Elivaldogene Autotemcel Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 3, 2025.

Applies to elivaldogene autotemcel: intravenous suspension.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests are needed every 6 months for at least 15 years to check for unwanted effects.

Male patients with female partners should use an effective form of birth control before having a procedure to collect your blood and for at least 6 months after the last dose.

This medicine may cause blood cancer (eg, myelodysplastic syndrome). Check with your doctor right away if you have chest pain, chills, cough or hoarseness, fever, lower back or side pain, painful or difficult urination, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

Elivaldogene autotemcel will lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers. Call your doctor right away if you have fever, chills, or any signs or symptoms of an infection.

This medicine may cause serious allergic reaction, including anaphylaxis, which may be life-threatening and requires immediate medical attention. Check with your doctor right away if you have a rash, itching, dizziness, fainting, fast heartbeat, trouble breathing or swallowing, or chest tightness while you are using this medicine.

While you are being treated with elivaldogene autotemcel, do not have any immunizations (vaccinations) without your doctor's approval. Live virus vaccinations should not be given for at least 6 weeks before start of treatment, during treatment, and until recovery following the last cycle of this medicine.

Do not donate blood, organs, tissues, or cells during treatment with this medicine.

Before you have any medical tests (eg, HIV test), tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Serious side effects

Along with its needed effects, elivaldogene autotemcel may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking elivaldogene autotemcel:

Other side effects

Some side effects of elivaldogene autotemcel may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to elivaldogene autotemcel: intravenous suspension.

General adverse events

The most common serious adverse reactions (with 3% or greater incidence) that were observed in 54% patients included febrile neutropenia, pyrexia (fever), seizure, myelodysplastic syndrome, pseudomonal bacteremia, pancytopenia, vascular device infection, mucositis, and vomiting.^[Ref]

Dermatologic

• Very common (10% or more): Alopecia (72%), pruritus (19%), rash (21%), skin hyperpigmentation (18%)^[Ref]

Cardiovascular

• Very common (10% or more): Tachycardia (15%)^[Ref]

Hematologic

• Very common (10% or more): Febrile neutropenia (73%), hypertension (12%)^[Ref]

Grade 3 or 4 laboratory hematologic abnormality that occurred in more than 40% of patients were leukopenia, lymphopenia, thrombocytopenia, neutropenia, anemia, and hypokalemia.^[Ref]

Local

• Very common (10% or more): Transfusion reaction (12%)^[Ref]

Metabolic

• Very common (10% or more): Decreased appetite (64%)^[Ref]

Nervous system

• Very common (10% or more): Anxiety (15%), headache (28%)^[Ref]

Ocular

• Very common (10% or more): Vision blurred (10%)^[Ref]

Other

• Very common (10% or more): Pyrexia (36%)^[Ref]

Respiratory

• Very common (10% or more): Cough (10%), epistaxis (19%), oropharyngeal pain (18%)^[Ref]

See also:

Further information

Elivaldogene autotemcel 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