COMETRIQ 20 mg hard capsules
Each capsule contains CABOZANTINIB [(2S) -2hydroxybutandioat] equivalent to 20 mg CABOZANTINIB.
The hard capsules are gray and have the inscription "XL184 20mg" in black on the capsule body. The capsule contains a white to off-white powder.
COMETRIQ is indicated for the treatment of medullary thyroid cancer in adult patients with progressive, unresectable, locally advanced or metastatic disease.
In patients whose Rearranged during Transfection- (RET) -Mutationsstatus is unknown or negative, should before deciding on the individual treatment a possibly lower benefits are taken into account (see important information in sections 4.4 and 5.1).
Dosage and method of administration
Treatment with COMETRIQ should be initiated by a doctor who has the use of anticancer medicines experience.
The recommended dose COMETRIQ is 140 mg taken once daily as an orange 80 mg capsule and three gray 20 mg capsules , Treatment should be continued until the patient is clinically no longer benefits from the treatment or unacceptable toxicity occurs.
It is to be expected that the majority of patients treated with COMETRIQ patient one or more dose adjustments (dose reduction and / or dose interruption) needed due to toxicities. Patients should be monitored closely during the first eight weeks of treatment (see section 4.4).
For the control of suspected adverse drug reactions may require temporary interruption of COMETRIQ therapy and / or dose reduction may be necessary. If a dose reduction is necessary, a reduction is advisable initially to 100 mg daily taken as an orange 80 mg capsule and a gray 20 mg capsule, and then daily to 60 mg, administered as three gray 20 mg capsules.
dose interruptions are recommended for the control of toxicities of grade 3 or higher according to CTCAE or intolerable toxicities grade 2.
dose reductions are recommended for events that would result in the case of their continued existence in a serious or intolerable condition.
Since most events at an early stage may occur in the course of treatment, the physician should monitor the patient during the first eight weeks of treatment closely to determine whether dosage adjustments are required.Events that occur generally at an early stage, are hypocalcemia, hypokalemia, thrombocytopenia, hypertension, palmarplantares erythrodysaesthesia syndrome (PPES) and gastrointestinal (GI) events (abdominal pain, mouth pain, mucosal inflammation, constipation, diarrhea, vomiting).
The appearance of some severe side effects (such as a GI fistula) may depend on the cumulative dose and occurs later in the course of treatment.
if the patient misses a dose, should the missed dose no longer be taken when the period up to taking the next is dose less than 12 hours. accompanying medicines accompanying medicinal products for which there are strong CYP3A4 inhibitors should be used with caution. The accompanying long-term use of strong CYP3A4 inducers should be avoided (see sections 4.4 and 4.5). The choice of an alternative concomitant medicinal product with no or a minimal potential to induce or inhibit CYP3A4 should be considered. Elderly patients In elderly patients (≥ 65 years) is recommended no specific dose adjustment for CABOZANTINIB. In people aged 75 years, however, a trend toward a higher rate of serious adverse events (SAEs) were observed. EthnicityThere is little experience with the use of CABOZANTINIB in non white-skinned patients. Patients with renal impairment CABOZANTINIB should in patients with impaired renal function be used with caution. In patients with severe renal impairment the use of CABOZANTINIB is not recommended because of the limited data on its use in patients present with severe renal impairment and the safety and efficacy have not been established.Patients with hepatic impairment CABOZANTINIB is for use in patients with hepatic impairment is not recommended because of the limited data on its use in patients with hepatic impairment are present and the safety and efficacy have not been established. patients with impaired cardiac function over the use in patients with heart failure are limited data. Therefore, no specific dose recommendations can be given. Children and adolescents The safety and efficacy of CABOZANTINIB in children and adolescents <18 years have not yet been established. There are no data available. Route of administration The capsules should be swallowed whole and not be opened. Patients should be instructed not to eat at least 2 hours before taking and to 1 hour after taking COMETRIQ.