Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Ipsen Pharma, 70 rue Balard, 75015 Paris, France
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 individual treatment decision (see important information in section 5.1).
Therapy with COMETRIQ should be initiated by a physician experienced in the administration of anticancer medicinal products.
COMETRIQ (cabozantinib) capsules and CABOMETYX (cabozantinib) tablets are not bioequivalent and should not be used interchangeably (see section 5.2).
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. Patients should therefore be closely monitored during the first eight weeks of therapy (see section 4.4).
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.
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.
Concomitant medicinal products that are strong inhibitors of CYP3A4 should be used with caution, and chronic use of concomitant medicinal products that are strong inducers of CYP3A4 should be avoided (see sections 4.4 and 4.5).
Selection of an alternative concomitant medicinal product with no or minimal potential to induce or inhibit CYP3A4 should be considered.
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.
There is little experience with cabozantinib in non-White patients.
Cabozantinib should be used with caution in patients with mild or moderate renal impairment. Cabozantinib is not recommended for use in patients with severe renal impairment as safety and efficacy have not been established in this population.
In patients with mild or moderate hepatic impairment the recommended dose of cabozantinib is 60 mg once daily. Close monitoring of overall safety is recommended in these patients (see section 5.2) 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.
There is limited data in patients with cardiac impairment. No specific dosing recommendations can be made.
The safety and efficacy of cabozantinib in children aged <18 years have not yet been established. No data are available.
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.
There is no specific treatment for cabozantinib overdose and possible symptoms of overdose have not been established.
In the event of suspected overdose, cabozantinib should be withheld and supportive care instituted. Metabolic clinical laboratory parameters should be monitored at least weekly or as deemed clinically appropriate to assess any possible changing trends. Adverse reactions associated with overdose are to be treated symptomatically.
3 years.
Do not store above 25ºC.
Store in the original package in order to protect from moisture.
PVC/PE/PCTFE-Al blisters with foil backing, sealed into a secondary heat-sealed card packaging.
Blister cards containing either:
21 x 20 mg capsules (60 mg/day dose for a 7-day supply)
7 x 20 mg and 7 x 80 mg capsules (100 mg/day dose for a 7-day supply)
21 x 20 mg and 7 x 80 mg capsules (140 mg/day dose for a 7-day supply)
28 day pack containing:
84 capsules (4 blister cards of 21 x 20 mg) (60 mg/day dose for a 28 day supply)
56 capsules (4 blister cards of 7 x 20 mg and 7 x 80 mg) (100 mg/day dose for a 28 day supply)
112 capsules (4 blister cards of 21 x 20mg and 7 x 80 mg) (140 mg/day dose for a 28 day supply)
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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