For Healthcare Professionals

MONJUVI Dosage & Administration Guide
MONJUVI Dosage & Administration Guide

MONJUVI Dosage & Administration Guide (Spanish)
(1.2MB) Explains the dosage schedule for MONJUVI (tafasitamab-cxix) + lenalidomide and offers guidance for adjusting the dose as needed.
MONJUVI Nurse-Patient Discussion Guide
MONJUVI Nurse-Patient Discussion Guide
(4MB) Helps caregivers understand how treatment with MONJUVI works; also offers caregiving tips and support.
MONJUVI Product Information Sheet
MONJUVI Product Information Sheet
(2.8MB) Includes information about MONJUVI and its select network of Specialty Distributors or Specialty Pharmacies.
MONJUVI Billing & Coding Guide
MONJUVI Billing & Coding Guide
(4MB) Provides information about relevant codes for MONJUVI, including product codes, procedure codes, and National Drug Codes.
MONJUVI J-Code Quick Reference Guide
MONJUVI J-Code Quick Reference Guide
(2MB) Assists with the reimbursement process for MONJUVI.

For Patients And Caregivers

MONJUVI Patient Brochure
MONJUVI Patient Brochure

(2.6MB) Provides a comprehensive overview of treatment with MONJUVI.
MONJUVI Caregiver Brochure
MONJUVI Caregiver Brochure
(2.5MB) Helps caregivers understand how treatment with MONJUVI works; also offers caregiving tips and support.
MONJUVI Patient Website
MONJUVI Patient Website
Patients can visit this site for information about MONJUVI and what to expect from treatment.
My MISSION Support Brochure
My MISSION Support Brochure
(2.5MB) Provides an overview of the patient support program.
MONJUVI Treatment Journal
MONJUVI Treatment Journal
(1.7MB) Enables patients to keep track of their treatment schedule, side effects, questions, and thoughts while on treatment.
MorphoSys Foundation website
MorphoSys Foundation
The MorphoSys Foundation is a non-profit charitable foundation that seeks to help patients access appropriate and necessary care and improve the lives of patients and their loved ones in areas of high unmet need.

My MISSION Support

My MISSION Support can help you understand health insurance coverage requirements, answer billing and coding questions, and enroll eligible patients in all program services, including financial assistance programs, helping to secure appropriate access to MONJUVI for eligible patients.

My MISSION Support's Program Specialists offer personalized assistance, with the goal of making MONJUVI access simple and streamlined, while providing holistic, compassionate support.

My MISSION Support: Robust access and support services for you and your patients

  1. Visit MyMISSIONSupport.com or call 855-421-6172 anytime between AM and 8 PM ET

Videos

MONJUVI Efficacy and Safety

Transcript

DOCTOR: Hello, I’m Dr. Eradat, Associate Clinical Professor of Medicine at the David Geffen School of Medicine at UCLA. Today, we will discuss the efficacy and safety of MONJUVI in combination with lenalidomide, followed by MONJUVI as monotherapy, as a second or later line of treatment in non-transplant–eligible adult patients who have diffuse large B-cell lymphoma. We’ll review the data from the L-MIND clinical trial, looking at results from both the 1-year primary analysis as well as the 3-year follow-up.

NARRATOR: MONJUVI (tafasitamab-cxix), in combination with lenalidomide, is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified, including diffuse large B-cell lymphoma arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.

NARRATOR: This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial or trials.

NARRATOR: MONJUVI can cause infusion-related reactions. In the L-MIND trial, infusion-related reactions, or IRRs, occurred in 6% of the 81 patients. Eighty percent of the IRRs occurred during cycle 1 or 2. Patients should be premedicated and monitored frequently during their infusion and based on the severity of the IRRs, interrupt or discontinue MONJUVI and institute appropriate medical management.

NARRATOR: In addition, MONJUVI can cause serious or severe myelosuppression, including neutropenia, thrombocytopenia, and anemia. Patients’ complete blood counts should be monitored prior to administration of each treatment cycle and throughout treatment. Patients with neutropenia should be monitored for signs of infection and MONJUVI should be withheld based on the severity of the adverse reaction.

NARRATOR: Fatal and serious infections, including opportunistic infections, occurred in patients during treatment with MONJUVI and following the last dose. Monitor your patients for signs and symptoms of infection and manage as appropriate.

NARRATOR: Because MONJUVI may cause fetal B-cell depletion when administered to a pregnant woman, you should advise pregnant women of the potential risk to a fetus, and advise women of reproductive potential to use effective contraception during treatment with MONJUVI and for at least 3 months after the last dose.

NARRATOR: We will be discussing more about the safety profile during this presentation.

DOCTOR: MONJUVI is a humanized CD19-directed monoclonal antibody that, upon binding to CD19, mediates B-cell lysis through apoptosis and immune effector mechanisms, including antibody-directed cellular phagocytosis, or ADCP, and antibody-directed cellular cytotoxicity, or ADCC.

DOCTOR: In studies conducted in vitro in diffuse large B-cell lymphoma tumor cells, tafasitamab-cxix, in combination with lenalidomide, resulted in increased ADCC activity compared to tafasitamab-cxix or lenalidomide alone.

