Applies to betibeglogene autotemcel: intravenous suspension.
Serious side effects
Along with its needed effects, betibeglogene 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 betibeglogene autotemcel:
More common
- Black, tarry stools
- blurred vision
- body aches or pain
- chest tightness
- chills
- confusion
- cough or hoarseness
- cracked lips
- diarrhea
- difficulty in swallowing
- dizziness
- ear congestion
- fainting
- fever
- headache
- lightheadedness
- loss of voice
- lower back or side pain
- muscle or bone pain
- pain in the arms or legs
- painful or difficult urination
- pale skin
- pounding in the ears
- slow or fast heartbeat
- sneezing
- sore throat
- stomach pain
- stuffy or runny nose
- tender, swollen glands in the neck
- trouble breathing
- ulcers, sores, or white spots on the lips, tongue, or inside the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
Less common
- Chest pain
- decreased urine output
- dilated neck veins
- fast, pounding, or irregular heartbeat or pulse
- irregular breathing
- swelling of the face, fingers, feet, or lower legs
- weight gain
Other side effects
Some side effects of betibeglogene 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
- Acid or sour stomach
- belching
- bleeding gums
- bloody nose
- constipation
- darkening of the skin
- decreased appetite
- hair loss or thinning of the hair
- heartburn
- indigestion
- lightening of the normal skin color
- lightening of treated areas of the dark skin
- nausea
- stomach discomfort or upset
For Healthcare Professionals
Applies to betibeglogene autotemcel: intravenous suspension.
Cardiovascular
-Increased heart rate on the day of treatment is likely.[Ref]
Common (1% to 10%): Hypertension, congestive heart failure, tachycardia[Ref]
Dermatologic
Very common (10% or more): Alopecia (44%), rash (27%), pigmentation disorder (24%), pruritus (22%)[Ref]
-Rash includes acne, dermatitis acneiform, dermatitis atopic, macule, petechiae, rash, follicular rash, macular rash, maculo-papular rash, pruritic rash, pustular rash, and vesicular rash.
-Pigmentation disorder includes oral pigmentation, pigmentation disorder, skin hyperpigmentation, and skin hypopigmentation.[Ref]
Gastrointestinal
-Mucositis includes anal inflammation, mucosal inflammation, oral mucosal exfoliation, oral mucosal roughening, pharyngeal inflammation, and stomatitis.
-Abdominal pain includes abdominal pain, lower abdominal pain, abdominal discomfort, and upper abdominal pain.
-Abdominal pain on the day of treatment is likely.[Ref]
Very common (10% or more): Mucositis (95%), vomiting (49%), abdominal pain (39), diarrhea (27%), nausea (24%), constipation (24%)
Common (1% to 10%): Dyspepsia, gingival bleeding[Ref]
General
The most common adverse reactions with a frequency of 20% or more were mucositis, febrile neutropenia, vomiting, pyrexia (fever), alopecia (hair loss), epistaxis (nosebleed), abdominal pain, musculoskeletal pain, cough, headache, diarrhea, rash, constipation, nausea, decreased appetite, pigmentation disorder, and pruritus (itch).
The most common serious adverse reactions with a frequency of more than 3% were pyrexia (fever), thrombocytopenia, liver veno-occlusive disease, febrile neutropenia, neutropenia, and stomatitis.[Ref]
Hematologic
-Decreased neutrophil counts occurred in Granulocyte-colony stimulating factor (G-CSF) dependent patients after its discontinuation.[Ref]
Very common (10% or more): Neutropenia (100%), thrombocytopenia (100%), leukopenia (100%), febrile neutropenia (51%), transfusion reaction (15%) , anemia (95%), lymphopenia (61%), decreased neutrophil count[Ref]
Hepatic
-Serious veno-occlusive liver disease occurred in 7% of patients.[Ref]
Very common (10% or more): Increased alanine aminotransferase (24%), hyperbilirubinemia (10%)
Common (1% to 10%): Veno-occlusive liver disease[Ref]
Local
Very common (10% or more): Procedural pain (15%)
Metabolic
Very common (10% or more): Decreased appetite (24%), hyponatremia (10%), hypophosphatemia (20%), hyperglycemia (14%), hypokalemia (12%)[Ref]
Musculoskeletal
-Musculoskeletal pain includes musculoskeletal pain, musculoskeletal chest pain, bone pain, musculoskeletal discomfort, chest pain, myalgia, neck pain, non-cardiac chest pain, pain in extremity, spinal pain, tendon pain, and back pain.[Ref]
Very common (10% or more): Musculoskeletal pain (37%)[Ref]
Nervous system
-Headache includes headache and migraine.[Ref]
Very common (10% or more): Headache (29%)[Ref]
Other
-Viral infection includes BK virus infection, positive human rhinovirus, influenza, influenza like illness, parainfluenza virus infection, rhinovirus infection, and positive SARS-CoV-2.
-Sepsis includes sepsis, bacterial sepsis, neutropenic sepsis, and fungal sepsis.[Ref]
Very common (10% or more): Pyrexia (49%), fatigue (12%), viral infection (17%)
Common (1% to 10%): Sepsis
Frequency not reported: Platelet engraftment delay[Ref]
Respiratory
Very common (10% or more): Upper respiratory tract infections (15%), nasopharyngitis (12%), epistaxis (42%), cough (34%), oropharyngeal pain (15%), dyspnea (12), hypoxia (12%), rhinitis (12%)
Common (1% to 10%): Pneumonia[Ref]
-Upper respiratory tract infections include upper airway cough syndrome, upper respiratory tract infection, viral upper respiratory tract infection, pharyngitis, and pharyngitis streptococcal.
-Cough includes cough, upper-airway cough syndrome, and productive cough.
-Oropharyngeal pain includes oropharyngeal pain, oral pain, oropharyngeal discomfort, and jaw pain.
-Rhinitis includes rhinitis, rhinorrhea, and allergic rhinitis.[Ref]
