Epkinly

About Epkinly 

• Epkinly is an antineoplastic which belongs to the class called anti-CD20 monoclonal antibodies. 
• Epkinly is a prescription medication prescribed for treating specific forms of diffuse large B-cell lymphoma (DLBCL) in adults. This innovative treatment contains Epcoritamab bysp, categorized as a bispecific CD20-directed CD3 T-cell engager. 
• Epkinly functions by guiding cytotoxic T-cells specifically to tumors, triggering an immune response against malignant cells. 
• Epcoritamab operates by binding to CD3 on T-cells and CD20 on B-cells, encouraging T-cell-mediated elimination of lymphoma B cells. This medication is intended for adults with relapsed or refractory high-grade B-cell lymphoma and DLBCL, who have previously undergone at least two cancer treatments.
• DLBCL is a prevalent form of non-Hodgkin’s lymphoma, known for its rapid growth and development of tumors in various bodily locations. It results from mutations in B-cells, the lymphocytes responsible for producing antibodies to combat infections.
• It’s crucial to note that the safety and efficacy of this medication in children have not been established.

Strength: 

Injection: A single-dose vial contains  4 mg/0.8 mL; 48 mg/0.8 mL of Epkinly. 

Recommended Dosage:

The drug is administered by a health care professional directly through subcutaneously. Administer EPKINLY injection to adequately hydrated patients. Administer premedication before each dose in the first treatment cycle. Inject EPKINLY subcutaneously to lower the occurrence and seriousness of CRS. Due to the potential for CRS (Cytokine release syndrome) and ICANS (Immune effector cell-associated neurotoxicity syndrome), patients should be hospitalized for 24 hours after receiving the 48 mg dose on Cycle 1 Day 15.

• The recommended dosage schedule for EPKINLY injection is in Cycle 1, on Day 1, a step-up dose of 0.16 mg is administered. On Day 8, a step-up dose of 0.8 mg is given. On Day 15, the first full dose of 48 mg is administered, followed by another 48 mg dose on Day 22. For Cycles 2 and 3, patients receive 48 mg on Days 1, 8, 15, and 22. In Cycles 4 to 9, 48 mg doses are given on Days 1 and 15. For Cycle 10 and beyond, the recommended dosage is 48 mg on Day 1. If a dose of EPKINLY is delayed, therapy should be restarted based on the recommendations. 
• To resume EPKINLY therapy after a dosage delay, specific recommendations apply based on the last dose and the time elapsed since. For the last dose of 0.16 mg on Cycle 1 Day 1, more than 8 days require patients to repeat 0.16 mg, followed by 0.8 mg the following week, and then two weekly doses of 48 mg before resuming the planned dosage schedule. If the last dose was 0.8 mg on Cycle 1 Day 8 and 14 days or less have passed, patients should take 48 mg and resume the recommended schedule; for more than 14 days, they follow the first scenario. 
• For a last dose of 48 mg on Cycle 1 Day 15 onwards and 14 days or less since, patients should take 48 mg and resume the recommended schedule; for over 14 days, they follow the first scenario. After more than 6 weeks, patients should follow the first scenario. In addition, pretreatment medication is advised to reduce the risk of CRS.
• EPKINLY premedications include prednisolone or dexamethasone, diphenhydramine or equivalent, and acetaminophen, taken before each weekly administration in Cycle 1. In subsequent cycles, patients previously experiencing Grade 2 or 3a CRS take prednisolone or dexamethasone before the next administration and for three days afterward unless there’s no Grade 2 or higher CRS.
• Your healthcare provider will decide how many treatment cycles you will receive.

Important

Dispose of any unused EPKINLY solutions when they exceed the allowable storage time. Administer the necessary EPKINLY volume subcutaneously in the lower abdomen or thigh, rotating injection sites between the left and right sides, especially during the weekly administrations in Cycles 1 to 3. Avoid injecting into tattoos, scars, or areas with red, bruised, tender, hard, or damaged skin.

If you experience dizziness, confusion, tremors, sleepiness, or any other symptoms that impair your consciousness, refrain from driving, operating heavy machinery, or engaging in other hazardous activities.

Warnings & Precautions

• Epkinly is contraindicated in patients with a history of known severe hypersensitivity to the components of Epkinly and its ingredients. 
• Before receiving EPKINLY, inform your healthcare provider about your medical conditions, including any current infections. If you are pregnant or planning to become pregnant, your healthcare provider will conduct a pregnancy test before starting treatment. 
• During EPKINLY treatment and for four months after your final dose, you must use effective contraception. If you become pregnant or suspect pregnancy during treatment, notify your healthcare provider. 
• If you are breastfeeding or planning to do so, note that it is uncertain whether EPKINLY passes into breast milk, so refrain from breastfeeding during treatment and for four months after your last EPKINLY dose. Do not take this medicine if you are planning to breastfeed. 
• EPKINLY may cause Cytokine release syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). 
• A step-up dosing schedule helps manage CRS. If CRS occurs, treatment is withheld until it resolves. ICANS is monitored, and if it happens, EPKINLY may be withheld until ICANS resolves. Permanent discontinuation depends on the severity.
• EPKINLY may lead to severe or life-threatening infections, so it’s crucial to keep a close eye on patients for signs of infection, including opportunistic ones, and administer appropriate treatment when necessary. 
• Additionally, regular monitoring of complete blood cell counts should be conducted during treatment to check for any cytopenias. This comprehensive approach ensures the safety and well-being of patients.

Common Epkinly  Side Effects:

• Cytokine release syndrome
• Fatigue
• Musculoskeletal pain
• Tiredness
• Shortness of breath
• Painful rash
• Sore throat
• Injection site reactions
• Pyrexia
• Abdominal
• Pain, nausea, and diarrhea
• Decreased lymphocyte count
• Decreased neutrophil count
• Decreased white blood cell count
• Decreased hemoglobin
• Decreased platelets

Use in Specific Population

• The use of EPKINLY in pediatric patients hasn’t been verified for safety and effectiveness. 
• In the clinical trial with patients experiencing relapsed or refractory LBCL, approximately 49% were aged 65 or older, and 19% were aged 75 or older. 
• Importantly, no significant variations in safety or efficacy were detected between older patients (65 years and above) and younger adults. 
• This data underscores the potential for EPKINLY to be a valuable treatment option for a broad adult population, irrespective of age, while emphasizing the need for further investigation in pediatric cases. 

Storage and Handling

• Store Epkinly refrigerated at 2°C – 8°C (36°F – 46°F) in the original carton.
• Protect  the medicine from light. Do not freeze. Do not shake.
• Epkinly is a sterile product, and it should not be used if the vial is damaged or the seal is broken. 
• Please use the diluted EPKINLY solution promptly after preparation. If immediate use is not possible, you can store the solution in the refrigerator at 2°C to 8°C (36°F to 46°F) for a maximum of 24 hours, or at room temperature, which should be around 20°C to 25°C (68°F to 77°F), for up to 12 hours. 
• The cumulative storage time, from the moment of preparation to administration, must not exceed 24 hours, and it’s important to shield the solution from direct sunlight.
• Allow the EPKINLY solution to reach room temperature for no more than 1 hour before administering it, and any unused solution should be discarded after the approved storage duration.