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Cometriq is a brand name for Cabozantinib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: COMETRIQ is indicated for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma. For patients in whom rearranged during transfection (RET) mutation status is not known or is negative, a possible lower benefit should be taken into account before…
Verbatim from this product's EMA label. Tap a section to expand.
Therapy with COMETRIQ should be initiated by a physician experienced in the administration of anticancer medicinal products. 2). The recommended dose of COMETRIQ is 140 mg once daily, taken as one 80 mg orange capsule and three 20 mg grey capsules.
Treatment should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs. It should be expected that a majority of patients treated with COMETRIQ will require one or more dose adjustments (reduction and/or interruption) due to toxicity.
4). Management of suspected adverse drug reactions may require temporary interruption and/or dose reduction of COMETRIQ therapy. When dose reduction is necessary, it is recommended to reduce to 100 mg daily, taken as one 80 mg orange capsule and one 20 mg grey capsule, and then to 60 mg daily, taken as three 20 mg grey capsules.
3 Dose interruptions are recommended for management of CTCAE grade 3 or greater toxicities or intolerable grade 2 toxicities. Dose reductions are recommended for events that, if persistent, could become serious or intolerable. As most events can occur early in the course of treatment, the physician should evaluate the patient closely during the first eight weeks of treatment to determine if dose modifications are warranted.
Events that generally have early onset include hypocalcaemia, hypokalaemia, thrombocytopenia, hypertension, palmar- plantar erythrodysaesthesia syndrome (PPES), and gastrointestinal (GI) events (abdominal or mouth pain, mucosal inflammation, constipation, diarrhoea, vomiting).
The occurrence of some serious adverse reactions (like GI fistula) might be dependent on the cumulative dose and might present in a later stage of treatment. If a patient misses a dose, the missed dose should not be taken if it is less than 12 hours before the next dose.
5). Selection of an alternative concomitant medicinal product with no or minimal potential to induce or inhibit CYP3A4 should be considered. Elderly patients No specific dose adjustment for the use of cabozantinib in older people (≥ 65 years) is recommended.
However, a trend in increased rate of SAEs has been observed in subjects aged 75 years and older. Race There is little experience with cabozantinib in non-White patients. Renal impairment Cabozantinib should be used with caution in patients with mild or moderate renal impairment.
Summary of safety profile The most common serious adverse reactions associated with cabozantinib are pneumonia, mucosal inflammation, hypocalcaemia, dysphagia, dehydration, pulmonary embolism, and hypertension. The most frequent adverse reactions of any grade (experienced by at least 20% of patients) included diarrhoea, PPES, weight decreased, decreased appetite, nausea, fatigue, dysgeusia, hair colour changes, hypertension, stomatitis, constipation, vomiting, mucosal inflammation, asthenia, and dysphonia.
The most common laboratory abnormalities were increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), increased alkaline phosphatase (ALP), lymphopenia, hypocalcaemia, 8 neutropenia, thrombocytopenia, hypophosphatemia, hyperbilirubinemia, hypomagnesaemia, and hypokalaemia.
Tabulated list of adverse reactions Adverse reactions are listed in Table 1 according to MedDRA system organ class and frequency categories. Frequencies are based on all grades and defined as very common (≥1/10), common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100), not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 8 Description of selected adverse reactions for further characterisation. The following terms have been combined to derive appropriate frequency categorisation: a Lowered haematology parameters: Lymphopenia and lymphocyte count decreased; Neutropenia and neutrophil count decreased; Thrombocytopenia and platelet count decreased.
bElevated haematology parameters: Eosinophil count increased and eosinophilia; Platelet count increased and thrombocytosis c Lowered biochemistry parameters: Hypoalbuminaemia and blood albumin decreased; Hypocalcaemia and blood calcium decreased; Hypokalaemia and blood potassium decreased; Hypomagnesaemia and blood magnesium decreased; Hypohosphatemia and blood phosphorus decreased.
Dose reductions and dose interruptions occurred in 79% and 72%, respectively, of cabozantinib-treated patients in the pivotal clinical study. Two dose reductions were required in 41% of patients. The median time to first dose reduction was 43 days, and to first dose interruption was 33 days.
2). Hepatotoxicity Abnormalities of liver function tests (increases in alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin) have been frequently observed in patients treated with cabozantinib. It is recommended to perform liver function tests (ALT, AST and bilirubin) before initiation of cabozantinib treatment and to monitor closely during treatment.
