Skysona Side Effects

Generic name: elivaldogene autotemcel

Medically reviewed by Drugs.com. Last updated on Dec 10, 2023.

Note: This document contains side effect information about elivaldogene autotemcel. Some dosage forms listed on this page may not apply to the brand name Skysona.

Applies to elivaldogene autotemcel: intravenous suspension.

Serious side effects of Skysona

Along with its needed effects, elivaldogene autotemcel (the active ingredient contained in Skysona) 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:

More common

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• blurred vision
• chest pain
• chills
• cough or hoarseness
• dizziness
• fast, pounding, or irregular heartbeat or pulse
• fever
• headache
• lower back or side pain
• nervousness
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• pounding in the ears
• seizures
• slow or fast heartbeat
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness

Incidence not known

• Chest tightness
• difficulty swallowing
• hives, itching, or skin rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

Other side effects of Skysona

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:

More common

• Back pain
• bloody nose
• constipation
• cracked lips
• darkening of the skin
• decreased appetite
• diarrhea
• fear
• flushing
• irritation or soreness of the mouth
• loss or thinning of the hair
• nausea
• stomach pain
• swelling or inflammation of the mouth
• vomiting

For Healthcare Professionals

Applies to elivaldogene autotemcel: intravenous suspension.

Cardiovascular

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

Dermatologic

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

General

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]

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]

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