Pronunciation:

ta-fa-SIT-a-mab

Brand Names:

• Monjuvi

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

Tafasitamab-cxix injection is used together with lenalidomide to treat certain types of diffuse large B-cell lymphoma (DLBCL) that has come back a second or later time or after other medicines did not work well and who cannot receive a stem cell transplant. Lymphoma is a type of cancer where the body makes abnormal white blood cells.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of tafasitamab-cxixl injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tafasitamab-cxix in the elderly. However, elderly patients are more likely to have serious unwanted effects to this medicine than younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Infection or
• Neutropenia (low number of white blood cells)—May decrease your body's ability to fight an infection.

Proper Use of This Medicine:

Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. It is usually given in 4 or more cycles. Each treatment cycle lasts for 28 days.

You may also receive other medicines (eg, allergy medicine, fever medicine, steroids) 30 minutes to 2 hours before starting treatment with this medicine.

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests are needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 3 months after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause an infusion reaction, which can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have a fever, chills, headache, feeling of warmth, redness of the face, neck, arms and occasionally, upper chest, trouble breathing, lightheadedness, fainting, or chest pain within a few hours after you receive it.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Black, tarry stools

bladder pain

bleeding gums

bloating or swelling of the face, arms, hands, lower legs, or feet

bloody or cloudy urine

chest pain

chills

confusion

cough producing mucus

decreased urine

diarrhea

difficult, burning, or painful urination

dizziness

dry mouth

ear congestion or pain

fainting

fast or slow heartbeat

fever

frequent urge to urinate

hoarseness or other voice changes

increased thirst

lightheadedness

loss of appetite

lower back or side pain

mood changes

muscle pain or cramps

nausea

numbness or tingling in the hands, feet, or lips

pale skin

persistent non-healing sore on the skin

pink growth on the skin

pinpoint red spots on the skin

rapid, shallow breathing

reddish patch or irritated area on the skin

runny nose

seizures

shiny bump on the skin

sneezing

sore throat

tightness in the chest

tingling of the hands or feet

trouble breathing

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

vomiting

white, yellow or waxy scar-like area on the skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Back pain

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

change in taste

constipation

difficulty in moving

joint or muscle pain

loss of taste

muscle spasm

redness of the skin

unusually warm skin

Less common

Hair loss

increased sweating

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.