2. Perforations, fistulas, and intra-abdominal abscesses Serious gastrointestinal (GI) perforations and fistulas, sometimes fatal, and intra-abdominal abscesses have been observed with cabozantinib. , Crohn’s disease, ulcerative colitis, peritonitis, or diverticulitis), have tumour infiltration of trachea, bronchi, or oesophagus, have complications from prior GI surgery (particularly when associated with delayed or incomplete healing), or have complications from prior radiation therapy to the thoracic cavity (including mediastinum) should be carefully evaluated before initiating cabozantinib therapy and subsequently they should be monitored closely for symptoms of perforations and fistulas.
Non-GI fistula should be ruled out as appropriate in cases of onset of mucositis after start of therapy. Cabozantinib should be discontinued in patients who experience a GI perforation or a GI or non-GI fistula. Thromboembolic events Events of venous thromboembolism, including pulmonary embolism and events of arterial thromboembolism, sometimes fatal, have been observed with cabozantinib.
Cabozantinib should be used with caution in patients who are at risk for, or who have a history of, these events. Cabozantinib should be discontinued in patients who develop an acute myocardial infarction or any other clinically significant arterial thromboembolic complication.
1. 4
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Cabozantinib is not recommended for use in patients with severe renal impairment as safety and efficacy have not been established in this population. Hepatic impairment In patients with mild or moderate hepatic impairment the recommended dose of cabozantinib is 60 mg once daily.
2) as dose adjustment or interruption may be required. Cabozantinib is not recommended for use in patients with severe hepatic impairment as safety and efficacy have not been established in this population. Patients with cardiac impairment There is limited data in patients with cardiac impairment.
No specific dosing recommendations can be made. Paediatric population The safety and efficacy of cabozantinib in children aged <18 years have not yet been established. No data are available. Method of administration COMETRIQ is for oral use.
The capsules should be swallowed whole and not opened. Patients should be instructed to not eat anything for at least 2 hours before through 1 hour after taking COMETRIQ.
d Elevated biochemistry parameters: Hyperbilirubinaemia and blood bilirubin increased; Hypothyroidism and blood thyroid stimulating hormone increased. e Abdominal pain, abdominal discomfort, abdominal pain upper and abdominal pain lower f Hypertension and blood pressure increased.
g Hypotension and blood pressure decreased. h No hypertensive crisis was reported in Cometriq clinical trials; the frequency is based on pooled cabozantinib data (including Cabometyx 60 mg tablet data). Description of selected adverse reactions A thyroid stimulating hormone (TSH) value above normal after first dose was observed in […]
Haemorrhage Severe haemorrhage, sometimes fatal, has been observed with cabozantinib. Patients who have evidence of involvement of the trachea or bronchi by tumour or a history of haemoptysis prior to treatment initiation should be carefully evaluated before initiating cabozantinib therapy.
Cabozantinib should not be administered to patients with serious haemorrhage or recent haemoptysis. Aneurysms and artery dissections The use of VEGF pathway inhibitors in patients with or without hypertension may promote the formation of aneurysms and/or artery dissections.
Before initiating cabozantinib, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm. 8). Prompt medical management, including supportive care with antiemetics, antidiarrhoeals, or antacids, should be instituted to prevent dehydration, electrolyte imbalances and weight loss.
2). 5 Wound complications Wound complications have been observed with cabozantinib. Cabozantinib treatment should be stopped at least 28 days prior to scheduled surgery, including dental surgery or invasive dental procedures, if possible.
The decision to resume cabozantinib therapy after surgery should be based on clinical judgment of adequate wound healing. Cabozantinib should be discontinued in patients with wound healing complications requiring medical intervention.
Hypertension Hypertension, including hypertensive crisis, has been observed with cabozantinib. Blood pressure should be well-controlled prior to initiating cabozantinib. After cabozantinib initiation blood pressure should be monitored early and regularly and treated as needed with appropriate anti-hypertensive therapy.
In the case of persistent hypertension despite use of anti-hypertensives, the cabozantinib treatment should be interrupted until blood pressure is controlled, after which cabozantinib can be resumed at a reduced dose. Cabozantinib should be discontinued if hypertension is severe and persistent despite anti-hypertensive therapy and dose reduction of cabozantinib.
In case of hypertensive crisis, cabozantinib should be discontinued. Cardiac Failure Cabozantinib has been associated with an increased risk of cardiac failure. g. hypertension, hypothyroidism and arterial thrombotic events), which can lead to cardiac failure.
Patients should be monitored for signs and symptoms of cardiac failure throughout treatment. 2) and TKI therapy should be discontinued in patients who develop severe cardiac failure. Osteonecrosis Events of osteonecrosis of the jaw (ONJ) have been observed with cabozantinib.
An oral examination should be performed prior to initiation of cabozantinib and periodically during cabozantinib therapy. Patients should be advised regarding oral hygiene practice. Cabozantinib treatment should be held at least 28 days prior to scheduled dental surgery or invasive dental procedures, if possible.
Caution should be used in […]