Votrient復治恩

Votrient

pazopanib

Manufacturer:

Novartis

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Pazopanib HCl
Indications/Uses
1st-line treatment of advanced renal cell carcinoma (RCC) & for patients who received prior cytokine therapy for advanced disease. Treatment of adult patients w/ selective subtypes of advanced soft tissue sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed w/in 12 mth after (neo) adjuvant therapy.
Dosage/Direction for Use
Adults 800 mg once daily. Dose modification should be in 200 mg increments in a step-wise fashion. Moderate hepatic impairment 200 mg once daily.
Administration
Should be taken on an empty stomach: Take at least 1 hr before or 2 hr after meals. Swallow whole, do not chew/crush. Do not eat/drink grapefruit products.
Contraindications
Special Precautions
Mild or moderate hepatic impairment. Not recommended in severe hepatic impairment. Conduct liver function tests prior & during therapy. Close monitoring of serum liver tests. Renal impairment (CrCl <30 mL/min). HTN; pre-existing cardiac dysfunction/heart failure; QT interval prolongation; MI, ischemic stroke, transient ischaemic attack; increased risk or history of thrombotic events; venous thromboembolic events; infections. Monitor patients for pulmonary symptoms indicative of interstitial lung disease/pneumonitis. Patients w/ significant risk of haemorrhage, GI perforation or fistula. Periodic monitoring of thyroid function. Baseline & periodic monitoring of ECG, electrolytes, BP & LVEF; urinalysis. Discontinue in case of evidence of hypertensive crisis or if HTN is severe & persists. May impair wound healing. Discontinue in the development of posterior reversible encephalopathy syndrome (PRES)/reversible posterior leukoencephalopathy syndrome (RPLS), thrombotic microangiopathy (TMA), nephrotic syndrome. Observe closely for signs & symptoms of pneumothorax. Concomitant use w/ antiarrhythmics or other medicinal products that may prolong QT interval; other systemic anti-cancer therapies (eg, pemetrexed & lapatinib); strong inhibitors of CYP3A4, P-gp or BRCP; CYP3A4 inducers; uridine diphosphate glucuronosyl transferase 1A1 substrates (eg, irinotecan); grapefruit juice. Women of childbearing potential & male patients should use adequate contraception during treatment & at least 2 wk after treatment. Pregnancy & lactation. Elderly ≥65 yr. Childn <2 yr & adolescents <18 yr.
Adverse Reactions
Diarrhoea, hair colour change, skin hypopigmentation, exfoliative rash, HTN, nausea, headache, fatigue, anorexia, vomiting, dysgeusia, stomatitis, decreased wt, pain, elevated ALT & AST.
Drug Interactions
Increased exposure & conc w/ CYP3A4 (eg, itraconazole, clarithromycin, atazanavir, idinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, grapefruit juice), P-gp & BCRP inhibitors, high-/low-fat food. Decreased plasma pazopanib conc w/ CYP3A4 (eg, rifampicin) inducers. Altered exposure & distribution w/ P-gp & BCRP inducers. Altered exposure &/or distribution of CYP3A4 substrates (eg, midazolam), CYP2C8 substrates (eg, paclitaxel) & UGT1A1 substrates (eg, irinotecan & its active metabolite SN-38). Increased ratio of dextrometrophan to dextrophan conc after administration of dextrometrophan. Decreased bioavailability w/ proton-pump inhibitors (eg, esomeprazole) & other agents that increase gastric pH. Increased incidence of ALT elevations w/ simvastatin & other statins.
ATC Classification
L01XE11 - pazopanib ; Belongs to the class of protein kinase inhibitors, other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Votrient film-coated tab 200 mg
Packing/Price
30's
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