Alpelisib (Piqray)

Trade Name : PIQRAY

Novartis Pharmaceuticals Corporation

TABLET

Strength 200 mg/1

Storage and handling for PIQRAY

ALPELISIB

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Alpelisib (Piqray) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

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PIQRAY is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
PIQRAY is a kinase inhibitor indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.

No data

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

Tablets: 50 mg, 150 mg, and 200 mg alpelisib
50 mg: Light pink, unscored, round and curved with beveled edges film-coated tablet, imprinted with u201cL7u201d on one side and u201cNVRu201d on the other side.
150 mg: Pale red, unscored, ovaloid and curved with beveled edges film-coated tablet, imprinted with u201cUL7u201d on one side and u201cNVRu201d on the other side.
200 mg: Light red, unscored, ovaloid and curved with beveled edges film-coated tablet, imprinted with u201cYL7u201d on one side and u201cNVRu201d on the other side.
Tablets: 50 mg, 150 mg, 200 mg

PIQRAY is contraindicated in patients with severe hypersensitivity to it or any of its components .
Severe hypersensitivity to PIQRAY or to any of its components ().

No data

Severe Hypersensitivity: Permanently discontinue PIQRAY. Promptly initiate appropriate treatment. ()n
Severe Cutaneous Reactions: Cases of severe cutaneous reactions, including Stevens-Johnson syndrome (SJS) and Erythema Multiforme (EM) were reported. Do not initiate treatment in patients with a history of SJS, EM, or Toxic Epidermal Necrolysis (TEN). Interrupt PIQRAY if signs or symptoms of severe cutaneous reactions are present, until etiology of the reaction has been determined. Consider consultation with a dermatologist. Permanently discontinue PIQRAY if SJS, EM, or TEN is confirmed. ()n
Hyperglycemia: Severe hyperglycemia, including ketoacidosis, was reported. The safety of PIQRAY in patients with Type 1 or uncontrolled Type 2 diabetes has not been established. Before initiating treatment with PIQRAY, test fasting plasma glucose (FPG), HbA1c, and optimize blood glucose. After initiating treatment, monitor periodically. Initiate or optimize anti-hyperglycemic medications as clinically indicated. Interrupt, reduce dose, or discontinue PIQRAY if severe hyperglycemia occurs. (, )n
Pneumonitis: Severe cases of pneumonitis and interstitial lung disease have been reported. Monitor for clinical symptoms or radiological changes. Interrupt or discontinue PIQRAY if severe pneumonitis occurs. (, )n
Diarrhea: Severe cases of diarrhea, including dehydration and acute kidney injury, have been reported. Most patients experience diarrhea (Grade u2264 2) during treatment with PIQRAY. Advise patients to start antidiarrheal treatment, increase oral fluids, and notify their healthcare provider if diarrhea occurs. Interrupt, reduce dose, or discontinue PIQRAY if severe diarrhea occurs. (, )n
Embryo-Fetal Toxicity: PIQRAY can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception (, , ). Also, refer to the Full Prescribing Information of fulvestrant for pregnancy and contraception information.

