How is Monjuvi given / administered?

Monjuvi is given by a healthcare provider as an intravenous (IV) infusion using a needle inserted into a vein. You will receive your medicine at a clinic or infusion center. Your first IV infusion will take about 1.5 to 2.5 hours; thereafter, your infusions will usually take 1.5 to 2 hours. You may need to be at the clinic for a longer period of time for preparation and observation.

In the clinic, you will receive medicines before the infusion to decrease your risk of an infusion reaction. In studies, most infusion reactions with Monjuvi occurred during the first or second cycle (the first or second month). These reactions may include fever, chills, rash, flushing, shortness of breath, and high blood pressure.

If you don’t have an infusion reaction, premedication may be stopped at a later date. Premedications include medicines like acetaminophen (Tylenol), antihistamines or corticosteroids (for example: prednisone or dexamethasone).

When was Monjuvi approved?

In July, 2020 the FDA approved Monjuvi (tafasitamab-cxix), used in combination with lenalidomide (Revlimid), for the treatment of diffuse large B-cell lymphoma (DLBCL) in adults. Monjuvi works with your immune system to help fight this type of lymphoma. This treatment is given on a long-term basis to help you maintain control of your disease.

What is the dose of Monjuvi?

Because Monjuvi dosing is based on your weight, your healthcare provider will determine your exact dose. The recommended dose of Monjuvi is 12 milligrams (mg) per kilogram (kg) of actual body weight given as an intravenous (IV) infusion based on a specific dosing schedule. You will receive treatment in “cycles”. Each treatment cycle lasts for 28 days.

Monjuvi dosing schedule:

• Cycle 1: Monjuvi is given on days 1, 4, 8, 15 and 22.
• Cycles 2 and 3: Monjuvi is given on days 1, 8, 15 and 22.
• Cycle 4 and beyond: Monjuvi is given on days 1 and 15.

Your healthcare provider will determine the number of treatments you should receive.

Monjuvi is used in combination with another medicine called lenalidomide (Revlimid). Lenalidomide 25 mg oral capsule is taken once a day on days 1 to 21 of each treatment cycle for the first 12 cycles (for about one year).

What are the most common or serious side effects with Monjuvi?

The most common side effects that occurred in at least 20% of patients (20 out of every 100 patients) included:

• neutropenia (low white blood cell count) (51%)
• feeling tired or weak (38%)
• anemia (low red blood cell count) (36%)
• diarrhea (36%)
• low blood platelet count (31%)
• cough (26%)
• fever (24%)
• swelling of the lower legs or hands (24%)
• respiratory tract infection (24%)
• decreased appetite (22%)

Serious side effects with Monjuvi, occurring in 6% or more of patients, included: infections (26%), such as pneumonia (7%) and febrile neutropenia (6%). With febrile neutropenia, you have a high fever with a low white blood cell count, and the risk or severity of an infection may be higher than normal.

If you have serious side effects, your healthcare provider may need to delay or stop your Monjuvi treatment. In studies, serious adverse reactions occurred in 52% of patients, with 15% of patients having to stop Monjuvi treatment permanently, and 65% of patients needing to delay treatment.

The most common side effects leading to discontinuation of treatment were infections (5%), nervous system disorders (2.5%), respiratory, thoracic and mediastinal disorders (2.5%).
The most common side effects leading to delay of treatment were blood and lymphatic system disorders (41%), and infections (27%).

Other serious side effects include infusion reactions, and low blood cell counts (platelets, red blood cells, and white blood cells).

Fatal side effects occurred in 5% of patients who received Monjuvi in studies and included stroke (1.2%), serious breathing problems (1.2%), progressive multifocal leukoencephalopathy (1.2%, a viral brain infection), and sudden death (1.2%).

Tell your healthcare provider right away if you:

• get a fever of 100.4°F (38°C) or above
• have any bruising or bleeding
• develop any signs or symptoms of an infection
• get a fever, chills, flushing, headache, or shortness of breath during an infusion of MonjuviI.

This is not all the information you need to know about Monjuvi (tafasitamab-cxix) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.