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ZELBORAF
Overview
What is ZELBORAF?
ZELBORAF (vemurafenib) is a kinase inhibitor available as 240 mg tablets for oral use. Vemurafenib has the chemical name propane-1-sulfonic acid {3-[5-(4-chlorophenyl)-1H-pyrrolo[2,3-b]pyridine-3-carbonyl]- 2,4-difluoro-phenyl}-amide. It has the molecular formula CHClFNOS and a molecular weight of 489.9. Vemurafenib has the following chemical structure:
Vemurafenib is a white to off-white crystalline solid. It is practically insoluble in aqueous media.
Tablets of ZELBORAF are for oral administration. Each tablet contains 240 mg of vemurafenib.
The inactive ingredients of ZELBORAF are: hypromellose acetate succinate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, and hydroxypropyl cellulose. pinkish white: poly (vinyl alcohol), titanium dioxide, polyethylene glycol 3350, talc, and iron oxide red.
What does ZELBORAF look like?
What are the available doses of ZELBORAF?
Tablet: 240 mg ()
What should I talk to my health care provider before I take ZELBORAF?
How should I use ZELBORAF?
ZELBORAF is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.
Confirm the presence of BRAF V600E mutation in melanoma tumor specimens prior to initiation of treatment with ZELBORAF . Information on FDA-approved tests for the detection of BRAF V600 mutations in melanoma is available at http://www.fda.gov/CompanionDiagnostics.
What interacts with ZELBORAF?
Sorry No Records found
What are the warnings of ZELBORAF?
Sorry No Records found
What are the precautions of ZELBORAF?
Sorry No Records found
What are the side effects of ZELBORAF?
Sorry No records found
What should I look out for while using ZELBORAF?
None.
What might happen if I take too much ZELBORAF?
There is no information on overdosage of ZELBORAF.
How should I store and handle ZELBORAF?
Storage and Stability: ZELBORAF (vemurafenib) is supplied as 240 mg film-coated tablets with VEM debossed on one side. The following packaging configurations are available:NDC 50242-090-01 single bottle of 120 countNDC 50242-090-02 single bottle of 112 countZELBORAF (vemurafenib) is supplied as 240 mg film-coated tablets with VEM debossed on one side. The following packaging configurations are available:NDC 50242-090-01 single bottle of 120 countNDC 50242-090-02 single bottle of 112 countZELBORAF (vemurafenib) is supplied as 240 mg film-coated tablets with VEM debossed on one side. The following packaging configurations are available:NDC 50242-090-01 single bottle of 120 countNDC 50242-090-02 single bottle of 112 count
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Vemurafenib is a low molecular weight, orally available inhibitor of some mutated forms of BRAF serine- threonine kinase, including BRAF V600E. Vemurafenib also inhibits other kinases in vitro such as CRAF, ARAF, wild-type BRAF, SRMS, ACK1, MAP4K5, and FGR at similar concentrations. Some mutations in the BRAF gene including V600E result in constitutively activated BRAF proteins, which can cause cell proliferation in the absence of growth factors that would normally be required for proliferation. Vemurafenib has anti-tumor effects in cellular and animal models of melanomas with mutated BRAF V600E.
Non-Clinical Toxicology
None.Ranitidine has been reported to affect the bioavailability of other drugs through several different mechanisms such as competition for renal tubular secretion, alteration of gastric pH, and inhibition of cytochrome P450 enzymes.
New Primary Cutaneous Malignancies: Perform dermatologic evaluations prior to initiation of therapy, every 2 months while on therapy, and for up to 6 months following discontinuation of ZELBORAF. Manage with excision and continue treatment without dose adjustment. ()
New Non-Cutaneous Squamous Cell Carcinoma: Evaluate for symptoms or clinical signs of new non-cutaneous SCC before initiation of treatment and periodically during treatment. ()
Other Malignancies: Monitor patients receiving ZELBORAF closely for signs or symptoms of other malignancies ().
Tumor Promotion in BRAF Wild-Type Melanoma: Increased cell proliferation can occur with BRAF inhibitors ().
Serious Hypersensitivity Reactions including anaphylaxis and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS Syndrome): Discontinue ZELBORAF for severe hypersensitivity reactions. ()
Severe Dermatologic Reactions, including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: Discontinue ZELBORAF for severe dermatologic reactions. ()
QT Prolongation: Monitor ECG and electrolytes before and during treatment. Withhold ZELBORAF for QTc of 500 ms or greater. Correct electrolyte abnormalities and control for cardiac risk factors for QT prolongation. ()
Hepatotoxicity: Measure liver enzymes and bilirubin before initiating ZELBORAF and monitor monthly during treatment. ()
Photosensitivity: Advise patients to avoid sun exposure. ()
Serious Ophthalmologic Reactions: Monitor for signs and symptoms of uveitis. ()
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of the potential risk to the fetus and to use effective contraception. (, , )
Radiation Sensitization and Radiation Recall: Severe cases have been reported. ().
Renal Failure: Measure serum creatinine before initiating ZELBORAF and monitor periodically during treatment ().
Dupuytren's Contracture and plantar fascial fibromatosis: Events should be managed with dose reduction, treatment interruption, or treatment discontinuation. ().
The following adverse reactions are discussed in greater detail in other sections of the label:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Interactions
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