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COMETRIQ
Overview
What is COMETRIQ?
COMETRIQ is the ()-malate salt of cabozantinib. Cabozantinib ()-malate is described chemically as -(4-(6,7-dimethoxyquinolin-4-yloxy)phenyl)--(4-fluorophenyl)cyclopropane- 1,1-dicarboxamide, (2)-hydroxybutanedioate. The molecular formula is CHFNO•CHO and the molecular weight is 635.6 Daltons as malate salt. The chemical structure of cabozantinib ()-malate salt is:
Cabozantinib ()-malate salt is a white to off-white solid that is practically insoluble in aqueous
media.
COMETRIQ (cabozantinib) capsules are supplied as printed hard gelatin capsules containing cabozantinib ()-malate equivalent to 20 mg or 80 mg cabozantinib and the following inactive ingredients: silicified microcrystalline cellulose, croscarmellose sodium, sodium starch glycolate, fumed silica, and stearic acid.
The grey gelatin capsule shells contain black iron oxide and titanium dioxide and the Swedish orange gelatin capsule shells contain red iron oxide, and titanium dioxide. The printing ink contains shellac glaze, black iron oxide, -butyl alcohol, isopropyl alcohol, propylene glycol, and ammonium hydroxide.
What does COMETRIQ look like?
What are the available doses of COMETRIQ?
20 mg and 80 mg capsules. ()
What should I talk to my health care provider before I take COMETRIQ?
How should I use COMETRIQ?
COMETRIQ is indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC).
Do NOT substitute COMETRIQ capsules with cabozantinib tablets.
The recommended daily dose of COMETRIQ is 140 mg (one 80-mg and three 20-mg capsules). Do not administer COMETRIQ with food. Instruct patients not to eat for at least 2 hours before and at least 1 hour after taking COMETRIQ. Continue treatment until disease progression or unacceptable toxicity occurs.
Swallow COMETRIQ capsules whole. Do not open COMETRIQ capsules.
Do not take a missed dose within 12 hours of the next dose.
Do not ingest foods (e.g., grapefruit, grapefruit juice) or nutritional supplements that are known to inhibit cytochrome P450 while taking COMETRIQ.
In Patients with Hepatic Impairment
[see (), ()]
What interacts with COMETRIQ?
Sorry No Records found
What are the warnings of COMETRIQ?
Sorry No Records found
What are the precautions of COMETRIQ?
Sorry No Records found
What are the side effects of COMETRIQ?
Sorry No records found
What should I look out for while using COMETRIQ?
None
Perforations and fistulas: Gastrointestinal perforations occurred in 3% and fistula formation in 1% of COMETRIQ-treated patients. Discontinue COMETRIQ for perforation or for fistula formation [See
Hemorrhage: Severe, sometimes fatal, hemorrhage including hemoptysis and gastrointestinal hemorrhage occurred in 3% of COMETRIQ-treated patients. Monitor patients for signs and symptoms of bleeding. Do not administer COMETRIQ to patients with severe hemorrhage [See
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What might happen if I take too much COMETRIQ?
One case of overdosage was reported in a patient who inadvertently took twice the intended dose (200 mg daily) for nine days. The patient suffered Grade 3 memory impairment, Grade 3 mental status changes, Grade 3 cognitive disturbance, Grade 2 weight loss, and Grade 1 increase in BUN. The extent of recovery was not documented.
How should I store and handle COMETRIQ?
Store at 20° to 25°C (68° to 77°F)[See USP Controlled Room Temperature].Protect from light.DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Store at 20° to 25°C (68° to 77°F)[See USP Controlled Room Temperature].Protect from light.DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.COMETRIQ 20 mg capsules are supplied as hard gelatin capsules with grey cap and grey body, printed with "XL184 20mg" in black ink and containing cabozantinib ()-malate salt equivalent to 20 mg cabozantinib.COMETRIQ 80 mg capsules are supplied as hard gelatin capsules with Swedish orange cap and Swedish orange body, printed with "XL184 80mg" in black ink and containing cabozantinib ()- malate salt equivalent to 80 mg cabozantinib.COMETRIQ capsules are supplied as follows:CartonsStore COMETRIQ at 20°C to 25°C (68°F to 77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].COMETRIQ 20 mg capsules are supplied as hard gelatin capsules with grey cap and grey body, printed with "XL184 20mg" in black ink and containing cabozantinib ()-malate salt equivalent to 20 mg cabozantinib.COMETRIQ 80 mg capsules are supplied as hard gelatin capsules with Swedish orange cap and Swedish orange body, printed with "XL184 80mg" in black ink and containing cabozantinib ()- malate salt equivalent to 80 mg cabozantinib.COMETRIQ capsules are supplied as follows:CartonsStore COMETRIQ at 20°C to 25°C (68°F to 77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].COMETRIQ 20 mg capsules are supplied as hard gelatin capsules with grey cap and grey body, printed with "XL184 20mg" in black ink and containing cabozantinib ()-malate salt equivalent to 20 mg cabozantinib.COMETRIQ 80 mg capsules are supplied as hard gelatin capsules with Swedish orange cap and Swedish orange body, printed with "XL184 80mg" in black ink and containing cabozantinib ()- malate salt equivalent to 80 mg cabozantinib.COMETRIQ capsules are supplied as follows:CartonsStore COMETRIQ at 20°C to 25°C (68°F to 77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].COMETRIQ 20 mg capsules are supplied as hard gelatin capsules with grey cap and grey body, printed with "XL184 20mg" in black ink and containing cabozantinib ()-malate salt equivalent to 20 mg cabozantinib.COMETRIQ 80 mg capsules are supplied as hard gelatin capsules with Swedish orange cap and Swedish orange body, printed with "XL184 80mg" in black ink and containing cabozantinib ()- malate salt equivalent to 80 mg cabozantinib.COMETRIQ capsules are supplied as follows:CartonsStore COMETRIQ at 20°C to 25°C (68°F to 77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
In vitro
Non-Clinical Toxicology
NonePerforations and fistulas: Gastrointestinal perforations occurred in 3% and fistula formation in 1% of COMETRIQ-treated patients. Discontinue COMETRIQ for perforation or for fistula formation [See
Hemorrhage: Severe, sometimes fatal, hemorrhage including hemoptysis and gastrointestinal hemorrhage occurred in 3% of COMETRIQ-treated patients. Monitor patients for signs and symptoms of bleeding. Do not administer COMETRIQ to patients with severe hemorrhage [See
Cyclobenzaprine may have life-threatening interactions with MAO inhibitors (see ). Postmarketing cases of serotonin syndrome have been reported during combined use of cyclobenzaprine hydrochloride and other drugs, such as selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, or monoamine oxidase (MAO) inhibitors. If concomitant treatment with cyclobenzaprine hydrochloride and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dose increases (see ).
Cyclobenzaprine hydrochloride may enhance the effects of alcohol, barbiturates, and other CNS depressants.
Tricyclic antidepressants may block the antihypertensive action of guanethidine and similarly acting compounds.
Tricyclic antidepressants may enhance the seizure risk in patients taking tramadol.
Array
Array
Gastrointestinal (GI) perforations and fistulas were reported in 3% and 1% of COMETRIQ-treated patients, respectively. All were serious and one GI fistula was fatal (< 1%). Non-GI fistulas including tracheal/esophageal were reported in 4% of COMETRIQ-treated patients. Two (1%) of these were fatal.
Monitor patients for symptoms of perforations and fistulas, including abscess. Discontinue COMETRIQ in patients who experience a perforation or a fistula.
The following serious adverse reactions are discussed elsewhere in the label:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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