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Brand Name :
Tafinlar
(United States) [Available]Synonyms :
dabrafenib 
Class :
Antineoplastics and BRAF Kinase Inhibitor
Brand Name :
Tafinlar
(United States) [Available]Synonyms :
dabrafenib 
Class :
Antineoplastics and BRAF Kinase Inhibitor
150
mg
Capsule
Oral
twice a day
Continue the therapy until disease progression or unacceptable effects occur 
150
mg
Capsule
Oral
twice a day
The dose can be taken either as single agent or in combination with trametinib Continue the therapy until disease progression or unacceptable effects occur 
It may increase the serum concentration of Dabrafenib 
may have an increased QTc-prolonging effect when combined with QT-prolonging agents
may have an increased QTc-prolonging effect when combined with QT-prolonging agents
may have an increased QTc-prolonging effect when combined with QT-prolonging agents
may have an increased QTc-prolonging effect when combined with QT-prolonging agents
may have an increased QTc-prolonging effect when combined with QT-prolonging agents
may enhance the serum concentration of CYP3A4 inhibitors
It may diminish the effect when combined with lumateperone by affecting CYP3A4 metabolism
may have an increased QTc-prolonging effect when combined with dabrafenib
It may diminish the effect when combined with efavirenz affecting CYP3A4 metabolism
when both drugs are combined, there may be an increased effect of cabozantinib by affecting hepatic or intestinal enzyme cyp3a4 metabolism  
when both drugs are combined, there may be an increased level of serum concentration of alpelisib   
when both drugs are combined, there may be a reduced effect of abemaciclib by affecting hepatic or intestinal enzyme cyp3a4 metabolism  
QTc interval is increased both by lenvatinib and dabrafenib
the effect of dabrafenib is decreased by lorlatinib, by altering intestinal or hepatic CYP3A4 enzyme metabolism
when both drugs are combined, there may be a reduced level or effect of romidepsin by affecting hepatic or intestinal enzyme cyp3a4 metabolism  
it decreases the effect or level of palbociclib by altering the intestinal or hepatic CYP3A4 enzyme metabolism
it decreases by affecting the hepatic enzyme CYP3A4 metabolism
may have an increased QTc-prolonging effect when combined with dabrafenib
may have an increased QTc-prolonging effect when combined with dabrafenib
may have an increased QTc-prolonging effect when combined with dabrafenib
may have an increased QTc-prolonging effect when combined with dabrafenib
When alprazolam and dabrafenib is used together, this leads to reduction in the alprazolam’s metabolism
When ponesimod is used together with dabrafenib, this leads to enhanced risk or seriousness of bradycardia
When dabrafenib is used together with adenosine, this leads to enhanced risk or seriousness of QTc prolongation
When dabrafenib is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When dabrafenib is used together with oleandomycin, this leads to enhanced concentration serum of dabrafenib
dabrafenib: it may increase the risk or severity of CNS depression
dabrafenib: it may increase the risk or severity of CNS depression
dabrafenib: it may increase the risk or severity of CNS depression
dabrafenib: it may increase the risk or severity of CNS depression
dabrafenib: it may increase the risk or severity of CNS depression
When dabrafenib is used together with ridaforolimus, this leads to enhanced concentration serum of dabrafenib
dabrafenib: it may increase the therapeutic efficacy of etynodiol
the serum concentration of flurandrenolide can be reduced when combined with dabrafenib
when both drugs combine dabrafenib will increase the effect of ifosfamide by affecting the enzyme CYP3A4 metabolism.
cyclophosphamide effect of action decreased by affecting enzyme CYP3A4 metabolism
when both drugs are combined, there may be an increased metabolism of dabrafenib 
increases serum level of cabazitaxel by affecting the enzyme CYP3A4
when both drugs are combined, there may be a decreased level or effect of imatinib by affecting hepatic or intestinal enzyme cyp3a4 metabolism 
decrease the serum level of docetaxel by affecting CYP3A4
trametinib may increase the adverse effects in some cases. dose modification may require
decrease the serum level of erdafitinib by affecting CYP3A4
CYP3A4 inhibitors increase the concentration of dabrafenib in serum
may have a decrease in excretion when combined with dabrafenib
Dabrafenib binds to the ATP pocket of BRAF to block it in a competitive and selective manner.Â
The RAS/RAF/MEK/ERK or MAPK pathway, which is linked to cell cycle progression, cell proliferation, and apoptotic arrest, is activated by the serine/threonine protein kinase BRAF.Â
Based on the findings of COMBI-AD, Phase III research of 870 patients with Stage III BRAF V600E/K mutation-positive melanoma treated with dabrafenib and trametinib following total surgical resection, trametinib has been approved for treatment in melanoma.Â
Adverse drug reactions: Â
Frequency defined Â
>10% Â
Hyperglycemia Â
Hypophosphatemia  Â
Hyperkeratosis  Â
Headache Â
Arthralgia Â
Papilloma Â
Alopecia Â
Increased alkaline phosphatase Â
Rash  Â
Back pain Â
Cough Â
Myalgia  Â
Constipation Â
1-10% Â
Cutaneous squamous cell carcinoma Â
Nasopharyngitis Â
Hyponatremia  Â
Cutaneous squamous cell carcinoma Â
Pancreatitis Â
Hypersensitivity manifesting Â
Â
NoneÂ
Contraindication:Â
None Â
Caution:Â
Primary malignanciesÂ
HemorrhageÂ
CardiomyopathyÂ
UveitisÂ
HyperglycemiaÂ
Serious febrile reactionsÂ
Pregnancy warnings:    Â
Breastfeeding warnings: Â
Pregnancy Categories:      Â
Category A: Satisfactory and well-controlled studies show no risk to the fetus in the first trimester or the later trimester.      Â
Category B: No evidence shown of risk to the fetus found in animal reproduction studies, and there are not enough studies on pregnant women      Â
Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for a result in humans must take care of potential risks in pregnant women      Â
Category D: There is adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits      Â
Category X: Drugs listed in this category outweigh risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.      Â
Category N: There is no data available for the drug under this category 
A kinase inhibitor called dabrafenib is primarily used to target the BRAF V600E mutation in a variety of cancer types. Trametinib and dabrafenib both block the RAS/RAF/MEK/ERK pathway, although they do so by blocking distinct pathway effectors.Â
The patients were given matching placebos or doses of dabrafenib plus trametinib. The primary goal of relapse-free survival (RFS) was achieved during a median follow-up of 2.8 years.
Make the suspension in the designated cup using about 5 mL of water for 1–4 tablets and about 10 mL of water for 5–15 tablets.Â
It could take at least three minutes to completely dissolve the pills, so use a teaspoon handle to gently swirl the water and the recommended number of tablets.Â
After the suspension is ready, administer it right away using a feeding tube, oral dosage syringe, or cup.Â
Administered dose orally two times daily about 12 hours apart.Â
Take it on an empty stomach at least one hour before or two hours after eating.Â
Missed dose:Â Â
It can be taken up to six hours before to the subsequent dose.Â
If vomiting happens after taking a dose, skip the following one and take it at the appointed time.Â
Patient information leafletÂ
Generic Name: dabrafenibÂ
Why do we use dabrafenib?Â
For non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, it is recommended in combination with trametinib.Â
In adults without adequate locoregional treatment alternatives, it is recommended in conjunction with trametinib to treat locally advanced or metastatic anaplastic thyroid carcinoma (ATC).Â
It is used in combination with trametinib to treat solid tumors in adults with BRAF V600E mutations that are metastatic or incurable and that have progressed after previous treatment.Â
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