Skysona Side Effects

Generic name: elivaldogene autotemcel

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

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

Applies to elivaldogene autotemcel: intravenous suspension.

Important warnings This medicine can cause some serious health issues

Intravenous route (suspension)

Hematologic malignancy, including life-threatening cases of myelodysplastic syndrome, has occurred in patients treated with elivaldogene autotemcel.

Patients have been diagnosed between 14 months and 7.5 years after elivaldogene autotemcel administration, and the cancers appear to be the result of the elivaldogene autotemcel lentiviral vector, Lenti-D, integration in proto-oncogenes.

Monitor patients closely for evidence of malignancy through complete blood counts at least every 6 months and through assessments for evidence for clonal expansion or predominance at least twice in the first year and annually thereafter; consider bone marrow evaluations as clinically indicated.

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 side effects

• 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 side effects

• 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.

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]

Further information

Skysona 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