DOCTOR: L-MIND was an open-label, multicenter, single-arm, phase 2 study that evaluated the efficacy and safety of MONJUVI in combination with lenalidomide in adult patients with relapsed or refractory diffuse large B-cell lymphoma.

DOCTOR: L-MIND included patients with relapsed or refractory diffuse large B-cell lymphoma after 1 to 3 prior systemic therapies, including a CD20-containing therapy. Patients were not eligible for, or refused, autologous stem cell transplant.

DOCTOR: The primary endpoint was the overall response rate, which was defined as the proportion of complete and partial responders.

DOCTOR: Duration of response was a select secondary endpoint.

DOCTOR: Efficacy was assessed by an Independent Review Committee using the International Working Group Response Criteria.

DOCTOR: Treatment was administered in 28-day cycles. MONJUVI was administered on days 1, 8, 15, and 22 of cycles 1 through 3, with an additional loading dose on day 4 of cycle 1. After cycle 3, MONJUVI was administered on days 1 and 15. Lenalidomide was administered on days 1 through 21 of cycles 1 through 12 only.

DOCTOR: Please see the Prescribing Information to learn more about administering premedications to minimize infusion-related reactions.

DOCTOR: This table shows the baseline characteristics of the patients with relapsed or refractory diffuse large B-cell lymphoma in the L-MIND study. Let’s take a look at some of the characteristics of patients in the study.

DOCTOR: Nearly 20% of patients had primary refractory disease.

DOCTOR: In addition, 49% received 1 prior line of therapy; 51% received 2 to 4 prior lines.

DOCTOR: For nearly 24% of patients, the first documented relapse or progression occurred within the first 12 months after initial diagnosis. Half of the patients studied were categorized as intermediate-high and high risk based on their IPI score.

DOCTOR: This trial included patients whose diffuse large B-cell lymphoma reoccurred or did not respond after 1 to 3 prior systemic therapies, including a CD20-containing therapy.

DOCTOR: Patients were not candidates for autologous stem cell transplant based on their age, comorbidities, whether they were refractory to salvage chemotherapy, and whether they refused high-dose chemotherapy and stem cell transplant.

DOCTOR: L-MIND included primary refractory patients and those with an IPI score of 3 to 5. In separate analyses, these characteristics of high-risk DLBCL were linked to poor outcomes.

DOCTOR: Let’s review the overall response rate shown with the combination of MONJUVI and lenalidomide in the 1-year primary analysis of L-MIND.

DOCTOR: Among the 71 patients with relapsed or refractory diffuse large B-cell lymphoma confirmed by central laboratory the overall response rate was 55%, which included 37% of patients who had a complete response. 18% of the patients had a partial response.

DOCTOR: This analysis is exploratory in nature, and L-MIND was not designed or powered to evaluate and compare multiple subgroups. These results should be interpreted with caution given the small sample size, which may lead to estimates that are unstable.

DOCTOR: The overall response rate was 63% for patients with 1 line of prior therapy, and 47% for those with 2 or more lines of prior therapy.

DOCTOR: The overall response rate was 62% for patients with low or low-intermediate risk and 49% for patients with intermediate-high and high risk, based on the IPI score.

DOCTOR: Now let’s take a look at the overall response rate data from the 3-year follow-up analysis. This analysis was conducted after the last patient enrolled had completed at least 35 months of follow-up.

DOCTOR: Among the same 71 patients with relapsed or refractory diffuse large B-cell lymphoma, the overall response rate was 54%, including 35% of patients who had a complete response, and 18% of patients who had a partial response.

DOCTOR: Let’s look at the duration of response data from L-MIND in patients who received treatment with the combination of MONJUVI and lenalidomide.

DOCTOR: In the 1-year primary analysis, the median duration of response among the 71 patients with relapsed or refractory diffuse large B-cell lymphoma was 21.7 months.

DOCTOR: Following 3 years of follow-up of the same 71 patients, the median duration of response was 43.9 months.

DOCTOR: The safety profile of the MONJUVI and lenalidomide combination was evaluated in the full L-MIND study population of 81 patients.

DOCTOR: Let’s begin by summarizing the adverse reactions leading to discontinuation, death, and serious adverse reactions.

DOCTOR: 52% of patients experienced serious adverse reactions, 5% experienced fatal adverse reactions, and 25% experienced an adverse reaction that led to discontinuation.

DOCTOR: The most common adverse reactions that occurred in more than 20% of patients are listed here.

DOCTOR: The most common adverse reactions in 10% or more of patients are summarized here. The most common hematological adverse reactions were neutropenia, anemia, and thrombocytopenia. 49% of patients had grade 3 or 4 neutropenia, 17% had grade 3 or 4 thrombocytopenia, and 12% of patients had grade 3 or 4 febrile neutropenia.

DOCTOR: Other clinically relevant adverse reactions that occurred in less than 10% of patients in L-MIND, such as the 6% rate of infusion-related reactions, are summarized in this table.

