to 26%), abdominal pain (up to 23.4%), nausea (up to 21.6%), constipation (up to 16%), vomiting (up to 12%), mucositis (up to 12%)

Abdominal pain included abdominal discomfort, abdominal pain, lower abdominal pain, upper abdominal pain, and abdominal tenderness.

Mucositis included aphthous ulcer, mouth ulceration, mucosal inflammation, oral pain, oropharyngeal pain, stomatitis, and tongue ulceration.

Genitourinary

• Very common (10% or more): Urinary tract infection (up to 13%)

Hematologic

• Very common (10% or more): Decreased lymphocyte count (up to 94%), decreased hemoglobin (up to 62%), decreased WBC (up to 58%), decreased neutrophils (up to 55%), decreased platelets (up to 49%), neutropenia (up to 28%), anemia (up to 19%), thrombocytopenia (up to 15%), lymphopenia
• Common (1% to 10%): Febrile neutropenia

Among large B-cell lymphoma (LBCL) patients (n=157) who received this drug at the recommended 2-step up dosage schedule in the clinical trial, grade 3 or 4 decreased neutrophils, decreased hemoglobin, and decreased platelets occurred in 32%, 12%, and 12% of patients, respectively; febrile neutropenia occurred in 2.5%. In follicular lymphoma (FL) patients who received this drug following the 2-step up dosage schedule in the clinical trial, grade 3 or 4 decreased neutrophils, decreased hemoglobin, and decreased platelets occurred in 30%, 10%, and 8% of patients, respectively; febrile neutropenia occurred in 3.1%.

Neutropenia included neutropenia and decreased neutrophil count. Neutropenia of any grade occurred in 28% of patients (n=382), including 23% as grade 3 to 4 events. The median time to onset of first neutropenia/decreased neutrophil count event was 65 days (range: 2 to 750 days); the median duration was 15 days (range: 2 to 415 days).

Anemia included anemia and decreased serum ferritin.

Thrombocytopenia included decreased platelet count and thrombocytopenia.

Lymphopenia included decreased lymphocyte count and lymphopenia.

Hepatic

• Very common (10% or more): Increased AST (up to 48%), increased ALT (up to 47%), increased bilirubin (up to 28%)
• Common (1% to 10%): Hepatitis E
• Uncommon (0.1% to 1%): Hepatotoxicity

Immunologic

• Very common (10% or more): Cytokine release syndrome (CRS; up to 56%)
• Common (1% to 10%): Development of antidrug antibodies
• Frequency not reported: Hemophagocytic lymphohistiocytosis

In LBCL patients receiving this drug at the recommended 2-step up dosage schedule in the clinical trial, CRS occurred in 51% (85/167); grade 1, 2, and 3 CRS occurred in 31%, 17%, and 3% of patients, respectively, and recurrent CRS occurred in 33% of patients with CRS. CRS of any grade occurred in 6.6% of patients after dosing on Cycle 1 Day 1 (0.16 mg), 13% after dosing on Cycle 1 Day 8 (0.8 mg), 44% after dosing on Cycle 1 Day 15 (48 mg), 4.6% after dosing on Cycle 1 Day 22 (48 mg), and 2.8% after dosing on Cycle 2 Day 1 (48 mg). The median time to onset from the most recent administered dose across all doses was 24 to 48 hours (range: 0 to 11 days) and after the first full 48 mg dose was 20.6 to 21 hours (range: 0 to 7 days). CRS resolved in 98% of LBCL patients and the median duration was 2 days (range: 1 to 27 days). In FL patients receiving this drug at the recommended 3-step up dosage schedule in the clinical trial, CRS occurred in 49% (42/86); grade 1 and 2 CRS occurred in 40% to 45% and 9% of patients, respectively, and recurrent CRS occurred in 23% of patients. Most (88%) CRS events occurred during Cycle 1; 12% to 14% occurred after dosing on Cycle 1 Day 1 (0.16 mg), 5.9% to 7% after dosing on Cycle 1 Day 8 (0.8 mg), 15% to 17% after dosing on Cycle 1 Day 15 (3 mg), and 37% to 49% after dosing on Cycle 1 Day 22 (48 mg). The median time to onset from the most recent administered dose across all doses was 59 hours (range: 0.1 to 8 days) and after the first full 48 mg dose was 61 hours (range: 0.1 to 8 days). CRS resolved in 100% of FL patients and the median duration was 2 days (range: 1 to 14 days). In both patients with LBCL and FL, the signs/symptoms of CRS included pyrexia, hypotension, hypoxia, dyspnea, chills, tachycardia (including sinus tachycardia), headache, nausea, and vomiting. Concurrent neurological adverse reactions associated with CRS occurred in 2.5% and 4.7% of patients with LBCL and FL, respectively. Concurrent neurological adverse reactions observed in patients with LBCL included headache, confusional state, tremors, dizziness, and ataxia; concurrent neurological adverse reactions observed in patients with FL included headache and dizziness.

