Highlights of prescribing information these highlights. Determine if patients are taking drugs that could slow heart rate or atrioventricular conduction see warnings and. Vemurafenib side effects, dosage, interactions drugs. Vemurafenib is approved to treat patients whose disease has a certain mutation in the braf gene, including. Sections or subsections omitted from the full prescribing information are not listed. Dermatologic toxicities occurred in 90% of patients and were severe ncictc grade 3 and higher in 15% of patients receiving vectibix monotherapy see dosage and administration 2.
Vemurafenib has favorable pharmacokinetics as compared to the other structurally similar braf v600 mutated kinases. Information below provided by the pharmaceutical company. Vemurafenib tab zelboraf by genentech is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Everyone living with a cancer diagnosis could use some support along the way. As for all medicines, data on the use of zelboraf are continuously monitored. The newly approved drug zelboraf appears to nearly double the length of time a person can expect to live with advanced melanoma skin cancer, a new study shows. Zelboraf vemurafenib dosing, indications, interactions. Interrupt and then reduce or discontinue stivarga for hepatotoxicity as manifested by elevated liver. Hepatotoxicity severe and sometimes fatal hepatotoxicity has occurred in clinical trials see warnings and precautions 5. Zelboraf vemurafenib is a kinase inhibitor available as 240 mg tablets for oral use. Skyrizi risankizumabrzaa full prescribing information.
Your healthcare provider will do blood tests to check your liver function before you start taking stivarga and during your treatment with stivarga to check for liver problems. In the event of toxicity, doses may be delayed, but all treatment must be administered within 16 weeks of the first dose see clinical studies 14. Highlights of prescribing information tafinlar with. Vumerity diroximel fumarate delayedrelease capsules, for oral use. The recommended tukysa dose reductions and dosage modifications for adverse reactions are provided in. Melanoma that cannot be removed by surgery or has metastasized spread to other parts of the body. Zelboraf vemurafenib is a type of cancer treatment called a cancer growth blocker. The solubility of sunitinib malate in aqueous media over the range ph 1. Highlights of prescribing information these highlights do. Exposure to ultraviolet radiation and sun sensitivity are additional risk factors for the disease. The log of the distribution coefficient octanolwater at ph 7 is 5. Vemurafenib can slow down the removal of other medications from your body, which may affect how they work.
Vemurafenib is also being studied in the treatment of other types of cancer. Ervebo ebola zaire vaccine, live suspension for intramuscular injection. Zelboraf may double survival for some melanoma patients. Cotellic is not indicated for treatment of patients with wildtype braf melanoma. The following packaging configurations are available. Vemurafenib is a kinase inhibitor available as 240 mg tablets for. Zelboraf vemurafenib cost, side effects, dosage for. Cotellic is a prescription medicine that is used with the medicine. Get emergency help right away if you get symptoms such as chest pain, shortness of breath, racing heartbeat, swelling in lower legs, feet and abdomen, feel lightheaded or faint, tiredness, nausea, vomiting, or sweat a lot. The recommended dose of yervoy ipilimumab is 3 mgkg administered intravenously iv over 90 minutes every 3 weeks for a maximum of 4 doses.
Stivarga regorafenib can cause liver problems, which can be serious and sometimes lead to death. Examples of affected drugs include caffeine, warfarin, among others. The risk factors most associated with malignant melanoma include a family history of melanoma, atypical moles, and previous melanoma. Refer to the dabrafenib prescribing information for recommended dabrafenib dosing information. The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication education rems cme, and. Ndc 5024209001 single bottle of 120 count ndc 5024209002 single bottle of 112 count. Gently transfer the vemurafenib from its package to a small medicine or other. Nilotinib drug substance, in the form of monohydrochloride monohydrate, is a white to slightly yellowish to slightly greenish yellow powder with the molecular formula and weight, respectively, of c 28 h 22 f 3 n 7 ohcl h 2 o and 584 corresponding molecular formula and weight of nilotinib base, anhydrous are c 28 h 22 f 3 n 7 o and 529. Vemurafenib is active against several human tumor serinethreonine protein kinase braf melanoma xenograft models. Tell your healthcare provider right away if you experience yellowing of.
