Skip to main content

Tebentafusp Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 2, 2023.

Applies to tebentafusp: intravenous solution.

Warning

Intravenous route (Solution)

Warning: Cytokine Release SyndromeCytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving tebentafusp-tebn. Monitor for at least 16 hours following first three infusions and then as clinically indicated.

Serious side effects of Tebentafusp

Along with its needed effects, tebentafusp 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 tebentafusp:

More common

Rare

Other side effects of Tebentafusp

Some side effects of tebentafusp 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

For Healthcare Professionals

Applies to tebentafusp: intravenous solution.

General

Serious side effects were reported in 28% of patients who received this drug and included cytokine release syndrome (CRS), rash, pyrexia, and hypotension. Side effects led to permanent discontinuation in 3.3% of patients and included anaphylactic reaction, brain edema, CRS, fatigue, hepatotoxicity, hypotension, and nausea. Side effects led to dosage interruption in 25% of patients and included fatigue, increased lipase, pyrexia, increased ALT, and increased AST. Side effects led to dose reduction in 5% of patients and included CRS and rash.

The most common side effects were CRS, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache, and vomiting; the most common laboratory abnormalities were decreased lymphocyte count, increased creatinine, increased glucose, increased AST, increased ALT, decreased hemoglobin, and decreased phosphate.[Ref]

Immunologic

Very common (10% or more): CRS (up to 89%), anti-drug antibodies (up to 33%)[Ref]

In 1 study, CRS (at least grade 2) occurred in 77% of patients treated with this drug; among these patients, 23%, 8%, and 0.8% received systemic corticosteroids, supplemental oxygen, and a vasopressor, respectively, for or during at least 1 infusion. In 1 study, 60% of patients had at least grade 2 CRS with more than 1 infusion (median of 2 events [range: 1 to 12 events]); most (84%) episodes of CRS started the day of infusion, and among cases that resolved, the median time to resolution was 2 days.[Ref]

Hematologic

Decreased lymphocyte count (grades 1 to 4: 91%; grades 3 to 4: 56%), decreased hemoglobin (grades 1 to 4: 51%; grades 3 to 4: 0.8%), decreased platelet count (grades 1 to 4: 16%), and decreased neutrophil count (grades 1 to 4: 14%; grades 3 to 4: 2%) have been reported.[Ref]

Very common (10% or more): Decreased lymphocyte count (up to 91%), decreased hemoglobin (up to 51%), decreased platelet count (up to 16%), decreased neutrophil count (up to 14%)[Ref]

Renal

Increased creatinine (grades 1 to 4: 87%; grades 3 to 4: 0.4%) has been reported.[Ref]

Very common (10% or more): Increased creatinine (up to 87%)[Ref]

Dermatologic

Very common (10% or more): Skin reactions (up to 91%), rash (up to 83%), pruritus (up to 69%), dry skin (up to 31%), skin hypopigmentation (up to 28%), cutaneous edema (up to 27%), erythema (up to 25%), hair color changes (up to 20%)

Frequency not reported: Alopecia, skin hyperpigmentation, night sweats[Ref]

In 1 study, skin reactions occurred in 91% of patients treated with this drug, including grade 2 (44%) and grade 3 (21%) events; skin reactions included rash (83%), pruritus (69%), erythema (25%), and cutaneous edema (27%). The median time to onset of skin reactions was 1 day (range: 1 to 55 days); the median time to improvement to grade 1 or lower was about 6 days.

Alopecia, skin hyperpigmentation, and night sweats were reported in less than 20% of patients.[Ref]

Other

Decreased phosphate (grades 1 to 4: 51%; grades 3 to 4: 11%), decreased albumin (grades 1 to 4: 47%; grades 3 to 4: 2.1%), decreased calcium (grades 1 to 4: 45%; grades 3 to 4: 1.6%), decreased magnesium (grades 1 to 4: 34%), increased alkaline phosphatase (grades 1 to 4: 34%; grades 3 to 4: 2.9%), decreased sodium (grades 1 to 4: 30%; grades 3 to 4: 2.9%), increased potassium (grades 1 to 4: 29%; grades 3 to 4: 1.6%), decreased potassium (grades 1 to 4: 17%; grades 3 to 4: 0.8%), and increased calcium (grades 1 to 4: 13%) have been reported.