Local

• Very common (10% or more): Injection site reactions (up to 58%)

Injection site reactions included injection site erythema, injection site hypertrophy, injection site inflammation, injection site mass, injection site pain, injection site pruritus, injection site rash, injection site reaction, injection site swelling, injection site urticaria, injection site nodule, injection site edema, and injection site bruising.

Metabolic

• Very common (10% or more): Decreased sodium (up to 56%), decreased phosphate (up to 56%), decreased potassium (up to 34%), decreased magnesium (up to 31%), increased potassium (up to 21%), decreased appetite (up to 12%)
• Common (1% to 10%): Tumor lysis syndrome, hypophosphatemia, hypokalemia, hypomagnesemia

Decreased sodium included decreased blood sodium and hyponatremia.

Tumor lysis syndrome occurred in 1% of patients (4/382). Median time to onset was 18 days (range: 8 to 33 days) and median duration was 3 days (range: 2 to 4 days).

Musculoskeletal

• Very common (10% or more): Musculoskeletal pain (up to 28%), arthralgia (up to 14%)

Musculoskeletal pain included back pain, bone pain, flank pain, musculoskeletal chest pain, musculoskeletal pain, myalgia, neck pain, noncardiac chest pain, pain, pain in extremity, and spinal pain.

Nervous system

• Very common (10% or more): Headache (up to 20%), neurological changes (up to 13%), peripheral neuropathy/paresthesia (up to 13%), dizziness (up to 11%)
• Common (1% to 10%): Immune effector cell-associated neurotoxicity syndrome (ICANS)

Neurological changes included amnesia, aphasia, balance disorder, brain fog, confusional state, dysphonia, encephalopathy, extrapyramidal disorder, hallucination, hypoacusis, memory impairment, mental status changes, tremor, and vertigo.

Peripheral neuropathy/paresthesia included Bell's palsy, hypoesthesia, neuralgia, peripheral neuropathy, paresthesia, peripheral sensory neuropathy, and polyneuropathy.

In LBCL patients receiving this drug at the recommended 2-step up dosage schedule in the clinical trial, ICANS occurred in 6% (10/157); grade 1 and 2 ICANS occurred in 4.5% and 1.3% of patients, respectively, and there was 1 fatal ICANS occurrence. Of the 10 ICANS events, 9 occurred within Cycle 1 of therapy, with a median time to onset of 16.5 days (range: 8 to 141 days) from the start of treatment; relative to the most recent administration of this drug, the median time to onset was 3 days (range: 1 to 13 days). The median duration was 4 to 5 days (range: 0 to 9 days) and ICANS resolved in 90% of LBCL patients with supportive care. In FL patients receiving this drug following the 2-step up dosage schedule in the clinical trial, ICANS occurred in 6% (8/127); grade 1 and 2 ICANS occurred in 3.9% and 2.4% of patients, respectively. The median time to onset was 21.5 days (range: 14 to 66 days) from the start of treatment; relative to the most recent administration of this drug, the median time to onset was 3 days (range: 0.4 to 7 days). The median duration was 2 days (range: 1 to 7 days) and ICANS resolved in 100% of FL patients. For patients with LBCL or FL, clinical manifestations of ICANS included (but were not limited to) confusional state, lethargy, tremor, dysgraphia, aphasia, and nonconvulsive status epilepticus.

