Mobocertinib Side Effects

Medically reviewed by Drugs.com. Last updated on Dec 11, 2024.

Applies to mobocertinib: oral capsule.

Important warnings This medicine can cause some serious health issues

Oral route (capsule)

Mobocertinib can cause life-threatening heart rate-corrected QT (QTc) prolongation, including Torsades de Pointes, which can be fatal, and requires monitoring of QTc and electrolytes at baseline and periodically during treatment.

Increase monitoring frequency in patients with risk factors for QTc prolongation.Avoid use of concomitant drugs which are known to prolong the QTc interval and use of strong or moderate CYP3A inhibitors with mobocertinib, which may further prolong the QTc.Withhold, reduce the dose, or permanently discontinue mobocertinib based on the severity of QTc prolongation.

Serious side effects of mobocertinib

Along with its needed effects, mobocertinib 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 immediately if any of the following side effects occur while taking mobocertinib:

More common side effects

• agitation
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody eye
• blurred vision or blue-green halos seen around objects
• coma
• confusion
• decreased urine output
• depression
• diarrhea
• dizziness
• dry eyes
• fainting
• fast, pounding, or irregular heartbeat or pulse
• headache
• hostility
• irregular heartbeat recurrent
• irritability
• lethargy
• muscle twitching
• nausea
• nervousness
• palpitations
• pounding in the ears
• rapid weight gain
• redness, swelling, and/or itching of the eyelid
• seizures
• sensitivity of the eyes to light
• stupor
• swelling of the face, ankles, or hands
• tingling of the hands or feet
• unusual tiredness or weakness
• unusual weight gain or loss

Less common side effects

• chest pain or discomfort
• chills
• cough
• dilated neck veins
• fever
• general feeling of discomfort or illness
• irregular breathing
• swelling of the face, fingers feet, or lower legs
• thickening of bronchial secretions
• trouble breathing

Other side effects of mobocertinib

Some side effects of mobocertinib 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

• acid or sour stomach
• belching
• body aches or pain
• burning, numbness, tingling, or painful sensations
• cracked lips
• decreased appetite
• difficulty in moving
• ear congestion
• heartburn
• indigestion
• loosening of the fingernails
• loss or thinning of the hair
• loss of voice
• muscle or bone pain
• pain in the arms or legs
• rash
• redness or soreness around the fingernails
• sneezing
• sore throat
• sores, ulcers, or white spots on the lips, tongue, or inside the mouth
• stomach discomfort, upset, or pain
• stuffy or runny nose
• swelling or inflammation of the mouth
• tender, swollen glands in the neck
• trouble in swallowing
• unsteadiness or awkwardness
• voice changes
• vomiting
• weakness in the arms, hands, legs, or feet

Less common side effects

• redness, swelling, pain of the skin
• scaling of the skin on the hands and feet
• ulceration of the skin

For healthcare professionals

Applies to mobocertinib: oral capsule.

General adverse events

The most common adverse reactions in patients treated with this drug were diarrhea, rash, anemia, increased blood creatinine, nausea, stomatitis, increased amylase, vomiting, decreased appetite, increased lipase, fatigue, dry skin, paronychia, hypokalemia, hypomagnesemia, decreased platelet count, decreased WBC count, and musculoskeletal pain. Serious adverse reactions occurred in 46% of patients treated with this drug; the most common serious adverse reactions were diarrhea, dyspnea, vomiting, pneumonia, pyrexia, acute kidney injury, dehydration, nausea, pleural effusion, and cardiac failure; fatal adverse reactions occurred in 1.8% of patients, including cardiac failure and pneumonitis. Permanent discontinuation occurred in up to 19% of patients; adverse reactions requiring permanent discontinuation of therapy in at least 2% of patients were diarrhea and nausea. Dosage interruption due to an adverse reaction occurred in up to 61% of patients; adverse reactions which required dosage interruption in greater than 5% of patients included diarrhea, nausea, stomatitis, rash, and vomiting. Dose reductions due to an adverse reaction occurred in up to 32% of patients; adverse reactions which required dose reduction in greater than 5% of patients included diarrhea, nausea, and rash.^[Ref]

Cardiovascular

• Very common (10% or more): Hypertension (includes hypertension, increased blood pressure; up to 14%)
• Common (1% to 10%): QTc interval prolongation (includes ECG QT prolonged, ventricular arrhythmia), cardiac failure (includes cardiac failure, congestive cardiac failure, decreased ejection fraction, cardiomyopathy), atrial fibrillation
• Uncommon (0.1% to 1%): Ventricular tachycardia, first-degree atrioventricular (AV) block, second-degree AV block, left bundle branch block, supraventricular extrasystoles, ventricular extrasystoles
• Frequency not reported: Torsades de pointes, cardiac toxicity (including decreased ejection fraction, cardiomyopathy, congestive heart failure)^[Ref]

In patients treated with this drug, QTc interval prolongation occurred in 8% of patients; Grade 3 QTc interval prolongation occurred in 1.6% of patients and Grade 4 QTc interval prolongation (torsades de pointes) occurred in 0.4% of patients. In the 253-patient subset of the pooled safety population who had scheduled and unscheduled ECGs, 2.4% of patients had QTc interval greater than 500 msec and 13% of patients had a change-from-baseline QTc interval greater than 60 msec; on-treatment ECGs were not routinely performed in the first 28 days of therapy. The median time to onset of QTc interval prolongation was 66 days and the median time to resolution was 29 days.

