Loncastuximab tesirine-lpyl (Intravenous)

Loncastuximab tesirine-lpyl injection is used 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 returned or did not respond to previous treatments in patients who have already tried 2 or more other medicines that did not work well. Lymphoma is a type of cancer where the body produces abnormal white blood cells.

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

It is very important that your doctor checks 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 while using this 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 (e.g., 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 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 (e.g., photosensitivity reaction, exfoliative rash, maculopapular rash, and erythema). Use sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

In deciding to use a medicine, you and your doctor will weigh the risks against the benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies to determine how age affects the use of loncastuximab tesirine-lpy injection in children. Safety and effectiveness have not been established for this group.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the use of loncastuximab tesirine-lpy injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together. In other cases, two different medicines may be used together even if there could be an interaction. In these situations, your doctor might adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical conditions may influence the use of this medicine. Make sure to inform your doctor if you have any other medical issues, especially:

• Edema (swelling) or
• Fluid retention (e.g., pleural effusion, pericardial effusion)—Use with caution as it may worsen these conditions.

• Infection (e.g., pneumonia, sepsis)—This may reduce your body's ability to fight an infection.

• Liver disease—Use with caution as the effects may be stronger due to slower removal of the medicine from the body.

Along with its intended effects, a medicine may also cause some unwanted effects. Not all of these side effects may happen, but if they do, they might 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. Your health care professional may also be able to tell you about ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, 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 sluggishness
• Vomiting

Other side effects not listed may also happen 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.

In the U.S.

• Zynlonta

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Loncastuximab Tesirine

Find detailed information on biosimilars for this medication.

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.