Cobimetinib

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

No

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Pharmaceutical Class

Kinase Inhibitor

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Controlled Drug Substance

No

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Drug Ingredient

Cobimetinib

Summary

  • Cobimetinib is used to treat certain types of melanoma that cannot be surgically removed or have spread to other parts of the body. It's also used for a condition known as histiocytic neoplasms.

  • Cobimetinib works by blocking abnormal proteins that signal cancer cells to multiply. This action helps to slow or stop the spread of cancer cells.

  • For adults, the usual dose of Cobimetinib is 60 mg taken orally once daily for the first 21 days of each 28-day cycle. It's taken as a tablet by mouth with or without food.

  • Common side effects of Cobimetinib include diarrhea, nausea, vomiting, photosensitivity, and fatigue. Serious adverse effects can include new skin cancers, bleeding, heart problems, severe skin reactions, eye problems, liver damage, and muscle problems.

  • Cobimetinib can cause fetal harm, so it's not recommended for pregnant women. It should not be taken with certain other medications, as they can increase its levels in the body or decrease its effectiveness. Cobimetinib is contraindicated in patients with known hypersensitivity to the drug or its components.

Indications and Purpose

How does Cobimetinib work?

Cobimetinib is a kinase inhibitor that blocks the action of abnormal proteins that signal cancer cells to multiply. By inhibiting these proteins, Cobimetinib helps slow or stop the spread of cancer cells, making it effective in treating certain types of melanoma and histiocytic neoplasms.

Is Cobimetinib effective?

Cobimetinib has been shown to be effective in treating unresectable or metastatic melanoma with a BRAF V600 mutation, in combination with vemurafenib. Clinical trials demonstrated improved progression-free survival and overall response rates in patients receiving Cobimetinib with vemurafenib compared to those receiving vemurafenib alone.

What is Cobimetinib?

Cobimetinib is used to treat certain types of melanoma that cannot be surgically removed or have spread to other parts of the body, often in combination with vemurafenib. It is also used for histiocytic neoplasms. Cobimetinib works by blocking abnormal proteins that signal cancer cells to multiply, helping to slow or stop the spread of cancer cells.

Directions for Use

For how long do I take Cobimetinib?

Cobimetinib is typically used in cycles of 28 days, with the medication taken for the first 21 days followed by a 7-day break. Treatment continues until the disease progresses or unacceptable toxicity occurs.

How do I dispose of Cobimetinib?

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 Cobimetinib?

Take Cobimetinib as a tablet by mouth, with or without food, once daily for the first 21 days of a 28-day cycle. Avoid eating grapefruit or drinking grapefruit juice while taking this medication, as it can affect how the medicine works.

How long does it take for Cobimetinib to start working?

Cobimetinib starts working within a few hours, reaching peak plasma concentration in about 2 to 4 hours. However, the full therapeutic effect may take several weeks, as it depends on the individual's response and the type of cancer being treated. Factors like overall health, other medications, and the specific cancer type can affect how quickly Cobimetinib works. Always follow your healthcare provider's instructions and attend regular check-ups to monitor your progress and adjust treatment as needed.

How should I store Cobimetinib?

Store Cobimetinib at room temperature, below 30°C (86°F). Keep the medication in its original container, tightly closed, and out of reach of children. Avoid storing it in the bathroom to prevent exposure to moisture.

What is the usual dose of Cobimetinib?

For adults, the usual dose of Cobimetinib is 60 mg taken orally once daily for the first 21 days of each 28-day cycle. The safety and effectiveness of Cobimetinib in children have not been established, so there is no recommended dose for pediatric patients.

Warnings and Precautions

Can Cobimetinib be taken safely while breastfeeding?

Women are advised not to breastfeed during treatment with Cobimetinib and for 2 weeks after the final dose due to the potential for serious adverse reactions in a breastfed infant. Consult your doctor for personalized advice on feeding your baby during this time.

Can Cobimetinib be taken safely while pregnant?

