Glofitamab Side Effects
Medically reviewed by Drugs.com. Last updated on Jan 3, 2025.
Applies to glofitamab: intravenous solution.
Important warnings
This medicine can cause some serious health issues
Intravenous route (solution)
Warning: Cytokine Release Syndrome. Cytokine Release Syndrome (CRS), including serious or fatal reactions, can occur in patients receiving glofitamab-gxbm.
Premedicate before each dose, and initiate treatment with the glofitamab-gxbm step-up dosing schedule to reduce the risk of CRS.
Withhold glofitamab-gxbm until CRS resolves or permanently discontinue based on severity.
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 treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for 1 month after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.
This medicine may cause cytokine release syndrome (CRS) and nervous system problems, including immune effector cell-associated neurotoxicity syndrome (ICANS). These may be life-threatening and require immediate attention. Tell your doctor right away if you have agitation, back pain, blurred vision, burning, throbbing, or stabbing pain, coma, confusion, double vision, drowsiness, feeling restless, fever, chills, hallucinations, headache, hearing loss, irritability, jerking movements, mood or mental changes, muscle spasms, nausea, lightheadedness, dizziness, fainting, rigid muscles, seizures, skin rash, stiff neck, tremor, trouble breathing, trouble speaking, unusual tiredness or weakness, or vomiting.
This medicine may cause serious infections. Check with your doctor right away if you have fever or chills, confusion, cough or hoarseness, lower back or side pain, or painful or difficult urination.
Check with your doctor right away if you have chest pain, cough, pain or swelling at the site of the tumor, tender or swollen lymph nodes, or trouble breathing. These may be symptoms of serious or worsening of tumor.
This medicine may cause dizziness, confusion, tremors, or sleepiness. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Serious side effects of glofitamab
Along with its needed effects, glofitamab 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 glofitamab:
More common side effects
- bloating or swelling of the face, arms, hands, lower legs, or feet
- burning, numbness, tingling, or painful sensations
- chest pain
- cough
- difficulty in moving
- dizziness or lightheadedness
- feeling of constant movement of self or surroundings
- headache
- joint or bone pain
- muscle cramps, pains, or stiffness
- pain or swelling at the site of the tumor
- rapid or irregular heartbeat
- rapid weight gain
- sensation of spinning
- swollen joints
- tender or swollen lymph nodes
- tingling of the hands or feet
- trembling and shaking of hands
- trouble breathing
- unsteadiness or awkwardness
- unusual weight gain or loss
- weakness
- weakness in arms, hands, legs, or feet
Less common side effects
- black, tarry stools
- chest tightness
- confusion as to time, place, or person
- fever or chills
- hallucinations
- holding false beliefs that cannot be changed by fact
- lower back or side pain
- mental depression or anxiety
- nightmares or unusually vivid dreams
- painful or difficult urination
- pale skin
- sleepiness or unusual drowsiness
- sneezing
- sore throat
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual excitement, nervousness, or restlessness
- unusual tiredness or weakness
Other side effects of glofitamab
Some side effects of glofitamab 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
- blistering, crusting, irritation, itching, or reddening of the skin
- constipation
- cracked, dry, or scaly skin
- diarrhea
- neck pain
- pain in the arms or legs
- stomach pain
- swelling
For healthcare professionals
Applies to glofitamab: intravenous solution.
General adverse events
The most common adverse reactions were cytokine release syndrome (CRS), fatigue, musculoskeletal pain, and rash. Serious adverse reactions occurred in 48% of patients and fatal reactions in 5%. These fatal reactions include COVID-19, sepsis, and delirium.[Ref]
Dermatologic
- Very common (10% or more): Rash (includes rash pruritic, erythema, palmar erythema, rash erythematous, rash maculopapular, pruritus, dermatitis, dermatitis acneiform, and dermatitis exfoliative) (20%)[Ref]
Gastrointestinal
- Very common (10% or more): Abdominal pain (includes abdominal discomfort, pain, and upper abdominal pain) (10%), diarrhea (14%), nausea (10%), constipation (14%)
- Frequency not reported: Gastrointestinal hemorrhage[Ref]
Hematologic
- Very common (10% or more): Decreased lymphocyte count (90%), decreased hemoglobin (72%), decreased neutrophils (56%), decreased platelets (56%)[Ref]
Immunologic
- Very common (10% or more): Cytokine release syndrome (70%)[Ref]
Musculoskeletal
- Very common (10% or more): Musculoskeletal pain (includes back pain, bone pain, flank pain, myalgia, neck pain, and pain in extremity) (21%)[Ref]
Nervous system
- Very common (10% or more): Headache (10%)
- Frequency not reported: Tremor, peripheral neuropathy[Ref]
Oncologic
- Very common (10% or more): Tumor flare (12%)
- Frequency not reported: Tumor lysis syndrome[Ref]
Other
- Very common (10% or more): Fatigue (20%), pyrexia (16%), edema including peripheral edema and face swelling (10%), decreased sodium (49%), decreased phosphate (69%), decreased potassium (32%), decreased fibrinogen (84%), decreased calcium (48%), increased gamma-glutamyl transferase (33%), increased uric acid (23%)
- Frequency not reported: Infections (includes sepsis, COVID-19, pneumonia, upper respiratory tract infections, herpes zoster, and myelitis), febrile neutropenia[Ref]
Psychiatric
- Common (1% to 10%): Mental status change[Ref]
See also:
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References
1. (2023) "Product Information. Columvi (glofitamab)." Genentech
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Further information
Glofitamab 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.