Chemical: Drug
dabrafenib
PharmGKB contains no prescribing info for this . Contact us to report known genotype-based dosing guidelines, or if you are interested in developing guidelines.
Annotated Labels
- Annotation of FDA Label for dabrafenib and BRAF,HRAS,KRAS,NRAS
- Annotation of FDA Label for dabrafenib and G6PD
- Annotation of EMA Label for dabrafenib and BRAF
- Annotation of HCSC Label for dabrafenib and BRAF
1. Annotation of FDA Label for dabrafenib and BRAF,HRAS,KRAS,NRAS
Summary
The drug label for dabrafenib (TAFINLAR) states that it is indicated for use in patients with unresectable or metastatic melanoma with a BRAF V600E mutation, or in combination with trametinib for patients with the V600K mutation, as detected by an FDA-approved test; the drug is not indicated for treatment of patients with wild-type BRAF melanoma. The label also notes that the drug may promote growth and development of malignancies with activation of RAS.
There's more of this label. Read more.
2. Annotation of FDA Label for dabrafenib and G6PD
Summary
The drug label for dabrafenib (TAFINLAR) states that it is indicated for use in patients with unresectable or metastatic melanoma with a BRAF V600E mutation, as detected by an FDA-approved test. The label also notes that patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency have a risk for developing hemolytic anemia, and that these patients should be closely observed when taking dabrafenib.
There's more of this label. Read more.
3. Annotation of EMA Label for dabrafenib and BRAF
Summary
Dabrafenib (Tafinlar) is indicated in adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation due to its mechanism of action as an inhibitor of RAF kinases. The EMA European Public Assessment Report (EPAR) states that testing for tumor BRAF V600 mutations is required as efficacy and safety of dabrafenib has not been established in patients with wildtype BRAF.
There's more of this label. Read more.
4. Annotation of HCSC Label for dabrafenib and BRAF
Summary
The product monograph for dabrafenib (TAFINLAR) states that it is indicated for treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
There's more of this label. Read more.
PharmGKB contains no Clinical Variants that meet the highest level of criteria.
Disclaimer: The PharmGKB's clinical annotations reflect expert consensus based on clinical evidence and peer-reviewed literature available at the time they are written and are intended only to assist clinicians in decision-making and to identify questions for further research. New evidence may have emerged since the time an annotation was submitted to the PharmGKB. The annotations are limited in scope and are not applicable to interventions or diseases that are not specifically identified.
The annotations do not account for individual variations among patients, and cannot be considered inclusive of all proper methods of care or exclusive of other treatments. It remains the responsibility of the health-care provider to determine the best course of treatment for a patient. Adherence to any guideline is voluntary, with the ultimate determination regarding its application to be made solely by the clinician and the patient. PharmGKB assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of the PharmGKB clinical annotations, or for any errors or omissions.
The table below contains information about pharmacogenomic variants on PharmGKB. Please follow the link in the "Variant" column for more information about a particular variant. Each link in the "Variant" column leads to the corresponding PharmGKB Variant Page. The Variant Page contains summary data, including PharmGKB manually curated information about variant-drug pairs based on individual PubMed publications. The PMIDs for these PubMed publications can be found on the Variant Page.
The tags in the first column of the table indicate what type of information can be found on the corresponding Variant Page.
Links in the "Gene" column lead to PharmGKB Gene Pages.
List of all variant annotations for dabrafenib
| Gene ? |
Variant?
(147) |
Alternate Names ? | Chemicals ? |
Alleles
?
(+ chr strand) |
Function ? |
Amino Acid?
