EPKINLY support and resources

MyNavCare^™ by Genmab offers resources, services, and support to help patients access EPKINLY throughout their treatment journey. Our support services include:

Financial Assistance

Explore financial assistance options for eligible patients.

Billing & Coverage

Access information and resources on billing, coding, acquisition, and more.

Forms & Resources

Find helpful access-related tools and documents to support your patients.

Patients and care partners can receive ongoing support from Patient Engagement Liaisons throughout their treatment journey.*

*MyNavCare Patient Engagement Liaisons are part of the MyNavCare Patient Support Program and do not provide medical advice or work under the direction of the prescribing healthcare providers. They are trained to direct patients to speak with their healthcare provider about any treatment-related questions.

Visit MyNavCare.com or call 1-866-NAV-CAR1
(1-866-628-2271) to enroll your patients today

Find helpful resources for your practice and patients

Resources for your practice

Adverse Reactions Management Guide

Adverse Reactions Management Guide

Dosing and Administration Guide

Dosing and Administration Guide

Dose Preparation Guide

Dose Preparation Guide

Treatment Reference Guide

Treatment Reference Guide

Resources for your patients and care partners

Patient Brochure

Patient Brochure

Care Partner Brochure

Care Partner Brochure

Market access resources

Product Acquisition Flashcard

Product Acquisition Flashcard

Product Replacement Card

Product Replacement Card

Click to download Epkinly
HCP Brochure.

HCP Brochure↓

Click to download Adverse Reactions Management Guide.

Adverse Reactions Management Guide↓

Click to download Dosing
and Administration Guide.

Dosing and Administration Guide↓

Click to download Dose
Preparation Guide.

Dose Preparation Guide↓

Click to download Product
Acquisition Flashcard.

Product Acquisition Flashcard↓

Click to download Product
Replacement Card.

Product Replacement Card↓

Resources for your patients and care partners

Click to download Patient Brochure.

Patient Brochure↓

Click to download Care Partner Brochure.

Care Partner Brochure↓

Click to download Wallet Card.

For questions and concerns about EPKINLY

MEDICAL INFORMATION

Phone: 1-855-4GENMAB

Visit: Genmab Medical Information

Visit: AbbVie Medical Information

REPORT AN ADVERSE EVENT

Email: Globaldrugsafety@Genmab.com

Phone: 1-855-4GENMAB

You are encouraged to report side effects of prescription drugs to the FDA.

Visit www.fda.gov/safety/medwatch or call 1-800-FDA-1088

REPORT A PRODUCT COMPLAINT

Email: ProductComplaint@genmab.com

Phone: 1-855-4GENMAB

FDA=Food and Drug Administration.

Interested in learning more about EPKINLY? Get in contact with a representative

START THE CONVERSATION

Find out how to order EPKINLY

GET STARTED NOW

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS

Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving EPKINLY. Initiate treatment with the EPKINLY step-up dosing schedule to reduce the incidence and severity of CRS. Withhold EPKINLY until CRS resolves or permanently discontinue based on severity.
Immune effector cell–associated neurotoxicity syndrome (ICANS), including life-threatening and fatal reactions, can occur with EPKINLY. Monitor patients for neurological signs or symptoms of ICANS during treatment. Withhold EPKINLY until ICANS resolves or permanently discontinue based on severity.

CRS

CRS occurred in 51% of patients in the clinical trial (37% grade 1, 17% grade 2, and 2.5% grade 3) and recurred in 16% of patients. Most events (92%) occurred during cycle 1, with 61% occurring after the 48 mg dose in cycle 1, day 15. In patients who experienced CRS, the signs and symptoms included pyrexia, hypotension, hypoxia, dyspnea, chills, and tachycardia. Concurrent neurological adverse reactions associated with CRS occurred in 2.5% of patients and included headache, confusional state, tremors, dizziness, and ataxia.
Administer pretreatment medications to reduce the risk of CRS. Following administration of the first 48 mg dose, patients should be hospitalized for 24 hours.
Monitor patients for potential CRS. At the first signs or symptoms of CRS, manage per current practice guidelines and administer supportive care as appropriate.

