Cabometyx

Cabometyx

cabozantinib

Manufacturer:

Ipsen Pharma

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Cabozantinib
Indications/Uses
Monotherapy for advanced renal cell carcinoma as 1st-line treatment of adults w/ intermediate or poor risk; adults following prior vascular endothelial growth factor-targeted therapy. In combination w/ nivolumab for 1st-line treatment of advanced renal cell carcinoma in adults. Monotherapy for hepatocellular carcinoma in adults who have previously been treated w/ sorafenib.
Dosage/Direction for Use
Monotherapy 60 mg once daily, may be reduced to 40 mg daily then to 20 mg daily. Combination therapy 40 mg once daily w/ nivolumab IV 240 mg every 2 wk or 480 mg every 4 wk. May be reduced to 20 mg once daily then to 20 mg every other day.
Administration
Should be taken on an empty stomach: Refrain from eating for at least 2 hr before & 1 hr after intake. Swallow whole, do not crush.
Contraindications
Special Precautions
Discontinue use if GI perforation or fistula, acute MI or other clinically significant thromboembolic complication, nephrotic syndrome develops; in patients w/ wound healing complications requiring medical intervention, posterior reversible encephalopathy syndrome; if severe/persistent HTN or hypertensive crisis, osteonecrosis of the jaw occurs. Interrupt, reduce or discontinue use in case of persistent or recurrent significant GI ARs, biochemical laboratory test abnormalities. Not to be administered in patients who have or at risk for severe haemorrhage. Aneurysms &/or artery dissections; palmar-plantar erythrodysaesthesia syndrome (PPES); history of QT interval prolongation, relevant pre-existing cardiac disease, bradycardia or electrolyte disturbances. Regularly monitor platelet levels, urine protein & periodic monitoring w/ on-treatment ECGs & electrolytes (serum Ca, K & Mg) during treatment. Perform LFTs prior to initiation & monitor liver enzymes during treatment. Monitor for signs & symptoms of hepatic encephalopathy, thyroid dysfunction. Perform oral exam prior to initiation & ensure good oral practice during treatment. Discontinue use at least 28 days prior to scheduled surgery including dental surgery or invasive dental procedures. Not to be used in patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Avoid chronic use w/ strong CYP3A4 inducers. Concomitant use w/ CYP3A4 inhibitors; bisphosphonates; antiarrhythmics; P-gp substrate eg, fexofenadine, aliskiren, ambrisentan, dabigatran etexilate, digoxin, colchicine, maraviroc, posaconazole, ranolazine, saxagliptin, sitagliptin, talinolol, tolvaptan; MRP2 inhibitors eg, cyclosporine, efavirenz, emtricitabine. May affect ability to drive & use machines. Not recommended in severe hepatic (Child-Pugh C) & renal impairment. Moderate hepatic & mild to moderate renal impairment. May impair male & female fertility. Women of childbearing potential & male partners should use effective contraception during & at least 4 mth after last dose. Not to be used during pregnancy & lactation. Childn & adolescents <18 yr.
Adverse Reactions
RCC monotherapy: Diarrhoea, HTN, dehydration, hyponatraemia, nausea, decreased appetite, embolism, fatigue, hypomagnesaemia, PPES. HCC monotherapy: Hepatic encephalopathy, PPES, asthenia, diarrhoea. RCC & combination therapy: Diarrhoea, pneumonitis, pulmonary embolism, pneumonia, hyponatremia, pyrexia, adrenal insufficiency, vomiting, dehydration.
Drug Interactions
Decreased clearance & increased plasma exposure w/ strong CYP3A4 inhibitors eg, ketoconazole, ritonavir, itraconazole, erythromycin, clarithromycin, grapefruit juice. Increased clearance & decreased plasma exposure w/ strong CYP3A4 inducers eg, phenytoin, carbamazepine, rifampicin, phenobarb, St. John's wort herbal-containing prep. Increased plasma conc w/ MRP2 inhibitors. Decreased exposure w/ bile salt-sequestering agents eg, cholestyramine, cholestagel. Monitor INR values w/ warfarin. Increased plasma conc of P-gp substrates eg, fexofenadine, aliskiren, ambrisentan, dabigatran, etexilate, digoxin, colchicine, maraviroc, posaconazole, ranolazine, saxagliptin, sitagliptin, talinolol, tolvaptan.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EX07 - cabozantinib ; Belongs to the class of other protein kinase inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Cabometyx FC tab 20 mg
Packing/Price
30's
Form
Cabometyx FC tab 40 mg
Packing/Price
30's
Form
Cabometyx FC tab 60 mg
Packing/Price
30's
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