What is ZELBORAF used for?

1 INDICATIONS AND USAGE ZELBORAF ® is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. ( 1.1 , 2.1 ) ZELBORAF ® is indicated for the treatment of patients with Erdheim- Chester Disease with BRAF V600 mutation. ( 1.2 , 2.1 ) Limitation of Use: ZELBORAF is not indicated for treatment of patients with wild-type BRAF melanoma ( 2.1 , 5.2 ) 1.1 Unresectable or Metastatic

How does ZELBORAF work?

11 DESCRIPTION ZELBORAF (vemurafenib) is a kinase inhibitor available as 240 mg tablets for oral use.

What pharmaceutical form is ZELBORAF available in?

ZELBORAF: Tabletki powlekane 240 mg (doustna)

Is ZELBORAF OTC or prescription only?

ZELBORAF requires a doctor's prescription.

What are the side effects of ZELBORAF?

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: New Primary Malignancies [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Dermatologic Reactions [see Warnings and Precautions (5.4) ] QT Prolongation [see Warnings and Precautions (5.5) ] Hepatotoxicity [see Warnings and Precautions (5.6) ] Photosensitivity [see Warnings and Precautions (5.7) ] Ophthalmologic Reactions [see War

Does ZELBORAF interact with other medications?

7 DRUG INTERACTIONS Avoid concomitant administration of ZELBORAF with strong CYP3A4 inhibitors or inducers. ( 7.1 ) CYP1A2 Substrates: ZELBORAF can increase concentrations of CYP1A2 substrates. Avoid concomitant use of ZELBORAF with CYP1A2 substrates with a narrow therapeutic window. If coadministration cannot be avoided, monitor closely for toxicities and consider dose reduction of CYP1A2 substrates. ( 7.2 ). 7.1 Effect of Strong CYP3A4 Inhibitors or Inducers on Vemurafenib St

Can ZELBORAF be used during pregnancy?

8 USE IN SPECIFIC POPULATIONS Lactation: Do not breastfeed while taking ZELBORAF. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on its mechanism of action, ZELBORAF can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on the use of ZELBORAF in pregnant women to determine the drug-associated risk; however, placental transfer of vemurafenib to a fetus has been reported. Exposure to vemurafenib could not be achieve

Who manufactures ZELBORAF?

Roche Registration GmbH (Niemcy)

What ATC class does ZELBORAF belong to?

ZELBORAF: ATC L01EC01. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

ZELBORAF

240 mg, Tabletki powlekane

INN: Vemurafenib

Data updated: 2026-04-13

Available in:

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Form

Tabletki powlekane

Dosage

240 mg

Route

doustna

Storage

Storage and Stability: Store at room temperature 20°C–25°C (68°F–77°F); excu‍‍‍‍‍‍‍rsions permitted between 15°C and 30°C (59°F and 86°F), See USP Controlled Room Temperature. Store in the original container with the lid tightly closed.

User Reviews

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