As for all medicines, data on the use of zelboraf are continuously monitored. Highlights of prescribing information tafinlar with. Vemurafenib is a cyp3a4 substrate and cyp1a2 inhibitor avoid coadministration of vemurafenib with strong cyp3a4 inhibitors eg, ketoconazole, itraconazole, clarithromycin, saquinavir, ritonavir, indinavir, nelfinavir, voriconazole and replace and use alternative drugs when possible. Zelboraf vemurafenib is supplied as 240 mg filmcoated tablets with vem debossed on one side. Cotellic is a prescription medicine that is used with the medicine. Zelboraf tablets price in india, vemurafenib by genentech. Action inhibits mutated forms of the enzyme kinase.
The following packaging configurations are available. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for decadron dexamethasone. Zelboraf fda prescribing information, side effects and uses. Zelboraf is not indicated for treatment of patients with wildtype braf melanoma. The solubility of sunitinib malate in aqueous media over the range ph 1. D indications genetic implication treatment of unresectable or metastatic melanoma with braf v600emutation. The recommended dose of yervoy ipilimumab is 3 mgkg administered intravenously iv over 90 minutes every 3 weeks for a maximum of 4 doses. It belongs to a group of cancer fighting medications called antineoplastics, and more specifically to a group of medications called monoclonal antibodies. Vumerity diroximel fumarate delayedrelease capsules, for oral use. Sunitinib malate is a yellow to orange powder with a pka of 8. 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. Hepatotoxicity severe and sometimes fatal hepatotoxicity has occurred in clinical trials see warnings and precautions 5. Refer to the dabrafenib prescribing information for recommended dabrafenib dosing information. Vemurafenib side effects, dosage, interactions drugs.
The recommended tukysa dose reductions and dosage modifications for adverse reactions are provided in. 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. Ervebo ebola zaire vaccine, live suspension for intramuscular injection. Interrupt and then reduce or discontinue stivarga for hepatotoxicity as manifested by elevated liver. Summary of investigation results hydroxyzine hydrochloride, hydroxyzine pamoate. It is used to treat metastatic melanoma skin cancer. Zelboraf vemurafenib is a type of cancer treatment called a cancer growth blocker. 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. Zelboraf may double survival for some melanoma patients.
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. 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 does not have antitumour effects against melanoma cell lines with the wildtype braf mutation. Determine if patients are taking drugs that could slow heart rate or atrioventricular conduction see warnings and. Zelboraf vemurafenib dosing, indications, interactions.
Vemurafenib is a cancer medicine that interferes with the growth and spread of cancer cells in the body. 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. Get emergency medical help if you have signs of an allergic reaction hives, difficult breathing, swelling in your face or throat or a severe skin reaction fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling seek medical treatment if you have a serious drug reaction that can affect many parts. Information below provided by the pharmaceutical company.
Vemurafenib is a competitive smallmolecule serinethreonine kinase inhibitor that functions by binding to the atpbinding domain of mutant braf. Tell your healthcare provider right away if you experience yellowing of. Braftovi encorafenib capsules, for oral use initial u. 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. Pharmaceuticals and medical devices agency of japan. 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. It has the molecular formula c 23 h 18 clf 2 n 3 o 3 s and a molecular weight of 489. It is used to treat melanoma, a type of skin cancer, and. Melanoma that cannot be removed by surgery or has metastasized spread to other parts of the body.
Official site for healthcare professionals nexavar. Dose increase or reduction is recommended based on individual safety and tolerability. Zelboraf is not indicated for use in patients with wildtype braf melanoma. Examples of affected drugs include caffeine, warfarin, among others. Vemurafenib is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. Vemurafenib has the chemical name propane1sulfonic acid 354chlorophenyl1hpyrrolo2,3bpyridine3carbonyl 2,4difluorophenylamide.
Here you will find information and tools you need to stay informed and connected, including. Vemurafenib blocks these downstream processes to inhibit tumour growth and eventually trigger apoptosis. 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. It inhibits braf v600e and also has inhibitory activity in vitro against several other kinds of kinases, including craf, araf and wildtype braf. Package inserts revised for vemurafenib, hydroxyzine in. Gently transfer the vemurafenib from its package to a small medicine or other. Vemurafenib is also being studied in the treatment of other types of cancer. See full prescribing information for complete boxed. Highlights of prescribing information these highlights.
Highlights of prescribing information advanced renal. Vemurafenib is an orally bioavailable, atpcompetitive, smallmolecule inhibitor of brafv600e kinase with potential antineoplastic activity. Zelboraf vemurafenib cost, side effects, dosage for. 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. Gloves are not necessary if you give the drug to yourself. Sections or subsections omitted from the full prescribing information are not listed.
Vemurafenib can slow down the removal of other medications from your body, which may affect how they work. Stivarga regorafenib can cause liver problems, which can be serious and sometimes lead to death. Side effects reported with zelboraf are carefully evaluated and any necessary action taken to protect patients. Melanoma is a lifethreatening form of skin cancer that occurs due to genetic and environmental factors. Vemurafenib is a highly efficient braf inhibitor for metastatic melanoma patients carrying the v600 mutation. This product information was approved at the time this auspar was published. Vemurafenib is approved to treat patients whose disease has a certain mutation in the braf gene, including. See 17 for patient counseling information and medication. 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. Cotellic is not indicated for treatment of patients with wildtype braf melanoma. Monitor hepatic function prior to and during treatment see warnings and precautions 5.
Highlights of prescribing information these highlights do. The log of the distribution coefficient octanolwater at ph 7 is 5. 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. The risk factors most associated with malignant melanoma include a family history of melanoma, atypical moles, and previous melanoma. Exposure to ultraviolet radiation and sun sensitivity are additional risk factors for the disease. Vemurafenib is used to treat melanoma skin cancer that.
Vemurafenib is active against several human tumor serinethreonine protein kinase braf melanoma xenograft models. Vemurafenib has favorable pharmacokinetics as compared to the other structurally similar braf v600 mutated kinases. 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 tab zelboraf by genentech is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Vemurafenib is a kinase inhibitor available as 240 mg tablets for. Vemurafenib is metabolized by cyp3a4 and the metabolites make up 5% of the components in plasma. Ndc 5024209001 single bottle of 120 count ndc 5024209002 single bottle of 112 count. Everyone living with a cancer diagnosis could use some support along the way. Highlights of prescribing information perforation can.
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