Pronunciation:

lon-kas-TUX-i-mab TES-ir-een - lpyl

Brand Names:

• Zynlonta

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Loncastuximab Tesirine

Uses of This Medicine:

Loncastuximab tesirine-lpyl injection is to treat large B-cell lymphoma (including diffuse large B-cell lymphoma [DLBCL], high grade B-cell lymphoma, or DLBCL from low grade lymphoma) that has come back or did not respond to previous treatment in patients who have received 2 or more other medicines did not work well. 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 loncastuximab tesirine-lpy 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 loncastuximab tesirine-lpy injection in the elderly.

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:

• Edema (swelling) or
• Fluid retention (eg, pleural effusion, pericardial effusion)—Use with caution. May make these conditions worse.

• Infection (eg, pneumonia, sepsis)—May decrease your body's ability to fight an infection.

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

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 must be given slowly, so the needle will have to stay in place for at least 30 minutes. It is usually given every 3 weeks.

This medicine should come with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have questions.

You may receive other medicines (eg, dexamethasone) before starting treatment with this medicine.

Precautions While Using This Medicine:

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

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Women should use an effective form of birth control to avoid pregnancy during treatment and for at least 9 months after the last dose. Men should use an effective form of birth control to avoid pregnancy in sexual partners during treatment and for at least 6 months after the last dose. If you think a pregnancy has occurred with the medicine, tell your doctor right away.

Talk with your doctor before using this medicine if you plan to have children. Some men who use this medicine have become infertile (unable to have children).

This medicine may cause fluid retention (eg, pleural effusion, pericardial effusion). Check with your doctor right away if you have chest pain or discomfort, swelling in the stomach and bloating, or trouble breathing while using this medicine.

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.

Check with your doctor right away if you have an increased sensitivity of the skin to sunlight, itching, rash with flat lesions or small raised lesions on the skin, redness or other discoloration of the skin, severe sunburn, or unusually warm skin. These may be symptoms of serious skin reactions (eg, photosensitivity reaction, exfoliative rash, maculopapular rash, and erythema). Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

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

bleeding gums

blood in the urine or stools

body aches or pain

chills

cough

ear congestion

fever

headache

increased sensitivity of the skin to sunlight

itching, skin rash

loss of voice

lower back or side pain

muscle or bone pain

pain or tenderness around the eyes and cheekbones

painful or difficult urination

pale skin

pinpoint red spots on the skin

redness or other discoloration of the skin

severe sunburn

sore throat

stuffy or runny nose

swelling of the hands, ankles, feet, or lower legs

swelling or puffiness of the face

tightness in the chest

trouble breathing

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

Less common

Anxiety

blistering, crusting, irritation, itching, or reddening of the skin

blue or pale skin

chest pain, possibly moving to the left arm, neck, or shoulder

confusion

cracked, dry, scaly skin

darkening of the skin

dizziness

dry cough

fainting

fast heartbeat

general feeling of discomfort or illness

lightheadedness

rapid, shallow breathing

sneezing

thickening of bronchial secretions

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

constipation

decreased appetite

diarrhea

difficulty in moving

joint pain

lack or loss of strength

muscle aches, cramps, or stiffness

nausea

stomach pain

swollen joints

unusual drowsiness, dullness, or feeling of sluggishness

vomiting

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.