Prab at 04:07, 19 September 2023

2023-09-19T04:07:44Z

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== '''What is Cobimetinib?''' ==

* Cobimetinib ('''Cotellic''') is a '''[[kinase inhibitor]]''' indicated used in combination with [[vemurafenib]] to treat advanced [[melanoma]] that has spread to other parts of the body or can’t be removed by surgery, and that has a certain type of abnormal gene (BRAF V600E or V600K mutation).

[[File:Cobimetinib.svg|thumb]]

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== '''What are the uses of this medicine?''' ==

This medicine is used with the medicine [[vemurafenib]], to treat a type of skin cancer called [[melanoma]]:
* that has spread to other parts of the body or cannot be removed by surgery, and
* that has a certain type of abnormal "BRAF" gene

== '''How does this medicine work?''' ==

* Cobimetinib (koe" bi me' ti nib) is a small molecule''' tyrosine kinase receptor inhibitor''' with potent activity '''against the mitogen-activated extracellular regulated kinase (MEK)''', which is an important component of the kinase cascade in the mitogen''' activated protein kinase (MAPK) pathway (RAS-RAF-MEK-ERK)'''.
* Components of the MAPK pathways are frequently mutated in patients with malignant melanoma, particularly the RAF isoform BRAF.
* BRAF-mutations cause a constitutive activation of the MAPK pathways, resulting in unregulated cell growth and proliferation.
* '''Inhibition of MEK '''has been found to be synergistic when combined with specific BRAF inhibitors as therapy of BRAF-mutated cancers.
* Clinical trials have shown that the addition of cobimetinib with [[vemurafenib]] (a specific BRAF-kinase inhibitor) results in improvements in survival in patients with [[melanoma]] who harbor the V600 BRAF mutation.

== '''Who Should Not Use this medicine ?''' ==

* This medicine have no usage limitations.

== '''What drug interactions can this medicine cause?''' ==

* Avoid concomitant administration of Cotellic with strong (eg: [[itraconazole]], [[ketoconazole]], [[clarithromycin]]) or moderate CYP3A inhibitors (eg: [[Amprenavir]], [[atazanavir]], [[ciprofloxacin]], [[diltiazem]], [[erythromycin]], [[fluconazole]], [[fosamprenavir]], [[verapamil]], and [[grapefruit juice]]) .
* Avoid concurrent use of Cotellic and strong or moderate CYP3A inducers including but not limited to [[carbamazepine]], [[efavirenz]], [[phenytoin]], [[rifampin]], and [[St. John's Wort]].

== '''Is this medicine FDA approved?''' ==

* It was approved for use in the United States in 2015.

== '''How should this medicine be used?''' ==

* Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to initiation of treatment with Cotellic with vemurafenib.

'''Recommended Dosage:'''
* The recommended dosage regimen of Cotellic is 60 mg (three 20 mg tablets) orally taken once daily for the first 21 days of each 28-day cycle until disease progression or unacceptable toxicity.

'''Concurrent CYP3A Inhibitors'''
* Do not take strong or moderate CYP3A inhibitors while taking Cotellic.
* If concurrent short term (14 days or less) use of moderate CYP3A inhibitors is unavoidable for patients who are taking Cotellic 60 mg, reduce Cotellic dose to 20 mg.

'''Administration'''
* Take Cotellic exactly as your healthcare provider tells you. Do not change your dose or stop taking Cotellic unless your healthcare provider tells you to.
* Take Cotellic one time a day for 21 days, followed by 7 days off treatment, to complete a 28-day treatment cycle.
* Take Cotellic with or without food.
* If you miss a dose of Cotellic or vomit after taking your dose, take your next dose as scheduled.

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

This medicine is available in fallowing doasage form:
* '''As Tablets:''' 20 mg

This medicine is available in fallowing brand namesː
*'''Cotellic'''

=='''What side effects can this medication cause?'''==

The most common side effects of this medicine include:
* [[diarrhea]]
* [[nausea]]
* fever
* vomiting

Cotellic may cause serious side effects, including:
* Risk of new skin cancers
* Bleeding problems
* Heart problems
* Severe rash
* Eye problems
* Liver problems
* Muscle problems ([[rhabdomyolysis]])
* Skin Sensitivity to sunlight ([[photosensitivity]])

==''' What special precautions should I follow?''' ==

* Avoid sunlight during treatment with Cotellic. Cotellic can make your skin sensitive to sunlight. You may burn more easily and get severe sunburns. To help protect against sunburn:
* When you go outside, wear clothes that protect your skin, including your head, face, hands, arms, and legs.
* Use lip balm and a broad-spectrum sunscreen with SPF 30 or higher.
* New primary [[malignancies]], cutaneous and non-cutaneous, can occur with Cotellic. Monitor patients for new malignancies prior to initiation of therapy, while on therapy, and for up to 6 months following the last dose of Cotellic.
* Major [[hemorrhagic]] events can occur with Cotellic. Monitor for signs and symptoms of bleeding.
* The risk of [[cardiomyopathy]] is increased in patients receiving Cotellic with vemurafenib compared with vemurafenib as a single agent. The safety of Cotellic has not been established in patients with decreased left ventricular ejection fraction (LVEF). Evaluate LVEF before treatment, after one month of treatment, then every 3 months thereafter during treatment with Cotellic.
* Severe rash and other skin reactions can occur with Cotellic. Monitor for severe skin rashes. Interrupt, reduce, or discontinue Cotellic.
* Ocular toxicities can occur with Cotellic, including serous [[retinopathy]] (fluid accumulation under layers of the retina). Perform an ophthalmological evaluation at regular intervals and for any visual disturbances. Permanently discontinue Cotellic for [[retinal vein occlusion]] (RVO).
* [[Hepatotoxicity]] can occur with Cotellic. Monitor liver laboratory tests during treatment and as clinically indicated.
* [[Rhabdomyolysis]] can occur with Cotellic. Monitor creatine phosphokinase periodically and as clinically indicated for signs and symptoms of rhabdomyolysis.
* Cotellic Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

== '''What to do in case of emergency/overdose?''' ==

* There is no information on overdosage of Cotellic.

== '''Can this medicine be used in pregnancy?''' ==

* Cotellic can cause fetal harm when administered to a pregnant woman.
* There are no available data on the use of Cotellic during pregnancy.

=='''Can this medicine be used in children?'''==

* The safety and effectiveness of Cotellic have not been established in pediatric patients.

== '''What are the active and inactive ingredients in this medicine?''' ==

* '''Active ingredient:''' cobimetinib fumarate
* '''Inactive ingredients:'''
Tablet Core: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate
Coating: polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc

== '''Who manufactures and distributes this medicine?''' ==

* '''Distributed by: '''Genentech USA, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco,

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

* Store Cotellic at room temperature below 30°C (86°F).
* Ask your healthcare provider or pharmacist how to safely throw away (dispose of) any unused or expired Cotellic.

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Cobimetinib - Revision history

Prab at 04:07, 19 September 2023