Cobimetinib can cause fetal harm when administered to a pregnant woman. Women of reproductive potential should use effective contraception during treatment and for 2 weeks after the final dose. If you become pregnant while taking Cobimetinib, contact your doctor immediately. There is no strong evidence from human studies, but animal studies have shown potential risks.

Can I take Cobimetinib with other prescription drugs?

Cobimetinib should not be taken with strong or moderate CYP3A inhibitors, as they can increase Cobimetinib levels in the body. If unavoidable, the Cobimetinib dose may need to be adjusted. Avoid using strong or moderate CYP3A inducers, as they can decrease Cobimetinib's effectiveness. Always inform your doctor about all medications you are taking.

Does Cobimetinib have adverse effects?

Adverse effects are unwanted or harmful effects caused by a medicine. Cobimetinib can cause several adverse effects, including diarrhea, rash, nausea, fever, and fatigue. These are common and may affect more than 10% of people. Serious adverse effects, though rare, include heart problems, severe skin reactions, and eye issues. If you experience any new or worsening symptoms, it's important to contact your healthcare provider immediately. Never stop taking Cobimetinib without consulting your doctor.

Does Cobimetinib have any safety warnings?

Cobimetinib comes with several safety warnings. It can cause heart problems, so monitoring for symptoms like shortness of breath or chest pain is important. Eye issues, such as blurred vision, may occur, requiring regular eye exams. Liver problems are another concern, so watch for symptoms like yellowing of the skin or dark urine. Skin reactions can also happen, so report any severe rashes. Always follow your healthcare provider's advice and report any new or worsening symptoms immediately.

Is Cobimetinib addictive?

Cobimetinib has no known potential for dependence or addiction. It is not habit-forming, and there are no behaviors or warning signs associated with physical or psychological dependence on this medicine. You can take Cobimetinib as prescribed by your healthcare provider without worrying about addiction. Always follow your doctor's instructions and report any concerns you may have about your treatment.

Is Cobimetinib safe for the elderly?

Clinical studies of Cobimetinib did not include enough patients aged 65 and older to determine if they respond differently from younger patients. However, elderly patients may be more likely to experience certain side effects. It's important for elderly patients to be closely monitored by their healthcare provider while taking Cobimetinib.

Is it safe to drink alcohol while taking Cobimetinib?

Most people tolerate Cobimetinib well, and occasional alcoholic drinks should not affect the way this medicine works. There are no well-established interactions between Cobimetinib and alcohol that would interfere with the medicine's effectiveness. However, it's always wise to consume alcohol in moderation and consult your healthcare provider if you have any concerns about drinking alcohol while taking Cobimetinib.

Is it safe to exercise while taking Cobimetinib?

Cobimetinib may cause fatigue and muscle problems, which could limit the ability to exercise. If you experience these side effects, it's important to listen to your body and rest as needed. Consult your doctor for personalized advice on exercise while taking Cobimetinib.

Is it safe to stop Cobimetinib?

Cobimetinib is used for managing certain types of cancer, which requires careful and continuous treatment. Stopping Cobimetinib abruptly can lead to the cancer progressing or worsening. There are no known withdrawal symptoms, but the risk of the disease returning or getting worse is significant. It's crucial to consult with your doctor before stopping Cobimetinib to discuss any concerns and to ensure a safe and effective treatment plan.

What are the most common side effects of Cobimetinib?

A side effect is an unwanted or unexpected reaction to a medicine. Common side effects of Cobimetinib include diarrhea, rash, nausea, fever, and fatigue, affecting more than 10% of users. It's important to note that new symptoms can occur when starting any medicine, and they may not always be related to the medicine itself. Always talk to your healthcare provider before stopping Cobimetinib, as they can help determine the cause of any new symptoms and adjust your treatment if needed.

Who should avoid taking Cobimetinib?

Important warnings for Cobimetinib include the risk of new skin cancers, bleeding problems, heart issues, severe skin reactions, eye problems, liver damage, muscle problems, and photosensitivity. Patients should be monitored for these conditions and report any symptoms to their doctor immediately. Cobimetinib is contraindicated in patients with known hypersensitivity to the drug or its components.