What is ZELBORAF used for?

ZELBORAF is a prescription medicine used to treat a type of skin cancer called melanoma that has spread to other parts of the body or cannot be removed by surgery, and that has a certain type of abnormal “BRAF” gene.

How is vemurafenib administered?

The recommended dose of ZELBORAF is 960 mg (four 240 mg tablets) orally every 12 hours with or without a meal. A missed dose can be taken up to 4 hours prior to the next dose. Treat patients with ZELBORAF until disease progression or unacceptable toxicity occurs.

Who makes vemurafenib?

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) approved Zelboraf (vemurafenib) for the treatment of BRAF V600E mutation-positive, inoperable or metastatic melanoma, as determined by an FDA-approved test.

Is it better to be BRAF positive or negative?

We have demonstrated that BRAF positive patients receiving targeted treatment have significantly better survival than their BRAF negative counterparts.

What do you predict about side effects of Zelboraf?

The most common adverse reactions of any grade (≥ 30% in either study) in ZELBORAF-treated patients were arthralgia, rash, alopecia, fatigue, photosensitivity reaction, nausea, pruritus, and skin papilloma. The most common (≥ 5%) Grade 3 adverse reactions were cuSCC and rash.

How effective is vemurafenib?

Vemurafenib has prolonged efficacy in patients with BRAF V600–mutant NSCLC (n = 62), as demonstrated by a 37% overall response rate. Response rates were similar in previously treated and untreated patients.

What do you predict about side effects of ZELBORAF?

What is V600E mutation?

From Wikipedia, the free encyclopedia. V600E is a mutation of the BRAF gene in which valine (V) is substituted by glutamic acid (E) at amino acid 600.

Has anyone survived melanoma 4?

According to the American Cancer Society , the 5-year survival rate for stage 4 melanoma is 15–20 percent. This means that an estimated 15–20 percent of people with stage 4 melanoma will be alive 5 years after diagnosis. Many different factors influence an individual’s chance of survival.

What does it mean if you are BRAF positive?

A BRAF mutation is a change in a BRAF gene. That change in the gene can lead to an alteration in a protein that regulates cell growth that could allow the melanoma to grow more aggressively. Approximately half of melanomas carry this mutation and are referred to as mutated, or BRAF positive.

What are the side effects of Trametinib?

More common

• Burning, itching, and pain in hairy areas, pus at the root of the hair.
• canker sores.
• change in taste.
• dry eyes.
• dry skin.
• itching, pain, redness, swelling, tenderness, or warmth on the skin.
• loosening of the fingernails.
• loss of taste.

Is Larotrectinib chemotherapy?

VITRAKVI® is an oral medicine that is not a chemotherapy.

How many mg of Zelboraf do you need?

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 C 23 H 18 ClF 2 N 3 O 3 S and a molecular weight of 489.9.

What are the inactive ingredients in Zelboraf tablets?

Each tablet contains 240 mg of vemurafenib. The inactive ingredients of ZELBORAF are: Tablet core: hypromellose acetate succinate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, and hydroxypropyl cellulose.

What are the side effects of Zelboraf Grade 3?

The most common adverse reactions of any grade (≥30% in either study) in ZELBORAF-treated patients were arthralgia, rash, alopecia, fatigue, photosensitivity reaction, nausea, pruritus, and skin papilloma. The most common (≥ 5%) Grade 3 adverse reactions were cuSCC and rash.

What’s the best temperature to store Zelboraf in?

The following packaging configurations are available: 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.