The following adverse reactions are discussed in greater detail in other sections of the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of PIQRAY was evaluated in a randomized, double-blind, placebo-controlled trial (SOLAR-1) in 571 patients with HR-positive, HER2-negative, advanced or metastatic breast cancer enrolled into two cohorts, with or without a PIK3CA mutation .
Patients received either PIQRAY 300 mg plus fulvestrant (n = 284) or placebo plus fulvestrant (n = 287). Fulvestrant 500 mg was administered intramuscularly on Cycle 1, Day 1 and 15 and then at Day 1 of each 28-day cycle during treatment phase.
Two patients (0.7%) died while on treatment with PIQRAY plus fulvestrant due to causes other than the underlying malignancy. Causes of death included one cardio-respiratory arrest and one second primary malignancy. Neither was suspected to be related to study treatment.
Serious adverse reactions occurred in 35% of patients receiving PIQRAY plus fulvestrant. Serious adverse reactions in > 2% of patients receiving PIQRAY plus fulvestrant included hyperglycemia (10%), rash (3.5%), diarrhea (2.8%), acute kidney injury (2.5%), abdominal pain (2.1%), and anemia (2.1%).
Osteonecrosis of the jaw (ONJ) was reported in 4.2% of patients (12/284) in the PIQRAY plus fulvestrant arm compared to 1.4% of patients (4/287) in the placebo arm. All patients experiencing ONJ had prior or concomitant bisphosphonates or RANK-ligand inhibitor administration.
Among patients receiving PIQRAY plus fulvestrant, 4.6% permanently discontinued both PIQRAY and fulvestrant and 21% permanently discontinued PIQRAY alone, due to ARs. The most frequent ARs leading to treatment discontinuation of PIQRAY in > 2% patients receiving PIQRAY plus fulvestrant were hyperglycemia (6%), rash (4.2%), diarrhea (2.8%), and fatigue (2.5%).
Dose reductions due to ARs occurred in 55% of patients receiving PIQRAY plus fulvestrant. The most frequent ARs leading to dose reduction in > 2% patients receiving PIQRAY plus fulvestrant were hyperglycemia (29%), rash (9%), diarrhea (6%), stomatitis (3.5%) and mucosal inflammation (2.1%).
The most common adverse reactions including laboratory abnormalities (all grades, incidence u2265 20%) were glucose increased, creatinine increased, diarrhea, rash, lymphocyte count decreased, GGT increased, nausea, ALT increased, fatigue, hemoglobin decreased, lipase increased, decreased appetite, stomatitis, vomiting, weight decreased, calcium decreased, glucose decreased, aPTT prolonged, and alopecia.
Adverse reactions and laboratory abnormalities are listed in Table 6 and Table 7, respectively.
Among the patients with Grade 2 or 3 rash, the median time to first onset of Grade 2 or 3 rash was 12 days. A subgroup of 86 patients received prophylaxis, including anti-histamines, prior to onset of rash. In these patients, rash was reported less frequently than in the overall population, for all grades rash (27% vs 54%), Grade 3 rash (12% vs 20%) and rash leading to permanent discontinuation of PIQRAY (3.5% vs 4.2%). Of the 153 patients who experienced rash, 141 had resolution of the rash.
Most common adverse reactions including laboratory abnormalities (all grades, incidence u2265 20%) were glucose increased, creatinine increased, diarrhea, rash, lymphocyte count decreased, GGT increased, nausea, ALT increased, fatigue, hemoglobin decreased, lipase increased, decreased appetite, stomatitis, vomiting, weight decreased, calcium decreased, glucose decreased, aPTT prolonged, and alopecia ().

No data

CYP3A4 Inducers: Avoid coadministration of PIQRAY with a strong CYP3A4 inducer. ()nttttttttt
BCRP Inhibitors: Avoid the use of BCRP inhibitors in patients treated with PIQRAY. If unable to use alternative drugs, closely monitor for increased adverse reactions. ()nttttttttt
CYP2C9 Substrates: Closely monitor when PIQRAY is coadministered with CYP2C9 substrates where decreases in the plasma concentration of these drugs may reduce activity. ()

Lactation: Advise not to breastfeed. ()

There is limited experience of overdose with PIQRAY in clinical trials. In the clinical studies, PIQRAY was administered at doses up to 450 mg once daily.
In cases where accidental overdosage of PIQRAY was reported in the clinical studies, the adverse reactions associated with the overdose were consistent with the known safety profile of PIQRAY and included hyperglycemia, nausea, asthenia, and rash.
Initiate general symptomatic and supportive measures in all cases of overdosage where necessary. There is no known antidote for PIQRAY.

PIQRAY (alpelisib) is a kinase inhibitor. The chemical name of alpelisib is (2)--[4-Methyl-5-[2-(2,2,2-trifluoro-1,1-dimethylethyl)-4-pyridinyl]-2-thiazolyl]-1,2-pyrrolidinedicarboxamide. Alpelisib is a white to almost white powder. The molecular formula for alpelisib is CHFNOS and the relative molecular mass is 441.47 g/mol. The chemical structure of alpelisib is shown below:
PIQRAY film-coated tablets are supplied for oral administration with three strengths that contain 50 mg, 150 mg and 200 mg of alpelisib. The tablets also contain 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.

