Mobocertinib Side Effects

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

Applies to mobocertinib: oral capsule.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment and for at least 1 month after the last dose. Males with female partners who are able to become pregnant should use an effective form of birth control during treatment and for at least 1 week after the last dose. If you think you have become pregnant, tell your doctor right away.

Check with your doctor right away if you have chest pain or discomfort, irregular or slow heart rate, fainting, or trouble breathing. These maybe symptoms of serious heart rhythm problems (eg, QT prolongation, torsades de pointes).

This medicine may cause swelling of the lungs (pneumonitis) or interstitial lung disease. These are life-threatening conditions and require immediate medical attention. The symptoms may be similar to the symptoms from lung cancer. Check with your doctor right away if you have new or worsening cough, fever, or trouble breathing.

Check with your doctor right away if you have chest pain, discomfort, or tightness, decreased urine output, dilated neck veins, dizziness, faintness, irregular breathing, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, trouble breathing, unusual tiredness or weakness, or weight gain. These may be symptoms of serious heart problems (eg, congestive heart failure, cardiomyopathy).

This medicine may cause diarrhea, and in some cases it can be severe. Your doctor will ask you to take medicine to treat first signs of diarrhea or to drink plenty of fluids.

Some men and women who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

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:

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]

See also:

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.

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