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Amivantamab Side Effects

Medically reviewed by Drugs.com. Last updated on Jun 26, 2023.

Applies to amivantamab: intravenous solution.

Serious side effects of Amivantamab

Along with its needed effects, amivantamab 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 amivantamab:

More common

Less common

Rare

Other side effects of Amivantamab

Some side effects of amivantamab 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 amivantamab: intravenous solution.

General

The most common adverse reactions with a frequency of 20% or greater were rash, infusion-related reaction, nail toxicity, dry skin, paronychia, musculoskeletal pain, dyspnea, nausea, edema, cough, fatigue, stomatitis, constipation, vomiting, dermatitis acneiform, hypoalbuminemia, increased ALT and pruritus.

The most common Grade 3 to 4 laboratory abnormalities with a frequency of 2% or greater were decreased lymphocytes, decreased albumin, decreased phosphate, decreased potassium, increased glucose, increased alkaline phosphatase, increased GGT, and decreased sodium.[Ref]

Dermatologic

Very common (10% or more): Rash (includes acne, dermatitis, acneiform dermatitis, eczema, asteatotic eczema, erythema, erythema multiforme, folliculitis, impetigo, palmar-plantar erythrodysesthesia syndrome, perineal rash, perioral dermatitis, pustule, rash, erythematous rash, macular rash, maculopapular rash, papular rash, pruritic rash, pustular rash, vesicular rash, skin exfoliation, skin lesion up to 85%), paronychia, pruritus (up to 18%), dry skin (includes dry skin, eczema, asteatotic eczema, skin fissures, xeroderma; up to 23%), nail toxicity (includes ingrowing nail, nail bed infection, nail cuticle fissure, nail disorder, nail ridging, onychoclasis, onycholysis, paronychia; up to 56%)

Uncommon (0.1% to 1%): Toxic epidermal necrolysis[Ref]

Rash occurred in 74% of patients treated with this drug, including Grade 3 rash in 3.3% of patients. Rash generally developed within the first 4 weeks of therapy with a median time to onset of 14 days (range: 1 to 276 days). Rash leading to dose reduction occurred in 5% of patients; this drug was permanently discontinued due to rash in 0.7% of patients.

Paronychia occurred in 50% of patients treated with this drug, including Grade 3 paronychia in 2% of patients. The median time from onset of paronychia to complete resolution was 235 days (range: 26 to 443 days). Paronychia leading to discontinuation of this drug occurred in 2% of patients.[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 36%), stomatitis (includes aphthous ulcer, cheilitis, glossitis, lip ulceration, mouth ulceration, mucosal inflammation, pharyngeal inflammation, stomatitis; up to 28%), constipation (up to 24%), vomiting (up to 22%), diarrhea (up to 16%), abdominal pain (includes abdominal discomfort, abdominal pain, lower abdominal pain, upper abdominal pain, epigastric discomfort, gastrointestinal pain; up to 11%)[Ref]

Hematologic

Very common (10% or more): Decreased lymphocytes (up to 38%), hemorrhage (includes epistaxis, gingival bleeding, hematuria, hemoptysis, hemorrhage, mouth hemorrhage, mucosal hemorrhage; up to 24%)[Ref]

Hepatic

Very common (10% or more): Increased ALT (up to 40%), increased AST (up to 34%), increased GGT (up to 29%)[Ref]

Immunologic

Common (1% to 10%): Positive for anti-drug antibodies[Ref]

Metabolic

Very common (10% or more): Hypoalbuminemia/decreased albumin (includes blood albumin decreased, hypoalbuminemia) (up to 83%), increased glucose (up to 56%), hypomagnesemia/decreased magnesium (up to 28%), hypokalemia/decreased potassium (up to 28%), decreased appetite (up to 18%), hypocalcemia (up to 21%)[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (includes arthralgia, arthritis, back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, myalgia, neck pain, noncardiac chest pain, pain in extremity, spinal pain; up to 48%), myalgia[Ref]

Nervous system

Very common (10% or more): Peripheral neuropathy (includes hypoesthesia, neuralgia, paresthesia, peripheral sensory neuropathy; up to 13%), dizziness (includes dizziness, exertional dizziness, vertigo; up to 12%), headache (includes headache, migraine; 10%)[Ref]

Ocular

In the safety population, keratitis and uveitis occurred in 0.7% and 0.3% of patients treated with this drug, respectively; all events were Grade 1 to 2.

According to some authorities, eye disorders (including keratitis [0.4%]) occurred in 12% of patients treated with this drug; most events were Grade 1 or 2, with Grade 3 events occurring in 0.2% of patients. Keratitis led to dose interruption in 0.2% of patients, and blurred vision led to discontinuation of this drug in 0.2% of patients.[Ref]

Common (1% to 10%): Visual impairment (includes blurred vision, reduced visual acuity, visual impairment), growth of eyelashes (includes growth of eyelashes, trichomegaly), keratitis, other eye disorders (includes blepharitis, conjunctival hyperemia, corneal irritation, dry eye, episcleritis, eye disorder, eye pruritus, noninfective conjunctivitis, ocular hyperemia), keratitis

Uncommon (0.1% to 1%): Uveitis

Frequency not reported: Ocular toxicity[Ref]

Other

In the safety population, IRR occurred in 66% of patients treated with this drug; among patients receiving treatment, 65% had an IRR with the Week 1 Day 1 infusion, 3.4% with the Week 1 Day 2 infusion, 0.4% with the Week 2 infusion, and cumulatively 1.1% with subsequent infusions. Of the reported IRR, 97% were Grade 1 to 2, 2.2% were Grade 3, and 0.4% were Grade 4. The median time to onset was 1 hour (range: 0.1 to 18 hours) after the start of the infusion. Infusion was modified due to IRR in 62% of patients; 1.3% of patients permanently discontinued this drug due to IRR.[Ref]

Very common (10% or more): Infusion-related reaction (IRR; up to 67%), increased Alk Phos (up to 53%), fatigue (includes asthenia, fatigue; up to 33%), decreased phosphate (up to 36%), edema (includes eye edema, eyelid edema, face edema, generalized edema, lip edema, localized edema, edema, peripheral edema, periorbital edema, periorbital swelling, peripheral swelling, swelling face; up to 29%), decreased sodium (up to 27%), pyrexia (up to 17%)[Ref]

Renal

Very common (10% or more): Increased creatinine (up to 48%)[Ref]

Respiratory

Very common (10% or more): Dyspnea (includes dyspnea, exertional dyspnea; up to 37%), cough (includes cough, productive cough, upper airway cough syndrome; up to 25%), pneumonia (includes atypical pneumonia, lower respiratory tract infection, pneumonia, aspiration pneumonia, pulmonary sepsis; 11%)

Common (1% to 10%): Interstitial lung disease (ILD)

Frequency not reported: ILD/Pneumonitis[Ref]

In the safety population, ILD/pneumonitis occurred in 3.3% of patients treated with this drug, including Grade 3 ILD/pneumonitis in 0.7% of patients; 3 patients (1%) discontinued this drug due to ILD/pneumonitis.[Ref]

Frequently asked questions

References

1. Product Information. Rybrevant (amivantamab). Janssen-Cilag Pty Ltd. 2022.

2. Product Information. Rybrevant (amivantamab). Janssen Biotech, Inc. 2021.

3. Product Information. Rybrevant (amivantamab). Janssen-Cilag Ltd. 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.

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