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ZELBORAF
Leukemias, lymphomas, and other hematologic cancers
Melanoma and other skin cancers
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Drug Name:

ZELBORAF Rx

Generic Name and Formulations:
Vemurafenib 240mg; tabs.

Company:
Genentech, Inc.

Therapeutic Use:

Indications for ZELBORAF:

Erdheim-Chester Disease (ECD) with BRAF V600 mutation.

Adult:

Swallow whole. ≥18yrs: 960mg every 12hrs; continue until disease progression or unacceptable toxicity. Concomitant strong CYP3A4 inducer: avoid; if unavoidable, increase dose by 240mg as tolerated (see full labeling). Dose modifications for adverse reactions: see full labeling.

Children:

<18yrs: not established.

Warnings/Precautions:

Risk of cutaneous squamous cell carcinoma (cuSCC): ≥65yrs, prior skin cancer, chronic sun exposure; if occurs, do excision and evaluate. Perform dermatologic evaluation before therapy, every 2 months during, and consider monitoring 6 months after discontinuation. Monitor for signs/symptoms of new non-cutaneous SCC and other malignancies. Long QT syndrome or QTc >500ms, uncorrectable electrolyte abnormalities, or concomitant drugs that prolong the QT interval: not recommended. Prior to and following initiation or after dose adjustment for QTc prolongation, evaluate ECG and electrolytes after 15 days, monthly during the 1st 3 months, then every 3 months thereafter, or more as clinically indicated. Severe hepatic or renal impairment. Monitor liver enzymes, bilirubin before initiating and monthly during treatment, or as needed. Measure SCr before initiating and periodically during treatment. Monitor for ophthalmologic reactions routinely. Avoid sun exposure. Embryo-fetal toxicity. Females of reproductive potential should use effective contraception during therapy and for at least 2 weeks after final dose. Pregnancy. Nursing mothers: not recommended (during and for 2 weeks after final dose).

Interactions:

Avoid concomitant strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, voriconazole, clarithromycin, saquinavir, ritonavir, indinavir, nelfinavir); consider alternatives. Avoid concomitant strong CYP3A4 inducers (eg, phenytoin, carbamazepine, rifampin); consider alternatives, or increase dose (see Adult). Avoid concomitant CYP1A2 (eg, tizanidine) and P-gp (eg, digoxin) substrates with narrow therapeutic indices; if unavoidable, consider dose reduction of substrates and monitor. Increased transaminase and bilirubin with concomitant ipilimumab. Concomitant or sequential administration with radiation treatment; monitor closely.

Pharmacological Class:

Kinase inhibitor.

Adverse Reactions:

Arthralgia, rash, alopecia, fatigue, photosensitivity, nausea, pruritus, skin papilloma; severe hypersensitivity or dermatologic reactions (permanently discontinue if occur), QT prolongation, hepatotoxicity, uveitis, blurry vision, photophobia, other malignancies, radiation sensitization and recall, renal failure, Dupuytren's contracture (may be severe), plantar fascial fibromatosis.

Generic Availability:

NO

How Supplied:

Tabs—112, 120

Indications for ZELBORAF:

Treatment of unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. Limitation of use: not for treatment of wild-type BRAF melanoma.

Adult:

Confirm BRAF V600E mutation-positive melanoma with FDA-approved test before initiating. Swallow whole. ≥18yrs: 960mg every 12hrs; continue until disease progression or unacceptable toxicity. Concomitant strong CYP3A4 inducer: avoid; if unavoidable, increase dose by 240mg as tolerated (see full labeling). Dose modifications for adverse reactions: see full labeling.

Children:

<18yrs: not established.

Warnings/Precautions:

Risk of cutaneous squamous cell carcinoma (cuSCC): ≥65yrs, prior skin cancer, chronic sun exposure; if occurs, do excision and evaluate. Perform dermatologic evaluation before therapy, every 2 months during, and consider monitoring 6 months after discontinuation. Monitor for signs/symptoms of new non-cutaneous SCC and other malignancies. Long QT syndrome or QTc >500ms, uncorrectable electrolyte abnormalities, or concomitant drugs that prolong the QT interval: not recommended. Prior to and following initiation or after dose adjustment for QTc prolongation, evaluate ECG and electrolytes after 15 days, monthly during the 1st 3 months, then every 3 months thereafter, or more as clinically indicated. Severe hepatic or renal impairment. Monitor liver enzymes, bilirubin before initiating and monthly during treatment, or as needed. Measure SCr before initiating and periodically during treatment. Monitor for ophthalmologic reactions routinely. Avoid sun exposure. Embryo-fetal toxicity. Females of reproductive potential should use effective contraception during therapy and for at least 2 weeks after final dose. Pregnancy. Nursing mothers: not recommended (during and for 2 weeks after final dose).

Interactions:

Avoid concomitant strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, voriconazole, clarithromycin, saquinavir, ritonavir, indinavir, nelfinavir); consider alternatives. Avoid concomitant strong CYP3A4 inducers (eg, phenytoin, carbamazepine, rifampin); consider alternatives, or increase dose (see Adult). Avoid concomitant CYP1A2 (eg, tizanidine) and P-gp (eg, digoxin) substrates with narrow therapeutic indices; if unavoidable, consider dose reduction of substrates and monitor. Increased transaminase and bilirubin with concomitant ipilimumab. Concomitant or sequential administration with radiation treatment; monitor closely.

Pharmacological Class:

Kinase inhibitor.

Adverse Reactions:

Arthralgia, rash, alopecia, fatigue, photosensitivity, nausea, pruritus, skin papilloma; severe hypersensitivity or dermatologic reactions (permanently discontinue if occur), QT prolongation, hepatotoxicity, uveitis, blurry vision, photophobia, other malignancies, radiation sensitization and recall, renal failure, Dupuytren's contracture (may be severe), plantar fascial fibromatosis.

Generic Availability:

NO

How Supplied:

Tabs—112, 120

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