DOCTOR: In addition, some select laboratory abnormalities that worsened from baseline in more than 20% of patients receiving MONJUVI are listed here.

DOCTOR: Let’s take a look at hematologic toxicity management and dosing modifications in L-MIND. More than 40% of patients received concomitant granulocyte colony-stimulating factor. Nearly half of patients had at least 1 dose reduction of lenalidomide. Nearly 80% of patients were able to receive a lenalidomide dose of at least 20 milligrams per day over the duration of their treatment. Permanent discontinuation of MONJUVI or lenalidomide due to an adverse reaction occurred in 25% of patients and permanent discontinuation of MONJUVI due to an adverse reaction occurred in 15%. Dosage interruptions of MONJUVI or lenalidomide due to an adverse reaction occurred in 69% of patients and dosage interruption of MONJUVI due to an adverse reaction occurred in 65%.

DOCTOR: Thank you for joining me for this presentation. Remember, MONJUVI, in combination with lenalidomide, is an FDA-approved treatment indicated in non-transplant–eligible adult patients with relapsed or refractory diffuse large B-cell lymphoma who have received at least 1 prior therapy.

NARRATOR: Indications & Usage

NARRATOR: MONJUVI (tafasitamab-cxix), in combination with lenalidomide, is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

NARRATOR: This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial or trials.

Important Safety Information

NARRATOR: Contraindications

NARRATOR: None.

Warnings and Precautions

Infusion-Related Reactions

NARRATOR: MONJUVI can cause infusion-related reactions (IRRs). In L-MIND, infusion-related reactions occurred in 6% of the 81 patients. Eighty percent of infusion-related reactions occurred during cycle 1 or 2. Signs and symptoms included fever, chills, rash, flushing, dyspnea, and hypertension. These reactions were managed with temporary interruption of the infusion and/or with supportive medication. Premedicate patients prior to starting MONJUVI infusion. Monitor patients frequently during infusion. Based on the severity of the infusion-related reaction, interrupt or discontinue MONJUVI. Institute appropriate medical management.

Myelosuppression

NARRATOR: MONJUVI can cause serious or severe myelosuppression, including neutropenia, thrombocytopenia, and anemia. In L-MIND, Grade 3 neutropenia occurred in 25% of patients, thrombocytopenia in 12%, and anemia in 7%. Grade 4 neutropenia occurred in 25% and thrombocytopenia in 6%. Neutropenia led to treatment discontinuation in 3.7% of patients.

NARRATOR: Monitor complete blood counts (CBC) prior to administration of each treatment cycle and throughout treatment. Monitor patients with neutropenia for signs of infection. Consider granulocyte colony-stimulating factor (G-CSF) administration. Withhold MONJUVI based on the severity of the adverse reaction. Refer to the lenalidomide prescribing information for dosage modifications.

Infections

NARRATOR: Fatal and serious infections, including opportunistic infections, occurred in patients during treatment with MONJUVI and following the last dose.

NARRATOR: In L-MIND, 73% of the 81 patients developed an infection. The most frequent infections were respiratory tract infection (24%), urinary tract infection (17%), bronchitis (16%), nasopharyngitis (10%) and pneumonia (10%). Grade 3 or higher infection occurred in 30% of the 81 patients. The most frequent grade 3 or higher infection was pneumonia (7%). Infection-related deaths were reported in 2.5% of the 81 patients.

NARRATOR: Monitor patients for signs and symptoms of infection and manage infections as appropriate.

Embryo-Fetal Toxicity

NARRATOR: Based on its mechanism of action, MONJUVI may cause fetal B-cell depletion when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise women of reproductive potential to use effective contraception during treatment with MONJUVI and for at least 3 months after the last dose.

NARRATOR: MONJUVI is initially administered in combination with lenalidomide. The combination of MONJUVI with lenalidomide is contraindicated in pregnant women because lenalidomide can cause birth defects and death of the unborn child. Refer to the lenalidomide prescribing information on use during pregnancy.

Adverse Reactions

NARRATOR: Serious adverse reactions occurred in 52% of patients who received MONJUVI. Serious adverse reactions in ≥6% of patients included infections (26%), including pneumonia (7%), and febrile neutropenia (6%). Fatal adverse reactions occurred in 5% of patients who received MONJUVI, including cerebrovascular accident (1.2%), respiratory failure (1.2%), progressive multifocal leukoencephalopathy (1.2%) and sudden death (1.2%).

NARRATOR: Permanent discontinuation of MONJUVI or lenalidomide due to an adverse reaction occurred in 25% of patients and permanent discontinuation of MONJUVI due to an adverse reaction occurred in 15%. The most frequent adverse reactions which resulted in permanent discontinuation of MONJUVI were infections (5%), nervous system disorders (2.5%), respiratory, thoracic and mediastinal disorders (2.5%).

NARRATOR: Dosage interruptions of MONJUVI or lenalidomide due to an adverse reaction occurred in 69% of patients and dosage interruption of MONJUVI due to an adverse reaction occurred in 65%. The most frequent adverse reactions which required a dosage interruption of MONJUVI were blood and lymphatic system disorders (41%), and infections (27%).

