Dabranuma® (Dabrafenib)

Send to friends

Your Email :*

Friend Email :*

Your Name :

Your Massage :

Security Code:*

Rate it :

Dabranuma® a kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test

INDICATIONS

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. (1.3, 2.1) • 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 (ORR) and duration of response (DoR). 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.

DOSAGE AND ADMINISTRATION Capsules: 50 mg, 75 mg

WARNINGS AND PRECAUTIONS

• New Primary Malignancies, Cutaneous and Non-Cutaneous

• Hemorrhage

• Cardiomyopathy

• Uveitis

• Serious Febrile Reactions

• Serious Skin Toxicities: Monitor for skin toxicities.

• Hyperglycemia

• Glucose-6-phosphate Dehydrogenase Deficiency (G6PD)

• Hemophagocytic Lymphohistiocytosis (HLH)

DRUG INTERACTIONS

• birth control medicines (contraceptives) containing hormones, such as pills, injections, or patches

• warfarin and acenocoumarol, medicines used to thin the blood

• digoxin, used to treat heart conditions

• medicines to treat fungal infections, such as ketoconazole, itraconazole, voriconazole and posaconazole

• some calcium channel blockers, used to treat high blood pressure, such as diltiazem, felodipine, nicardipine, nifedipine or verapamil

• medicines to treat cancer, such as cabazitaxel

• some medicines to lower fat (lipids) in the blood stream, such as gemfibrozil

• some medicines used to treat certain psychiatric conditions, such as haloperidol • some antibiotics, such as clarithromycin, doxycyline and telithromycin

• some medicines for tuberculosis (TB), such as rifampicin

• some medicines that reduce cholesterol levels, such as atorvastatin and simvastatin

• some immunosuppressants, such as cyclosporin, tacrolimus and sirolimus

• some anti-inflammatory medicines, such as dexamethasone and methylprednisolone

• some medicines to treat HIV, such as ritonavir, amprenavir, indinavir, darunavir, delavirdine, efavirenz, fosamprenavir, lopinavir, nelfinavir, tipranavir, saquinavir and atazanavir

• some medicines used for pain relief, such as fentanyl and methadone

• medicines to treat seizures (epilepsy), such as phenytoin, phenobarbital, primidone, valproic acid or carbamazepine

• antidepressant medicines such as nefazodone and the herbal medicine St John’s wort (Hypericum perforatum)