Vemurafenib is an orally bioavailable, atpcompetitive, smallmolecule inhibitor of brafv600e kinase with potential antineoplastic activity. Zelboraf is not indicated for treatment of patients with wildtype braf melanoma. See full prescribing information for complete boxed. Vemurafenib blocks these downstream processes to inhibit tumour growth and eventually trigger apoptosis. Cotellic is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with a braf v600e or v600k mutation, in combination with vemurafenib. It has the molecular formula c 23 h 18 clf 2 n 3 o 3 s and a molecular weight of 489. Vemurafenib has the chemical name propane1sulfonic acid 354chlorophenyl1hpyrrolo2,3bpyridine3carbonyl 2,4difluorophenylamide. Zelboraf vemurafenib is a braf inhibitor that blocks the function of the v600emutated braf protein which can stop the melanoma cells from growing and dividing. Vemurafenib is metabolized by cyp3a4 and the metabolites make up 5% of the components in plasma. Over the course of treatment, patients who tolerate inlyta for at least two consecutive weeks with no adverse reactions grade 2 according to the common toxicity criteria for adverse events ctcae, are normotensive, and are not receiving antihypertension medication, may.
It is used to treat metastatic melanoma skin cancer. It inhibits braf v600e and also has inhibitory activity in vitro against several other kinds of kinases, including craf, araf and wildtype braf. This product information was approved at the time this auspar was published. Zelboraf is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with braf v600e mutation as detected by an fdaapproved test. Vemurafenib is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Highlights of prescribing information perforation can. Braftovi encorafenib capsules, for oral use initial u. Zelboraf is not indicated for use in patients with wildtype braf melanoma. A specific test, approved by fda, known as the braf v600e or braf v600k mutation, is recommended before starting cobimetinib therapy to determine the chance that the medication will kill melanoma cells. Vemurafenib is a highly efficient braf inhibitor for metastatic melanoma patients carrying the v600 mutation.
Action inhibits mutated forms of the enzyme kinase. Zelboraf vemurafenib is supplied as 240 mg filmcoated tablets with vem debossed on one side. It is used to treat melanoma, a type of skin cancer, and. See 17 for patient counseling information and medication.
Dose increase or reduction is recommended based on individual safety and tolerability. Zelboraf vemurafenib tablets are indicated for the treatment of patients with unresectable or metastatic melanoma with braf v600e mutation as detected by an fdaapproved test. Side effects reported with zelboraf are carefully evaluated and any necessary action taken to protect patients. Vemurafenib selectively binds to the atpbinding site of brafv600e kinase and inhibits its activity, which may result in an inhibition of an overactivated mapk signaling pathway downstream in brafv600e kinaseexpressing tumor cells and a reduction. Vemurafenib is used to treat melanoma skin cancer that. If a family member, friend, or caregiver needs to give vemurafenib to you, they also need to follow these steps. Vemurafenib definition of vemurafenib by medical dictionary. Vemurafenib does not have antitumour effects against melanoma cell lines with the wildtype braf mutation.
Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for decadron dexamethasone. Vemurafenib is a competitive smallmolecule serinethreonine kinase inhibitor that functions by binding to the atpbinding domain of mutant braf. Melanoma is a lifethreatening form of skin cancer that occurs due to genetic and environmental factors. Gloves are not necessary if you give the drug to yourself. Here you will find information and tools you need to stay informed and connected, including. Product information for auspar zelboraf vemurafenib roche products pty ltd pm20110079534 final 17 december 2012. Zelboraf fda prescribing information, side effects and uses. Summary of investigation results hydroxyzine hydrochloride, hydroxyzine pamoate. If your healthcare provider prescribes zelboraf vemurafenib, also read the medication guide that comes with zelboraf. Vemurafenib is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. Sunitinib malate is a yellow to orange powder with a pka of 8.
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