Lyfgenia Side Effects

Generic name: lovotibeglogene autotemcel

Note: This document contains side effect information about lovotibeglogene autotemcel. Some dosage forms listed on this page may not apply 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

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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer