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EPKINLY is a brand name for Epcoritamab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
). 5. Overdose In the event of overdose, monitor the patient for any signs or symptoms of adverse reactions and administer appropriate supportive treatment. For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764- 7669).
6. Dosage Forms, Strengths, Composition, and Packaging Table 6. 8 mL (60 mg/mL) single dose vial The vial stopper is not made from natural rubber latex (made of bromobutyl rubber). 7. Warnings and Precautions Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX.
Driving and Operating Machinery EPKINLY may have an influence on the ability to drive or operate machinery. , symptoms of CRS or ICANS, such as pyrexia, tachycardia, hypotension, chills, hypoxia, depressed level of consciousness) should be advised not to drive or use machines until symptoms resolve.
Endocrine and Metabolism Tumour Lysis Syndrome Tumour Lysis Syndrome (TLS) has been reported in patients receiving EPKINLY (see 8 ADVERSE REACTIONS). Patients at an increased risk for TLS are recommended to receive hydration and prophylactic treatment with a uric acid lowering agent.
Patients should be monitored for signs or symptoms of TLS, especially patients with high tumour burden or rapidly proliferative tumours, and patients with reduced renal function. Patients should be monitored for blood chemistries and abnormalities should be managed promptly.
3 Pharmacokinetics, Special Populations and Conditions). Immune Cytokine Release Syndrome Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving EPKINLY. The most common signs and symptoms of CRS include pyrexia, hypotension and hypoxia.
Other signs and symptoms of CRS in greater than two patients include chills, tachycardia, headache and dyspnea. The median time to onset of CRS from the most recent administered EPKINLY dose was 2 days (range: 1 to 11 days). 2 to 7 days).
Most CRS events occurred in Cycle 1 and were associated with the first full dose of EPKINLY. Median duration of CRS was 3 Days (range: 1 to 27 days). Administer prophylactic medications including corticosteroids to mitigate the risk of CRS (see 4 DOSAGE AND ADMINISTRATION).
In addition to EPKINLY (epcoritamab injection / epcoritamab for injection) Page 15 of 42 corticosteroids use, tocilizumab was used to manage CRS event in 15% of patients. Monitor patients for CRS following EPKINLY administrations during Cycle 1 and in subsequent cycles as needed at the discretion of the health professional.
For 24 hours following administration of the first full dose of 48 mg, patients should remain within proximity of a healthcare facility and be monitored for signs and symptoms of CRS, or alternatively consider hospitalization. At the first signs or symptoms of CRS, institute treatment of supportive care with tocilizumab and/or corticosteroids as per institutional guidelines considering the recommendations listed in Table 7.
5 x 109/L or higher. 5 Missed Dose for how to properly resume treatment. Thrombocytopenia1 (see 8 ADVERSE REACTIONS) Platelet count less than 50 x 109/L • Withhold EPKINLY until platelet count is 50 x 109/L or higher. 5 Missed Dose for how to properly resume treatment.
Other adverse reactions1 (see 8 ADVERSE REACTIONS) Grade 3 or higher • Withhold EPKINLY until the toxicity resolves to Grade ≤ 1. • For events associated with severe outcomes, consider permanent discontinuation of therapy. CRS and ICANS graded according to ASTCT consensus criteria.
1. 0. Dosing in Special Populations Pediatrics (< 18 years of age) EPKINLY is not indicated in the pediatric population, as the safety and efficacy of EPKINLY in pediatric patients less than 18 years of age have not been evaluated. Geriatric (≥ 65 years of age) In the EPCORE NHL-1 study, 48 (31%) patients were ≥ 65 to < 75 years of age and 29 (18%) patients were ≥ 75 years of age.
No clinically meaningful differences in safety or efficacy were observed between patients ≥ 65 years of age compared with younger adult patients. EPKINLY (epcoritamab injection / epcoritamab for injection) Page 10 of 42 Renal impairment Dose adjustments are not considered necessary in patients with mild to moderate renal impairment.
Patients with severe renal impairment were excluded from clinical studies with EPKINLY and no dose recommendations can be made for these patients. Hepatic impairment Dose adjustments are not considered necessary in patients with mild hepatic impairment.
Patients with moderate or severe hepatic impairment were excluded from clinical studies with EPKINLY and no dose recommendations can be made for these patients. 3. Reconstitution Dose Preparation Use aseptic techniques to prepare EPKINLY.
Filtration of the diluted solution is not recommended because of potential loss of active ingredient. The following table outlines the materials needed for preparation of the step-up doses. Table 4. 16 mg) Preparation Instructions – (2 dilutions required): Use an appropriately sized syringe, vial and needle for each transfer step.
