About ZYNLONTA®

How ZYNLONTA® works

ZYNLONTA® is what’s called an antibody-drug conjugate, or ADC

Learn about the mechanism of action for ZYNLONTA® (loncastuximab tesirine-lpyl)
aAn antibody is a protein naturally produced by the body’s immune system, which can also be manufactured and given as a treatment.

ZYNLONTA® study results

In a clinical trial, 145 patients with DLBCL that has come back (relapsed) or did not respond to previous treatment (refractory) were treated with ZYNLONTA® to see how well it worked.

Many patients responded to treatment with ZYNLONTA®

Study results

aComplete response is the disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured.

bPartial response is a decrease (usually at least 50% in DLBCL) in the size or extent of cancer in the body, in response to treatment.

Patients who received ZYNLONTA® in the study

  • Patients had relapsed or refractory large B-cell lymphoma. Most (88%) had a type of disease called DLBCL not otherwise specified (NOS)
  • Some had types of disease that are difficult to treat, including DLBCL arising from low-grade lymphoma (20%), or high-grade B-cell lymphoma (8%)
  • Age range was from 23 to 94 (median: 66). More than half (59%) were male. And most were Caucasian (90%)
  • Patients had at least 2 and as many as 7 therapies before ZYNLONTA®
  • Some had a previous stem cell transplant (17%), while some had received CAR-T-cell therapy (9%)
  • More than half of patients (63%) did not respond to their previous treatment

CAR-T = chimeric antigen receptor T cell; DLBCL = diffuse large B-cell lymphoma.

How ZYNLONTA® is given

How will I receive ZYNLONTA®?

ZYNLONTA® is given by intravenous (IV) infusion by a trained healthcare provider at a clinic or infusion center through a needle placed in a vein. You will receive an IV infusion once every 3 weeks. Each infusion lasts 30 minutes.

Infusion schedule

ZYNLONTA® (loncastuximab tesirine-lpyl) infusion schedule

Your healthcare provider will decide how many treatments you need.

Steroid premedication

Before every ZYNLONTA® treatment, you may be given a prescription steroid to take twice a day for 3 days, starting the day before your infusion. Your healthcare provider will determine if this is appropriate for you and may choose to give you the steroid as an oral medication or IV infusion.

What may affect your treatment

Your healthcare provider may stop your treatment, delay your treatment, or change your dose of ZYNLONTA® if you have certain side effects. Your healthcare provider will do blood tests regularly to check for side effects of ZYNLONTA®.

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What is ZYNLONTA®?

ZYNLONTA® is a prescription medicine used to treat adults with certain types of large B-cell lymphoma that has come back (relapsed) or that did not respond to previous treatment (refractory), who have already received two or more treatments for their cancer.

It is not known if ZYNLONTA® is safe and effective in children.

The approval of ZYNLONTA® is based on a type of response rate. There is an ongoing study to confirm the clinical benefit of ZYNLONTA®.

Important Safety Information

What are the possible side effects of ZYNLONTA®?

ZYNLONTA® may cause serious side effects, including:

  • Fluid Retention: Your body may hold too much fluid during treatment with ZYNLONTA®. This can be serious. Tell your healthcare provider if you develop new or worsening swelling or puffiness, weight gain, chest pain, shortness of breath, or trouble breathing.
  • Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with ZYNLONTA® but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with ZYNLONTA®. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or any bruising or bleeding.
  • Infections: Serious infections, including infections that can cause death, have happened in people treated with ZYNLONTA®. Tell your healthcare provider right away if you have new or worsening signs or symptoms of infection, including: fever, chills, flu-like symptoms (cough, tiredness or weakness, and body aches), headache, breathing problems, or cuts or scrapes that are red, warm, swollen or painful.
  • Skin Reactions: Serious skin reactions have happened in people treated with ZYNLONTA®. Tell your healthcare provider if you get new or worsening skin reactions, including sensitivity to sunlight, skin rash, peeling, redness or irritation. You may burn more easily or get severe sunburns.

The most common side effects of ZYNLONTA® include:

  • feeling tired or weak
  • skin rash
  • swelling
  • nausea
  • muscle or joint pain
  • increase in blood sugar (hyperglycemia)
  • changes in certain blood or laboratory tests

ZYNLONTA® may cause fertility problems in males which may affect your ability to father children. Talk to your healthcare provider if this is a concern for you. These are not all of the possible side effects of ZYNLONTA®.  Call your healthcare provider for medical advice about side effects.

What should I avoid while receiving ZYNLONTA®?

Avoid or limit your exposure to sunlight, including sunlight through glass, such as buildings or vehicle windows and artificial sunlight such as sunlamps or tanning beds. Exposure to sunlight during treatment with ZYNLONTA® can cause skin reaction or rash. Use sun protection measures such as sunscreen and wear loose-fitting clothes that cover your skin while out in sunlight.

Before you receive ZYNLONTA®, tell your healthcare provider about all of your medical conditions, including if you:

  • have an active infection or have had one recently.
  • have liver problems.
  • are pregnant or plan to become pregnant. ZYNLONTA® can harm your unborn baby.

    Females who can become pregnant:

    • Your healthcare provider may do a pregnancy test before starting treatment with ZYNLONTA®.
    • You should use effective birth control (contraception) during treatment with ZYNLONTA® and for 9 months after the last dose of ZYNLONTA®. Talk to your healthcare provider about effective birth control. Tell your healthcare provider right away if you become pregnant or think that you are pregnant during treatment with ZYNLONTA®.

    Males with female partners who can become pregnant:

    • You should use effective birth control (contraception) during treatment with ZYNLONTA® and for 6 months after the last dose of ZYNLONTA®.
  • are breastfeeding or plan to breastfeed. It is not known if ZYNLONTA® passes into breast milk. Do not breastfeed during treatment with ZYNLONTA® and for 3 months after the last dose of ZYNLONTA®.

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get new medicine.

You may report side effects to the FDA at  (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to ADC Therapeutics at 1-855-690-0340.

Please see the full Prescribing Information for ZYNLONTA®, including Patient Information, for additional Important Safety Information.