Cometriq

What is Cometriq?

• Cometriq (Cabozantinib) is a kinase inhibitor used to treat progressive medullary thyroid cancer that has spread to other parts of the body.

Cabozantinib

What are the uses of this medicine?

• Cometriq is a prescription medicine used to treat people with medullary thyroid cancer that has spread to other parts of the body.

How does this medicine work?

• Cabozantinib inhibits the tyrosine kinase activity of RET, MET, VEGFR-1, -2 and -3, KIT, TRKB, FLT-3, AXL, ROS1, TYRO3, MER, and TIE-2.
• These receptor tyrosine kinases are involved in both normal cellular function and pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, drug resistance, and maintenance of the tumor microenvironment.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• 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.
• Avoid ingestion of foods (e.g., grapefruit, grapefruit juice) or nutritional supplements that are known to inhibit cytochrome P450 while taking Cometriq.
• 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.
• Concomitant administration of MRP2 inhibitors may increase the exposure to cabozantinib.

Is this medicine FDA approved?

• In November 2012, cabozantinib in its capsule formulation was approved by the U.S. Food and Drug Administration (FDA) under the name Cometriq for treating patients with medullary thyroid cancer.

How should this medicine be used?

• Do NOT substitute Cometriq capsules with cabozantinib tablets.

Recommended dosage:

• 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.

• Hepatic Impairment: The recommended starting dose of Cometriq is 80 mg in patients with mild or moderate hepatic impairment.

Dosage Modifications For Coadministration With Strong CYP3A4 Inhibitors

• Reduce the daily Cometriq dose by 40 mg (for example, from 140 mg to 100 mg daily or from 100 mg to 60 mg daily).

Dosage Modifications For Coadministration With Strong CYP3A4 Inducers

• Increase the daily Cometriq dose by 40 mg (for example, from 140 mg to 180 mg daily or from 100 mg to 140 mg daily) as tolerated.

Administration:

• Take Cometriq exactly as your healthcare provider tells you to take it.
• Do not take Cometriq with food. Do not eat for at least 2 hours before and at least 1 hour after taking Cometriq.
• Swallow Cometriq capsules whole with a full glass (at least 8 ounces) of water.
• Do not crush or open Cometriq capsules.
• If you miss a dose and your next dose is in
• less than 12 hours, take your next dose at the normal time. Do not make up the missed dose.
• hours or more, take the missed dose as soon as you remember. Take your next dose at the normal time.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 20 mg and 80 mg.

This medicine is available in fallowing brand namesː

• Cometriq

What side effects can this medication cause?

The most common side effects of this medicine include:

• diarrhea
• redness, swelling or pain in your mouth or throat, or mouth sores. Tell your healthcare provider if these symptoms prevent you from eating or drinking.
• weight loss
• decreased appetite
• nausea
• tiredness
• hair color turning lighter
• change in taste
• pain in your abdomen
• constipation
• increased liver function blood tests
• decreased calcium and phosphate blood levels
• decreased white blood cell counts
• decreased platelet counts
• increased bilirubin blood levels

Cometriq may cause serious side effects, including:

• intestinal wall (perforation)
• bleeding (hemorrhage)
• blood clots, stroke, heart attack, and chest pain
• wound healing problems
• high blood pressure (hypertension)
• severe jaw bone problems (osteonecrosis)
• diarrhea
• a skin problem called hand-foot skin reaction
• protein in your urine and possible kidney problems
• Reversible Posterior Leukoencephalopathy Syndrome (RPLS)

What special precautions should I follow?

• Gastrointestinal (GI) perforations and fistulas, including fatal cases, were reported in 3% and 1% of Cometriq-treated patients. Monitor for symptoms. Discontinue Cometriq for Grade 4 fistula or perforation.
• Severe and fatal hemorrhage occurred with Cometriq. Do not administer Cometriq if recent history of hemorrhage.
• Cometriq increased the incidence of thrombotic events. Discontinue Cometriq for myocardial infarction or serious arterial or venous thromboembolic events.
• Wound complications have been reported with Cometriq. 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.
• Cometriq can an increase the incidence of treatment-emergent hypertension. 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.
• Osteonecrosis of the jaw (ONJ) occurred in 1% of Cometriq-treated patients. Withhold Cometriq for at least 3 weeks prior to invasive dental procedure and for development of ONJ.
• Diarrhea occurred in 63% of patients treated with Cometriq. May be severe. Interrupt Cometriq immediately until diarrhea resolves or decreases to Grade 1. Recommend standard antidiarrheal treatments.
• Palmar-plantar erythrodysesthesia (PPE) occurred in 50% of patients treated with Cometriq. Interrupt Cometriq until PPE resolves or decreases to Grade 1.
• Proteinuria was observed in 2% of patients receiving Cometriq. Monitor urine protein. Discontinue for nephrotic syndrome.
• Based on data from animal studies and its mechanism of action, Cometriq can cause fetal harm when administered to a pregnant woman. Monitor urine protein. Discontinue for nephrotic syndrome.
• Reversible Posterior Leukoencephalopathy Syndrome (RPLS) may occur. Discontinue Cometriq.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• memory impairment
• mental status changes
• cognitive disturbance
• weight loss

Can this medicine be used in pregnancy?

• Based on findings from animal studies and its mechanism of action, Cometriq can cause fetal harm when administered to a pregnant woman.

Can this medicine be used in children?

• The safety and effectiveness of Cometriq in pediatric patients have not been studied.

What are the active and inactive ingredients in this medicine?

• Active ingredient: cabozantinib
• Inactive ingredients: silicified microcrystalline cellulose, croscarmellose sodium, sodium starch glycolate, fumed silica, and stearic acid
• Capsule shells: Grey gelatin capsule shells contain black iron oxide and titanium dioxide. 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.

Who manufactures and distributes this medicine?

• Manufactured for Exelixis, Inc. Alameda, CA

What should I know about storage and disposal of this medication?

• Store Cometriq at room temperature 68°F to 77°F (20°C to 25°C).

• Dailymed label info on Cometriq
• FDA Cometriq

Cometriq Resources
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