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Trustinib® (Trametinib)

Trustinib® (Trametinib)

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Tablets 0.5-2 mg


Trametinib is a reversible inhibitor of MEK1 and MEK2 activation and of MEK1 and MEK2 kinase activity. Trametinib inhibits cell growth of various BRAF V600 mutation-positive tumors.  




INDICATIONS

Trustinib® is a kinase inhibitor indicated as a single agent for the treatment of BRAF-inhibitor treatment-naïve patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. 


Trustinib® is indicated, in combination with dabrafenib, for: 

- the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. 
- the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. 
- the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. 
- the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options. 
- the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 
- the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. 
Limitations of Use: Trustinib® is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition.


It is not known if Trustinib® used in combination with dabrafenib is safe and effective in children less than 1 year of age. 
It is not known if Trustinib® used alone is safe and effective in children.

DOSAGE AND ADMINISTRATION

The dosage of Trustinib® is determined by your healthcare provider, but the usual dosage of Trustinib® is as follows:
The recommended dosage of Trustinib® in adult patients is 2 mg orally once daily. The recommended dosage for Trustinib® in pediatric patients is based on body weight.


Take Trustinib® at least 1 hour before or at least 2 hours after a meal.

WARNINGS AND PRECAUTIONS

Trustinib® may cause serious side effects including:

 
Risk of new skin cancers. 
bleeding problems. 
inflammation of the intestines, or tears (perforation) of the stomach or intestines. 
blood clots. 
heart problems
eye problems.
lung or breathing problems. 
serious skin reactions. increased blood sugar (hyperglycemia)
hemophagocytic lymphohistiocytosis (HLH).
Trustinib® can cause new or worsening high blood pressure (hypertension). 

Call your healthcare provider right away if you have aforementioned symptoms.

DRUG INTERACTIONS

Since the drug interactions with Trustinib® are not limited to the following medicines tell your healthcare provider or pharmacist if you are taking, have recently taken or might take any other medicines. This includes herbal medicines and other medicines you bought without a prescription. 


This is because Trustinib® can affect the way some other medicines work. Also, some other medicines can affect the way Trustinib® works.
Verapamil - used to treat high blood pressure and to control angina
Cyclosporine - an immunosuppressive agent used to treat organ rejection post-transplant
Ritonavir - a drug used for the treatment of HIV/AIDS
Quinidine - used to treat certain types of irregular heartbeats
Itraconazole – used to treat fungal infections

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