Description
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.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
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.
Pediatric
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.
Geriatric
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.
Breastfeeding
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.
Drug Interactions
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
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
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
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.
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