NARRATOR: The most common adverse reactions (≥20%) were neutropenia (51%), fatigue (38%), anemia (36%), diarrhea (36%), thrombocytopenia (31%), cough (26%), pyrexia (24%), peripheral edema (24%), respiratory tract infection (24%), and decreased appetite (22%).

NARRATOR: You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to MORPHOSYS US INC. at (844) 667-1992.

NARRATOR: Please see the full Prescribing Information for additional Important Safety Information available at MONJUVI.com.

MONJUVI Preparation and Administration

Transcript

Thank you for joining this presentation about the dosage and administration of MONJUVI. In this video, you will learn how to administer MONJUVI to your patients with relapsed or refractory DLBCL. Erin Blackwell, an Oncology Clinical Nurse Educator from Incyte, will show you how to prepare the infusion. Erin has been a registered nurse for more than 8 years, and has worked in a variety of roles as an oncology and infusion nurse. You will also learn more about the treatment schedule, how to manage adverse reactions if they occur, what to advise your patients about possible adverse reactions, and where to find support and educational resources.

Before your patient’s first day of treatment with MONJUVI, discussing the details of the infusion process may help put him or her at ease. Here are a few important points you may want to mention to your patients:

Patients should consider bringing a caregiver to their appointments. Having a caregiver present can be an important means of support. Caregivers can assist patients with remembering the details of both their symptoms and treatment. They can also help provide clarification in conversations with the treatment team.

Explain that lab work may be done before or during infusion appointments, which may impact the length of appointments. Clarify how long the infusion will take on the first appointment and on subsequent visits. We will discuss this in more detail in the Administration section of this presentation. Encourage patients to bring reading materials or something to keep them occupied during their infusion. Suggest that patients dress in warm and comfortable clothing. Discuss the need for premedications, given prior to the infusion, to help minimize infusion-related reactions. We will talk more about this in the Premedications section of this presentation.

MONJUVI is the first and only FDA-approved second-line therapy for adult non-transplant–eligible patients with diffuse large B-cell lymphoma, or DLBCL, in combination with lenalidomide. Additionally, MONJUVI is the only CD19-targeted monoclonal antibody that can be administered in your office. This allows patients with DLBCL to continue to be treated in the office or clinic after relapse or first-line failure, preserving their continuity of care, and making treatment accessible. MONJUVI (tafasitamab-cxix), in combination with lenalidomide, is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.

This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial or trials.

MONJUVI can cause infusion-related reactions. In the L-MIND trial, infusion-related reactions, or IRRs, occurred in 6% of the 81 patients. Eighty percent of the IRRs occurred during cycle 1 or 2. Patients should be premedicated and monitored frequently during their infusion and based on the severity of the IRRs, interrupt or discontinue MONJUVI and institute appropriate medical management.

In addition, MONJUVI can cause serious or severe myelosuppression, including neutropenia, thrombocytopenia, and anemia. Patient’s complete blood counts should be monitored prior to administration of each treatment cycle and throughout treatment. Patients with neutropenia should be monitored for signs of infection and MONJUVI should be withheld based on the severity of the adverse reaction.

Fatal and serious infections, including opportunistic infections, occurred in patients during treatment with MONJUVI and following the last dose. Monitor your patients for signs and symptoms of infection and manage as appropriate. Lastly, because MONJUVI may cause fetal B-cell depletion when administered to a pregnant woman, you should advise pregnant women of the potential risk to a fetus, and advise women of reproductive potential to use effective contraception during treatment with MONJUVI and for at least 3 months after the last dose. We will be discussing more about the safety profile during this presentation.

Premedication, seen here, should be administered 30 minutes to 2 hours prior to starting MONJUVI infusion to minimize infusion-related reactions. Premedications may include acetaminophen, histamine H1 receptor antagonists, histamine H2 receptor antagonists, and/or glucocorticosteroids. Administer premedications 30 minutes to 2 hours before starting the MONJUVI infusion to minimize infusion-related reactions. If a patient experiences an infusion-related reaction, administer premedications before each subsequent infusion. For patients who did not experience infusion-related reactions during the first 3 infusions, premedication is optional before each subsequent infusion.

The recommended dose of MONJUVI is 12 milligrams per kilogram based on actual body weight. Administer MONJUVI in combination with lenalidomide 25 milligrams orally on days 1 to 21 of each 28-day cycle for a maximum of 12 cycles. For example, a patient weighing 176 pounds, or 80 kilograms, would require 960 milligrams of MONJUVI. This would require 5 vials of MONJUVI reconstituted for dilution in a 250-milliliter bag of 0.9% Sodium Chloride.

Each vial contains 200 mg of MONJUVI. We will be discussing reconstitution and dilution in more detail later in this video. MONJUVI is administered as an intravenous infusion in your office or infusion center, according to the following dosing schedule. This graph shows the treatment schedule up to cycle 12. Each cycle is 28 days long. During the first cycle, MONJUVI is administered on days 1, 4, 8, 15, and 22. During cycles 2 and 3, MONJUVI is administered on days 1, 8, 15, and 22. From cycle 4 onward, MONJUVI is administered only on days 1 and 15. After 12 cycles, continue MONJUVI as monotherapy until disease progression or unacceptable toxicity. In summary, MONJUVI is given weekly during cycles 1 through 3, with a loading dose on day 4 of cycle 1. Beginning with cycle 4, MONJUVI is given every 2 weeks.