ICANS

ICANS occurred in 6% of patients in the clinical trial (4.5% grade 1, 1.3% grade 2, 0.6% fatal). Of the 10 ICANS events, 9 occurred in cycle 1 of treatment. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Clinical manifestations of ICANS included, but were not limited to, confusional state, lethargy, tremor, dysgraphia, aphasia, and non-convulsive status epilepticus.
Monitor patients for potential ICANS. At the first signs or symptoms of ICANS, manage per current practice guidelines and administer supportive care as appropriate.

Infections

EPKINLY can cause serious and fatal infections. In the clinical trial, serious infections, including opportunistic infections, were reported in 15% of patients treated with EPKINLY at the recommended dose (14% grade 3 or 4, 1.3% fatal).
Monitor patients for signs and symptoms of infection prior to and during treatment and treat appropriately. Avoid administration in patients with active infections. Withhold or consider permanent discontinuation of EPKINLY based on severity. Prior to starting EPKINLY, provide Pneumocystis jirovecii pneumonia (PJP) prophylaxis and consider prophylaxis against herpes virus.

Cytopenias

EPKINLY can cause serious or severe cytopenias. In the clinical trial, grade 3 or 4 events occurred in 32% (neutropenia), 12% (anemia), and 12% (thrombocytopenia) of patients. Febrile neutropenia occurred in 2.5%.
Monitor complete blood counts throughout treatment. Based on severity of cytopenias, temporarily withhold or permanently discontinue EPKINLY. Consider prophylactic granulocyte colony-stimulating factor administration as applicable.

Embryo-Fetal Toxicity

EPKINLY may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with EPKINLY and for 4 months after the last dose. Verify pregnancy status in females of reproductive potential prior to initiating EPKINLY.

Adverse Reactions

Most common (≥20%) adverse reactions were CRS, fatigue, musculoskeletal pain, injection site reactions, pyrexia, abdominal pain, nausea, and diarrhea. Most common grade 3 to 4 laboratory abnormalities (≥10%) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets.

Lactation

Advise women not to breastfeed during treatment and for 4 months after the last dose of EPKINLY.

INDICATION

EPKINLY is indicated for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma (HGBL) after 2 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).

Please see full Prescribing Information, including Boxed Warnings.

INDICATION

EPKINLY is indicated for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma (HGBL) after 2 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).

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS: CRS and ICANS

Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving EPKINLY. Initiate treatment with the EPKINLY step-up dosing schedule to reduce the incidence and severity of CRS. Withhold EPKINLY until CRS resolves or permanently discontinue based on severity.
Immune effector cell–associated neurotoxicity syndrome (ICANS), including life-threatening and fatal reactions, can occur with EPKINLY. Monitor patients for neurological signs or symptoms of ICANS during treatment. Withhold EPKINLY until ICANS resolves or permanently discontinue based on severity.

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS: CRS and ICANS

Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving EPKINLY. Initiate treatment with the EPKINLY step-up dosing schedule to reduce the incidence and severity of CRS. Withhold EPKINLY until CRS resolves or permanently discontinue based on severity.
Immune effector cell–associated neurotoxicity syndrome (ICANS), including life-threatening and fatal reactions, can occur with EPKINLY. Monitor patients for neurological signs or symptoms of ICANS during treatment. Withhold EPKINLY until ICANS resolves or permanently discontinue based on severity.

INDICATION

EPKINLY is indicated for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma (HGBL) after 2 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).

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS: CRS and ICANS

Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving EPKINLY. Initiate treatment with the EPKINLY step-up dosing schedule to reduce the incidence and severity of CRS. Withhold EPKINLY until CRS resolves or permanently discontinue based on severity.
Immune effector cell–associated neurotoxicity syndrome (ICANS), including life-threatening and fatal reactions, can occur with EPKINLY. Monitor patients for neurological signs or symptoms of ICANS during treatment. Withhold EPKINLY until ICANS resolves or permanently discontinue based on severity.

