Lenmeldy Side Effects

Generic name: atidarsagene autotemcel

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

Applies to atidarsagene autotemcel: intravenous suspension.

Important warnings This medicine can cause some serious health issues

You may get infections or bleed more easily.

Call your doctor if you have unusual bleeding or signs of infection (fever, cough, skin sores, painful urination).

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:

• unusual bruising or bleeding;

• sudden numbness or weakness on one side of the body, chest pain, problems with vision or speech, pain or swelling in one leg;

• problems with thinking or memory, muscle movement problems, weakness, vomiting, trouble swallowing; or

• chills, fever, infections.

Common side effects may include:

• fever, mouth sores, skin sores, sore throat, cough;

• swelling around your midsection, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

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

• cold symptoms such as stuffy nose, sneezing, sore throat;

• rash; or

• abnormal lab results.

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 atidarsagene autotemcel: intravenous suspension.

General adverse events

The most common adverse reactions occurring in at least 10% of all pediatric patients within the first year of treatment included febrile neutropenia, stomatitis, elevated D-dimer, respiratory tract infections, rash, device-related infections, other viral infections, neutropenia, elevated liver enzymes, pyrexia, gastroenteritis, and hepatomegaly. The reported adverse effects include events potentially related to busulfan-based myeloablative conditioning.^[Ref]

Cardiovascular

• Frequency not reported: Veno-occlusive disease

Dermatologic

• Very common (10% or more): Rash (33%)

Rash also includes dermatitis, bullous dermatitis, erythematous rash, drug eruption, and maculopapular rash.

Gastrointestinal

• Very common (10% or more): Stomatitis (77%), gastroenteritis (21%)

Gastroenteritis also includes enteritis, Aeromonas gastroenteritis, and rotavirus gastroenteritis.

Hematologic

• Very common (10% or more): Febrile neutropenia (85%), elevated levels of D-dimer greater than 4.2 nmol/L (67%), neutropenia following conditioning (28%)
• Common (1% to 10%): Anemia
• Frequency not reported: Delayed platelet engraftment

Hepatic

• Very common (10% or more): Hepatomegaly (18%), elevated liver enzymes (23%)
• Frequency not reported: Elevated liver enzymes (AST/ALT)

Immunologic

• Frequency not reported: Anti-arylsulfatase A antibodies

Nervous system

• Frequency not reported: Encephalitis, cerebral infarction secondary to a thrombotic event

Other

• Very common (10% or more): Pyrexia (21%), device-related infections (31%), other viral infections (28%)

Device-related infections also includes events of bacterial sepsis, catheter-site cellulitis, catheter-site infection, sepsis, and vascular-device infection.

Other viral infections also includes adenovirus infection, cytomegalovirus infection, cytomegalovirus test positive, cytomegalovirus viremia, enterovirus infection, hand-foot-and-mouth disease, herpes zoster, positive SARS-CoV-2 test, and viral infection (excluding rotavirus gastroenteritis).

Respiratory

• Very common (10% or more): Respiratory infections (54%)

Respiratory infections also includes bronchitis, nasopharyngitis, pharyngitis, pneumonia, rhinitis, tonsillitis, upper respiratory fungal infection, and upper respiratory tract infection.

Further information

Lenmeldy 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