It is important to note that 45.7% of patients, or 37 out of 81, had at least one dose reduction of lenalidomide. Additionally, 77.5% of patients, or 62 out of 81, were able to receive a lenalidomide dose of at least 20 milligrams per day over the duration of their treatment. Refer to the lenalidomide prescribing information for lenalidomide dosage recommendations. MONJUVI should be administered by a healthcare professional with immediate access to emergency equipment and appropriate medical support to manage infusion-related reactions. Visit the Interactive Treatment Calendar on our website at MonjuviHCP.com to create a customized treatment schedule for your patients using the infusion number and cycle number at any point during their treatment.

Before administering the infusion, MONJUVI must first be reconstituted and diluted. Let’s review each process, step by step. Calculate the dose in milligrams and determine the number of vials needed. Based on our earlier example, a patient weighing 176 pounds will require 4.8 vials, so a total of 5 vials will need to be reconstituted for dilution. Each vial contains 200 mg of MONJUVI. The average patient will require 4 to 6 vials. However, patients should always be weighed prior to each cycle to confirm the appropriate dosing. Reconstitute each 200-milligram MONJUVI vial with 5 milliliters of Sterile Water for Injection, USP with the stream directed toward the wall of each vial to obtain a final concentration of 40 milligrams per milliliter of tafasitamab-cxix. Gently swirl the vial or vials until the contents have completely dissolved. Do not shake or swirl vigorously. Complete dissolution may take up to 5 minutes. Visually inspect the reconstituted solution for particulate matter or discoloration. The reconstituted solution should appear as a colorless to slightly yellow solution. Discard the vial or vials if the solution is cloudy, discolored, or contains visible particles. Use the reconstituted MONJUVI solution immediately. If needed, store the reconstituted solution in the vial for a maximum of 12 hours either refrigerated at 36oF to 46oF (2oC to 8oC) or room temperature at 68oF to 77oF (20oC to 25oC) before dilution. Protect from light during storage.

Determine the volume, in milliliters, of the 40 milligrams per milliliter reconstituted MONJUVI solution needed based on the required dose. Our 176-pound patient would require 24 milliliters of reconstituted MONJUVI solution. Therefore, 24 milliliters of 0.9% Sodium Chloride would need to be removed from the bag and replaced with reconstituted MONJUVI to create the final diluted product. The final concentration would be 3.84 milligrams per milliliter. The unused portion of reconstituted MONJUVI should be discarded.

Now that we’ve reviewed how to determine the volume of MONJUVI solution you need, I will show you the rest of the dilution process. Remove a volume equal to the required MONJUVI solution from a 250 milliliter 0.9% Sodium Chloride Injection, USP infusion bag and discard it. Withdraw the necessary amount of MONJUVI and slowly dilute in the infusion bag that contains the 0.9% Sodium Chloride Injection, USP to a final concentration of 2 milligrams per milliliter to 8 milligrams per milliliter. Discard any unused portion of MONJUVI remaining in the vial. Gently mix the intravenous bag by slowly inverting the bag. Do not shake. Visually inspect the infusion bag with the diluted MONJUVI infusion solution for particulate matter and discoloration prior to administration.

If not used immediately, store the diluted MONJUVI infusion solution refrigerated for up to 18 hours at 36oF to 46oF (2oC to 8oC) and/or at room temperature for up to 12 hours at 68oF to 77oF (20oC to 25oC). The room temperature storage includes time for infusion. Protect from light during storage. Do not shake or freeze the reconstituted or diluted infusion solutions.

Administer MONJUVI as an intravenous infusion. For the first infusion, use an infusion rate of 70 milliliters per hour for the first 30 minutes, then increase the rate so that the infusion is administered within 1.5 to 2.5 hours. In the L-MIND study, after the first 30 minutes, the rate of infusion was increased to 125 milliliters per hour over a 2-hour period. Administer all subsequent infusions within 1.5 to 2 hours.

In the L-MIND clinical trial, vital signs were measured immediately prior to each infusion, at 15 minutes, 30 minutes, every 60 minutes, and at the end of each infusion. Infuse the entire contents of the bag containing MONJUVI. Do not co-administer other drugs through the same infusion line. No incompatibilities have been observed between MONJUVI with infusion containers made of polypropylene (PP), polyvinylchloride (PVC), polyethylene (PE), polyethylenterephthalate (PET), or glass and infusion sets made of polyurethane (PUR) or PVC.

