Lyfgenia Side Effects

Generic name: lovotibeglogene autotemcel

Note: This document provides detailed information about Lyfgenia Side Effects associated with lovotibeglogene autotemcel. Some dosage forms listed on this page may not apply specifically to the brand name Lyfgenia.

Applies to lovotibeglogene autotemcel: intravenous suspension.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Tell your medical caregivers right away if you have:

• chills, fever, infections;

• swollen glands;

• severe headache;

• stomach or back pain;

• tiredness;

• unusual bruising or bleeding; or

• nosebleeds, bleeding gums, blood in your urine or vomit, bloody or tarry stools, or coughing up blood.

Common side effects may include:

• blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;

• fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or

• easy bruising, unusual bleeding, purple or red spots under your skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For healthcare professionals

Applies to lovotibeglogene autotemcel: intravenous suspension.

General adverse events

The most commonly reported grade 3 or greater adverse reactions were anemia, febrile neutropenia, leukopenia, neutropenia, stomatitis, and thrombocytopenia.^[Ref]

Gastrointestinal

• Very common (10% or more): Stomatitis (71%)
• Common (1% to 10%): Nausea

Hematologic

• Very common (10% or more): Thrombocytopenia (69%), neutropenia (60%), febrile neutropenia (44%), anemia (33%), leukopenia (33%), sickle cell anemia with crisis (16%)
• Frequency not reported: Delayed platelet engraftment, neutrophil engraftment failure

Mobilization and apheresis triggered serious adverse effects of sickle cell crisis in 14% of patients. Sickle cell anemia with crisis included events prior to Month 6 and non-adjudicated occurrences.

Hypersensitivity

• Frequency not reported: Hypersensitivity reactions

Metabolic

• Very common (10% or more): Decreased appetite (11%)

Oncologic

• Frequency not reported: Hematologic malignancy, insertional oncogenesis

Other

• Common (1% to 10%): Bacteremia, pyrexia
• Frequency not reported: Infusion-related reactions

Infusion-related reaction events included hot flush and decreased diastolic blood pressure.

Respiratory

• Very common (10% or more): Pharyngeal inflammation (11%)

Hepatic

• Very common (10% or more): Increased AST (18%), increased ALT (13%), increased gamma-glutamyl transferase (13%)
• Common (1% to 10%): Increased blood bilirubin

Further information

Lyfgenia side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer