Cometriq Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Cometriq Indications
Indications
Progressive, metastatic medullary thyroid cancer (MTC).
Cometriq Dosage and Administration
Adult
Children
Cometriq Contraindications
Not Applicable
Cometriq Boxed Warnings
Not Applicable
Cometriq Warnings/Precautions
Warnings/Precautions
Not substitutable with cabozantinib tabs. Permanently discontinue if the following occurs: GI perforation, GI fistula (Grade 4), severe hemorrhage (Grade 3/4), acute MI, serious thromboembolic events that require medical intervention, hypertensive crisis or severe hypertension despite optimal medical management, nephrotic syndrome, reversible posterior leukoencephalopathy syndrome. Withhold for intolerable Grade 2 reactions, Grade 3/4 reactions, or osteonecrosis of the jaw. Recent history of hemorrhage (including hemoptysis, hematemesis, melena): do not administer. Monitor for GI perforations/fistulas. Monitor BP regularly; withhold for hypertension inadequately controlled with medical management; resume at reduced dose when resolved. Withhold therapy if intolerable Grade 2 diarrhea, unmanageable Grade 3/4 diarrhea, or intolerable Grade 2/3 palmar-plantar erythrodysesthesia (PPE) develops until improvement to Grade 1; resume at reduced dose. Monitor urine protein regularly. Perform oral exam prior to initiation and periodically during therapy. Impaired wound healing: withhold for ≥3 weeks prior to elective surgery (including dental); do not give for ≥2 weeks after major surgery and until adequate healing. Monitor blood calcium levels during therapy, and replace as needed; withhold and resume at reduced dose depending on severity. Severe hepatic impairment: not recommended. Severe renal impairment. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 4 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 4 months after the last dose).
Cometriq Pharmacokinetics
Absorption
Median time to peak cabozantinib plasma concentrations ranged from 2–5 hours post-dose.
Cabozantinib Cmax and AUC values increased by 41% and 57%, respectively, following a high-fat meal relative to fasted conditions in healthy subjects.
Distribution
Volume of distribution: ~349 L. Plasma protein bound: ≥99.7%.
Elimination
Fecal (54%), renal (27%). Half-life (predicted): ~55 hours. Clearance at steady-state: 4.4 L/hr.
Cometriq Interactions
Interactions
Cometriq Adverse Reactions
Adverse Reactions
Cometriq Clinical Trials
See Literature
Cometriq Note
Not Applicable
Cometriq Patient Counseling
See Literature
Images
