Mobocertinib

What is Mobocertinib?

• Mobocertinib (Exkivity) is a kinase inhibitor used treat locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations.

Mobocertinib

Mobocertinib

What are the uses of this medicine?

Mobocertinib (Exkivity) is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC):

• that has spread to other parts of the body (metastatic) and cannot be removed by surgery, and
• has a certain abnormal epidermal growth factor receptor (EGFR) gene, and
• whose disease has worsened while on or after chemotherapy that contains platinum

How does this medicine work?

• An orally available inhibitor of specific mutant forms of both human epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2; ERBB2), with potential antineoplastic activity.
• Upon oral administration, mobocertinib specifically and irreversibly binds to and inhibits certain mutant forms of EGFR and HER2.
• This prevents EGFR- and HER2-mediated signaling and leads to cell death in EGFR mutant- and HER2 mutant-expressing tumor cells.
• EGFR and HER2, receptor tyrosine kinases mutated in many tumor cell types, play key roles in tumor cell proliferation and tumor vascularization.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Avoid concomitant use of Exkivity with strong or moderate CYP3A inhibitors.
• If concomitant use of a moderate CYP3A inhibitor is unavoidable, reduce the dose of Exkivity.
• Avoid concomitant use of Exkivity with strong or moderate CYP3A inducers.

Is this medicine FDA approved?

• Mobocertinib was approved for medical use in the United States in September 2021.
• It is a first-in-class oral treatment to target EGFR Exon20 insertion mutations.

How should this medicine be used?

• Select patients with locally advanced or metastatic NSCLC for treatment with Exkivity based on the presence of EGFR exon 20 insertion mutations.

Recommended dosage:

• The recommended dosage of Exkivity is 160 mg orally once daily until disease progression or unacceptable toxicity.

Administration:

• Take your prescribed dose of Exkivity 1 time each day.
• Take Exkivity with or without food.
• Swallow Exkivity capsules whole. Do not open, chew, or dissolve the contents of the capsules.
• Do not change your dose or stop taking Exkivity unless your healthcare provider tells you to.
• Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with Exkivity if you develop certain side effects.
• If you miss a dose of Exkivity, and it has been more than 6 hours, skip the dose and take your next dose at your regularly scheduled time the next day.
• If you vomit a dose of Exkivity, do not take an extra dose. Take your next dose at your regularly scheduled time the next day.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 40 mg

This medicine is available in fallowing brand namesː

• Exkivity

What side effects can this medication cause?

The most common side effects of this medicine include:

• diarrhea
• rash
• nausea
• mouth sores
• vomiting
• decrease appetite
• infection of skin around nails
• tiredness
• dry skin
• muscle or bone pain

Exkivity may cause serious side effects, including:

• QTc prolongation and Torsades de Pointes
• Lung problems
• Heart problems, including heart failure
• Diarrhea

What special precautions should I follow?

• Exkivity can cause life-threatening heart rate-corrected QT (QTc) prolongation, including Torsades de Pointes, which can be fatal. Withhold, reduce the dose, or permanently discontinue Exkivity based on the severity of the QTc prolongation.
• Exkivity can cause ILD/pneumonitis, which can be fatal. Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis. Immediately withhold Exkivity in patients with suspected ILD/pneumonitis and permanently discontinue Exkivity if ILD/pneumonitis is confirmed.
• Exkivity can cause cardiac toxicity (including decreased ejection fraction, cardiomyopathy, and congestive heart failure) resulting in heart failure which can be fatal. Monitor cardiac function, including left ventricular ejection fraction, at baseline and during treatment. Withhold, resume at reduced dose or permanently discontinue based on severity.
• Exkivity can cause diarrhea, which can be severe. Diarrhea may lead to dehydration or electrolyte imbalance, with or without renal impairment. Monitor electrolytes and advise patients to start an antidiarrheal agent at first episode of diarrhea and to increase fluid and electrolyte intake. Withhold, reduce the dose, or permanently discontinue Exkivity based on the severity.
• Based on findings from animal studies and its mechanism of action, Exkivity can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus and to use effective non-hormonal contraception.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on findings from animal studies and its mechanism of action, Exkivity can cause fetal harm when administered to a pregnant woman.
• There are no available data on Exkivity use in pregnant women.

Can this medicine be used in children?

• The safety and effectiveness of Exkivity in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: mobocertinib
• Inactive ingredients: None
• Capsule shells: gelatin and titanium dioxide. The printing ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water.

Who manufactures and distributes this medicine?

Distributed by:

• Takeda Pharmaceuticals America, Inc., Lexington, MA
• Exkivity™ is a trademark of Takeda Pharmaceuticals International AG.

What should I know about storage and disposal of this medication?

• Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F).

• Dailymed label info on Mobocertinib
• FDA Mobocertinib

Mobocertinib Resources
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Mobocertinib Resources
Need Help Finding a Doctor? Need help finding a doctor or specialist anywhere in the world? Explore our world directory. WikiMD's DocFinder can assist you in locating millions of physicians.	Medical Knowledge Access the latest research - Most recent articles Ongoing trials.

Translate to: East Asian 中文, 日本, 한국어, South Asian हिन्दी, Urdu, বাংলা, తెలుగు, தமிழ், ಕನ್ನಡ,
Southeast Asian Indonesian, Vietnamese, Thai, မြန်မာဘာသာ, European español, Deutsch, français, русский, português do Brasil, Italian, polski