Deepika vegiraju at 08:47, 17 May 2022

2022-05-17T08:47:09Z

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== '''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.

[[File:Mobocertinib.svg|thumb|Mobocertinib]]

[[File:Mobocertinib.png|thumb|Mobocertinib]]

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== '''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?''' ==

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* 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:
* [[QT prolongation|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, estimated|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?''' ==

* {{overdose}}

== '''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).

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{{Targeted cancer therapeutic agents}}
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[[Category:Amides]]
[[Category:Breakthrough therapy]]
[[Category:Dimethylamino compounds]]
[[Category:Indoles]]
[[Category:Isopropyl esters]]
[[Category:Kinase inhibitors]]
[[Category:Orphan drugs]]
[[Category:Pyrimidines]]

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Mobocertinib - Revision history

Deepika vegiraju at 08:47, 17 May 2022