Trezilent

Trezilent

Manufacturer:

Novartis

Distributor:

DKSH
Concise Prescribing Info
Contents
Alpelisib
Indications/Uses
In combination w/ fulvestrant for postmenopausal women & men w/ hormone-receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after endocrine-based regimen.
Dosage/Direction for Use
300 mg once daily on continuous basis w/ fulvestrant 500 mg on days 1, 15 & 29 then once mthly thereafter.
Administration
Should be taken with food: Take at the same time each day w/ food or immediately after meals. Swallow whole, do not chew/crush/split.
Contraindications
Special Precautions
Discontinue use if severe hypersensitivity occurs; if pneumonitis is confirmed. Not to be initiated in patients w/ history of Stevens-Johnson syndrome, erythema multiforme or toxic epidermal necrolysis. Patients w/ type 1 & uncontrolled type 2 diabetes; severe diarrhea. Monitor new or worsening resp symptoms. Ensure adequate fluid intake. Monitor blood glucose &/or fasting plasma glucose at least once every wk for 1st 2 wk, then at least once every 4 wk & as clinically indicated; HbA1c every 3 mth & as clinically indicated. Severe renal impairment. May impair female & male fertility. Women & men of childbearing potential should use effective contraception during & for 1 wk after last dose. Pregnancy & lactation. Paed patients. Elderly ≥75 yr.
Adverse Reactions
Diarrhoea, nausea, vomiting, stomatitis, abdominal pain, dyspepsia; fatigue, mucosal inflammation & dryness, peripheral oedema, pyrexia; UTI; decreased wt & appetite; headache, dysgeusia; rash, alopecia, pruritus, dry skin; increased activated partial thromboplastin time, blood creatinine, alanine aminotransferase, γ-glutamyl transferase & lipase; decreased Hb, albumin, corrected Ca, lymphocyte & platelet count, K & Mg; increased/decreased plasma glucose.
Drug Interactions
Decreased conc w/ strong CYP3A4 inducers. Increased conc w/ BCRP inhibitors. Reduced plasma conc of CYP2C9 substrates eg, warfarin.
ATC Classification
L01EM03 - alpelisib ; Belongs to the class of phosphatidylinositol-3-kinase (Pi3K) inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Trezilent FC tab 150 mg
Packing/Price
28's
Form
Trezilent FC tab 200 mg
Packing/Price
14's
Form
Trezilent FC tab 50 mg
Packing/Price
14's
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