In the event that adverse reactions occur during treatment with MONJUVI, dosage modifications are recommended. Specific guidance on how to modify the dose in response to infusion-related reactions or myelosuppression is provided in Table 2 in the Prescribing Information. Depending on the severity of the infusion-related reaction, the infusion may need to be interrupted for symptoms to resolve and either resumed at a lower rate, or, in case of Grade 4 reactions, permanently discontinued. Complete blood counts should also be monitored in all patients prior to receiving each MONJUVI treatment cycle and throughout treatment. Manage myelosuppression using dose modifications and growth factor support. Depending on the platelet and neutrophil counts, patients may need to interrupt treatment. After complete blood count recovery, MONJUVI can be resumed at the same dose, but lenalidomide should be resumed at a reduced dose.

Before your patients begin treatment with MONJUVI, there are several important topics to discuss. Infusion-related reactions. Advise patients to contact their healthcare provider if they experience signs and symptoms of infusion-related reactions. Myelosuppression. Fever of 100.4°F (38°C) or greater, or bruising or bleeding, should be reported immediately. Advise patients of the need for periodic monitoring of blood counts. Infections. Fever of 100.4°F (38°C) or greater or signs or symptoms of infection should be reported immediately. Embryo-fetal toxicity. Advise pregnant women of the potential risk to a fetus. Women of reproductive potential should inform their healthcare provider of a known or suspected pregnancy. Advise women of reproductive potential to use effective contraception during treatment with MONJUVI and for at least 3 months after the last dose. Advise patients that lenalidomide has the potential to cause fetal harm and has specific requirements regarding contraception, pregnancy testing, blood and sperm donation, and transmission in sperm. Lenalidomide is only available through a REMS program. Lactation. Advise women not to breastfeed during treatment with MONJUVI and for at least 3 months after the last dose.

MONJUVI is an accessible therapy that can be administered to patients with relapsed or refractory DLBCL in both offices and clinics. My MISSION Support offers personalized patient support and education. When a patient enrolls in My MISSION Support, they may opt into receiving additional support and education from an oncology professional. These professionals are specially trained to support a patient’s ongoing journey with MONJUVI treatment by providing general disease and treatment information, routine phone-based check-ins, and referrals to additional resources. A patient’s doctor should always be their first point of contact for any questions about their condition or treatment.

Indications & Usage

MONJUVI (tafasitamab-cxix), in combination with lenalidomide, is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Important Safety Information

Contraindications

None.

Warnings and Precautions

Infusion-Related Reactions

MONJUVI can cause infusion-related reactions (IRRs). In L-MIND, infusion-related reactions occurred in 6% of the 81 patients. Eighty percent of infusion-related reactions occurred during cycle 1 or 2. Signs and symptoms included fever, chills, rash, flushing, dyspnea, and hypertension. These reactions were managed with temporary interruption of the infusion and/or with supportive medication. Premedicate patients prior to starting MONJUVI infusion. Monitor patients frequently during infusion. Based on the severity of the infusion-related reaction, interrupt or discontinue MONJUVI. Institute appropriate medical management.

Myelosuppression

MONJUVI can cause serious or severe myelosuppression, including neutropenia, thrombocytopenia, and anemia. In L-MIND, Grade 3 neutropenia occurred in 25% of patients, thrombocytopenia in 12%, and anemia in 7%. Grade 4 neutropenia occurred in 25% and thrombocytopenia in 6%. Neutropenia led to treatment discontinuation in 3.7% of patients.

Monitor complete blood counts (CBC) prior to administration of each treatment cycle and throughout treatment. Monitor patients with neutropenia for signs of infection. Consider granulocyte colony-stimulating factor (G-CSF) administration. Withhold MONJUVI based on the severity of the adverse reaction. Refer to the lenalidomide prescribing information for dosage modifications.

Infections

Fatal and serious infections, including opportunistic infections, occurred in patients during treatment with MONJUVI and following the last dose.

In L-MIND, 73% of the 81 patients developed an infection. The most frequent infections were respiratory tract infection (24%), urinary tract infection (17%), bronchitis (16%), nasopharyngitis (10%) and pneumonia (10%). Grade 3 or higher infection occurred in 30% of the 81 patients. The most frequent grade 3 or higher infection was pneumonia (7%). Infection-related deaths were reported in 2.5% of the 81 patients.

Monitor patients for signs and symptoms of infection and manage infections as appropriate.

Embryo-Fetal Toxicity

Based on its mechanism of action, MONJUVI may cause fetal B-cell depletion when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise women of reproductive potential to use effective contraception during treatment with MONJUVI and for at least 3 months after the last dose.

MONJUVI is initially administered in combination with lenalidomide. The combination of MONJUVI with lenalidomide is contraindicated in pregnant women because lenalidomide can cause birth defects and death of the unborn child. Refer to the lenalidomide prescribing information on use during pregnancy.

Adverse Reactions

Serious adverse reactions occurred in 52% of patients who received MONJUVI. Serious adverse reactions in ≥6% of patients included infections (26%), including pneumonia (7%), and febrile neutropenia (6%). Fatal adverse reactions occurred in 5% of patients who received MONJUVI, including cerebrovascular accident (1.2%), respiratory failure (1.2%), progressive multifocal leukoencephalopathy (1.2%) and sudden death (1.2%).

