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
- Back pain
- bleeding gums
- blistering, crusting, irritation, itching, or reddening of the skin
- blood in the urine
- bloody nose
- burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings
- chest pain or tightness
- chills
- cough
- coughing or spitting up blood
- cracked, dry, or scaly skin
- dry, itching skin
- fever
- flushing
- headache
- loosening of the fingernails
- muscle or bone pain
- nausea and vomiting
- nerve pain
- rash with flat lesions or small raised lesions on the skin
- redness or soreness around the fingernails
- sneezing
- swelling
- trouble breathing
- unsteadiness or awkwardness
- weakness in the arms, hands, legs, or feet
Less common
- Anxiety
- dizziness or lightheadedness
- fainting
- fast heartbeat
- general feeling of discomfort or illness
- thickening of bronchial secretions
Rare
- Blistering, peeling, or loosening of the skin
- blurred vision or other change in vision
- diarrhea
- eye redness, irritation, or pain
- red irritated eyes
- red skin lesions, often with a purple center
- sensitivity of the eye to light
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- tearing
- unusual tiredness or weakness
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
- Canker sores
- chapped, red, or swollen lips
- constipation
- decreased appetite
- difficulty in moving
- lack or loss of strength
- muscle aches, cramps, or stiffness
- pain in the arms or legs
- pain in the joints
- redness, swelling, or soreness of the tongue
- scaling, redness, burning, pain, or other signs of inflammation of the lips
- stomach pain
- swelling or inflammation of the mouth
For Healthcare Professionals
Applies to amivantamab: intravenous solution.
Dermatologic
Rash occurred in 75% of patients treated with this drug, including Grade 3 rash in 3.7% 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 7% of patients; this drug was permanently discontinued due to rash in 0.7% of patients.
Paronychia occurred in 43% 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]
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, toxic epidermal necrolysis; up to 84%), paronychia (up to 50%), pruritus (up to 18%), dry skin (includes dry skin, eczema, asteatotic eczema, skin fissures, xeroderma; up to 14%), nail toxicity (includes ingrowing nail, nail bed infection, nail cuticle fissure, nail disorder, nail ridging, onychoclasis, onycholysis, paronychia)
Uncommon (0.1% to 1%): Toxic epidermal necrolysis[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 26%), constipation (up to 23%), 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 36%), hemorrhage (includes epistaxis, gingival bleeding, hematuria, hemoptysis, hemorrhage, mouth hemorrhage, mucosal hemorrhage; up to 19%)[Ref]
Hepatic
Very common (10% or more): Increased ALT (up to 38%), increased AST (up to 33%), increased GGT (up to 27%)[Ref]
Immunologic
Common (1% to 10%): Positive for anti-drug antibodies[Ref]
Metabolic
Very common (10% or more): Hypoalbuminemia/decreased albumin (up to 79%), increased glucose (up to 56%), hypomagnesemia/decreased magnesium (up to 27%), hypokalemia/decreased potassium (up to 26%), decreased appetite (up to 15%), hypocalcemia[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 47%), 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
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)
Uncommon (0.1% to 1%): Keratitis, uveitis
Frequency not reported: Ocular toxicity[Ref]
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]
Other
Very common (10% or more): Infusion-related reaction (IRR; up to 67%), increased alkaline phosphatase (up to 53%), fatigue (includes asthenia, fatigue; up to 33%), decreased phosphate (up to 33%), 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 27%), decreased sodium (up to 27%), pyrexia (up to 13%)[Ref]
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]
Renal
Very common (10% or more): Increased creatinine (up to 46%)[Ref]
Respiratory
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]
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; 10%)
Common (1% to 10%): Interstitial lung disease (ILD)
Frequency not reported: ILD/pneumonitis[Ref]
