Loncastuximab tesirine

Loncastuximab tesirine

Loncastuximab tesirine

What is loncastuximab tesirine?

Loncastuximab tesirine may also be used for purposes not listed in this medication guide.

Side effects of loncastuximab tesirine

If necessary, get emergency medical helpSigns of an allergic reaction:hives; difficult breathing; Swelling of your face, lips, tongue, or throat.

Loncastuximab tesirine can cause serious side effects. Call your doctor immediately if you have:

• new or worsening rash, peeling, redness, or irritation;

• new or worsening swelling, weight gain, chest pain, shortness of breath, or difficulty breathing;

• Fluid buildup in or around the lungs - pain when breathing, shortness of breath when lying down, wheezing, shortness of breath, cough with foamy mucus, cold and clammy skin, anxiety, fast heartbeat;

• low blood cell count - fever, chills, tiredness, mouth sores, sore skin, easy bruising, unusual bleeding, pale skin, cold hands and feet, lightheadedness or shortness of breath; or

• Signs of serious infection – flu symptoms, cough, weakness, body aches, headache, difficulty breathing, or skin sores with pain, redness, warmth, or swelling.

Common side effects of loncastuximab tesirine may include:

• tiredness or weakness;

• rash;

• Swelling;

• nausea;

• muscle or joint pain;

• increase in blood sugar; or

• Changes in blood or laboratory tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.

Warnings

You can get infections more easily, even serious or fatal infections. Call your doctor if you have fever, chills, flu symptoms (cough, fatigue, weakness, body aches), headache, trouble breathing, or skin sores with pain, redness, warmth, or swelling.

Before you take this medicine

Tell your doctor if you have ever had:

• liver problems; or

• an infection.

Loncastuximab tesirine can harm an unborn babyif the mother or father is using loncastuximab tesirine.

• If you are a woman,You may need a pregnancy test to make sure you are not pregnant. Use contraception while using this medication and for at least 9 months after your last dose.

• If you are a man,Use contraceptives if your sexual partner can become pregnant. Continue using birth control for at least 6 months after the last dose.

• Tell your doctor immediately if pregnancy occurs.

While using this medicine, it may be more difficult for a man to get a woman pregnant.You should still use contraception to prevent pregnancy because the medicine can harm an unborn baby.

Do not breast-feed while using this medicine.and for at least 3 months after your last dose.

How should I use loncastuximab tesirine?

Loncastuximab tesirine is injected into a vein by a doctor, usually every three weeks.

You may be given other medications to prevent serious side effects. Take these medicines for as long as your doctor tells you.

You can get infections more easily, even serious or fatal infections. You will need frequent medical tests and further doses may be delayed based on the results.

Loncastuximab tesirine dosage information

Usual Adult Dose for Lymphoma:

0.15 mg/kg i.v. over 30 minutes on the first day of each cycle (every 3 weeks) for 2 cycles, then 0.075 mg/kg IV. over 30 minutes every 3 weeks for subsequent cycles

Comments:
- Premedication with dexamethasone 4 mg orally or intravenously twice daily for 3 days starting the day before taking this medication.
-If administration of dexamethasone does not begin the day before this medication, administration of dexamethasone should begin at least 2 hours before administration of this medication.

Use: For the treatment of adult patients with relapsed or refractory large B-cell lymphoma after 2 or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL), unless otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your loncastuximab tesirine injection.

What happens if I overdose?

In the medical field, an overdose would be treated quickly.

What should I avoid when using loncastuximab tesirine?

Loncastuximab tesirine may cause milder sunburn. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when outdoors.

What other drugs will affect loncastuximab tesirine?

Other medications may affect loncastuximab tesirine, including prescription and over-the-counter medications, vitamins, and herbal products. Tell your doctor about all medications you are currently taking and any medications you are taking or stopping.

More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the prescribed indication.