Start with nexavar sorafenib as a foundation for a systemic treatment plan 15. Highlights of prescribing information cardiac dysfunction. Tell your healthcare provider right away if you have rashes, redness, pain, swelling, or blisters on the palms of your hands or soles of your feet. The use of concomitant strong cyp3a4 inducers should be avoided e. It is not known if cometriq is safe and effective in children. Coadministration with a strong cyp3a4 inhibitor increased the exposure of cabozantinib, which may increase the risk of exposurerelated adverse reactions. Highlights of prescribing information these highlights do. Oncology related including new drugs, antagonists, etc. It is a small molecule inhibitor of the tyrosine kinases cmet and vegfr2, and also inhibits axl and ret. Cabometyx cabozantinib tablets and cometriq cabozantinib capsules are not. Highlights of prescribing information perforation can occur. Your healthcare provider should tell you when you may start taking cabometyx again after surgery. Cometriq fda prescribing information, side effects and uses.
Cometriq is prescribed to treat medullary thyroid cancer in adults. Fatal andor serious and severe diarrhea or colitis occurred in 14% to 19% of zydeligtreated patients. Highlights of prescribing information tafinlar with. Our cometriq cabozantinib side effects drug center provides a comprehensive view of available drug information on the potential side effects when taking this medication. In 2012 cabozantinib in its capsule formulation was. Cometriq is indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer mtc. Cometriq 20mg gelatin capsules are grey with xl184 20mg printed in black on the body of the capsule. Administration of a strong cyp3a4 inhibitor, ketoconazole to healthy subjects increased singledose plasma cabozantinib exposure by 38% cabometyx. Cometriq has been shown to inhibit the activity of met. If you have difficulty viewing the document below, please click here to view the full prescribing information, including the boxed warning. Cometriq while maintaining optimal therapeutic outcomes. Cometriq cabozantinib is indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer mtc. Cometriq is the trade name for the generic chemotherapy drug cabozantinib. Cometriq is a prescription medicine used to treat people with medullary thyroid cancer that has spread to other parts of the body.
Plavix has been evaluated for safety in more than 54,000 patients, including over 21,000 patients treated for one year or more. Cabometyx cabozantinib is indicated for the treatment of patients with hepatocellular carcinoma hcc who have been previously treated with sorafenib. Highlights of prescribing information palmarplantar. Cabozantin cabometyx, cometriq eocco policy policy type. Eocco010 description cabozantinib cabometyx, cometriq is an orally administered tyrosine kinase inhibitor of ret, met, vegfr123, kit, trkb, flt3, and tie2. Cabozantinib, sold under the brandname cabometyx and cometriq, is a medication used to treat medullary thyroid cancer and a second line treatment for renal cell carcinoma among others. The clinically important adverse reactions observed in trials comparing plavix plus aspirin to placebo plus aspirin and trials comparing plavix alone to. Side effects of cometriq cabozantinib capsules, warnings, uses. The clinically important adverse reactions observed in trials comparing plavix plus aspirin to placebo plus aspirin and trials comparing plavix alone to aspirin alone are discussed below.
Talk to your healthcare provider about the risks and benefits of using this medication when pregnant see. Do not substitute cabometyx tablets with cabozantinib capsules. Authorization of 24 months may be granted to members prescribed cometriq for medullary thyroid cancer whose disease meets one of the following. Highlights of prescribing information perforation can. For disease that is of predominantly clear cell histology, cometriq will be used for disease that has progressed on prior antiangiogenic therapy e. It is an oral receptor tyrosine kinase inhibitor for more detail.
Dec 23, 2019 cometriq 20mg gelatin capsules are grey with xl184 20mg printed in black on the body of the capsule. Although patients with thyroid cancer generally fare well, there is a subset for which this is not necessarily true. Protein in your urine and possible kidney problems. The active substance in cometriq, cabozantinib, is a tyrosine kinase inhibitor. Cometriq may react with a number of other medications see cometriq drug interactions. Highlights of prescribing information when administering. History of serious thrombosis with prior lasparaginase therapy. Coronavirus covid19 update at exelixis, we remain committed to serving the needs of people who take cabometyx. If patients must be coadministered a strong cyp3a4 inducer, based on pharmacokinetic studies, a torisel dose increase from 25 mgweek up to 50 mgweek should be considered. Cometriq cabozantinib 100mg dailydose pack 1 dose pack 56 capsules per 28 days cometriq cabozantinib 140mg dailydose pack 1 dose pack 112 capsules per 28 days approval criteria requests for cometriq cabozantinib capsules may be approved if the following criteria are met. This emedtv web page discusses why cometriq is only used when the cancer has progressed to other areas of the body. Tell your healthcare provider if you plan to have any surgery before or during treatment with cabometyx. It is a medicine used to treat medullary thyroid cancer, a rare type of. Fda grants regular approval to cabometyx for firstline.
Cometriq is a prescription medicine used to treat people with medullary thyroid cancer mtc that has spread to other parts of the body called metastatic mtc it is not known if cometriq is safe and effective in children. You should stop taking cabometyx at least 3 weeks before planned surgery. On december 19, 2017, the food and drug administration granted regular approval to cabozantinib cabometyx, exelixis, inc. Call your doctor for medical advice about side effects. Cometriq cabozantinib capsules are supplied as printed hard gelatin capsules containing cabozantinib smalate equivalent to 20 mg or 80 mg cabozantinib and the following inactive ingredients.
