Ipsen Pharma


Zuellig Pharma
Concise Prescribing Info
Advanced renal cell carcinoma in treatment-naive adults w/ intermediate or poor risk; adults following prior vascular endothelial growth factor-targeted therapy. Monotherapy for hepatocellular carcinoma in adults who have previously been treated w/ sorafenib.
Dosage/Direction for Use
60 mg once daily, may be reduced to 40 mg daily then to 20 mg daily.
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.
Special Precautions
Discontinue use if severe/persistent HTN or hypertensive crisis occurs; GI perforations or fistulas, acute MI, other clinically significant arterial thromboembolic complication or nephrotic syndrome develops; patients w/ reversible posterior leukoencephalopathy syndrome, wound healing complications requiring medical intervention. Interrupt or reduce dose, or discontinue use in case of persistent or recurrent significant GI disorders & biochemical laboratory test abnormalities. Not to be administered in patients who have or at risk for severe haemorrhage. Palmar-plantar erythrodysaesthesia syndrome (PPES); aneurysms & artery dissections. History of QT interval prolongation, patients taking antiarrhythmics or w/ pre-existing cardiac disease, bradycardia or electrolyte disturbances. Perform periodic monitoring w/ on-treatment ECG & electrolytes (serum Mg, K & Ca). Monitor for signs & symptoms of hepatic encephalopathy. Monitor urine protein regularly, platelet levels & biochemical parameters during treatment. Perform liver function tests prior to treatment. Discontinue use at least 28 days prior to scheduled surgery including dental surgery. Avoid chronic use of strong CYP3A4 inducers. Concomitant use w/ P-gp substrates (eg, fexofenadine, aliskiren, ambrisentan, dabigatran, etexilate, digoxin, colchicine, maraviroc, posaconazole, ranolazine, saxagliptin, sitagliptin, talinolol, tolvaptan), MRP2 (eg, cyclosporine, efavirenz, emtricitabine) & strong CYP3A4 inhibitors. Not to be used in patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Not recommended in severe renal & hepatic impairment (Child-Pugh C). Mild or moderate renal impairment. May impair male & female fertility. Women of childbearing potential & male partners should use effective contraception during & at least 4 mth after treatment. Not to be used during pregnancy & lactation. Childn & adolescents <18 yr.
Adverse Reactions
Anaemia; hypothyroidism; metabolism & nutrition disorders; dysgeusia, headache, dizziness; HTN, haemorrhage; dysphonia, dyspnoea, cough; GI disorders; PPES, rash; pain in extremity; fatigue, mucosal inflammation, asthenia, peripheral oedema; decreased wt, increased serum ALT & AST. Abscess; thrombocytopenia, neutropenia; peripheral sensory neuropathy; tinnitus; venous & arterial thrombosis; pulmonary embolism; hepatic encephalopathy; pruritus, alopecia, dry skin, dermatitis acneiform; hair colour change; muscle spasms, arthralgia; proteinuria; increased blood ALP, creatinine & cholesterol, GGT, amylase, lipase, decreased WBC count.
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. Plasma protein displacement interaction w/ warfarin. Increased plasma conc of P-gp substrates eg, fexofenadine, aliskiren, ambrisentan, dabigatran, etexilate, digoxin, colchicine, maraviroc, posaconazole, ranolazine, saxagliptin, sitagliptin, talinolol, tolvaptan.
ATC Classification
L01EX07 - cabozantinib ; Belongs to the class of other protein kinase inhibitors. Used in the treatment of cancer.
Cabometyx FC tab 20 mg
Cabometyx FC tab 40 mg
Cabometyx FC tab 60 mg
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