Betibeglogene Autotemcel Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 5, 2025.

Applies to betibeglogene autotemcel: intravenous suspension.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests are needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Female patients should use effective birth control during treatment with this medicine and for at least 6 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 6 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

Betibeglogene autotemcel injection will lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may cause serious allergic reaction, including anaphylaxis, which may be life-threatening and requires immediate medical attention. Check with your doctor right away if you have a rash, itching, dizziness, fainting, fast heartbeat, trouble breathing or swallowing, or chest tightness while you are using this medicine.

Do not donate blood, organs, tissues, or cells during treatment with this medicine.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

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 side effects

• 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 side effects

• 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 side effects

• 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.

General adverse events

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]

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]

Cardiovascular

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

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

• Very common (10% or more): Increased alanine aminotransferase (24%), hyperbilirubinemia (10%)
• Common (1% to 10%): Veno-occlusive liver disease^[Ref]

Serious veno-occlusive liver disease occurred in 7% of patients.^[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]

See also:

Further information

Betibeglogene autotemcel 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