Drug Action
Cabozantinib is an inhibitor of several protein kinases.
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Drug reference
Cabozantinib is an inhibitor of several protein kinases.
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Treatment of progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma (initiated by a specialist) ▶BY MOUTH USING CAPSULES ▶Adult: 140 mg once daily, for dose adjustment or treatment interruption due to side-effects, consult product literature (closely monitor for first 8 weeks of therapy) Advanced renal cell carcinoma (initiated by a specialist) ▶BY MOUTH USING TABLETS ▶Adult: 60 mg once daily, for dose adjustment or treatment interruption due to side-effects, consult product literature (closely monitor for first 8 weeks of therapy) DOSE EQUIVALENCE AND CONVERSION ▶Cabozantinib tablets and capsules are not bioequivalent—consult product literature when switching formulations.
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Reversible posterior leucoencephalopathy syndrome
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Hypertension—discontinue treatment if Immune system and malignant disease uncontrolled despite medical intervention. palmar- plantar erythrodysaesthesia syndrome—consider treatment interruption if severe and restart at a lower dose when resolved to grade 1. patients at increased risk of fistulas—consult product literature. patients at increased risk of gastro-intestinal perforation—consult product literature. patients at increased risk of intra-abdominal abscess—consult product literature. patients at risk of haemorrhage (including tumour involvement of the trachea or bronchi)—discontinue if symptoms develop. patients at risk of thromboembolic events including myocardial infarction—discontinue if symptoms develop. risk of osteonecrosis of the jaw. susceptibility to QT- interval prolongation (e.g. cardiac disease, electrolyte disturbances, bradycardia, concomitant use of drugs that prolong the QT interval)—monitor ECG and electrolytes periodically CAUTIONS, FURTHER INFORMATION ▶Elective surgery Withhold treatment for at least 28 days before elective surgery and restart only if adequate wound healing—discontinue in patients with wound healing complications requiring medical intervention. ▶Risk of osteonecrosis of the jaw Discontinue treatment at least 28 days before elective invasive dental procedures— monitor for symptoms before and during treatment and discontinue if osteonecrosis develops.
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NICE decisions ▶Cabozantinib for previously treated advanced renal cell carcinoma (August 2017) NICE TA463 Cabozantinib (Cabometyx ®) is recommended, within its marketing authorisation, as an option for treating advanced renal cell carcinoma in adults after vascular endothelial growth factor (VEGF)-targeted therapy, only if the company provides cabozantinib with the discount agreed in the patient access scheme. www.nice.org.uk/guidance/ta463 ▶Cabozantinib for untreated advanced renal cell carcinoma (October 2018) NICE TA542 Cabozantinib (Cabometyx ®) is recommended, within its marketing authorisation, for adults with untreated advanced renal cell carcinoma that is intermediate- or poor-risk as defined in the International Metastatic Renal Cell Carcinoma Database Consortium criteria. It is recommended only if the manufacturer provides cabozantinib according to the commercial arrangement. www.nice.org.uk/guidance/ta542 ▶Cabozantinib for treating medullary thyroid cancer (March 2018) NICE TA516 Cabozantinib (Cometriq ®) is recommended, within its marketing authorisation, as an option for treating progressive medullary thyroid cancer in adults with unresectable, locally advanced or metastatic disease, only if the manufacturer provides cabozantinib with the discount agreed in the patient access scheme. www.nice.org.uk/guidance/ta516 Scottish Medicines Consortium (SMC) decisions SMC No. 1234/17 The Scottish Medicines Consortium has advised (June 2017) that cabozantinib (Cabometyx ®) is accepted for use within NHS Scotland for the treatment of advanced renal cell carcinoma in adults following vascular endothelial growth factor (VEGF)-targeted therapy. This advice is contingent upon continuing availability of the patient access scheme or a list price that is equivalent or lower. SMC No. SMC2136 The Scottish Medicines Consortium has advised (February 2019) that cabozantinib (Cabometyx ®) is not recommended for use within NHS Scotland for the treatment of advanced renal cell carcinoma in treatment- naive adults with intermediate or poor risk as the economic case was not demonstrated.
