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Zynlonta 10mg Vial
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Indications & Clinical Uses
- Zynlonta 10mg is a single-dose vial of freeze-dried powder containing loncastuximab tesirine (loncastuximab tesirine-lpyl in the US), an antibody-drug conjugate cancer medicine.
- In the US it is approved under accelerated approval, based on response rate, for adults with relapsed or refractory large B-cell lymphoma after two or more prior systemic therapies.
- In the EU it holds a conditional marketing authorisation, granted on 20 December 2022, for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma after two or more prior treatments.
- Zynlonta is given only in a hospital or clinic by a healthcare professional, as a 30-minute intravenous infusion every 3 weeks, at 0.15 mg/kg for the first two cycles and 0.075 mg/kg after that, with dexamethasone beforehand.
Side Effects
- The most common side effects, affecting at least 20% of patients, are low platelets (thrombocytopenia), raised gamma-glutamyltransferase, low neutrophils (neutropenia), anaemia, high blood sugar, raised liver enzymes, tiredness, low albumin, rash, swelling (oedema), nausea and muscle and bone pain.
- Serious effects include fluid build-up around the lungs, heart or abdomen (effusion) and swelling, severe low blood counts (grade 3 to 4 neutropenia in 32% and thrombocytopenia in 20%), serious or fatal infections (2%) and serious skin reactions including photosensitivity.
- Tell your care team about new breathlessness, chest pain, abdominal swelling, fever, unusual bruising, or skin rash.
- The US label has no boxed warning.
Precautions & Warnings
- Zynlonta is prepared and given by healthcare professionals.
- Dexamethasone 4 mg twice daily for 3 days, starting the day before each infusion, is given as premedication.
- Your care team will check blood counts, liver tests and any swelling or fluid build-up throughout treatment and may delay or stop doses.
- Limit sun exposure and use protection because of skin reactions.
- It can harm an unborn baby: females should use contraception during treatment and for 10 months after the last dose, and males for 7 months.
- Do not breastfeed during treatment and for 3 months afterwards.
- Safety and effectiveness in children have not been established.
- Vials are kept refrigerated at 2 to 8 degrees C in the carton, protected from light.
Avoid Interactions
- Increase the effect or toxicity: the US label reviewed does not list specific drug interactions, but combining Zynlonta with other medicines that lower blood counts or affect the liver could add to toxicity, so tell your care team about every medicine you take.
- Reduce the effect: none listed.
- Tell your prescriber about all prescription medicines, over-the-counter products, herbal products and supplements before treatment.
- Bring an up-to-date medicine list to every visit, and tell your care team before you start any new medicine during treatment, so that it can be checked against your blood counts and liver tests.
References
Frequently Asked Questions
Zynlonta (loncastuximab tesirine) treats adults with relapsed or refractory large B-cell lymphoma after two or more earlier treatments. In the EU it is authorised for diffuse large B-cell lymphoma and high-grade B-cell lymphoma. Approval is accelerated in the US and conditional in the EU.
Zynlonta (loncastuximab tesirine) is given by a healthcare professional as a 30-minute intravenous infusion every 3 weeks. The dose is 0.15 mg/kg for the first two cycles, then 0.075 mg/kg. You take dexamethasone tablets or injection the day before and for 3 days as premedication.
Zynlonta (loncastuximab tesirine) commonly causes low platelets, low white cells, anaemia, raised liver enzymes, high blood sugar, tiredness, rash, swelling and nausea. Serious effects include fluid around the lungs or heart, infections and skin reactions. Report breathlessness, chest pain, fever or unusual bruising.
Avoid pregnancy and breastfeeding, and limit sun exposure, during Zynlonta (loncastuximab tesirine) treatment because of the skin reactions and fetal risk. The US label lists no specific drug interactions, but tell your care team about every medicine and supplement you use.
During Zynlonta (loncastuximab tesirine) treatment your care team checks blood counts, liver tests and watches for swelling or fluid around the lungs, heart or abdomen. Doses may be delayed or stopped if serious side effects appear. Ask your team how often these tests are scheduled for you.
No. Zynlonta (loncastuximab tesirine) can harm an unborn baby. Females should use contraception during treatment and for 10 months after the last dose; males should do so for 7 months. Do not breastfeed during treatment and for 3 months afterwards.
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