Tafasitamab is used in combination with lenalidomide to treat diffuse large B-cell lymphoma in adults who cannot receive a stem cell transplant.

Tafasitamab is given after other cancer treatments did not work or have stopped working.

Tafasitamab was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to tafasitamab, but further studies are needed.

Tafasitamab may also be used for purposes not listed in this medication guide.

Tafasitamab affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have signs of infection (fever, cough with mucus, chest tightness, shortness of breath, or pain or burning when you urinate).

tafasitamab may harm an unborn baby. Use effective birth control to prevent pregnancy while using tafasitamab and for at least 3 months after your last dose.

Carefully follow all instructions about the use of birth control while you are using tafasitamab in combination with lenalidomide.

Tafasitamab is given as an infusion into a vein. A healthcare provider will give you this injection.

Tafasitamab is given in a 28-day treatment cycle. You may need to use the medicine only on certain days of each cycle. Your doctor will determine how long to treat you with tafasitamab.

This medicine must be given slowly, and the infusion can take up to 2.5 hours to complete.

You may be given other medications to help prevent serious side effects or an allergic reaction. Keep using these medicines for as long as your doctor has prescribed.

Tafasitamab affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

Usual Adult Dose for Lymphoma:

12 mg/kg IV (based on actual body weight; Administer in combination with lenalidomide 25 mg orally for a maximum of 12 cycles, then continue this drug as monotherapy until disease progression or unacceptable toxicity:
CYCLE 1: 12 mg/kg IV on Days 1, 4, 8, 15, and 22
CYCLE 2: 12 mg/kg IV on Days 1, 8, 15, and 22
CYCLE 3: 12 mg/kg IV on Days 1 and 15
-NOTE: Each therapy cycle is 28 days.
-For the first infusion, use an infusion rate of 70 mL/h for the first 30 minutes, then increase the rate so that the infusion is administered within 1.5 to 2.5 hours; administer all subsequent infusions within 1.5 to 2 hours.

Comments:
-Refer to the lenalidomide prescribing information for lenalidomide dosage recommendations.
-Administer premedications 30 minutes to 2 hours prior to starting infusion to minimize infusion-related reactions.
-Premedications may include acetaminophen, histamine H1 receptor antagonists, histamine H2 receptor antagonists, and/or glucocorticosteroids.
-For patients not experiencing infusion-related reactions during the first 3 infusions, premedication is optional for subsequent infusions.
-If a patient experiences an infusion-related reaction, administer premedications before each subsequent infusion.

Use: This drug 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)

Tell your doctor if you have any signs of infection, or if you have recently had an infection.

Tafasitamab may harm an unborn baby. Use effective birth control to prevent pregnancy while using this medicine and for at least 3 months after your last dose. Tell your doctor if you become pregnant.

Tafasitamab is sometimes used in combination with lenalidomide. Both men and women using lenalidomide must use effective birth control. Even one dose can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking lenalidomide at the time of conception or during pregnancy.

Carefully follow all instructions about the use of birth control while you are using tafasitamab in combination with other medicines.

Do not breastfeed while receiving tafasitamab, and for at least 3 months after your last dose.

Call your doctor for instructions if you miss an appointment for your tafasitamab injection.

Since tafasitamab is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver if you feel chilled, warm, sweaty, anxious, or have a headache, trouble breathing, or pounding in your neck or ears.

Tafasitamab may cause serious side effects. Call your doctor at once if you have:

• cough with mucus, chest tightness, shortness of breath;

• fever above 100.4 degrees F (38 degrees C);

• pain or burning when you urinate;

• easy bruising, unusual bleeding, purple or red spots under your skin;

• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or

• low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of tafasitamab may include:

• low blood cell counts;

• fever;

• feeling weak or tired;

• cough;

• cold symptoms such as stuffy nose, sneezing, sore throat;

• loss of appetite, diarrhea; or

• swelling in your hands or lower legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect tafasitamab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.