Cabometyx

Cabometyx

cabozantinib

Manufacturer:

Ipsen

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Cabozantinib
Indications/Uses
Advanced renal cell carcinoma in treatment-naive adults w/ intermediate or poor risk & in adults following prior vascular endothelial growth factor-targeted therapy. Monotherapy for hepatocellular carcinoma in adults previously treated w/ sorafenib.
Dosage/Direction for Use
60 mg once daily. May reduce dose to 40 mg daily, then 20 mg daily if necessary.
Administration
Should be taken on an empty stomach.
Contraindications
Special Precautions
Closely evaluate patients during the first 8 wk of treatment to determine if dose modifications are warranted. Perform liver function tests (eg, ALT, AST & bilirubin) prior to initiation of treatment. Monitor patients for signs & symptoms of hepatic encephalopathy; perforations & fistulas including abscesses & sepsis. Discontinue use if unmanageable GI perforations or fistula is experienced; develop acute MI or any other clinically significant arterial thromboembolic complication; severe & persistent HTN & hypertensive crisis; posterior reversible encephalopathy syndrome; at least 28 days prior to scheduled surgery including dental surgery, & in those w/ wound healing complications; if nephrotic syndrome develops. Institute prompt medical management to prevent dehydration, electrolyte imbalances & wt loss. Consider dose interruption or reduction, or permanent discontinuation in persistent or recurrent significant GI AR. Patients who are at risk for, or who have a history of venous thromboembolism, including pulmonary embolism & arterial thromboembolism. Patients w/ history of severe bleeding; do not administer to patients that have, or are at risk for severe haemorrhage. Patients w/ risk factors eg, HTN or history of aneurysm. Monitor platelet levels during treatment. Control BP prior to initiating treatment; monitor for HTN. Osteonecrosis of the jaw (ONJ) has been observed. Perform oral exam prior to initiation & periodically during cabozatinib therapy. Advise patients regarding oral hygiene practice. Co-administration w/ agents associated w/ ONJ eg, biphosphonates. Palmar-plantar erythrodysaesthesia syndrome (PPES) may occur. Regularly monitor urine protein during treatment. Patients w/ history of QT interval prolongation, those taking antiarrhythmics, or w/ relevant pre-existing cardiac disease, bradycardia, electrolyte disturbances. Consider periodic monitoring of patients w/ on-treatment ECGs & electrolytes (serum Ca, K & Mg); & monitor biochemical parameters during treatment. Concurrent administration w/ strong CYP3A4 inhibitors & inducers, P-gp substrates, MRP2 inhibitors. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Closely monitor patients w/ mild or moderate hepatic impairment. Patients w/ mild or moderate renal impairment. Not recommended for use in patients w/ severe renal or hepatic impairment. Patients w/ cardiac impairment. Women of childbearing potential must avoid pregnancy during therapy. Effective contraceptive methods should be used by male or female patients & their partners during therapy & for at least 4 mth after completion. Pregnancy. Discontinue breast-feeding during treatment & for at least 4 mth after completion. Childn & adolescents <18 yr.
Adverse Reactions
Anaemia, thrombocytopenia; hypothyroidism; decreased appetite, hypomagnesaemia, hypokalaemia, hypoalbuminaemia; dysgeusia, headache, dizziness; HTN, haemorrhage; dysphonia, dyspnoea, cough; diarrhea, nausea, vomiting, stomatitis, constipation, abdominal & upper abdominal pain, dyspepsia; PPES, rash; pain in extremity; fatigue, mucosal inflammation, asthenia, peripheral oedema; decreased wt, increased serum ALT & AST. Abcscess; neutropenia, lymphopenia; dehydration, hypophosphataemia, hyponatraemia, hypocalcaemia, hyperkalaemia, hyperbilirubinemia, hyperglycaemia, hypoglycaemia; peripheral neuropathy (including sensory); tinnitus; DVT, venous & arterial thrombosis; pulmonary embolism; GI perforation, fistula, GERD, haemorrhoids, oral pain, dry mouth, dysphagia, glossodynia; hepatic encephalopathy; pruritus, alopecia, dry skin, dermatitis acneiform, hair colour change, hyperkeratosis; muscle spasms, arthralgia; proteinuria; increased GGT, amylase, lipase, blood ALP, creatinine, cholesterol, & triglycerides.
Drug Interactions
Decreased clearance & increased plasma exposure w/ strong CYP3A4 inhibitors (eg, ritonavir, itraconazole, erythromycin, clarithromycin, grapefruit juice). Increased clearance & decreased plasma exposure w/ strong CYP3A4 inducers (eg, phenytoin, carbamazepine, rifampicin, phenobarb or herbal prep containing St. John's Wort). May increase plasma conc w/ MRP2 inhibitors. Potentially decrease exposure w/ bile salt-sequestering agents (eg, cholestyramine & cholestagel). May not guarantee unchanged contraceptive effect; an additional contraceptive method (eg, barrier method) is recommended. Possible plasma protein displacement interaction w/ warfarin; monitor INR values. Potentially increase 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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