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RISKS OF INCORRECT DOSING OF ORAL ANTI-CANCER MEDICINES See Cytotoxic drugs p. 938.
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→Appendix 1: cabozantinib
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▶Common or very common Abscess. alopecia. anxiety. appetite decreased. arrhythmias. arthralgia. asthenia. chills. cholelithiasis. confusion. constipation. dehydration. depression. diarrhoea. dizziness. dysphagia . dysphonia. dysuria. ear pain. electrolyte imbalance. embolism and thrombosis. fistula. gastrointestinal discomfort. gastrointestinal disorders. haemorrhage. hair changes. headache. healing impaired. hyperbilirubinaemia. hypertension. hypoalbuminaemia. hypotension. hypothyroidism. increased risk of infection. lymphopenia. mucositis. muscle spasms. nausea. neutropenia. oedema. oral disorders. oropharyngeal pain . osteonecrosis of jaw. pain. pallor. pancreatitis. paraesthesia. peripheral coldness. peripheral neuropathy. proteinuria. skin reactions. taste altered. thrombocytopenia. tinnitus. tremor. vision blurred. vomiting. weight decreased ▶Uncommon Abnormal dreams. acute kidney injury. amenorrhoea. angina pectoris. ataxia. cataract. concentration impaired. conjunctivitis. cyst. delirium. encephalopathy. hearing impairment. loss of consciousness. respiratory disorders. rhabdomyolysis. skin ulcer. speech disorder. telangiectasia. throat oedema . transient ischaemic attack
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Patients and their sexual partners must use effective contraception (in addition to barrier method) during treatment and for at least 4 months after the last dose.
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Manufacturer advises avoid unless potential benefit outweighs risk—toxicity in animal studies. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises discontinue breast-feeding during treatment and for at least 4 months after the last dose.
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For capsules manufacturer advises caution in mild to moderate impairment (risk of increased exposure); avoid in severe impairment (no information available). For tablets manufacturer advises caution in moderate impairment (limited information available); avoid in severe impairment (no information available). Dose adjustments For capsules manufacturer advises dose Immune system and malignant disease reduction to 60 mg once daily in mild to moderate impairment.
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Manufacturer advises caution in renal impairment. Avoid in severe impairment.
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Monitor urine protein regularly and discontinue if nephrotic syndrome develops.
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There can be variation in the licensing of different medicines containing the same drug. Tablet CAUTIONARY AND ADVISORY LABELS 23, 25 ▶Cabometyx (Ipsen Ltd) A Cabozantinib (as Cabozantinib s-malate) 20 mg Cabometyx 20mg tablets | 30 tablet P £5,143.00 Cabozantinib (as Cabozantinib s-malate) 40 mg Cabometyx 40mg tablets | 30 tablet P £5,143.00 Cabozantinib (as Cabozantinib s-malate) 60 mg Cabometyx 60mg tablets | 30 tablet P £5,143.00 Capsule CAUTIONARY AND ADVISORY LABELS 23, 25 ▶Cometriq (Ipsen Ltd) A Cabozantinib (as Cabozantinib s-malate) 20 mg Cometriq 20mg capsules | 84 capsule P £4,800.00 Cabozantinib (as Cabozantinib s-malate) 80 mg Cometriq 80mg capsules | 7 capsule P s Cometriq 20mg capsules and Cometriq 80mg capsules | 56 capsule P £4,800.00 | 112 capsule P £4,800.00
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Food should not be consumed for at least 2 hours before and at least 1 hour after each dose. Driving and skilled tasks Fatigue and weakness may affect performance of skilled tasks e.g. driving.
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140 mg once daily, for dose adjustment or
First-line fragment. Read the complete Indications and Dose section above.
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60 mg once daily, for dose adjustment or
First-line fragment. Read the complete Indications and Dose section above.
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