Votrient

Votrient

pazopanib

Manufacturer:

Novartis

Distributor:

DKSH
Concise Prescribing Info
Contents
Pazopanib HCl
Indications/Uses
Advanced &/or metastatic renal cell carcinoma. Patients w/ advanced soft tissue sarcoma who have received prior chemotherapy.
Dosage/Direction for Use
800 mg once daily, may be increased/decreased in 200-mg increments stepwise. Moderate hepatic impairment Reduce dose to 200 mg daily.
Administration
Should be taken on an empty stomach: Take at least 1 hr before or 2 hr after meals. Swallow whole, do not break/crush.
Contraindications
Special Precautions
Discontinue use if severe/persistent HTN or hypertensive crisis occurs; posterior reversible encephalopathy syndrome/reversible posterior leukoencephalopathy syndrome, interstitial lung disease/pneumonitis, thrombotic microangiopathy, wound dehiscence or nephrotic syndrome develops. History of QT interval prolongation, patients taking antiarrhythmics or QT prolonging drugs or w/ preexisting cardiac disease; arterial thrombotic or venous thromboembolic events; patients w/ significant risk of haemorrhage; GI perforation or fistula; tumor lysis syndrome; infections. Monitor for clinical signs or symptoms of CHF. Perform serum liver test prior to initiation at wk 3, 5, 7 & 9 then at mth 3 & 4; continue periodic testing after mth 4. Proactively monitor thyroid function. Periodically evaluate left ventricular ejection fraction & monitor liver enzymes; ECG & electrolytes eg, Ca, Mg, K; urinalysis. Not indicated in combination w/ other systemic anticancer agents. Concomitant use w/ simvastatin. May affect ability to drive & use machines. Not recommended in severe renal impairment or patients undergoing peritoneal dialysis or haemodialysis; severe hepatic impairment. Women of childbearing potential should use effective contraception. Not to be used during pregnancy & lactation. Not recommended in ped patients <2 yr.
Adverse Reactions
Anorexia, headache, asymptomatic bradycardia, HTN, abdominal pain, diarrhea, nausea, vomiting, hair depigmentation, fatigue, laboratory abnormalities, arthralgia. Asthenia, tumour pain, decreased wt, dizziness, dysgeusia, cough, dyspnea, stomatitis, alopecia, exfoliative rash, palmar-plantar erythrodysesthesia syndrome, skin depigmentation, musculoskeletal & chest pain, myalgia, peripheral edema, increased alanine & aspartate aminotransferase.
Drug Interactions
Altered metabolism w/ CYP3A4 inhibitors & inducers. Increased plasma conc w/ strong CYP3A4 inhibitors eg, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole; grapefruit juice, P-gp & BCRP inhibitor eg, lapatinib. Decreased plasma conc w/ CYP3A4 inducers eg, rifampicin. Increased mean AUC & Cmax of midazolam, dextromethorphan, paclitaxel. Increased conc of drugs primarily eliminated through UGT1A1 & OATP1B1. Increased incidence of ALT elevations w/ simvastatin. Increased AUC & Cmax w/ high- or low-fat meal. Decreased bioavailability w/ esomeprazole. Avoid drugs increasing gastric pH.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EX03 - pazopanib ; Belongs to the class of other protein kinase inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Votrient FC tab 200 mg
Packing/Price
30's
Form
Votrient FC tab 400 mg
Packing/Price
30's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in