Zynteglo Side Effects

Generic name: betibeglogene autotemcel

Medically reviewed by Drugs.com. Last updated on Dec 28, 2023.

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

Applies to betibeglogene autotemcel: intravenous suspension.

Serious side effects of Zynteglo

Along with its needed effects, betibeglogene autotemcel (the active ingredient contained in Zynteglo) 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 of Zynteglo

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

Common (1% to 10%): Hypertension, congestive heart failure, tachycardia^[Ref]

-Increased heart rate on the day of treatment is likely.^[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

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]

-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]

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

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]

-Decreased neutrophil counts occurred in Granulocyte-colony stimulating factor (G-CSF) dependent patients after its discontinuation.^[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

Very common (10% or more): Musculoskeletal pain (37%)^[Ref]

-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]

Nervous system

Very common (10% or more): Headache (29%)^[Ref]

-Headache includes headache and migraine.^[Ref]

Other

Very common (10% or more): Pyrexia (49%), fatigue (12%), viral infection (17%)

Common (1% to 10%): Sepsis

Frequency not reported: Platelet engraftment delay^[Ref]

-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]

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]