Translation |
|
|---|---|---|---|---|---|---|---|
VA
|
HLA-DRB1 | *07:01:01:01 | N/A | N/A | N/A | ||
| rs113488022 | NC_000007.13:g.140453136A>C, NC_000007.13:g.140453136A>G, NC_000007.13:g.140453136A>T, NC_000007.14:g.140753336A>C, NC_000007.14:g.140753336A>G, NC_000007.14:g.140753336A>T, NG_007873.3:g.176429T>A, NG_007873.3:g.176429T>C, NG_007873.3:g.176429T>G, NM_004333.4:c.1799T>A, NM_004333.4:c.1799T>C, NM_004333.4:c.1799T>G, NP_004324.2:p.Val600Ala, NP_004324.2:p.Val600Glu, NP_004324.2:p.Val600Gly, XM_005250045.1:c.1799T>A, XM_005250045.1:c.1799T>C, XM_005250045.1:c.1799T>G, XM_005250046.1:c.1799T>A, XM_005250046.1:c.1799T>C, XM_005250046.1:c.1799T>G, XM_005250047.1:c.1799T>A, XM_005250047.1:c.1799T>C, XM_005250047.1:c.1799T>G, XM_011516529.1:c.1799T>A, XM_011516529.1:c.1799T>C, XM_011516529.1:c.1799T>G, XM_011516530.1:c.1695-3918T>A, XM_011516530.1:c.1695-3918T>C, XM_011516530.1:c.1695-3918T>G, XP_005250102.1:p.Val600Ala, XP_005250102.1:p.Val600Glu, XP_005250102.1:p.Val600Gly, XP_005250103.1:p.Val600Ala, XP_005250103.1:p.Val600Glu, XP_005250103.1:p.Val600Gly, XP_005250104.1:p.Val600Ala, XP_005250104.1:p.Val600Glu, XP_005250104.1:p.Val600Gly, XP_011514831.1:p.Val600Ala, XP_011514831.1:p.Val600Glu, XP_011514831.1:p.Val600Gly, XR_242190.1:n.1807T>A, XR_242190.1:n.1807T>C, XR_242190.1:n.1807T>G, XR_927520.1:n.1807T>A, XR_927520.1:n.1807T>C, XR_927520.1:n.1807T>G, XR_927521.1:n.1807T>A, XR_927521.1:n.1807T>C, XR_927521.1:n.1807T>G, XR_927522.1:n.1703-3918T>A, XR_927522.1:n.1703-3918T>C, XR_927522.1:n.1703-3918T>G, XR_927523.1:n.1703-3918T>A, XR_927523.1:n.1703-3918T>C, XR_927523.1:n.1703-3918T>G |
A > T
|
SNP |
V600E
|
Overview
- GSK2118436
- Tafinlar
PharmGKB Accession Id
PA166114911
Type(s):
Drug
Description
Dabrafenib is a tyrosine kinase inhibitor that is active against BRAF, a kinase in the RAS/RAF/MEK/ERK MAP kinase signaling cascade [Article:23844038].
Source: PharmGKB [Article:23844038]
Indication
Dabrafenib is indicated for use in patients with unresectable or metastatic melanoma with a BRAF V600E (rs113488022) mutation.
Source: PharmGKB
Other Vocabularies
- ATC: Protein kinase inhibitors (L01XE)
- RxNorm: dabrafenib (1424911)
PharmGKB Curated Pathways
Pathways created internally by PharmGKB based primarily on literature evidence.
-
Vemurafenib Pathway, Pharmacodynamics
Simplified diagram of mechanism of action of vemurafenib and downstream signaling effects.
Genes that are associated with this drug in PharmGKB's database based on (1) variant annotations, (2) literature review, (3) pathways or (4) information automatically retrieved from DrugBank, depending on the "evidence" and "source" listed below.
Curated Information ?
| Evidence | Gene |
|---|---|
| ABCB1 | |
| ABCG2 | |
| BRAF | |
| CYP2B6 | |
| CYP2C19 | |
| CYP2C8 | |
| CYP2C9 | |
| CYP3A4 | |
| G6PD | |
| HLA-DRB1 | |
| HRAS | |
| KRAS | |
| NRAS | |
| SLC22A6 | |
| SLC22A8 | |
| SLC35A2 | |
| SLCO1B1 | |
| SLCO1B3 |
Drug Targets
| Gene | Description |
|---|---|
| BRAF | [PMID: 23844038] (source: PharmGKB ) |
Publications related to dabrafenib: 12
LinkOuts
- PubChem Substance:
- Dabrafenib (135267955)
Clinical Trials
These are trials that mention dabrafenib and are related to either pharmacogenetics or pharmacogenomics.
NURSA Datasets
No NURSA datasets available.