cometriq
Cometriq (Cabozantinib S-Malate) is a kinase inhibitor used to treat Renal Cell Carcinoma.
Cabozantinib S-Malate · by Exelixis
Key facts
- Active ingredient
- Cabozantinib S-Malate
- Drug class
- Kinase Inhibitor
- Form
- Capsule, Kit
- Strength
- Cabozantinib S-MALATE EQ 20MG Base · Cabozantinib S-MALATE EQ 80MG Base
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- renal cell carcinoma
- Manufacturer
- Exelixis
- FDA application
- NDA203756
What is Cometriq?
From the FDA label:COMETRIQ is the ( S )-malate salt of cabozantinib, a kinase inhibitor. Cabozantinib ( S )-malate is described chemically as N -(4-(6,7-dimethoxyquinolin-4-yloxy)phenyl)- N' -(4-fluorophenyl)cyclopropane- 1,1-dicarboxamide, (2 S )-hydroxybutanedioate. The molecular formula is C 28 H 24 FN 3 O 5 •C 4 H 6 O 5 and the molecular weight is 635.6 Daltons as malate salt. The chemical structure of cabozantinib ( S )-malate salt is: Cabozantinib ( S )-malate salt is a white to off-white solid that is practically insoluble in aqueous media. COMETRIQ (cabozantinib) capsules for oral use are supplied as printed hard gelatin capsules containing cabozantinib ( S )-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, N -butyl alcohol, isopropyl alcohol, propylene glycol, and ammonium hydroxide.
How to use
Cometriq is sold in more than one form (Capsule and Kit), and each is dosed differently. The instructions below come from the FDA label for application NDA203756 — follow the label that came with the product you were actually prescribed.
Recommended Dose: 140 mg orally, once daily. ( 2.1 ) Instruct patients not to eat for at least 2 hours before and at least 1 hour after taking COMETRIQ. ( 2.1 ) Do NOT substitute COMETRIQ capsules with cabozantinib tablets. ( 2.1 ) Hepatic Impairment: The recommended starting dose of COMETRIQ is 80 mg in patients with mild or moderate hepatic impairment. ( 2.1 ) 2.1 Recommended Dosage Do NOT substitute COMETRIQ capsules with cabozantinib tablets. The recommended daily dose of COMETRIQ is 140 mg once daily without food until disease progression or unacceptable toxicity. Instruct patients not to eat for at least 2 hours before and at least 1 hour after taking COMETRIQ. 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. 2.2 Dosage Modifications for Adverse Reactions Withhold COMETRIQ for NCI CTCAE Grade 4 hematologic adverse reactions, Grade 3 or greater non-hematologic adverse reactions, intolerable Grade 2 adverse reactions, or osteonecrosis of the jaw. Upon resolution/improvement of the adverse reaction (i.e., return to baseline or resolution to Grade 1), reduce the dose as follows: If previously receiving 140 mg daily dose, resume treatment at 100 mg daily…
Side effects
The following clinically significant adverse reactions are discussed elsewhere in the labeling: Perforations and Fistula [see Warnings and Precautions (5.1) ] Hemorrhage [see Warnings and Precautions (5.2) ] Thromboembolic Events [see Warnings and Precautions (5.3) ] Impaired Wound Healing [see Warnings and Precautions (5.4) ] Hypertension and Hypertensive Crisis [see Warnings and Precautions (5.5) ] Cardiac Failure [see Warnings and Precautions (5.6) ] Osteonecrosis of the Jaw [see Warnings and Precautions (5.7) ] Diarrhea [see Warnings and Precautions (5.8) ] Palmar-Plantar Erythrodysesthesia [see Warnings and Precautions (5.9) ] Proteinuria [see Warnings and Precautions (5.10) ] Reversible Posterior Leukoencephalopathy Syndrome [see Warnings and Precautions (5.11) ] Hypocalcemia [see Warnings and Precautions (5.13) ] The most common adverse reactions (≥ 25%) are diarrhea, stomatitis, palmar-plantar erythrodysesthesia (PPE), decreased weight, decreased appetite, nausea, fatigue, oral pain, hair color changes, dysgeusia, hypertension, abdominal pain, and constipation. The most common laboratory abnormalities (≥ 25%) are increased AST, increased ALT, lymphopenia, increased alkaline phosphatase, hypocalcemia, neutropenia, thrombocytopenia, hypophosphatemia, and hyperbilirubinemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Exelixis, Inc. at 1-855-500-3935 or FDA at…
