Dabrafenib
Melanoma
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Drug Status
Government Approvals
US(FDA), UK(BNF)
WHO Essential Medicine
NO
Known Teratogen
Definite
Pharmaceutical Class
Kinase Inhibitor
Controlled Drug Substance
No
Dabrafenib
Summary
Dabrafenib is used to treat certain types of cancer, including melanoma, non-small cell lung cancer, and thyroid cancer, often in combination with another drug called trametinib.
Dabrafenib works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps to stop the spread of cancer cells.
For adults, the usual dose of Dabrafenib is 150 mg taken orally twice daily. For children, the dosage is based on weight. Always follow your doctor's specific dosage instructions.
Common side effects include headache, nausea, diarrhea, vomiting, and decreased appetite. Serious adverse effects can include new skin cancers, hemorrhage, cardiomyopathy, and uveitis.
Dabrafenib may increase the risk of new skin cancers and other malignancies. It is contraindicated in patients with wild-type BRAF tumors and should not be used in pregnant or breastfeeding women.
Indications and Purpose
How does Dabrafenib work?
Dabrafenib works by inhibiting certain mutated forms of the BRAF kinase, which are involved in the growth and spread of cancer cells. By blocking this pathway, Dabrafenib helps to slow down or stop the proliferation of cancer cells, making it effective in treating cancers with BRAF V600 mutations.
Is Dabrafenib effective?
Dabrafenib has been shown to be effective in treating BRAF V600 mutation-positive unresectable or metastatic melanoma, as well as in combination with trametinib for non-small cell lung cancer and anaplastic thyroid cancer. Clinical trials have demonstrated significant improvements in progression-free survival and overall response rates, supporting its use in these conditions.
What is Dabrafenib?
Dabrafenib is used to treat certain types of melanoma, non-small cell lung cancer, and thyroid cancer, often in combination with trametinib. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, helping to stop the spread of cancer cells. Dabrafenib is a kinase inhibitor, targeting specific mutations in the BRAF gene.
Directions for Use
For how long do I take Dabrafenib?
The duration of Dabrafenib treatment varies based on the condition being treated. For unresectable or metastatic melanoma, treatment continues until disease progression or unacceptable toxicity. In the adjuvant setting, treatment is recommended for up to 1 year unless there is disease recurrence or unacceptable toxicity. Always follow your doctor's guidance.
How do I dispose of Dabrafenib?
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 Dabrafenib?
Dabrafenib should be taken on an empty stomach, either 1 hour before or 2 hours after a meal, to ensure proper absorption. It is important to take the medication at the same times each day, approximately 12 hours apart. There are no specific food restrictions, but patients should follow their doctor's dietary advice.
How long does it take for Dabrafenib to start working?
Dabrafenib typically starts working within a few days to weeks, with peak effects seen after several weeks of treatment. The time it takes to work can vary based on individual factors like your overall health and the specific cancer being treated. Always follow your healthcare provider's instructions and attend regular check-ups to monitor the medicine's effectiveness.
How should I store Dabrafenib?
Dabrafenib should be stored at room temperature, between 20°C to 25°C (68°F to 77°F), and kept in its original container with the desiccant to protect it from moisture. It should be kept out of reach of children and not stored in pillboxes or organizers.
What is the usual dose of Dabrafenib?
For adults, the usual dose of Dabrafenib is 150 mg taken orally twice daily. For children, the dosage is weight-based. For example, children weighing 26 to 37 kg should take 75 mg twice daily, while those weighing 51 kg or more should take 150 mg twice daily. Always follow your doctor's specific dosage instructions.
Warnings and Precautions
Can Dabrafenib be taken safely while breastfeeding?
Women are advised not to breastfeed during treatment with Dabrafenib and for 2 weeks after the last dose due to the potential for serious adverse reactions in breastfed children. It is not known if Dabrafenib is excreted in human milk, so caution is advised.
