Vemurafenib

Melanoma

Drug Status

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Government Approvals

US(FDA), UK(BNF)

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WHO Essential Medicine

NO

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Known Teratogen

Definite

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Pharmaceutical Class

Kinase Inhibitor

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Controlled Drug Substance

No

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Drug Ingredient

Vemurafenib

Summary

  • Vemurafenib is used to treat certain types of melanoma and Erdheim-Chester disease that have a specific genetic mutation called BRAF V600.

  • Vemurafenib is a kinase inhibitor. It works by blocking the action of an abnormal protein, BRAF V600, which signals cancer cells to multiply. By inhibiting this protein, Vemurafenib helps slow or stop the spread of cancer cells.

  • The usual adult dose for Vemurafenib is 960 mg, taken orally twice a day with or without food. The exact duration varies based on individual response and tolerance.

  • Common side effects of Vemurafenib include joint pain, rash, fatigue, and nausea. Serious adverse effects can include new skin cancers, severe skin reactions, and QT prolongation.

  • Vemurafenib can cause fetal harm and should not be used during pregnancy. Women of reproductive potential should use effective contraception during treatment and for 2 weeks after the final dose. It can also interact with certain drugs, affecting its concentration in the body or the effectiveness of other drugs. Patients should be monitored for skin cancers, severe skin reactions, QT prolongation, and liver injury.

Indications and Purpose

How does Vemurafenib work?

Vemurafenib is a kinase inhibitor that blocks the action of an abnormal protein, BRAF V600, which signals cancer cells to multiply. By inhibiting this protein, Vemurafenib helps slow or stop the spread of cancer cells.

Is Vemurafenib effective?

Vemurafenib has been shown to improve overall survival and progression-free survival in patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. Clinical trials demonstrated significant increases in survival rates compared to control groups.

What is Vemurafenib?

Vemurafenib is used to treat certain types of melanoma and Erdheim-Chester disease with BRAF V600 mutations. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, helping to slow or stop the spread of cancer cells.

Directions for Use

For how long do I take Vemurafenib?

Vemurafenib is typically used until disease progression or unacceptable toxicity occurs. The exact duration varies based on individual response and tolerance.

How do I dispose of Vemurafenib?

If you can, bring unused medicines to a drug take-back program or collection site at a pharmacy or hospital. They will dispose of this medicine properly so they don't harm people or the environment. If you can't find a take-back program, you can throw most medicines in the trash at home. But first, take them out of their original containers, mix them with something undesirable like used coffee grounds, seal the mixture in a plastic bag and throw it away.

How do I take Vemurafenib?

Vemurafenib should be taken orally, 960 mg twice a day, with or without food. There are no specific food restrictions, but it should be taken at the same times each day to maintain consistent levels in the body.

How long does it take for Vemurafenib to start working?

Vemurafenib can start working within a few weeks, but the exact time frame varies depending on the individual's response to the treatment. Regular monitoring by a healthcare provider will help assess its effectiveness.

How should I store Vemurafenib?

Vemurafenib should be stored at room temperature, between 68°F to 77°F (20°C to 25°C), in its original container with the lid tightly closed to protect from moisture.

What is the usual dose of Vemurafenib?

The usual adult dose for Vemurafenib is 960 mg taken orally twice a day, with or without food. For children, the safety and effectiveness have not been established, and dosing should be determined by a healthcare provider.

Warnings and Precautions

Can I take Vemurafenib with other prescription drugs?

Vemurafenib can interact with strong CYP3A4 inhibitors and inducers, affecting its concentration in the body. It may also interact with drugs metabolized by CYP1A2 and P-gp substrates, potentially altering their effectiveness or increasing side effects.

Can Vemurafenib be taken safely while breastfeeding?

Women should not breastfeed while taking Vemurafenib and for 2 weeks after the final dose due to the potential for serious adverse reactions in the breastfed infant.

Can Vemurafenib be taken safely while pregnant?

Vemurafenib can cause fetal harm and should not be used during pregnancy. Women of reproductive potential should use effective contraception during treatment and for 2 weeks after the final dose. There is no strong evidence from human studies, but the potential risk is based on its mechanism of action.

Does Vemurafenib have adverse effects?

Adverse effects are unwanted or harmful effects caused by a medicine. Vemurafenib can cause several adverse effects. Common ones include joint pain, rash, and fatigue. Serious but rare effects may include severe skin reactions, heart problems, or liver issues, which require immediate medical attention. It's important to report any new or worsening symptoms to your healthcare provider. Never stop taking Vemurafenib without consulting your doctor, as they can help manage side effects and adjust your treatment if needed.

Does Vemurafenib have any safety warnings?

Vemurafenib comes with several safety warnings. It can cause severe skin reactions, so watch for new or worsening skin rashes. It may affect heart rhythm, leading to dizziness or fainting, so report these symptoms immediately. Liver problems are possible, so look out for yellowing of the skin or eyes. Eye issues, like blurred vision, can occur, so regular eye exams are recommended. Always inform your doctor about any new symptoms and follow their advice to manage potential risks effectively.

Is it safe to drink alcohol while taking Vemurafenib?

Most people tolerate Vemurafenib well, and occasional alcoholic drinks should not affect the way this medicine works. There are no well-established interactions between Vemurafenib and alcohol that would interfere with the medicine's effectiveness or cause harm. However, it's always wise to drink alcohol in moderation and be mindful of how your body reacts. If you experience any unusual symptoms, consult your healthcare provider for guidance.

Is it safe to exercise while taking Vemurafenib?

Vemurafenib may cause fatigue and joint pain, which could limit the ability to exercise. If you experience these symptoms, consult your doctor for advice on managing them and adjusting your exercise routine.

Is it safe to stop Vemurafenib?

Vemurafenib is used for the treatment of certain types of cancer, which often require long-term management. Stopping this medicine abruptly can lead to the progression of the disease, as it may allow cancer cells to grow unchecked. There are no known withdrawal symptoms, but the risk of cancer worsening is significant. It's crucial to consult with your doctor before stopping Vemurafenib, as they can provide guidance on how to safely discontinue or adjust your treatment plan if necessary.

Is Vemurafenib addictive?

Vemurafenib is not known to be addictive or habit-forming. It does not have the potential to cause physical or psychological dependence. Therefore, there are no specific behaviors or warning signs related to addiction for this medicine. It's important to take Vemurafenib exactly as prescribed by your healthcare provider and to discuss any concerns or questions with them. Always follow your doctor's instructions and never adjust your dosage without consulting them first.

Is Vemurafenib safe for the elderly?

Elderly patients may be more likely to experience certain side effects, such as cutaneous squamous cell carcinoma and decreased appetite. It's important for elderly patients to be closely monitored by their healthcare provider while taking Vemurafenib.

What are the most common side effects of Vemurafenib?

A side effect is an unwanted reaction to a medicine. Common side effects of Vemurafenib include joint pain, rash, hair loss, fatigue, and nausea. These effects vary in frequency and may not affect everyone. It's important to note that new symptoms can occur when starting any medicine, and they might not be related to the medicine itself. Always talk to your healthcare provider before stopping Vemurafenib, as they can help manage side effects and ensure your treatment is safe and effective.

Who should avoid taking Vemurafenib?

Important warnings for Vemurafenib include the risk of new skin cancers, severe skin reactions, QT prolongation, liver injury, and photosensitivity. Patients should be monitored for these conditions and inform their doctor of any concerning symptoms.