Loncastuximab tesirine-lpyl

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What is Loncastuximab tesirine-lpyl?[edit | edit source]

  • Loncastuximab tesirine-lpyl (Zynlonta) is a CD19-directed antibody and alkylating agent conjugate used to treat adults with certain types of large B-cell lymphoma.
Loncastuximab tesirine



What are the uses of this medicine?[edit | edit source]

  • Loncastuximab tesirine-lpyl (Zynlonta) is 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.


How does this medicine work?[edit | edit source]

  • Loncastuximab tesirine-lpyl is an antibody-drug conjugate (ADC) targeting CD19.
  • The monoclonal IgG1 kappa antibody component binds to human CD19, a transmembrane protein expressed on the surface of cells of B-lineage origin.
  • The small molecule component is SG3199, a PBD dimer and alkylating agent.
  • Upon binding to CD19, loncastuximab tesirine-lpyl is internalized followed by release of SG3199 via proteolytic cleavage.
  • The released SG3199 binds to the DNA minor groove and forms highly cytotoxic DNA interstrand crosslinks, subsequently inducing cell death. Loncastuximab tesirine-lpyl had anticancer activity in animal models of lymphoma.


Who Should Not Use this medicine ?[edit | edit source]

  • This medicine have no usage limitations.


Is this medicine FDA approved?[edit | edit source]

  • It was approved for use in the United States in 2021.


How should this medicine be used?[edit | edit source]

Recommended Premedication

  • Unless contraindicated, administer dexamethasone 4 mg orally or intravenously twice daily for 3 days beginning the day before administering Zynlonta.
  • If dexamethasone administration does not begin the day before Zynlonta, dexamethasone should begin at least 2 hours prior to administration of Zynlonta.

Recommended dosage Zynlonta is an intravenous infusion over 30 minutes on Day 1 of each cycle (every 3 weeks). The recommended dosage is:

  • 0.15 mg/kg every 3 weeks for 2 cycles.
  • 0.075 mg/kg every 3 weeks for subsequent cycles

Administration

  • Zynlonta is given to you by your healthcare provider as an intravenous (IV) infusion into your vein over 30 minutes.
  • Zynlonta is usually given every 3 weeks.
  • Your healthcare provider may give you medicine before each infusion to decrease your chance of side effects.
  • Your healthcare provider may stop your treatment, delay your treatment, or change your dose of Zynlonta if you have severe side effects.
  • Your healthcare provider should do blood tests regularly to check for side effects of Zynlonta.
  • Your healthcare provider will decide how many treatments you need.


What are the dosage forms and brand names of this medicine?[edit | edit source]

This medicine is available in fallowing doasage form:

  • As injection: 10 mg of loncastuximab tesirine-lpyl as a lyophilized powder in a single-dose vial for reconstitution and further dilution.

This medicine is available in fallowing brand namesː

  • Zynlonta


What side effects can this medication cause?[edit | edit source]

The most common side effects of this medicine 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


What special precautions should I follow?[edit | edit source]

  • 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.
  • Monitor for the development of pleural effusion, pericardial effusion, ascites, peripheral edema, and general edema. Consider diagnostic imaging when symptoms develop or worsen.
  • This medicine may cause myelosuppression. Monitor blood cell counts. Withhold, reduce, or discontinue Zynlonta based on severity.
  • Monitor for infection and treat promptly.
  • This medicine Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.


What to do in case of emergency/overdose?[edit | edit source]

  • In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.


Can this medicine be used in pregnancy?[edit | edit source]

  • There are no available data on the use of Zynlonta in pregnant women to evaluate for drug-associated risk.


Can this medicine be used in children?[edit | edit source]

  • Safety and effectiveness of Zynlonta in pediatric patients have not been established.


What are the active and inactive ingredients in this medicine?[edit | edit source]

  • Active ingredient: loncastuximab tesirine-lpyl
  • Inactive ingredients: L-histidine, L-histidine monohydrochloride, polysorbate 20, and sucrose.


Who manufactures and distributes this medicine?[edit | edit source]

  • Manufactured by: ADC Therapeutics SA, Route de la Corniche 3B, 1066 Epalinges, Switzerland
  • U.S. license number 2166
  • Distributed by: ADC Therapeutics America, Murray Hill, New Jersey 07974


What should I know about storage and disposal of this medication?[edit | edit source]

Storage

  • Store refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light.
  • Do not use beyond the expiration date shown on the carton.
  • Do not freeze.
  • Do not shake.

Special Handling

  • Zynlonta is a hazardous drug.
  • Follow applicable special handling and disposal procedures.1
  • Any unused drug product or waste material should be disposed in accordance with local requirements.


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