Permanent discontinuation of MONJUVI or lenalidomide due to an adverse reaction occurred in 25% of patients and permanent discontinuation of MONJUVI due to an adverse reaction occurred in 15%. The most frequent adverse reactions which resulted in permanent discontinuation of MONJUVI were infections (5%), nervous system disorders (2.5%), respiratory, thoracic and mediastinal disorders (2.5%).

Dosage interruptions of MONJUVI or lenalidomide due to an adverse reaction occurred in 69% of patients and dosage interruption of MONJUVI due to an adverse reaction occurred in 65%. The most frequent adverse reactions which required a dosage interruption of MONJUVI were blood and lymphatic system disorders (41%), and infections (27%).

The most common adverse reactions (≥20%) were neutropenia (51%), fatigue (38%), anemia (36%), diarrhea (36%), thrombocytopenia (31%), cough (26%), pyrexia (24%), peripheral edema (24%), respiratory tract infection (24%), and decreased appetite (22%).

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to MORPHOSYS US INC. at (844) 667-1992.

Please see the full Prescribing Information for additional Important Safety Information.

MONJUVI Mechanism of Action

Transcript

MONJUVI (tafasitamab-cxix), in combination with lenalidomide, is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Important Safety Information

Contraindications: None

Warnings and Precautions:

  • Infusion-Related Reactions (IRRs). MONJUVI can cause IRRs, including fever, chills, rash, flushing, dyspnea, and hypertension. Premedicate patients and monitor frequently during infusion. Based on the severity of the IRR, interrupt or discontinue MONJUVI and institute appropriate medical management.
  • Myelosuppression. MONJUVI can cause serious or severe myelosuppression, including neutropenia, thrombocytopenia, and anemia. Monitor complete blood counts (CBC) prior to administration of each treatment cycle and throughout treatment. Monitor patients with neutropenia for signs of infection. Consider granulocyte colony-stimulating factor administration. Withhold MONJUVI based on the severity of the adverse reaction. Refer to the lenalidomide prescribing information for dosage modifications.
  • Infections. Fatal and serious infections, including opportunistic infections, occurred in patients during treatment with MONJUVI and following the last dose. 73% of the 81 patients developed an infection. The most frequent infections were respiratory tract infection, urinary tract infection, bronchitis, nasopharyngitis and pneumonia. Grade 3 or higher infection occurred (30% of 81 patients). The most frequent grade 3 or higher infection was pneumonia. Infection-related deaths were reported (2.5% of 81 patients). Monitor patients for signs and symptoms of infection and manage infections as appropriate.
  • Embryo-Fetal Toxicity. Based on its mechanism of action, MONJUVI may cause fetal B-cell depletion when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus and women of reproductive potential to use effective contraception during treatment with MONJUVI and for at least 3 months after the last dose. The combination of MONJUVI with lenalidomide is contraindicated in pregnant women. Refer to the lenalidomide prescribing information on use during pregnancy.

Adverse Reactions: The most common adverse reactions (≥20%) were neutropenia (51%), fatigue (38%), anemia (36%), diarrhea (36%), thrombocytopenia (31%), cough (26%), pyrexia (24%), peripheral edema (24%), respiratory tract infection (24%), and decreased appetite (22%).

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to MORPHOSYS US INC. at (844) 667-1992.

Please see the full Prescribing Information for additional Important Safety Information.

MONJUVI Patient: Maggie's Mission

Transcript

MAGGIE: Hi. My name is Maggie. I am married to my husband for 55 years and I have two sons. I have a grandson and I have two great-grandchildren. I worked as a secretary my entire life.

MAGGIE: I love singing in the choir. I also do solo work with the church. I sing with a local community choir, and I do solo work with them. I play bells at church. I love doing that. I love reading. I do studying and I read. I especially love mysteries and thrillers.

MAGGIE: I read outside on my front porch when it’s nice. I love sitting outside where it’s nice and quiet and the atmosphere is just beautiful and hopefully the weather is as well.

MAGGIE: One evening on my way home from choir practice, this individual pulled out in front of me, and I wrecked into her. And going to the hospital, they did a CT scan and through the CT scan they noticed that the enlarged lymph nodes was extreme. They were extensive throughout my whole body. So, they had to do another biopsy and at this time they determined I had cancer.

NARRATOR: Diffuse large B-cell lymphoma, or DLBCL, is the most common type of non-Hodgkin lymphoma, or NHL.

NARRATOR: DLBCL is a fast-growing NHL. It affects B-lymphocytes, also known as B cells, a type of white blood cell that helps the body fight infections. As they develop, cancerous B cells become larger than normal and multiply uncontrollably.

MAGGIE: It was difficult having DLBCL during COVID. I felt isolated. I could only contact my friends and family through texting, through telephone, through video chat. It was a difficult time for me.

BUCK: I supported her by being with her, taking care of her, and just be here 24/7.

BUCK: We’ve had some stressful things happen in our life and we were both there for each other and I just dropped everything and left the world just keep on going by and she was my number one. And she’s still, always is my number one.

MAGGIE: Initially when I was diagnosed with the cancer, they prescribed six cycles of chemotherapy. During my chemotherapy, I had some problems that the medicine affected my heart so I could not continue with that. They had to back off on the amount they gave me and because of that it did not eradicate the cancer.