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS: CRS and ICANS

Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving EPKINLY. Initiate treatment with the EPKINLY step-up dosing schedule to reduce the incidence and severity of CRS. Withhold EPKINLY until CRS resolves or permanently discontinue based on severity.
Immune effector cell–associated neurotoxicity syndrome (ICANS), including life-threatening and fatal reactions, can occur with EPKINLY. Monitor patients for neurological signs or symptoms of ICANS during treatment. Withhold EPKINLY until ICANS resolves or permanently discontinue based on severity.

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS

Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving EPKINLY. Initiate treatment with the EPKINLY step-up dosing schedule to reduce the incidence and severity of CRS. Withhold EPKINLY until CRS resolves or permanently discontinue based on severity.
Immune effector cell–associated neurotoxicity syndrome (ICANS), including life-threatening and fatal reactions, can occur with EPKINLY. Monitor patients for neurological signs or symptoms of ICANS during treatment. Withhold EPKINLY until ICANS resolves or permanently discontinue based on severity.

CRS

CRS occurred in 51% of patients in the clinical trial (37% grade 1, 17% grade 2, and 2.5% grade 3) and recurred in 16% of patients. Most events (92%) occurred during cycle 1, with 61% occurring after the 48 mg dose in cycle 1, day 15. In patients who experienced CRS, the signs and symptoms included pyrexia, hypotension, hypoxia, dyspnea, chills, and tachycardia. Concurrent neurological adverse reactions associated with CRS occurred in 2.5% of patients and included headache, confusional state, tremors, dizziness, and ataxia.
Administer pretreatment medications to reduce the risk of CRS. Following administration of the first 48 mg dose, patients should be hospitalized for 24 hours.
Monitor patients for potential CRS. At the first signs or symptoms of CRS, manage per current practice guidelines and administer supportive care as appropriate.

ICANS

ICANS occurred in 6% of patients in the clinical trial (4.5% grade 1, 1.3% grade 2, 0.6% fatal). Of the 10 ICANS events, 9 occurred in cycle 1 of treatment. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Clinical manifestations of ICANS included, but were not limited to, confusional state, lethargy, tremor, dysgraphia, aphasia, and non-convulsive status epilepticus.
Monitor patients for potential ICANS. At the first signs or symptoms of ICANS, manage per current practice guidelines and administer supportive care as appropriate.

Infections

EPKINLY can cause serious and fatal infections. In the clinical trial, serious infections, including opportunistic infections, were reported in 15% of patients treated with EPKINLY at the recommended dose (14% grade 3 or 4, 1.3% fatal).
Monitor patients for signs and symptoms of infection prior to and during treatment and treat appropriately. Avoid administration in patients with active infections. Withhold or consider permanent discontinuation of EPKINLY based on severity. Prior to starting EPKINLY, provide Pneumocystis jirovecii pneumonia (PJP) prophylaxis and consider prophylaxis against herpes virus.

Cytopenias

EPKINLY can cause serious or severe cytopenias. In the clinical trial, grade 3 or 4 events occurred in 32% (neutropenia), 12% (anemia), and 12% (thrombocytopenia) of patients. Febrile neutropenia occurred in 2.5%.
Monitor complete blood counts throughout treatment. Based on severity of cytopenias, temporarily withhold or permanently discontinue EPKINLY. Consider prophylactic granulocyte colony-stimulating factor administration as applicable.

Embryo-Fetal Toxicity

EPKINLY may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with EPKINLY and for 4 months after the last dose. Verify pregnancy status in females of reproductive potential prior to initiating EPKINLY.

Adverse Reactions

Most common (≥20%) adverse reactions were CRS, fatigue, musculoskeletal pain, injection site reactions, pyrexia, abdominal pain, nausea, and diarrhea. Most common grade 3 to 4 laboratory abnormalities (≥10%) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets.

Lactation

Advise women not to breastfeed during treatment and for 4 months after the last dose of EPKINLY.

INDICATION

EPKINLY is indicated for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma (HGBL) after 2 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).

Please see full Prescribing Information, including Boxed Warnings.