Can Dabrafenib be taken safely while pregnant?
Dabrafenib can cause fetal harm when administered to pregnant women, as shown in animal studies. It is recommended that women of reproductive potential use effective non-hormonal contraception during treatment and for 2 weeks after the last dose. If pregnancy occurs, patients should be informed of the potential risk to the fetus.
Can I take Dabrafenib with other prescription drugs?
Dabrafenib can interact with strong inhibitors or inducers of CYP3A4 and CYP2C8, which may affect its concentration in the body. It can also decrease the effectiveness of hormonal contraceptives and other medications metabolized by these enzymes. Patients should inform their doctor of all medications they are taking to avoid potential interactions.
Does Dabrafenib have adverse effects?
Adverse effects are unwanted or harmful effects caused by a medicine. Dabrafenib can cause adverse effects like fever, fatigue, nausea, headache, and joint pain. Serious but rare effects include skin changes, heart problems, or eye issues, which need immediate medical attention. Always report new symptoms to your healthcare provider and consult them before stopping the medicine.
Does Dabrafenib have any safety warnings?
Dabrafenib comes with safety warnings, including the risk of new skin cancers, heart problems, and eye issues. It's important to monitor for skin changes, chest pain, or vision changes. These warnings are due to the potential for serious side effects. Regular check-ups with your doctor are crucial to catch any issues early. Always report any new or worsening symptoms to your healthcare provider.
Is Dabrafenib addictive?
Dabrafenib is not addictive and has no known potential for dependence. It does not cause physical or psychological dependence, so there are no specific behaviors or warning signs to watch for. You can take Dabrafenib as prescribed without worrying about addiction. Always follow your healthcare provider's instructions for use.
Is Dabrafenib safe for the elderly?
In clinical studies, no overall differences in the effectiveness or safety of Dabrafenib were observed between elderly patients and younger adults. However, elderly patients may experience more serious adverse reactions and may require more frequent dose adjustments. It's important for elderly patients to be closely monitored by their healthcare provider while taking Dabrafenib.
Is it safe to drink alcohol while taking Dabrafenib?
Most people tolerate Dabrafenib well, and occasional alcoholic drinks should not affect the way this medicine works. There are no well-established interactions between Dabrafenib and alcohol that would interfere with its effectiveness or cause harm. However, it's always wise to drink alcohol in moderation and consult your healthcare provider if you have any concerns.
Is it safe to exercise while taking Dabrafenib?
Most people tolerate Dabrafenib well, and it should not limit your ability to exercise. However, if you experience symptoms like fatigue or joint pain, which can occur with this medicine, you might need to adjust your exercise routine. Consider avoiding strenuous activities or high-impact sports if these symptoms arise. Always listen to your body and consult your healthcare provider if you have concerns about exercising while on Dabrafenib.
Is it safe to stop Dabrafenib?
Dabrafenib is used for managing certain types of cancer, which requires long-term treatment. Stopping it abruptly can lead to the cancer progressing or worsening. There are no known withdrawal symptoms, but the risk of cancer growth is significant. Always consult your doctor before stopping Dabrafenib to discuss the best course of action.
What are the most common side effects of Dabrafenib?
A side effect is an unwanted reaction to a medicine. Common side effects of Dabrafenib include fever, headache, joint pain, nausea, and fatigue. These effects can vary in frequency and may not be directly related to the medicine. It's important to talk to your healthcare provider if you experience new symptoms, as they can help determine if it's related to Dabrafenib or another cause. Always consult your doctor before stopping any medication.
Who should avoid taking Dabrafenib?
Dabrafenib may increase the risk of new skin cancers and other malignancies. It can also cause serious side effects like hemorrhage, cardiomyopathy, and uveitis. Patients should be monitored for these conditions. Dabrafenib is contraindicated in patients with wild-type BRAF tumors and should not be used in pregnant or breastfeeding women due to potential harm to the fetus or infant.