3 Pharmacokinetics, Special Populations and Conditions). 2. Contraindications • EPKINLY is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 3. Serious Warnings and Precautions Box Serious Warnings and Precautions • Cytokine Release Syndrome (CRS), which may be serious or life-threatening occurred in patients receiving EPKINLY.
Initiate treatment with EPKINLY step-up dosing schedule to reduce the risk of CRS. Withhold EPKINLY until CRS resolves, provide supportive care and treatment as needed, or permanently discontinue based on severity (see 7 WARNINGS AND PRECAUTIONS).
• Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), which include life- threatening and fatal events have occurred in patients receiving EPKINLY. ICANS can be concurrent with CRS, occur following resolution of CRS, or occur in the absence of CRS.
Withhold EPKINLY until ICANS resolves or permanently discontinue based on severity (see 7 WARNINGS AND PRECAUTIONS). • Progressive Multifocal leukoencephalopathy (PML), which include life-threatening and fatal events have occurred in patients receiving EPKINLY.
Withhold EPKINLY if PML is suspected and permanently discontinue if PML is confirmed (see 7 WARNINGS AND PRECAUTIONS). EPKINLY (epcoritamab injection / epcoritamab for injection) Page 6 of 42 • Haemophagocytic lymphohistiocytosis (HLH), including fatal cases, have been reported in patients receiving EPKINLY, and in some instances HLH has been reported independently of CRS (see 7 WARNINGS AND PRECAUTIONS).
Patients should be monitored in proximity to a healthcare facility for 24 hours after the first full dose of EPKINLY for signs and symptoms of CRS and ICANS. 4. 1. Dosing Considerations • Counsel patients on the risks associated with EPKINLY and distribute the Patient Card prior to administration of the first step-up dose.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Counsel patients on the signs and symptoms associated with CRS and instruct patients to contact their health professional and seek immediate medical attention should signs or symptoms occur at any time. Management of CRS may require either temporary delay or discontinuation of EPKINLY based on the severity of CRS as per recommendations in Table 7.
Patients who experience CRS should be monitored more frequently during the next scheduled EPKINLY administration. Withhold or discontinue EPKINLY as indicated in Table 3 (see 4 DOSAGE AND ADMINISTRATION). Haemophagocytic lymphohistiocytosis (HLH), including fatal cases, have been reported in patients receiving EPKINLY, and in some instances HLH has been reported independently of CRS.
HLH should be considered when the presentation of CRS is atypical or unresponsive and/or when clinical manifestations of HLH present such as prolonged fever, cytopenias, hyperferritinemia, coagulopathy and elevated liver enzymes. If HLH is suspected, withhold EPKINLY and initiate treatment for HLH per current practice guidelines.
Table 7. , advanced age, high tumour burden, circulating tumour cells, fever refractory to antipyretics): Tocilizumab 8 mg/kg IV over 1 hour (not to exceed 800 mg per dose). Repeat tocilizumab after at least 8 hours as needed. Maximum of 2 doses in a 24-hour period.
, siltuximab, anakinra). […]
8 mL (5 mg/mL) EPKINLY (epcoritamab for injection) vial with the light blue cap from the refrigerator. b) Allow the vial to come to room temperature for no more than 1 hour. c) Gently swirl the EPKINLY vial. DO NOT invert, vortex, or vigorously shake the vial.
2) Perform first dilution a) Label an appropriately sized empty vial as “Dilution A”. 8 mL of EPKINLY into the Dilution A vial. 9% Sodium Chloride Injection, sterile solution, into the Dilution A vial. d) Gently swirl the Dilution A vial for 30 – 45 seconds.
8 mg/mL. 3) Perform second dilution a) Label an appropriately sized empty vial as “Dilution B”. 0 mL of solution from the Dilution A vial into the Dilution B vial. The Dilution A vial is no longer needed. 9% Sodium Chloride Injection, sterile solution, into the Dilution B vial.
d) Gently swirl the Dilution B vial for 30 – 45 seconds. 16 mg/mL. 4) Withdraw dose a) Using a 1 mL syringe for SC injection, withdraw 1 mL of EPKINLY from the Dilution B vial. 16 mg and include the time of day. Discard the vial and any unused portions of EPKINLY in accordance with local requirements.
Use prepared EPKINLY immediately or store EPKINLY solution in a refrigerator and protect from light up to 24 hours from the time of preparation (see 11 STORAGE, STABILITY AND DISPOSAL). 8 mg) Preparation Instructions – (1 dilution required): Use an appropriately sized syringe, vial and needle for each transfer step.
