Glofitamab Side Effects

Medically reviewed by Drugs.com. Last updated on Dec 6, 2024.

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.

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]

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.

Medical Disclaimer