Piqray Tablets / Film-coated
Alpelisib
200 mg + 50 mg
NOVARTIS PHARMACEUTICALS CORPORATION
| Pack size | 56's (28’s tablets of 200 mg + 28’s tablets of 50 mg) |
|---|---|
| Dispensing mode | POM |
| Source | USA |
| Agent | CITY MEDICAL STORE |
| Retail Price | 28240.50 AED |
Available as:
Indications
Piqray Tablets / Film-coated is used for:
Breast Cancer
Adult Dose
Breast Cancer
Kinase inhibitor indicated in combination with fulvestrant for 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 following progression on or after an endocrine-based regimen
Alpelisib 300 mg PO qDay AND
Fulvestrant 500 mg IM on Days 1, 15, and 29, and once monthly thereafter
Continue treatment until disease progression or unacceptable toxicity occurs
Refer to the full prescribing information for fulvestrant
Child Dose
Renal Dose
Renal impairment
Mild-to-moderate (CrCl 30 to <90 mL/min): No dosage adjustment required
Severe (CrCl <30 mL/min): Pharmacokinetic data are unknown
Administration
Take orally with food
Administer dose at approximately same time each day
Contra Indications
Hypersensitivity to alpelisib or any of its components
Precautions
Severe hypersensitivity reactions (eg, anaphylaxis, anaphylactic shock) reported; reactions manifested by symptoms including, but not limited to, dyspnea, flushing, rash, fever, or tachycardia
Severe cutaneous reactions, including Stevens-Johnson syndrome (SJS) and erythema multiforme (EM) reported; do not initiate with history of SJS, EM, or toxic epidermal necrolysis (TEN); if SJS, TEN, or EM confirmed, permanently discontinue; do not reintroduce in patients who have experienced previous severe cutaneous reactions during treatment
Severe pneumonitis, including acute interstitial pneumonitis and interstitial lung disease, reported; consider noninfectious pneumonitis in patients presenting with nonspecific respiratory signs and symptoms (eg, hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic examinations) and in whom infectious, neoplastic, and other causes have been excluded
Severe diarrhea, including dehydration and acute kidney injury, occurred; advise patients to start antidiarrheal treatment, increase oral fluids, and notify their healthcare provider if diarrhea occurs
Pregnancy-Lactation
Pregnancy
Based on animal data and mechanism of action, fetal harm may occur when administered to pregnant women
No data available in pregnant women to inform the drug-associated risk
Advise pregnant women and females of reproductive potential of fetal risk
Verify pregnancy status in females of reproductive potential before initiating
Animal data
In animal reproduction studies, oral administration to pregnant rats and rabbits during organogenesis caused adverse developmental outcomes, including embryofetal mortality (postimplantation loss), reduced fetal weights, and increased incidences of fetal malformations at maternal exposures ?0.8 times the exposure in humans based on AUC at the recommended dose of 300 mg/day
Contraception
Females of reproductive potential: Use effective contraception during treatment and for 1 week after the last dose
Male patients with female partners of reproductive potential: Use condoms and effective contraception during treatment and for 1 week after the last dose
Infertility
Based on findings from animal studies, fertility in males and females of reproductive potential may be impaired
Lactation
There are no data on the presence of alpelisib in human milk, its effects on milk production, or the breastfed child
Because of potential for serious adverse reactions in the breastfed child, advise lactating women to not breastfeed during treatment and for 1 week after the last dose
Interactions
Adverse Effects
Side effects of Alpelisib :
>10% (In Combination with Fulvestrant)
Glucose increased (79%)
Creatinine increased (67%)
Diarrhea (58%)
Rash (52%)
Lymphocyte count decreased (52%)
GGT increased (52%)
Nausea (45%)
ALT increased (44%)
Fatigue (42%)
Hemoglobin decreased (42%)
Lipase increased (42%)
Glucose increased, grade 3-4 (39%)
Decreased appetite (36%)
Stomatitis (30%)
Vomiting (27%)
Decreased weight (27%)
Calcium (corrected) decreased (27%)
Glucose decreased (26%)
aPTT prolonged (21%)
Alopecia (20%)
Rash, grade 3-4 (20%)
Mucosal inflammation (19%)
Pruritus (18%)
Dry skin (18%)
Dysgeusia (18%)
Headache (18%)
Abdominal pain (17%)
Peripheral edema (15%)
Pyrexia (14%)
Platelet count decreased (14%)
Potassium decreased (14%)
Albumin decreased (14%)
Mucosal dryness (12%)
Dyspepsia (11%)
Magnesium decreased (11%)
GGT increased, grade 3-4 (11%)
Mechanism of Action
Phosphatidylinositol-3-kinase (PI3K) inhibitor with inhibitory activity predominantly against PI3K-alpha
In breast cancer, alpelisib inhibits the phosphorylation of PI3K downstream targets and has shown activity in cell lines possessing a PIK3CA mutation
PI3K inhibition has been shown to induce an increase in ER transcription in breast cancer cells
Combination with fulvestrant demonstrates an increase in antitumor activity compared with either treatment alone
Note
Piqray 200 mg + 50 mg Tablets / Film-coated manufactured by NOVARTIS PHARMACEUTICALS CORPORATION. Its generic name is Alpelisib. Piqray is availble in United Arab Emirates.
Farmaco UAE drug index information on Piqray Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.