8 mL (5 mg/mL) EPKINLY (epcoritamab for injection) vial with the light blue cap from the refrigerator. b) Allow the vial to come to room temperature for no more than 1 hour. c) Gently swirl the EPKINLY vial. DO NOT invert, vortex, or vigorously shake the vial.
2) Perform dilution a) Label an appropriately sized empty vial as “Dilution A”. 8 mL of EPKINLY into the Dilution A vial. 9% Sodium Chloride Injection, sterile solution, into the Dilution A vial. d) Gently swirl the Dilution A vial for 30 – 45 seconds.
8 mg/mL. 3) Withdraw dose a) Using a 1 mL syringe for SC injection, withdraw 1 mL of EPKINLY from the Dilution A vial. 8 mg and include the time of day. Discard the vial and any unused portions of EPKINLY in accordance with local requirements.
Use prepared EPKINLY immediately or store EPKINLY solution in a refrigerator and protect from light up to 24 hours from the time of preparation (see 11 STORAGE, STABILITY AND DISPOSAL). EPKINLY (epcoritamab injection / epcoritamab […]
• EPKINLY should only be administered under the supervision of a health professional experienced in the treatment of cancer patients and who has access to appropriate medical support to manage severe reactions such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
• EPKINLY should not be administered to patients with active infections. • EPKINLY should not be administered to patients who have recently (within 4 weeks) received a live or live-attenuated vaccine (see 7 WARNINGS AND PRECAUTIONS).
Premedication and Prophylaxis • Consider initiating prophylaxis against Pneumocystis jirovecii pneumonia (PJP) and herpes virus infections prior to starting treatment with EPKINLY. • EPKINLY should be administered to adequately hydrated patients.
Details on recommended premedication for CRS is detailed in Table 1. Table 1. Epcoritamab Premedication for CRS Cycle Patient requiring premedication Premedication Administration Cycle 1 All patients • Prednisolone (100 mg oral or IV) or equivalent • 30-120 minutes prior to each weekly administration of EPKINLY • And for three consecutive days following each weekly administration of EPKINLY in Cycle 1 EPKINLY (epcoritamab injection / epcoritamab for injection) Page 7 of 42 • Diphenhydramine (50 mg oral or IV) or equivalent • Acetaminophen (650 to 1000 mg oral) • 30-120 minutes prior to the administration of EPKINLY Cycle 2 and beyond Patients who experienced Grade 2 or 3a CRS with previous dose • Prednisolone (100 mg oral or IV) or equivalent • 30-120 minutes prior to next administration of EPKINLY after a grade 2 or 3a CRS event • And for three consecutive days following the next administration of EPKINLY until EPKINLY is given without subsequent CRS of Grade 2 or higher a.
Patients will be permanently discontinued from EPKINLY after a Grade 4 CRS event. Monitoring Monitor patients for potential CRS and immune effector cell-associated neurotoxicity syndrome (ICANS) following EPKINLY administrations during Cycle 1 and in subsequent cycles as needed at the discretion of the health professional.
For 24 hours following administration of the first full dose of 48 mg (Day 15 of Cycle 1), patients should remain within proximity of a healthcare facility and be monitored for signs and symptoms of CRS and ICANS, or alternatively consider hospitalization.
Counsel patients on the signs and symptoms associated with CRS and ICANS and on seeking immediate medical attention should signs or symptoms occur at any time (see 7 WARNINGS AND PRECAUTIONS). 2. Recommended Dose and Dosage Adjustment • EPKINLY is administered by subcutaneous (SC) injection only in 28-day cycles.
4 Administration). 4 Administration). • Weekly 48 mg doses of EPKINLY continue for Cycles 2 and 3 using the EPKINLY vial with the orange cap. • Starting in Cycle 4 and continuing through Cycle 9, the 48 mg EPKINLY doses are administered once every two weeks (Days 1 and 15 only of each cycle).
• Starting in Cycle 10, the 48 mg EPKINLY dose is taken once every 4 weeks (Day 1 only of each 28-day cycle). • EPKINLY is taken according to the following schedule until disease progression or unacceptable toxicity. EPKINLY (epcoritamab injection / epcoritamab for injection) Page 8 of 42 Table 2.
8 mgb 15, 22 48 mg Weekly Cycle 2 & 3 1, 8, 15, 22 48 mg Every two weeks Cycle 4-9 1, 15 48 mg […]