Applies to elivaldogene autotemcel: intravenous suspension.
Warning
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
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:
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
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]