Flushing and influenza-like illness were reported in less than 20% of patients.[Ref]

Very common (10% or more): Pyrexia (up to 76%), fatigue (up to 64%), decreased phosphate (up to 51%), chills (up to 48%), decreased albumin (up to 47%), edema (up to 45%), decreased calcium (up to 45%), decreased magnesium (up to 34%), increased alkaline phosphatase (up to 34%), decreased sodium (up to 30%), increased potassium (up to 29%), decreased potassium (up to 17%), increased calcium (up to 13%)

Frequency not reported: Flushing, influenza-like illness[Ref]

Metabolic

Increased glucose (grades 1 to 4: 66%; grades 3 to 4: 3.3%) and decreased glucose (grades 1 to 4: 18%; grades 3 to 4: 0.4%) have been reported.

Decreased appetite was reported in less than 20% of patients.[Ref]

Very common (10% or more): Increased glucose (up to 66%), decreased glucose (up to 18%)

Frequency not reported: Decreased appetite[Ref]

Hepatic

Very common (10% or more): Increased ALT/AST (up to 65%), increased AST (up to 55%), increased ALT (up to 52%), increased bilirubin (up to 27%)

Common (1% to 10%): Liver enzyme elevations

Frequency not reported: Hepatotoxicity[Ref]

Increased AST (grades 1 to 4: 55%; grades 3 to 4: 13%), increased ALT (grades 1 to 4: 52%; grades 3 to 4: 9%), and increased bilirubin (grades 1 to 4: 27%; grades 3 to 4: 4.1%) have been reported.

In 1 study, increases in ALT and AST were observed in 65% of patients treated with this drug; in those with ALT/AST elevations, 73% initially occurred within the first 3 infusions. Most patients with grade 3 or 4 ALT/AST elevations had improvement to grade 1 or lower within 7 days. For events observed outside the setting of CRS, the median time to onset was 129 days; grade 3 or greater liver enzyme elevations outside the setting of CRS occurred in about 8% of patients. Liver enzyme elevations led to permanent discontinuation in 0.4% of patients.[Ref]

Gastrointestinal

Increased lipase (grades 1 to 4: 37%; grades 3 to 4: 15%) and increased amylase (grades 1 to 4: 23%; grades 3 to 4: 4.1%) have been reported.

Constipation was reported in less than 20% of patients.[Ref]

Very common (10% or more): Nausea (up to 49%), abdominal pain (up to 45%), increased lipase (up to 37%), vomiting (up to 30%), diarrhea (up to 25%), increased amylase (up to 23%)

Frequency not reported: Constipation[Ref]

Cardiovascular

Hypertension and tachycardia/sinus tachycardia were reported in less than 20% of patients.[Ref]

Very common (10% or more): Hypotension (up to 39%)

Frequency not reported: Hypertension, tachycardia/sinus tachycardia[Ref]

Nervous system

Very common (10% or more): Headache (up to 31%)

Frequency not reported: Paresthesia, dizziness, brain edema[Ref]

Paresthesia and dizziness were reported in less than 20% of patients.[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (up to 22%)

Frequency not reported: Back pain, muscle spasms, myalgia, pain in extremity[Ref]

Back pain, muscle spasms, myalgia, and pain in extremity were reported in less than 20% of patients.[Ref]

Hypersensitivity

Frequency not reported: Anaphylactic reaction[Ref]

Respiratory

Frequency not reported: Dyspnea, oropharyngeal pain, pulmonary embolism[Ref]

Dyspnea and oropharyngeal pain were reported in less than 20% of patients.

A fatal pulmonary embolism occurred in 1 patient.[Ref]

References

1. Product Information. Kimmtrak (tebentafusp). Immunocore LLC. 2022.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.