No data

Carcinogenicity studies have not been conducted with alpelisib.
Alpelisib was not mutagenic in an in vitro bacterial reverse mutation (Ames) assay, or aneugenic or clastogenic in human cell micronucleus and chromosome aberration tests in vitro. Alpelisib was not genotoxic in an in vivo rat micronucleus test.
Fertility studies in animals have not been conducted. In repeated-dose toxicity studies up to 13 weeks duration, adverse effects were observed in reproductive organs including vaginal atrophy and estrous cycle variations in rats at doses u2265 6 mg/kg/day (approximately 0.6 times the exposure in humans at the recommended dose of 300 mg/day based on AUC), and prostate atrophy in dogs at doses u2265 15 mg/kg/day (approximately 2.6 times the exposure in humans at the recommended dose of 300 mg/day based on AUC).

SOLAR-1 (NCT02437318) was a randomized, double-blind, placebo-controlled trial of PIQRAY plus fulvestrant versus placebo plus fulvestrant in 572 patients with HR-positive, HER2-negative, advanced or metastatic breast cancer whose disease had progressed or recurred on or after an aromatase inhibitor-based treatment (with or without CDK4/6 combination). Patients were excluded if they had inflammatory breast cancer, diabetes mellitus Type 1 or uncontrolled Type 2, or pneumonitis. Randomization was stratified by presence of lung and/or liver metastasis and previous treatment with CDK4/6 inhibitor(s). Overall, 60% of enrolled patients had tumors with one or more PIK3CA mutations in tissue, 50% had liver/lung metastases, and 6% had previously been treated with a CDK4/6 inhibitor.
There were 341 patients enrolled by tumor tissue in the cohort with a PIK3CA mutation and 231 enrolled in the cohort without a PIK3CA mutation. Of the 341 patients in the cohort with a PIK3CA mutation, 336 (99%) patients had one or more PIK3CA mutations confirmed in tumor tissue using the FDA-approved PIK3CA RGQ PCR Kit. Out of the 336 patients with PIK3CA mutations confirmed in tumor tissue, 19 patients had no plasma specimen available for testing with the FDA-approved PIK3CA RGQ PCR Kit. Of the remaining 317 patients with PIK3CA mutations confirmed in tumor tissue, 177 patients (56%) had PIK3CA mutations identified in plasma specimen, and 140 patients (44%) did not have PIK3CA mutations identified in plasma specimen.
Patients received either PIQRAY (300 mg) or placebo orally once daily on a continuous basis, plus fulvestrant (500 mg) administered intramuscularly on Cycle 1, Days 1 and 15, and then on Day 1 of every 28-day cycle. Patients received treatment until radiographic disease progression or unacceptable toxicity. Tumor assessments were performed every 8 weeks for the first 18 months and every 12 weeks thereafter.
The median age of patients was 63 years (range 25 to 92). Most patients were women (99.8%) and most patients were White (66%), followed by Asian (22%), Other/Unknown (10%), Black or African American (1.4%), and American Indian or Alaskan Native (0.9%). Baseline ECOG performance status was 0 (68%) or 1 (32%).
Patient demographics for those with PIK3CA-mutated tumors were generally representative of the broader study population. The median duration of exposure to PIQRAY plus fulvestrant was 8.2 months with 59% of patients exposed for > 6 months.
The majority of patients (98%) received prior hormonal therapy as the last treatment (48% metastatic setting, 52% adjuvant setting). Primary endocrine resistance, defined as relapsed within 24 months on adjuvant endocrine therapy or progression within 6 months on endocrine therapy for advanced disease, was observed in 13% of patients and secondary endocrine resistance, defined as relapsed after 24 months on adjuvant endocrine therapy, relapsed within 12 months of the end of adjuvant endocrine therapy, or progression after 6 months on endocrine therapy for advanced disease, was observed in 72% of patients.
The major efficacy outcome was investigator-assessed progression-free survival (PFS) in the cohort with a PIK3CA mutation per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Additional efficacy outcome measures were overall response rate (ORR) and overall survival (OS) in the cohort with a PIK3CA mutation.
Efficacy results for the cohort with a PIK3CA mutation in tumor tissue are presented in Table 8 and Figure 1. PFS results for the cohort with a PIK3CA mutation by investigator assessment were supported by consistent results from a blinded independent review committee (BIRC) assessment. Consistent results were seen in patients with tissue or plasma PIK3CA mutations. At the time of final PFS analysis, 27% (92/341) of patients had died, and overall survival follow-up was immature.
No PFS benefit was observed in patients whose tumors did not have a PIK3CA tissue mutation (HR = 0.85; 95% CI: 0.58, 1.25).
Figure 1: Progression Free Survival in SOLAR-1 (Per Investigator Assessment of Patients with a PIK3CA Tumor Mutation)

