Deepika vegiraju at 13:06, 17 June 2023

2023-06-17T13:06:12Z

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== '''What is Alpelisib?''' ==

* Alpelisib ('''Piqray''') is a [[kinase inhibitor]] used in combination with the medicine [[fulvestrant]] to treat women who have gone through menopause and men with advanced or [[metastatic]] [[breast cancer]].

[[File:Alpelisib.svg|thumb]]

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

This medicine is used in combination with the medicine [[fulvestrant]] to treat women who have gone through [[menopause]] and men:
* who have hormone receptor (HR)-positive, [[human epidermal growth factor receptor 2]] (HER2)-negative advanced breast cancer or breast cancer that has spread to other parts of the body ([[metastatic]]), with an abnormal phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA) gene, and
* whose disease has progressed on or after [[endocrine therapy]].

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

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* An orally bioavailable phosphatidylinositol 3-kinase (PI3K) inhibitor with potential [[antineoplastic activity]].
* Alpelisib '''specifically inhibits PI3K in the PI3K/AKT kinase (or protein kinase B) signaling pathway, thereby inhibiting the activation of the PI3K signaling pathway'''.
* This may''' result in inhibition of tumor cell growth and survival in susceptible tumor cell populations'''.
* Activation of the PI3K signaling pathway is frequently associated with [[tumorigenesis]].
* '''Dysregulated PI3K signaling may contribute to tumor resistance''' to a variety of antineoplastic agents.

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

This medicine cannot be used in patients with:
* severe [[hypersensitivity]] to it or any of its components

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

* Avoid coadministration of Piqray with strong CYP3A4 inducers. Coadministration of Piqray with a strong CYP3A4 inducer may decrease alpelisib concentration , which may decrease alpelisib activity.
* Avoid the use of BCRP inhibitors in patients treated with Piqray.
* Coadministration of Piqray with a breast cancer resistance protein (BCRP) inhibitor may increase alpelisib concentration , which may increase the risk of toxicities.

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

* It was approved for use in the United States in 2019.

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

* Select patients for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer with Piqray, based on the '''presence of one or more PIK3CA mutations''' in tumor tissue or plasma specimens.

'''Recommended Dosage'''
* Recommended Dose: 300 mg (two 150 mg tablets) taken orally once daily with food.
* For adverse reactions, consider dose interruption, dose reduction, or discontinuation.

'''Administration'''
* Take Piqray exactly as your healthcare provider tells you.
* Do not change your dose or stop taking Piqray unless your healthcare provider tells you.
* Take Piqray 1 time each day, at about the same time each day.
* Take Piqray with food.
* Swallow Piqray tablets whole. Do not chew, crush or split the tablets.
* Do not take any Piqray tablets that are broken, cracked, or that look damaged.
* If you miss a dose of Piqray, you may still take it with food up to 9 hours after the time you usually take it. If it has been more than 9 hours after you usually take your dose, skip the dose for that day. The next day, take the dose at your usual time. Do not take 2 doses to make up for a missed dose.
* If you vomit after taking a dose of Piqray, do not take another dose on that day. Take your next dose at your usual time.
* If you take too much Piqray, call your healthcare provider or go to the nearest hospital emergency room right away.

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

This medicine is available in fallowing doasage form:
* '''As Tablets:''' 50 mg, 150 mg, and 200 mg

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

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

The most common side effects of this medicine include:
* rash
* [[nausea]]
* tiredness and weakness
* decreased appetite
* [[mouth sores]]
* vomiting
* weight loss
* hair loss
* changes in certain blood tests

Piqray may cause serious side effects, including:
* Severe allergic reactions
* Severe skin reactions
* High blood sugar levels ([[hyperglycemia]])
* Lung problems ([[pneumonitis]])
* [[Diarrhea]]

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

* Severe hypersensitivity reactions, including [[anaphylaxis]] and [[anaphylactic shock]], can occur in patients treated with Piqray. Advise patients of the signs and symptoms of severe hypersensitivity reactions. Permanently discontinue Piqray in the event of severe hypersensitivity.
* Severe cutaneous adverse reactions (SCARs), including [[Stevens johnson syndrome|Stevens-Johnson Syndrome]] (SJS), [[erythema multiforme]] (EM), [[toxic epidermal necrolysis]] (TEN), and [[drug reaction with eosinophilia and systemic symptoms]] (DRESS) can occur in patients treated with Piqray. Advise patients of the signs and symptoms of SCARs (e.g., a prodrome of fever, flu-like symptoms, mucosal lesions, progressive skin rash, or lymphadenopathy).
* Severe [[hyperglycemia]], including [[ketoacidosis]], can occur in patients treated with Piqray. Based on the severity of the hyperglycemia, Piqray may require dose interruption, reduction, or discontinuation.
* Severe [[pneumonitis]], including acute interstitial pneumonitis and interstitial lung disease, can occur in patients treated with Piqray. Permanently discontinue Piqray in all patients with confirmed pneumonitis.
* Severe [[diarrhea]], including dehydration and acute kidney injury, can occur in patients treated with Piqray. Based on the severity of the diarrhea, Piqray may require dose interruption, reduction, or discontinuation.
* Piqray can cause fetal harm. Advise patients of potential risk to a fetus and to use effective [[contraception]].

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

In cases where accidental overdosage of Piqray was reported in the clinical studies, the adverse reactions associated with the overdose were [[hyperglycemia]], nausea, [[asthenia]], and rash.

'''Management for overdosage:'''
Initiate general symptomatic and supportive measures in all cases of overdosage where necessary. There is no known antidote for Piqray.

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

* Piqray can cause fetal harm when administered to a pregnant woman . There are no available data in pregnant women to inform the drug-associated risk.

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

* The safety and efficacy of Piqray in pediatric patients have not been established.

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

* '''Active ingredient:''' alpelisib
* '''Inactive ingredients:''' hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, and sodium starch glycolate. The film-coating contains hypromellose, iron oxide black, iron oxide red, macrogol/polyethylene glycol (PEG) 4000, talc, and titanium dioxide.

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

* '''Distributed by:''' [[Novartis Pharmaceuticals Corporation]], East Hanover, New Jersey

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

* Store Piqray at room temperature between 68°F to 77°F (20°C to 25°C).
* Keep Piqray and all medicines out of the reach of children.

{{Chemotherapeutic agents}}
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[[Category:Amides]]
[[Category:Novartis brands]]
[[Category:Phosphoinositide 3-kinase inhibitors]]
[[Category:Pyridines]]
[[Category:Pyrrolidines]]
[[Category:Thiazoles]]
[[Category:Trifluoromethyl compounds]]
[[Category:Ureas]]
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Alpelisib - Revision history

Deepika vegiraju at 13:06, 17 June 2023