Warnings
Important safety information
Perforations and Fistulas: Monitor for symptoms. Discontinue COMETRIQ for Grade 4 fistula or perforation. ( 5.1 ) Hemorrhage: Do not administer COMETRIQ if recent history of hemorrhage. ( 5.2 ) Thrombotic Events: Discontinue COMETRIQ for myocardial infarction or serious arterial or venous thromboembolic events. ( 5.3 ) Impaired Wound Healing: Withhold COMETRIQ for at least 3 weeks before elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of COMETRIQ after resolution of wound healing complications has not been established. ( 5.4 ) Hypertension and hypertensive crisis: Monitor blood pressure regularly. Interrupt for hypertension that is not adequately controlled with anti- hypertensive therapy. Discontinue COMETRIQ for hypertensive crisis or severe hypertension that cannot be controlled with anti-hypertensive therapy. ( 5.5 ) Cardiac Failure: Monitor patients for signs and symptoms of cardiac failure throughout treatment. ( 5.6 ) Osteonecrosis of the Jaw (ONJ): Withhold COMETRIQ for at least 3 weeks prior to invasive dental procedure and for development of ONJ. ( 5.7 ) Diarrhea: May be severe. Interrupt COMETRIQ immediately until diarrhea resolves or decreases to Grade 1. Recommend standard antidiarrheal treatments. ( 5.8 ) Palmar-Plantar Erythrodysesthesia (PPE): Interrupt COMETRIQ until PPE resolves or decreases to Grade 1. ( 5.9 ) Proteinuria: Monitor urine protein. Discontinue for nephrotic syndrome. ( 5.10 ) Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue COMETRIQ. ( 5.11 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. ( 5.12 , 8.1 , 8.3 ) Hypocalcemia: Monitor blood calcium levels and replace calcium as necessary during treatment. Withhold COMETRIQ and resume at reduced dose upon recovery or permanently discontinue COMETRIQ depending on severity. ( 5.13 ) 5.1 Perforations and Fistulas Gastrointestinal (GI) perforations and fistulas, including fatal cases, were reported in 3% and 1% of COMETRIQ-treated patients (N=214), respectively. Non-GI fistulas including tracheal/esophageal, including fatal cases, were reported in 4% of COMETRIQ-treated patients. Monitor patients for symptoms of perforations and fistulas, including abscess and sepsis. Discontinue COMETRIQ in patients who experience a Grade 4 fistula or a GI perforation [see Dosage and Administration (2.2) ] . 5.2 Hemorrhage Severe and fatal hemorrhage occurred with COMETRIQ. The incidence of Grade ≥ 3 hemorrhagic events was higher in COMETRIQ-treated patients compared with placebo (3% vs. 1%). Discontinue COMETRIQ for Grade 3 or 4 hemorrhage [see Dosage and Administration (2.2) ] . Do not administer COMETRIQ to patients with a recent history of hemorrhage, including hemoptysis, hematemesis, or melena. 5.3 Thromboembolic Events COMETRIQ increased the incidence of thrombotic events (venous thromboembolism: 6% vs. 3% and arterial thromboembolism: 2% vs. 0% in COMETRIQ-treated and placebo-treated patients, respectively). Discontinue COMETRIQ in patients who develop an acute myocardial infarction or arterial or venous thromboembolic events that require medical intervention [see Dosage and Administration (2.2) ] . 5.4 Impaired Wound Healing Wound complications have been reported with COMETRIQ. Withhold COMETRIQ for at least 3 weeks prior to elective surgery. Do not administer COMETRIQ for at least 2 weeks after major surgery and until adequate wound healing. The safety of resumption of COMETRIQ after resolution of wound healing complications has not been established. 5.5 Hypertension and Hypertensive Crisis COMETRIQ can cause hypertension, including hypertensive crisis. Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (modified JNC criteria) stage 1 or 2 hypertension was identified in 61% in COMETRIQ-treated patients compared with 30% of placebo-treated patients in the randomized trial [see Adverse Reactions (6.1) ] . Do not initiate COMETRIQ in patients with uncontrolled hypertension. Monitor blood pressure regularly during COMETRIQ treatment. Withhold COMETRIQ for hypertension that is not adequately controlled with medical management; when controlled, resume COMETRIQ at a reduced dose. Discontinue COMETRIQ for severe hypertension that cannot be controlled with anti-hypertensive therapy and for hypertensive crisis [see Dosage and Administration (2.2) ] . 5.6 Cardiac Failure COMETRIQ can cause severe and fatal cardiac failure [see Adverse Reactions (6.1) ] . Cardiac failure occurred in 0.9% of patients treated with COMETRIQ as a single agent. Median time to onset of cardiac failure was 76 days (range: 60 days to 92 days). Consider baseline and periodic evaluations of left ventricular ejection fraction. Monitor for signs and symptoms of cardiovascular events. Withhold and resume at a reduced dose upon recovery or permanently discontinue COMETRIQ depending on the severity [see Dosage and Administration (2.2) ] . 5.7 Osteonecrosis of the Jaw Osteonecrosis of the jaw (ONJ) occurred in 1% of COMETRIQ-treated patients. ONJ can manifest as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration or erosion, persistent jaw pain or slow healing of the mouth or jaw after dental surgery. Perform an oral examination prior to initiation of COMETRIQ and periodically during COMETRIQ therapy. Advise patients regarding good oral hygiene practices. Withhold COMETRIQ treatment for at least 3 weeks prior to scheduled dental surgery, or invasive dental procedures, if possible. Withhold COMETRIQ for development of ONJ until complete resolution [see Dosage and Administration (2.2) ] . 5.8 Diarrhea Diarrhea occurred in 63% of patients treated with COMETRIQ. Grade 3-4 diarrhea occurred in 16% of patients treated with COMETRIQ [see Adverse Reactions (6.1) ] . Withhold COMETRIQ until improvement to Grade 1 and resume COMETRIQ at a reduced dose for intolerable Grade 2 diarrhea, Grade 3 diarrhea that cannot be managed with standard antidiarrheal treatments, or Grade 4 diarrhea. 5.9 Palmar-Plantar Erythrodysesthesia Palmar-plantar erythrodysesthesia (PPE) occurred in 50% of patients treated with COMETRIQ, including 13% Grade 3 [see Adverse Reactions (6.1) ] . Withhold COMETRIQ until improvement to Grade 1 and resume COMETRIQ at a reduced dose for intolerable Grade 2 PPE or Grade 3 PPE. 5.10 Proteinuria Proteinuria was observed in 2% of patients receiving COMETRIQ, including one with nephrotic syndrome. Monitor urine protein regularly during COMETRIQ treatment. Discontinue COMETRIQ in patients who develop nephrotic syndrome. 5.11 Reversible Posterior Leukoencephalopathy Syndrome Reversible Posterior Leukoencephalopathy Syndrome (RPLS), a syndrome of subcortical vasogenic edema diagnosed by characteristic finding on MRI, occurred in one (<1%) patient. Perform an evaluation for RPLS in any patient presenting with seizures, headache, visual disturbances, confusion or altered mental function. Discontinue COMETRIQ in patients who develop RPLS [see Dosage and Administration (2.2) ] . 5.12 Embryo-Fetal Toxicity Based on data from animal studies and its mechanism of action, COMETRIQ can cause fetal harm when administered to a pregnant woman. Cabozantinib administration to pregnant animals during organogenesis resulted in embryolethality at exposures below those occurring clinically at the recommended dose, and in increased incidences of skeletal variations in rats and visceral variations and malformations in rabbits. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with COMETRIQ and for 4 months after the last dose [see Use in Specific Populations ( 8.1 ), ( 8.3 ), and Clinical Pharmacology ( 12.1 )] . 5.13 Hypocalcemia…
Who should not take Cometriq
None None. ( 4 )
Overdose — what happens if you take too much