BUCK: If she has cancer, I have cancer, right, because it’s a team. It’s a team effort and you have to work as a team. You’re going to have to pull together, you have to stand together, be faithful to one another.

MAGGIE: When the cancer came back, it was scary for both of us. We had a lot of trips to be treated for the DLBCL and it took a lot of our time. It completely changed our lives. We could not live our normal lives, because we had to live around this diagnosis.

MAGGIE: When the cancer returned, my original oncologist referred me to another oncologist who specialized in DLBCL. He said that there were four options available. Two of the options would not work for me. But he said one that might work is MONJUVI.

NARRATOR: MONJUVI (tafasitamab-cxix) is a prescription medicine given with lenalidomide to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) that has come back (relapsed) or that did not respond to previous treatment (refractory) and who cannot receive a stem cell transplant.

NARRATOR: It is not known if MONJUVI is safe and effective in children.

NARRATOR: The approval of MONJUVI is based on a type of response rate. There is an ongoing study to confirm the clinical benefit of MONJUVI.

MAGGIE: I did come home and go online and look up MONJUVI. There was a lot of information available on the website.

MAGGIE: One of the things I did before I went for my infusion was to write any questions down. I did this on my phone so that I had it available and when I got there, I was able to ask them, so I had everything clear in my mind as to what was going to happen.

MAGGIE: With the treatment of MONJUVI, I would go to the local hospital to have an IV infusion and I would take medicine by mouth at home.

MAGGIE: The nurse would hook me up for my infusion and it would take a while for it to run. And while that was running, I would either watch television that they had there, or I would read because I love to read.

MAGGIE: The nurses did explain that there could be side effects with the MONJUVI. I was just to be aware of them and they did explain what they were.

Important Safety Information

NARRATOR: Important information I should know, including possible side effects, about MONJUVI:

NARRATOR: MONJUVI may cause serious side effects, including infusion-related reactions, low blood cell counts, and infections.

NARRATOR: The most common side effects of MONJUVI include feeling tired or weak, diarrhea, cough, fever, swelling of lower legs or hands, respiratory tract infection, and decreased appetite.

NARRATOR: Continue watching to learn more about these and other side effects.

MAGGIE: I have a lot of gratitude for my husband, for my family, for my two sons. They’ve been there to support me the whole way. My family, my friends. They would always touch base with me to see how I was doing, to make sure everything was fine. So, I have a lot of gratitude for everyone that’s been around me.

MAGGIE: We’re on a mission to do more traveling and spend more time together. We especially love to travel to different parts of the country and even out of the country.

MAGGIE: My husband and I are both looking forward to a cruise we have planned to celebrate our 55th wedding anniversary.

MAGGIE: I enjoy going out and working in my garden. I enjoy keeping track of my family, especially my grandson and our two new great-grandchildren. I love speaking with them and seeing pictures of them.

MAGGIE: It is hard hearing that your DLBCL has returned. But I would recommend that you keep an open mind. Stay positive. Keep in touch with your family and friends, because they’re going to uplift you and keep you positive.

MAGGIE: My life now since the DLBCL has changed. I’m not as active as I used to be physically. It seemed to affect my body where I’m not walking as much as I used to. But we still, both my husband and I, keep active. He’s active outside, as well as I am and I’m active in activities in the home and keeping things going here.

MAGGIE: My outlook is very positive. I love life. I live it happily and I’m just glad to be here.

Important Safety Information

NARRATOR: What are the possible side effects of MONJUVI?

NARRATOR: MONJUVI may cause serious side effects, including infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get fever, chills, flushing, headache, or shortness of breath during an infusion of MONJUVI.

NARRATOR: Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4 °F (38 °C) or above, or any bruising or bleeding.

NARRATOR: Infections. Serious infections, including infections that can cause death, have happened in people during treatment with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4 °F (38 °C) or above, or develop any signs or symptoms of an infection.

NARRATOR: The most common side effects of MONJUVI include feeling tired or weak, diarrhea, cough, fever, swelling of lower legs or hands, respiratory tract infection, and decreased appetite.

NARRATOR: These are not all the possible side effects of MONJUVI. Your healthcare provider will give you medicines before each infusion to decrease your chance of infusion reactions. If you do not have any reactions, your healthcare provider may decide that you do not need these medicines with later infusions. Your healthcare provider may need to delay or completely stop treatment with MONJUVI if you have severe side effects.

NARRATOR: Before you receive MONJUVI, tell your healthcare provider about all your medical conditions, including if you have an active infection or have had one recently.

NARRATOR: Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.

NARRATOR: You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your last dose of MONJUVI.

NARRATOR: Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with MONJUVI.

NARRATOR: Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment and for at least 3 months after your last dose of MONJUVI.

NARRATOR: You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.

NARRATOR: Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

NARRATOR: Call your doctor for medical advice about side effects. You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to MORPHOSYS US INC. at (844) 667-1992.

NARRATOR: Please see the full Prescribing Information, including Patient Information, for additional Important Safety Information.