Loncastuximab Tesirine

Loncastuximab Tesirine is a prescription medication used to treat adults with certain types of large B-cell lymphoma that have relapsed or that did not respond to previous treatment (refractory), and who have already received two or more treatments for their cancer.

• Loncastuximab Tesirine is available under the following different brand names: Zynlonta, loncastuximab Tesirine-lpyl.

Common side effects of Loncastuximab Tesirine include:

• Tiredness or weakness.
• Rash.
• Swelling.
• Nausea.
• Muscle or joint pain.
• Increase in blood sugar; or
• Changes in blood or lab tests.

Serious side effects of Loncastuximab Tesirine include:

• Fatigue,
• Rash,
• Fluid retention (edema),
• Nausea,
• Musculoskeletal pain,
• Itching,
• Skin sensitivity to sunlight,
• Diarrhoea,
• Abdominal pain,
• Vomiting,
• Constipation,
• Decreased appetite,
• Shortness of breath,
• "Water on the lungs" (pleural effusion),
• Upper respiratory tract infection,
• Low platelets (thrombocytopenia),
• Increased gamma-glutamyl transferase,
• Low white blood cells (neutropenia),
• Anaemia,
• High blood sugar (hyperglycemia),
• Transaminase elevation, and
• Low blood albumin (hypoalbuminemia)

Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, Lightheadedness, or passing out;

Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

Rare side effects of Loncastuximab Tesirine include:

none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, of lyophilized powder for reconstitution

• 10 mg/vial

Large B-Cell Lymphoma

Adult dosage

• Cycles 1-2: 0.15 mg/kg Intravenous every 3 Weeks
• Cycle 3 and thereafter: 0.075 mg/kg Intravenous every 3 weeks

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Loncastuximab Tesirine has no noted severe interactions with any other drugs.
• Loncastuximab Tesirine has no noted serious interactions with any other drugs.
• Loncastuximab Tesirine has no noted moderate interactions with any other drugs.
• Loncastuximab Tesirine has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Loncastuximab Tesirine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Loncastuximab Tesirine?”

Cautions

• Serious effusion and edema reported; consider diagnostic imaging for symptoms of pleural effusion or pericardial effusion (.g, new or worsened dyspnea, chest pain, and/or ascites [.g, abdominal swelling, and bloating])
• Can cause severe myelosuppression, including neutropenia, thrombocytopenia, and anemia; monitor complete blood cell counts throughout treatment; cytopenias may require interruption, dose reduction, or discontinuation of the drug; consider prophylactic granulocyte colony-stimulating factor administration as applicable.
• Fatal and serious infections, including opportunistic infections, are reported; monitor for new or worsening signs or symptoms consistent with infection.
• Cutaneous reactions may occur, including photosensitivity reaction, rash (including exfoliative and maculopapular), and erythema; advise patients to minimize or avoid exposure to direct natural or artificial sunlight including exposure through glass windows; instruct patients to protect skin from exposure to sunlight by wearing sun-protective clothing and/or the use of sunscreen products; if skin reaction or rash develops, consider dermatologic consultation.
• Based on its mechanism of action, can cause embryofetal harm when administered to pregnant females; contains a genotoxic compound (SG3199) and affects actively dividing cells

Pregnancy and Lactation

• Based on its mechanism of action, can cause embryofoetal harm when administered to pregnant females because it contains SG3199 (a genotoxic compound that crosslinks DNA) and affects actively dividing cells
• Advise pregnant females of the potential risk to the fetus.
• Verify pregnancy status for females of reproductive potential before initiating.
• Contraception
  • Females of reproductive potential: Use effective contraception during treatment and for 10 months after the last dose.
  • Males with female partners of reproductive potential: Use effective contraception during treatment and for 7 months after the last dose.
• Infertility
  • Based on animal studies, may impair fertility in males
  • Effects were not reversible in male cynomolgus mona keys during 12-a week drug-free period.
• Lactation
  • Data are not available regarding the presence of human milk, its effects on breastfed children, or its effects on milk production.
  • Owing to the potential for serious adverse reactions in breastfed children, advise females not to breastfeed during treatment and for 3 months after the last dose.