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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Strong CYP3A4 Inhibitors: Reduce the COMETRIQ dosage. ( 2.2 , 7.1 ) Strong CYP3A4 Inducers: Increase the COMETRIQ dosage. ( 2.2 , 7.2 ) 7.1 Effect of CYP3A4 Inhibitors Administration of a strong CYP3A4 inhibitor, ketoconazole to healthy subjects increased single-dose plasma cabozantinib exposure by 38%. Avoid taking a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) while taking COMETRIQ or reduce the dosage of COMETRIQ if concomitant use with strong CYP3A4 inhibitors cannot be avoided [see Dosage and Administration ( 2.2 ), Clinical Pharmacology ( 12.3 )] . Avoid ingestion of foods (e.g., grapefruit, grapefruit juice) or nutritional supplements that are known to inhibit cytochrome P450 while taking COMETRIQ. 7.2 Effect of CYP3A4 Inducers Administration of a strong CYP3A4 inducer, rifampin to healthy subjects decreased single-dose plasma cabozantinib exposure by 77%. Avoid chronic co-administration of strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, St. John’s Wort) with COMETRIQ or increase the dosage of COMETRIQ if concomitant use with strong CYP3A4 inducers cannot be avoided [see Dosage and Administration ( 2.2 ), Clinical Pharmacology ( 12.3 )]. 7.3 Effect of MRP2 Inhibitors Concomitant administration of MRP2 inhibitors may increase the exposure to cabozantinib. Monitor patients for increased toxicity when MRP2 inhibitors (e.g., abacavir, adefovir, cidofovir, furosemide, lamivudine, nevirapine, ritonavir, probenecid, saquinavir, and tenofovir) are co-administered with COMETRIQ [see Clinical Pharmacology ( 12.3 )] .
Drug class
How this class works, per Tyrosine Kinase Inhibitors - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Cometriq ranks — best-rated kinase inhibitor for:
Dosage forms
Capsule and Kit
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Cometriq treat?
- Cometriq (Cabozantinib S-Malate) may be used to treat renal cell carcinoma, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Cometriq work?
- Cometriq is a kinase inhibitor. Kinase inhibitors block protein kinases, the enzymes that relay 'grow and divide' signals inside cells. By shutting down the overactive kinase signals that a tumor depends on, they help slow or stop cancer cells from multiplying.
- Is there a coupon or discount for Cometriq?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Cometriq. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Cometriq?
- Cometriq is marketed by Exelixis. You can see Exelixis's full profile, rating, and other products on pharmaranks.
- Is Cometriq a brand-name or generic drug?
- Cometriq is a brand-name product with the active ingredient Cabozantinib S-Malate.
- Is Cometriq available over the counter?
- No. Cometriq is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Cometriq come in?
- Cometriq is currently marketed as capsule and kit, per the FDA's National Drug Code Directory.
- What class of drug is Cometriq?
- Cometriq is classified as kinase inhibitor, per the FDA's Established Pharmacologic Class.
- Is Cometriq FDA-registered?
- Cometriq is on record with the U.S. FDA under application number NDA203756. You can verify this on its official FDA label.
- Is Cometriq safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Cometriq. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Cometriq?
- Cometriq's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are discussed elsewhere in the labeling: Perforations and Fistula [see Warnings and Precautions (5.1) ] Hemorrhage [see Warnings and Precautions (5.2) ] Thromboembolic Events [see Warnings and Precautions (5.3) ] Impaired Wound Healing [see Warn… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
Reviews
No reviews yet. Be the first to write one.
People also viewed
ofev
Nintedanib Esylate
sprycel
Dasatinib
afinitor
Everolimus
calquence
Acalabrutinib
cotellic
Cobimetinib Fumarate
danziten
Nilotinib Tartrate
Compare Cometriq head-to-head
More kinase inhibitor drugs
Browse medications A–Z
Research products from A to Z, compare independent ratings, and find alternatives.
cometriq
New