• Dabrafenib is available as a capsule which should be taken by mouth either at least one hour before food or 2 hours after food.
• Take dabrafenib capsules at the same time every day and make sure that there is a gap of 12 hours maintained between two doses.
• Do not split, crush or open the contents of dabrafenib capsules.
• If a dose of dabrafenib is missed, take the missed dose of dabrafenib within 6 hours of the next scheduled dose of dabrafenib.
• If the next dose of dabrafenib is scheduled to be taken in 6 hours, leave the missed dose and take the following dose as per the next scheduled time.
• The dose of dabrafenib can be adjusted if side effects occur. The treatment with dabrafenib can be stopped temporarily and can be started again when the side effects subside.
• If the side effects are severe and bothersome, the treatment with dabrafenib can be permanently discontinued and patients must be treated appropriately.
• The dose of dabrafenib can be reduced to 100 mg twice daily when side effects occur followed by a further dose reduction of 75 mg and 50 mg twice daily subsequently.
• Permanently discontinue dabrafenib treatment, if the patient is unable to tolerate the dose of 50 mg two times daily.
• The dose adjustment of dabrafenib is not required in patients with mild liver or kidney damage.
• Allergic to dabrafenib
• Pregnancy and breastfeeding
• Treatment to correct infertility
• Severe kidney or liver disease
Dabrafenib should not be given to children under 18 years of age as safety and effectiveness of dabrafenib have not been studied in these age groups.
• Take dabrafenib capsules at the same time every day and make sure that there is a gap of 12 hours maintained between two doses.
• Do not split, crush or open the contents of dabrafenib capsules.
• If a dose of dabrafenib is missed, take the missed dose of dabrafenib within 6 hours of the next scheduled dose of dabrafenib.
• If the next dose of dabrafenib is scheduled to be taken in 6 hours, leave the missed dose and take the following dose as per the next scheduled time.
Dosage & When it is to be taken
• The recommended dose of dabrafenib for adults is 150 mg taken two times daily either as a single agent or together with trametinib until the progression of the disease or up until the treatment with the drug does not result in intolerable toxicity.• The dose of dabrafenib can be adjusted if side effects occur. The treatment with dabrafenib can be stopped temporarily and can be started again when the side effects subside.
• If the side effects are severe and bothersome, the treatment with dabrafenib can be permanently discontinued and patients must be treated appropriately.
• The dose of dabrafenib can be reduced to 100 mg twice daily when side effects occur followed by a further dose reduction of 75 mg and 50 mg twice daily subsequently.
• Permanently discontinue dabrafenib treatment, if the patient is unable to tolerate the dose of 50 mg two times daily.
• The dose adjustment of dabrafenib is not required in patients with mild liver or kidney damage.
When it is not to be taken (Contraindications)
Dabrafenib should not be used in patients with-• Allergic to dabrafenib
• Pregnancy and breastfeeding
• Treatment to correct infertility
• Severe kidney or liver disease
Dabrafenib should not be given to children under 18 years of age as safety and effectiveness of dabrafenib have not been studied in these age groups.