Eocco010 description cabozantinib cabometyx, cometriq is an orally administered tyrosine kinase inhibitor of ret, met. The most common laboratory abnormalities incidence. The incidence of grade 3 to 5 hemorrhagic events was 5% in cabometyx. Accelerated approval was granted for fl and sll based on. Asymptomatic distant metastases if structurally progressive and unresectable iii. Severe and fatal hemorrhages occurred with cabometyx. Oncaspar pegaspargase is indicated as a component of a multiagent chemotherapeutic regimen for the treatment of pediatric and adult patients with. This is not a complete list of side effects and others may occur. The antiangiogenic ceiling in hepatocellular carcinoma. Unresectable locoregional disease that is symptomatic or structurally progressive. Full text the treatment landscape in thyroid cancer.
It is not known if zykadia is safe and effective in. Unresectable locoregional disease that is symptomatic or structurally progressive ii. Monitor hepatic function prior to and during treatment see warnings and precautions 5. Is caused by a defect in a gene called anaplastic lymphoma kinase alk and has spread to other parts of the body. Cabometyx is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma rcc who have received prior anti angiogenic therapy. History of serious hypersensitivity reactions, including anaphylaxis, to oncaspar or to any of the excipients. Erivedge vismodegib capsules, for oral use initial u. Refer to the dabrafenib prescribing information for recommended dabrafenib dosing information. Cabometyx cabozantinib is contraindicated in patients who are. In some cases, health care professionals may use the generic name cabozantinib when referring to the trade name cometriq.
Cometriq 80mg gelatin capsules are swedish orange with xl184 80mg printed in black on the body of the capsule. Interrupt and then reduce or discontinue stivarga for hepatotoxicity as manifested by elevated liver. Carefirst bluecross blueshield is the shared business name of carefirst of maryland, inc. It also offers an explanation of how this drug works. Instruct patients not to eat for at least 2 hours before and at least 1 hour after taking cabometyx. Cabometyx cabozantinib tablets and cometriq cabozantinib capsules are not bioequivalent and should not be used interchangeably see section 5. If a patient must switch from cabozantinib capsules to cabozantinib tablets, the patient should continue at a cabometyx dose not to exceed 60 mg or the current cometriq dose whichever is lower. Cabozantinib in patients with advanced and progressing.
Please see the accompanying full prescribing information for cometriq. The printed package leaflet of the medicinal product must state the name and address of the. Monitor for the development of severe diarrhea or colitis. Cometriq increased the incidence of thrombotic events venous thromboembolism. Labeling package insert, labelingcontainercarton labels. Official site for healthcare professionals nexavar. Package label carton 100 mg daily dose of cometriq. Cometriq, cabometyx cabozantinib dosing, indications. Blinatumomab is a bispecific cd19directed cd3 tcell engager that binds to cd19 expressed on the surface of cells of blineage origin and. Cometriq is a cancer medicine that contains the active substance cabozantinib smalate.
Nccn clinical practice guidelines in oncology nonsmall cell lung cancer version 3. Cometriq is a pregnancy category d medication, which means it may harm an unborn child. Cometriq cabozantinib capsules 100 mg daily dose blister cards each 100 mg daily dose contains a combination of one swedish orange 80 mg and one grey 20 mg capsule. Hepatotoxicity severe and sometimes fatal hepatotoxicity has occurred in clinical trials see warnings and precautions 5. Cometriq treatment results in an increased incidence of treatmentemergent hypertension with joint national committee on prevention, detection, evaluation, and treatment of high blood pressure modified jnc criteria stage 1 or 2 hypertension identified in 61% in cometriqtreated patients compared with 30% of placebotreated patients in the randomized trial. Stivarga regorafenib is a prescription medicine used to treat people with.
If previously receiving 60 mg daily dose, resume treatment at 40 mg daily. Handfoot skin reactions are common with cometriq and can be severe. Feb 14, 2020 nearly all cometriq treated patients 96% vs. Zykadia is a prescription medicine that is used to treat people with nonsmall cell lung cancer nsclc that. Highlights of prescribing information these highlights do not. Talk to your healthcare provider about the risks and benefits of using this medication when pregnant see cometriq and pregnancy. Wound healing problems have happened in some people who take cabometyx.
Cabometyx cabozantinib is indicated for the treatment of patients with. Severe and sometimes fatal hepatotoxicity has occurred in clinical trials. Gastrointestinal perforations occurred in 3% and fistula formation in 1% of. These tyrosine kinases are involved in both normal cellular function and pathologic processes, such as. Do not administer cometriq to patients with a recent history of hemorrhage, including hemoptysis, hematemesis, or melena.
Cometriq cabozantinib is a cancer medicine indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer mtc 1,2. For disease that is of nonclear histology, cometriq will be used as firstline systemic therapy. Coadministration with a strong cyp3a4 inhibitor increased the exposure of cabozantinib, which may increase the. This medicinal product is subject to additional monitoring. Highlights of prescribing information antiplatelet. Cabometyx, inncabozantinib european medicines agency. Please scroll down to see important safety information for cometriq and click here to see the full prescribing information. Zivaflibercept acts as a soluble receptor that binds to human vegfa equilibrium dissociation constant kd of 0.
1325 284 1185 1222 434 989 1212 354 568 504 1131 1445 1469 371 985 1321 284 13 637 275 310 1344 68 468 928 1016 118 1442 770 1161 784 1216 125 255 763 1318 174 901 68