Zuellig Pharma
Concise Prescribing Info
Monotherapy for adult patients w/ BRAF V600 mutation +ve unresectable or metastatic melanoma.
Dosage/Direction for Use
4 tab bd, continue until disease progression or development of unacceptable toxicity.
May be taken with or without food: Avoid consistently taking both daily doses on an empty stomach. Swallow whole w/ water, do not chew/crush.
Special Precautions
Discontinue use if severe hypersensitivity & dermatologic reaction occurs. Not to be used in patients w/ wild-type BRAF malignant melanoma. Not recommended in patients w/ uncorrectable electrolyte abnormalities & long QT syndrome or taking medicinal products prolonging QT interval. New primary melanoma; prior or concurrent cancer associated w/ RAS mutation; pancreatitis; Dupuytren's contracture & plantar fascial fibromatosis. Monitor routinely for ophth reactions. Regularly check for cutaneous & non-cutaneous squamous cell carcinoma during & up to 6 mth after treatment & undergo CT scans. Perform genital & anal exam prior to & after treatment. Measure liver enzymes, bilirubin & serum creatinine prior to & monitor during treatment. Avoid exposure to direct sunlight. Non-Caucasian patients. Not recommended in concomitant use w/ CYP1A2- & CYP3A4-metabolised medicines w/ narrow therapeutic window; ipilimumab. Concomitant use w/ RT; warfarin; P-gp substrates; strong CYP3A4/P-gp inhibitors. May affect ability to drive & use machines. Renal & hepatic impairment. Women of childbearing potential should use effective contraception during & at least 6 mth after last dose. Not to be used during pregnancy. Lactation. Childn & adolescents <18 yr.
Adverse Reactions
Skin SCC, keratoacanthoma, seborrheic keratosis, skin papilloma; decreased appetite; headache, dysgeusia, dizziness; cough; diarrhoea, vomiting, nausea, constipation; photosensitivity reaction, actinic keratosis, rash, maculopapular rash, pruritus, hyperkeratosis, erythema, palmar-plantar erythrodysaesthesia syndrome, alopecia, dry skin, sunburn; arthralgia, myalgia, pain in extremity, musculoskeletal & back pain; fatigue, pyrexia, peripheral oedema, asthenia. Folliculitis; basal cell carcinoma, new primary melanoma; neutropenia; 7th nerve paralysis, peripheral neuropathy; uveitis; vasculitis; papular rash, panniculitis (including erythema nodosum), keratosis pilaris; arthritis; increased ALT, alkaline phosphatase, AST, bilirubin, GGT & blood creatinine, decreased wt, QT prolongation; potentiation of radiation toxicity.
Drug Interactions
Increased plasma exposure of drugs w/ narrow therapeutic window (eg, agomelatine, alosetron, duloxetine, melatonin, ramelteon, tacrine, tizanidine & theophylline), CYP1A2 substrate (eg, caffeine), P-gp substrates (eg, aliskiren, ambrisentan, colchicine, dabigatran etexilate, digoxin, everolimus, fexofenadine, lapatinib, maraviroc, nilotinib, posaconazole, ranolazine, sirolimus, sitagliptin, talinolol, topotecan) & BCRP-transported medicines (eg, MTX, mitoxantrone, rosuvastatin). Decreased plasma conc of CYP3A4 substrates; CYP2B6 substrates eg, bupropion. Decreased AUC of midazolam. Increased AUC of warfarin. Increased conc of CYP2C8 substrates w/ narrow therapeutic window. Increased AUC w/ strong CYP3A4, glucuronidation &/or transport protein inhibitors eg, ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole, nefazodone, atazanavir. Decreased plasma exposure w/ rifampicin. Suboptimal exposure w/ strong P-gp, glucuronidation &/or CYP3A4 inducers eg, rifampicin, rifabutin, carbamazepine, phenytoin or St John's wort (Hypericum perforatum). Affected pharmacokinetics w/ inhibitors of P-gp (eg, verapamil, cyclosporine, quinidine) or BCRP (eg, cyclosporine, gefitinib).
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EC01 - vemurafenib ; Belongs to the class of B-Raf serine-threonine kinase (BRAF) inhibitors. Used in the treatment of cancer.
Zelboraf FC tab 240 mg
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