Ocular

• Frequency not reported: Vision changes

Oncologic

• Common (1% to 10%): Second primary malignancies, tumor flare

Tumor flare occurred in 3% of LBCL patients (n=167), all of which were grade 2. The median time to onset was 17 days (range: 9 to 34 days); the median duration was 15.5 days (range: 1 to 50 days).

Other

• Very common (10% or more): Serious infections (up to 40%), fatigue (up to 37%), increased alkaline phosphatase (up to 29%), viral infection (up to 28%), pyrexia/fever (up to 26%), edema (up to 17%), herpesvirus infection (up to 12%)
• Common (1% to 10%): Sepsis, fungal infection
• Frequency not reported: CMV infection

In LBCL patients receiving this drug at the recommended 2-step up dosage schedule in the clinical trial, serious infections (including opportunistic infections) were reported in up to 25% and were most commonly due to sepsis, pneumonia, COVID-19, COVID-19 pneumonia, cellulitis, bacteremia, septic shock, upper respiratory tract infection, and progressive multifocal leukoencephalopathy; fatal serious infections occurred in 7 of 167 LBCL patients and included COVID-19. The median time to onset of first serious infection was 56 days (range: 4 to 631 days); the median duration was 15 days (range: 4 to 125 days). In FL patients receiving this drug following the 2-step up dosage schedule in the clinical trial, serious infections (including opportunistic infections) were reported in 40% and were most commonly due to COVID-19 (20%), pneumonia (13%), and urinary tract infections (3%); fatal infections occurred in 6% of FL patients and included COVID-19 (5%), pneumonia (0.8%), and sepsis (0.8%).

Fatigue included asthenia, fatigue, and lethargy.

Viral infection included COVID-19, CMV chorioretinitis, CMV colitis, CMV infection, CMV infection reactivation, viral gastroenteritis, herpes simplex, herpes simplex reactivation, herpes virus infection, herpes zoster, oral herpes, post-acute COVID-19 syndrome, and varicella zoster virus infection.

Pyrexia included pyrexia and increased body temperature.

Edema included edema, peripheral edema, face edema, generalized edema, swelling, face swelling, and peripheral swelling.

Herpesvirus infection included herpes simplex, herpes simplex reactivation, herpes virus infection, herpes zoster, oral herpes, and varicella zoster virus infection.

Sepsis included bacteremia, sepsis, and septic shock.

Fungal infection included Candida infection, esophageal candidiasis, oral candidiasis, and oropharyngeal candidiasis.

Psychiatric

• Very common (10% or more): Insomnia (up to 13%)

Renal

• Very common (10% or more): Increased creatinine (up to 36%), renal insufficiency (up to 10%)

Renal insufficiency included acute kidney injury, increased blood creatinine, and renal impairment.

Respiratory

• Very common (10% or more): COVID-19 (up to 40%), upper respiratory tract infection (up to 29%), cough (up to 20%), pneumonia (up to 17%), dyspnea (up to 17%)
• Common (1% to 10%): Pneumonitis, pleural effusion
• Uncommon (0.1% to 1%): Pulmonary embolism
• Frequency not reported: COVID-19 pneumonia, lower respiratory tract infections, respiratory tract infections

COVID-19 included COVID-19, COVID-19 pneumonia, and positive test for severe acute respiratory syndrome coronavirus 2.

Upper respiratory tract infection included upper respiratory infection, sinusitis, laryngitis, viral laryngitis, nasopharyngitis, fungal oropharyngitis, pharyngitis, respiratory syncytial virus infection, rhinitis, rhinovirus infection, tonsillitis, and upper respiratory tract infection.

Pneumonia included pneumonia, COVID-19 pneumonia, bronchopulmonary aspergillosis, infectious pleural effusion, infective exacerbation of bronchiectasis, Pneumocystis jirovecii pneumonia, and respiratory syncytial viral pneumonia.

Frequently asked questions

• What are Monoclonal Antibodies and how do they work?
• What is the success rate of Epkinly?

Further information

Epkinly side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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