In patients treated with this drug, cardiac failure/toxicity (including congestive cardiac failure, decreased ejection fraction, and cardiomyopathy) occurred in 2.3% of patients; Grade 3, Grade 4, and fatal cardiac failure occurred in 0.8%, 0.4%, and 0.4% of patients, respectively. The median time to onset of cardiac failure was 150 days and the median time to resolution was 13 days.^[Ref]

Dermatologic

• Very common (10% or more): Rash (includes acne, dermatitis, acneiform dermatitis, rash, macular rash, maculopapular rash, papular rash, pruritic rash, pustular rash, urticaria, eczema, erythema, folliculitis; up to 78%), paronychia (includes nail bed tenderness, nail disorder, nail infection, onycholysis, paronychia; up to 39%), dry skin (includes dry skin, skin fissures, skin exfoliation; up to 32%), pruritus (up to 24%), alopecia (up to 19%)
• Common (1% to 10%): Palmar-plantar erythrodysesthesia syndrome, urticaria^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (up to 93%), elevated pancreatic enzymes (amylase and lipase; up to 51%), nausea (up to 47%), stomatitis (includes angular cheilitis, aphthous ulcer, cheilitis, mouth ulceration, mucosal inflammation, odynophagia, stomatitis; up to 46%), increased amylase (up to 40%), vomiting (up to 40%), increased lipase (up to 35%), abdominal pain (includes abdominal discomfort, abdominal pain, upper abdominal pain, abdominal tenderness, gastrointestinal pain; up to 18%), gastroesophageal reflux disease (up to 15%), dyspepsia (up to 11%)^[Ref]

In clinical studies, 74% of patients experienced Grade 1 or 2 diarrhea; Grade 3 and 4 diarrhea occurred in 20% and 0.4% of patients, respectively. The median time to onset was 5 days and the median time to resolution was 3 days; resolution occurred in 48% of patients.

In patients treated with this drug, elevated pancreatic enzymes (amylase and lipase) occurred in 51% of patients; Grade 3 and 4 elevated pancreatic enzymes occurred in 14% and 3.9% of patients, respectively. The median time to onset was 30 days and the median time to resolution was 29 days.^[Ref]

Hematologic

• Very common (10% or more): Anemia (up to 67%), decreased RBCs (up to 59%), decreased lymphocytes (up to 52%), decreased platelet count (up to 27%), decreased leukocytes/WBC count (up to 25%)^[Ref]

Hepatic

• Very common (10% or more): Elevated liver enzymes (ALT and AST; up to 32%), increased ALT (up to 24%), increased AST (up to 23%)^[Ref]

In patients treated with this drug, elevated liver enzymes (ALT and AST) occurred in 32% of patients; Grade 3 and 4 elevated liver enzymes occurred in 2.3% and 0.4% of patients, respectively. The median time to onset was 43 days and the median time to resolution was 25 days.^[Ref]

Metabolic

• Very common (10% or more): Decreased appetite (up to 35%), hypokalemia (up to 29%), hypomagnesemia (up to 29%), dehydration (up to 12%)^[Ref]

Musculoskeletal

• Very common (10% or more): Musculoskeletal pain (includes arthralgia, back pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, myalgia, neck pain, noncardiac chest pain, pain in extremity, spinal pain; up to 34%)^[Ref]

Nervous system

• Very common (10% or more): Headache (10%)
• Common (1% to 10%): Peripheral neuropathy^[Ref]

Ocular

• Very common (10% or more): Ocular toxicity (includes dry eye, eye pruritus, abnormal sensation in eye, eye discharge, blepharitis, trichiasis, conjunctival hemorrhage, vitreous floaters, blurred vision, corneal edema; up to 11%)^[Ref]

Other

• Very common (10% or more): Fatigue (includes fatigue, asthenia; up to 33%), decreased potassium (up to 29%), increased alkaline phosphatase (up to 25%), decreased albumin (up to 23%), decreased magnesium (up to 23%), decreased weight (up to 21%), decreased sodium (up to 20%)
• Common (1% to 10%): Edema^[Ref]

Psychiatric

• Common (1% to 10%): Insomnia^[Ref]

Renal

• Very common (10% or more): Increased creatinine (up to 52%)
• Common (1% to 10%): Renal failure (includes acute kidney injury, decreased creatinine renal clearance, decreased GFR, renal failure, renal impairment), acute kidney injury^[Ref]

In patients treated with this drug, increased creatinine occurred in 52% of patients; Grade 3 and 4 increased creatinine occurred in 3.9% and 0.8% of patients, respectively. The median time to onset was 29 days and the median time to resolution was 29 days.^[Ref]

Respiratory

• Very common (10% or more): Dyspnea (includes dyspnea, exertional dyspnea; up to 19%), cough (includes cough, productive cough, upper airway cough syndrome; up to 17%), upper respiratory tract infection (includes nasopharyngitis, pharyngitis, respiratory tract infection, rhinitis, sinusitis, upper respiratory tract infection; up to 16%), rhinorrhea (up to 13%)
• Common (1% to 10%): Interstitial lung disease (includes interstitial lung disease [ILD], pneumonitis, respiratory failure), pneumonitis, pneumonia^[Ref]

In patients treated with this drug at the recommended dosage of 160 mg once a day, ILD/pneumonitis occurred in 4.3% of patients including 0.8% Grade 3 events and 1.2% fatal events. The median time to onset was 55 days and the median time to resolution was 17 days; resolution occurred in 45% of patients.^[Ref]

Frequently asked questions

• How effective is Exkivity (mobocertinib) for NSCLC?

Further information

Mobocertinib 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