PIQRAY (alpelisib) 50 mg, 150 mg, and 200 mg film-coated tablets .
300 mg daily dose: Each carton contains 2 blister packs. Each blister pack contains a 14-day supply of 28 tablets (28 tablets, 150 mg alpelisib per tablet). NDC 0078-0708-02
250 mg daily dose: Each carton contains 2 blister packs. Each blister pack contains a 14-day supply of 28 tablets (14 tablets, 200 mg alpelisib per tablet and 14 tablets, 50 mg alpelisib per tablet). NDC 0078-0715-02
200 mg daily dose: Each carton contains 1 blister pack. Each blister pack contains a 28-day supply of 28 tablets (28 tablets, 200 mg alpelisib per tablet). NDC 0078-0701-84
Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F), excursions permitted between 15u00b0C and 30u00b0C (59u00b0F and 86u00b0F) .

Advise the patient to read the FDA-approved patient labeling (Patient Information).
Severe Hypersensitivity
Inform patients of the signs and symptoms of hypersensitivity. Advise patients to contact their healthcare provider immediately for signs and symptoms of hypersensitivity .
Severe Cutaneous Reactions
Inform patients of the signs and symptoms of severe cutaneous reactions. Advise patients to contact their healthcare provider immediately for signs and symptoms of severe cutaneous reactions .
Hyperglycemia
Advise patients of the possibility of developing hyperglycemia and the need to monitor blood glucose periodically during therapy. Advise patients to contact their healthcare provider immediately for signs and symptoms of hyperglycemia .
Pneumonitis
Inform patients of the possibility of developing pneumonitis and to immediately contact their healthcare provider if they experience respiratory problems .
Diarrhea
Advise patients that PIQRAY may cause diarrhea, which may be severe in some cases. Inform patients to start antidiarrheal treatment, increase oral fluids, and notify their healthcare provider if diarrhea occurs while taking PIQRAY .
Embryo-Fetal Toxicity
Lactation
Advise women not to breastfeed during treatment with PIQRAY and for 1 week after the last dose . Refer to the Full Prescribing Information of fulvestrant for lactation information.
Infertility
Advise males and females of reproductive potential that PIQRAY may impair fertility . Refer to the Full Prescribing Information of fulvestrant for infertility information.
Drug Interactions
Advise patients to avoid the use of strong CYP3A4 inducers in patients treated with PIQRAY. Advise patients to avoid the use of BCRP inhibitors in patients treated with PIQRAY. If unable to use alternative drugs, closely monitor for increased adverse reactions. Advise patients that close monitoring may be required when PIQRAY is coadministered with CYP2C9 substrates where decreases in the plasma concentration of CYP2C9 substrates may reduce activity of these drugs .
Dosing
Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936
u00a9 Novartis
T2019-57

No data

PRINCIPAL DISPLAY PANEL
NDC 0078-0708-02
PIQRAYn
(alpelisib) tablets
300 mg daily dose
Take two 150 mg tablets once daily
Rx only
Usual Dosage:
28-Day Supply
Contains:
NOVARTIS

PRINCIPAL DISPLAY PANEL
NDC 0078-0715-02
PIQRAYn
(alpelisib) tablets
250 mg daily dose
Take one 200 mg tablet one 50 mg tablet once daily
Rx only
Usual Dosage:n- and
28-Day Supply
Contains:
200 mg
50 mg
NOVARTIS

PRINCIPAL DISPLAY PANEL
NDC 0078-0701-84
PIQRAYn
(alpelisib) tablets
200 mg daily dose
Take one 200 mg tablet once daily
Rx only
Usual Dosage:
28-Day Supply
Contains:
NOVARTIS

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